- Monday, October 2, 2023
6:30 AM – 10:00 AM EDT
Speaker Ready Room Open
6:30 AM – 10:00 AM EDT
Speaker Ready Room Hours
6:30 AM – 4:00 PM EDT
Registration Open
6:30 AM – 4:00 PM EDT
Registration Hours
7:00 AM – 8:00 AM EDT
Preconference Workshops: Breakfast & Networking for Registrants
7:00 AM – 8:00 AM EDT
Preconference Workshops: Breakfast & Networking for Registrants
8:00 AM – 8:30 AM EDT
Preconference Workshops: Welcome Workshop Registrants!
8:00 AM – 8:30 AM EDT
Preconference Workshops: Welcome Workshop Registrants!
8:30 AM – 4:00 PM EDT
Common pitfalls in Manufacturer technical documentation submissions to Notified Bodies; Ways to overcome these
8:30 AM – 4:00 PM EDT
Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.Presenter: – BSI Group
Presenter: – BSI Group
Presenter: – BSI Group
Presenter: – DNV Product Assurance AS
Presenter: – National Standards Authority of Ireland
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Purvi S. Patel, PhD, CEng, MIMechE (she/her/hers) – BSI Group ### 1950306###Presenter###Regulatory Lead###BSI Group###Presenter: – BSI Group
### she/her/hers @@@ Vishal Thakker, MEng (he/him/his) – BSI Group ### 1614543###Presenter###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###Presenter: – BSI Group
### he/him/his @@@ Rachel Mead, BEng MIET (she/her/hers) – BSI Group ### 2016362###Presenter###Clinical Regulatory Lead###BSI Group ###Presenter: – BSI Group
### she/her/hers @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
### @@@ Gareth Enright, MEng – National Standards Authority of Ireland ### 2074276###Presenter###Certification & Inspection Officer ###National Standards Authority of Ireland###Presenter: – National Standards Authority of Ireland
###
8:30 AM – 4:00 PM EDT
Communication toolkit for a successful regulatory compliance strategy
8:30 AM – 4:00 PM EDT
Communication Toolkit for a Successful Regulatory Compliance StrategyPresenter: – nexialist
Presenter: – nexialist
Presenter: – GMED North America
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Corinne Delorme, MS, RAC – nexialist ### 1523467###Presenter###Regulatory Intelligence Director###nexialist###Presenter: – nexialist
### @@@ Vincent Castéras, PhD – nexialist ### 1543942###Presenter###CEO and Founder###nexialist###Presenter: – nexialist
### @@@ Florianne Torset-Bonfillou, MS, RAC – GMED North America ### 579831###Presenter###Senior International Regulatory Project Manager ###GMED North America###Presenter: – GMED North America
###
8:30 AM – 4:00 PM EDT
What are the requirements for an IND submission?
8:30 AM – 4:00 PM EDT
What are the Requirements for an IND Submission?Workshop Leader: – HMC-Regulation
Presenter: – Synthego Corporation
Presenter: – Amplicore Inc
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Hagit Marchaim, PhD MBA (she/her/hers) – HMC-Regulation ### 1947145###Workshop Leader###Owner and principal consultant at Dr. Hagit Marchaim RA Consulting (HMC-regulation)###HMC-Regulation###Workshop Leader: – HMC-Regulation
### she/her/hers @@@ Lina Jamis, MS (she/her/hers) – Synthego Corporation ### 2099003###Presenter###Associate Director, Regulatory Affairs###Synthego Corporation###Presenter: – Synthego Corporation
### she/her/hers @@@ Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – Amplicore Inc ### 1546697###Presenter###Director Regulatory Affairs and Operations###Amplicore Inc###Presenter: – Amplicore Inc
### he/him/his
10:30 AM – 11:00 AM EDT
Preconference Workshops: Networking Break for Workshop Registrants
10:30 AM – 11:00 AM EDT
Preconference Workshops: Networking Break for Workshop Registrants
12:30 PM – 1:30 PM EDT
Preconference Workshops: Lunch & Networking for Registrants
12:30 PM – 1:30 PM EDT
Preconference Workshops: Lunch & Networking for Registrants
- Tuesday, October 3, 2023
6:30 AM – 4:00 PM EDT
Speaker Ready Room Open
6:30 AM – 4:00 PM EDT
Speaker Ready Room Hours
6:30 AM – 7:00 PM EDT
Registration Open
6:30 AM – 7:00 PM EDT
Registration Hours
7:00 AM – 8:00 AM EDT
Preconference Workshops: Breakfast & Networking for Registrants
7:00 AM – 8:00 AM EDT
Preconference Workshops: Breakfast & Networking for Registrants
7:00 AM – 6:00 PM EDT
Event App Support Desk Hours
7:00 AM – 6:00 PM EDT
Event App Support Desk Hours
8:00 AM – 8:30 AM EDT
Preconference Workshops: Welcome Workshop Registrants!
8:00 AM – 8:30 AM EDT
Preconference Workshops: Welcome Workshop Registrants!
8:00 AM – 6:00 PM EDT
RAPS Store Hours
8:30 AM – 4:00 PM EDT
Drug Development in EU: regulatory standards, support and new approaches
8:30 AM – 4:00 PM EDT
Drug Development in EU: Regulatory Standards, Support and New ApproachesPresenter: – Austrian Medicines and Medical Devices Agency
Presenter: – khhconsulting
Presenter: – Spanish Agency for Medicines and Medical Devices
Presenter: – European Medicines Agency
Presenter: – Malta Medicines Authority
Presenter (Remote): – Granzer Regulatory Consulting & Services GmbH
Presenter: – NDA Partners
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Presenter###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Presenter: – Austrian Medicines and Medical Devices Agency
### @@@ Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###Presenter: – khhconsulting
### he/him/his @@@ Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Presenter###Representative from Spain at the CHMP (EMA)###Spanish Agency for Medicines and Medical Devices###Presenter: – Spanish Agency for Medicines and Medical Devices
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Presenter###Principal Scientific Administrator###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Presenter###Post-Licensing Director###Malta Medicines Authority###Presenter: – Malta Medicines Authority
### @@@ Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH ### 573390###Presenter (Remote)###Principal Consultant###Granzer Regulatory Consulting & Services GmbH###Presenter (Remote): – Granzer Regulatory Consulting & Services GmbH
### @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Presenter###Partner###NDA Partners###Presenter: – NDA Partners
###
8:30 AM – 4:00 PM EDT
IVDR Technical Documentation Pre-conference Workshop
8:30 AM – 4:00 PM EDT
IVDR Technical Documentation Pre-conference WorkshopPresenter: – TUV Sud GmbH
Presenter: – NSAI
Presenter: – GMED Certification Division
Presenter: – BSI Group The Netherlands B.V.
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: – NSAI
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: – GMED Certification Division
### @@@ Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V. ### 1945990###Presenter###Head of IVD notified body###BSI Group The Netherlands B.V.###Presenter: – BSI Group The Netherlands B.V.
###
8:30 AM – 4:00 PM EDT
PRRC – A new EU Requirement
8:30 AM – 4:00 PM EDT
PRRC – A New EU RequirementWorkshop Leader: – Akra Team GmbH
Presenter: – MD-CLINICALS SA
Presenter: – Qserve Group
Presenter: – DNV Product Assurance AS
Presenter: – Axon Lawyers
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Workshop Leader###Chief Executive Officer###Akra Team GmbH###Workshop Leader: – Akra Team GmbH
### he/him/his @@@ Danielle Giroud, MSci (she/her/hers) – MD-CLINICALS SA ### 1187621###Presenter###CEO###MD-CLINICALS SA###Presenter: – MD-CLINICALS SA
### she/her/hers @@@ Keith Morel, PhD (he/him/his) – Qserve Group ### 535522###Presenter###VP Regulatory Compliance###Qserve Group###Presenter: – Qserve Group
### he/him/his @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### 8:30 AM – 4:00 PM EDT
US Regulatory Essentials for Devices and IVDs
8:30 AM – 4:00 PM EDT
US Regulatory Essentials for Devices and IVDsPresenter: – Independent
Presenter: – DuVal & Associates, P.A.
Presenter: – Greenlight Guru
Presenter: – AtriCure, Inc.
Presenter: – Qserve Group
Presenter (Remote): – Cook Incorporated
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
David Chadwick, PhD, RAC, FRAPS – Independent ### 549204###Presenter###Regulatory Scientist###Independent###Presenter: – Independent
### @@@ Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A. ### 535473###Presenter###President & CEO,###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
### @@@ Etienne Nichols, PMP, CSM – Greenlight Guru ### 1397975###Presenter###Medical Device Guru###Greenlight Guru###Presenter: – Greenlight Guru
### @@@ Tony Blank – AtriCure, Inc. ### 1036809###Presenter###Senior Director, Regulatory Affairs###AtriCure, Inc.###Presenter: – AtriCure, Inc.
### @@@ Christie Hughes, MPH, MLS(ASCP) – Qserve Group ### 1389439###Presenter###Principal Consultant, IVD Expert###Qserve Group###Presenter: – Qserve Group
### @@@ Larry Pool (he/him/his) – Cook Incorporated ### 1397977###Presenter (Remote)###Dir, Post Market Surveillance###Cook Incorporated###Presenter (Remote): – Cook Incorporated
### he/him/his
10:30 AM – 11:00 AM EDT
Preconference Workshops: Networking Break for Workshop Registrants
10:30 AM – 11:00 AM EDT
Preconference Workshops: Networking Break for Workshop Registrants
12:00 PM – 6:30 PM EDT
Press Office Hours
12:00 PM – 6:30 PM EDT
Press Office Hours
12:30 PM – 1:30 PM EDT
Preconference Workshops: Lunch & Networking for Registrants
12:30 PM – 1:30 PM EDT
Preconference Workshops: Lunch & Networking for Registrants
2:30 PM – 3:30 PM EDT
Career Development Session for Students
2:30 PM – 3:30 PM EDT
Career Development Session for StudentsPresenter: – Qserve Group
Presenter: – Elemed
Presenter: – Qserve Group BV
Presenter: – MEDIcept
Presenter: – University of Southern California
Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Presenter###CSO###Qserve Group###Presenter: – Qserve Group
### @@@ Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: – Elemed
### she/her/hers @@@ Daniëlle Motta, MSc. – Qserve Group BV ### 1649497###Presenter###Head of Global Registrations###Qserve Group BV###Presenter: – Qserve Group BV
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Presenter###Managing Director and Vice President###MEDIcept###Presenter: – MEDIcept
### @@@ Susan Bain, DRSc – University of Southern California ### 2125647###Presenter###Assistant Professor, Department of Regulatory and Quality Sciences###University of Southern California###Presenter: – University of Southern California
### 3:00 PM – 11:59 PM EDT
Wellness at RAPS Convergence
3:00 PM – 11:59 PM EDT
Wellness ChallengeNetworking Opportunity
3:30 PM – 4:00 PM EDT
Student Career Development Meet and Greet
3:30 PM – 4:00 PM EDT
Student Career Development Meet and Greet
4:30 PM – 6:00 PM EDT
RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory Professional
4:30 PM – 6:00 PM EDT
RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory ProfessionalFacilitator: – Velvet Chainsaw Consulting
Guest Speaker: – Planning Committee Chair Convergence 2023
Guest Speaker: – Regulatory Affairs Professionals Society (RAPS)
Guest Speaker: – Qserve Group
Moderator: – Thermo Fisher Scientific
Panelist: – European Medicines Agency
Panelist: – Cedience Inc.
Panelist: – Principled Impact
Panelist: – Health Canada
Panelist: – United States Food and Drug Administration
Sarah T. Michel, CSP (she/her/hers) – Velvet Chainsaw Consulting ### 542411###Facilitator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Facilitator: – Velvet Chainsaw Consulting
### she/her/hers @@@ Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023 ### 535468###Guest Speaker###Global Reg Policy & Intelligence and AdPromo###Planning Committee Chair Convergence 2023###Guest Speaker: – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Bill McMoil – Regulatory Affairs Professionals Society (RAPS) ### 1083161###Guest Speaker###RAPS Executive Director###Regulatory Affairs Professionals Society (RAPS)###Guest Speaker: – Regulatory Affairs Professionals Society (RAPS)
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Guest Speaker###CSO###Qserve Group###Guest Speaker: – Qserve Group
### @@@ Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific ### 1083158###Moderator###Director, Global Strategic Regulatory Affairs###Thermo Fisher Scientific###Moderator: – Thermo Fisher Scientific
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Panelist###Head of Scientific Advice###European Medicines Agency###Panelist: – European Medicines Agency
### he/him/his @@@ Amin Osmani, MSc – Cedience Inc. ### 2098346###Panelist###CEO###Cedience Inc.###Panelist: – Cedience Inc.
### @@@ Amrit Ray, MD, MBA (he/him/his) – Principled Impact ### 2098157###Panelist###CEO###Principled Impact###Panelist: – Principled Impact
### he/him/his @@@ Kelly Robinson – Health Canada ### 2135302###Panelist###Director General, Marketed Health Products Directorate###Health Canada###Panelist: – Health Canada
### @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: – United States Food and Drug Administration
### 6:00 PM – 7:00 PM EDT
Opening Reception in Exhibit Hall
6:00 PM – 7:00 PM EDT
Opening Reception in Exhibit HallNetworking Opportunity
- Wednesday, October 4, 2023
12:00 AM – 11:59 PM EDT
Wellness at RAPS Convergence
12:00 AM – 11:59 PM EDT
Wellness ChallengeNetworking Opportunity
6:30 AM – 4:30 PM EDT
Speaker Ready Room Open
6:30 AM – 4:30 PM EDT
Speaker Ready Room Hours
6:30 AM – 6:00 PM EDT
Registration Open
6:30 AM – 6:00 PM EDT
Registration Hours
7:00 AM – 8:00 AM EDT
Community Gathering & Continental Breakfast
7:00 AM – 8:00 AM EDT
Community Gathering & Continental BreakfastNetworking Opportunity
7:00 AM – 6:00 PM EDT
Event App Support Desk Hours
7:00 AM – 6:00 PM EDT
Event App Support Desk Hours
7:30 AM – 6:00 PM EDT
RAPS Store Hours
7:30 AM – 7:00 PM EDT
Press Office Hours
7:30 AM – 7:00 PM EDT
Press Office Hours
8:00 AM – 9:15 AM EDT
Advancing Health Equity, a Strategic Priority for FDA/CDRH and Health Canada
8:00 AM – 9:15 AM EDT
Advancing Health Equity, a Strategic Priority for FDA/CDRH and Health CanadaModerator: – Veeva Systems
Presenter: – Health Canada
Presenter: – U.S. Food and Drug Administration/ CDRH
Devices (includes Medical Devices and In Vitro Diagnostics)
Amra Racic – Veeva Systems ### 535477###Moderator###Sr. Director Global Government Affairs###Veeva Systems###Moderator: – Veeva Systems
### @@@ Sally Prawdzik (she/her/hers) – Health Canada ### 2119758###Presenter###Acting Director of Policy and International Programs###Health Canada###Presenter: – Health Canada
### she/her/hers @@@ Michelle Tarver, MD, PhD (she/her/hers) – U.S. Food and Drug Administration/ CDRH ### 1052823###Presenter###Deputy Center Director, Transformation###U.S. Food and Drug Administration/ CDRH###Presenter: – U.S. Food and Drug Administration/ CDRH
### she/her/hers
8:00 AM – 9:15 AM EDT
Combination Products - New
8:00 AM – 9:15 AM EDT
Drug-Led Combination Products - Submission Guidance and ContentsPresenter: – Genentech and Roche
Presenter:
Presenter: – CP Pathways LLC
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Chin-Wei Soo, DRSc, FRAPS (he/him/his) – Genentech and Roche ### 1946101###Presenter###Global Regulatory Head, Devices and Combination Products###Genentech and Roche###Presenter: – Genentech and Roche
### he/him/his @@@ Courtney Evans ### 2113017###Presenter#########Presenter:
### @@@ Douglass S. Mead, III, RAC – CP Pathways LLC ### 1946088###Presenter###Principal Consultant and President###CP Pathways LLC###Presenter: – CP Pathways LLC
###
8:00 AM – 9:15 AM EDT
Decoding Orphan Drug development: Bridging boundaries and thinking “outside the box”
8:00 AM – 9:15 AM EDT
Decoding Orphan Drug development: Bridging Boundaries and Thinking “Outside the Box”Session Leader: – Allucent
Presenter (Remote): – European Medicines Agency
Presenter: – Jazz Pharmaceuticals
Presenter: – ADRES, Advanced Regulatory Services Israel Ltd.
Biopharmaceuticals (includes Biologics and Drugs)
Luis Rocha, PhD – Allucent ### 1946108###Session Leader###Regulatory Affairs Scientist###Allucent###Session Leader: – Allucent
### @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Presenter (Remote)###Head of Orphan Drugs###European Medicines Agency###Presenter (Remote): – European Medicines Agency
### @@@ Punam Sandhu, PhD – Jazz Pharmaceuticals ### 1946099###Presenter###Head of Oncology, Global Regulatory Affairs###Jazz Pharmaceuticals###Presenter: – Jazz Pharmaceuticals
### @@@ Rivka Zaibel (she/her/hers) – ADRES, Advanced Regulatory Services Israel Ltd. ### 1946093###Presenter###President and Founder###ADRES, Advanced Regulatory Services Israel Ltd.###Presenter: – ADRES, Advanced Regulatory Services Israel Ltd.
### she/her/hers
8:00 AM – 9:15 AM EDT
EU-MDR Implementation: Latest News
8:00 AM – 9:15 AM EDT
EU-MDR Implementation: Latest NewsModerator: – TÜV SÜD
Moderator: – Akra Team GmbH
Presenter (Remote): – European Commission, Directorate-General Health and Food safety
Presenter: – Qserve Group
Presenter: – BSI
Devices (includes Medical Devices and In Vitro Diagnostics)
Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###Moderator: – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: – Akra Team GmbH
### he/him/his @@@ Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety ### 2122609###Presenter (Remote)###Legal officer###European Commission, Directorate-General Health and Food safety ###Presenter (Remote): – European Commission, Directorate-General Health and Food safety
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Presenter###CSO###Qserve Group###Presenter: – Qserve Group
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: – BSI
###
8:00 AM – 9:15 AM EDT
Health Authority Forum: European Medicines Agency (EMA)
8:00 AM – 9:15 AM EDT
Health Authority Forum: European Medicines Agency (EMA)Moderator: – European Medicines Agency
Presenter: – European Medicines Agency
Presenter: – Austrian Medicines and Medical Devices Agency
Presenter: – European Medicines Agency
Presenter (Remote): – European Medicines Agency
Health Authority Forum
Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Moderator###Principal Scientific Administrator###European Medicines Agency###Moderator: – European Medicines Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Presenter###EMA Liaison Official to FDA###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Presenter###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Presenter: – Austrian Medicines and Medical Devices Agency
### @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: – European Medicines Agency
### he/him/his @@@ Caroline Pothet (she/her/hers) – European Medicines Agency ### 1942126###Presenter (Remote)###Head of Advanced Therapies and Hematological Diseases###European Medicines Agency###Presenter (Remote): – European Medicines Agency
### she/her/hers
8:00 AM – 9:15 AM EDT
Patient Perspective - New
8:00 AM – 9:15 AM EDT
Maximizing the Impact of Patient-centric Data: Meaningful Interactions Informing Regulatory Decision-making.Moderator: – PhRMA
Presenter: – FDA
Presenter: – Pfizer
Presenter (Remote):
Presenter: – Sumitomo Pharma America, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Maria A. Apostolaros, JD, PharmD, MS, BSc, RPh, CCEP – PhRMA ### 1346339###Moderator###Deputy Vice President###PhRMA###Moderator: – PhRMA
### @@@ Robyn Bent, RN, MS (she/her/hers) – FDA ### 1724460###Presenter###FDA/CDER/OCD, Supervisory General Health Scientist###FDA###Presenter: – FDA
### she/her/hers @@@ Josh Coulter, MA (he/him/his) – Pfizer ### 2098133###Presenter###Director, Preference Elicitation###Pfizer###Presenter: – Pfizer
### he/him/his @@@ Claire Espinasse ### 2132791###Presenter (Remote)#########Presenter (Remote):
### @@@ Nicholas Langevin – Sumitomo Pharma America, Inc. ### 2045398###Presenter###Director, Regulatory Affairs###Sumitomo Pharma America, Inc.###Presenter: – Sumitomo Pharma America, Inc.
###
8:00 AM – 9:15 AM EDT
Risk Management – The Importance of Lifecycle Traceability
8:00 AM – 9:15 AM EDT
Risk Management – The Importance of Lifecycle TraceabilitySession Leader: – MEDIcept
Presenter: – MEDIcept Inc.
Devices (includes Medical Devices and In Vitro Diagnostics)
Kimberly A. Trautman, MS – MEDIcept ### 1945643###Session Leader###Managing Director and Vice President###MEDIcept###Session Leader: – MEDIcept
### @@@ Brian Siroka (he/him/his) – MEDIcept Inc. ### 1981335###Presenter###Associate Consultant###MEDIcept Inc.###Presenter: – MEDIcept Inc.
### he/him/his8:00 AM – 9:15 AM EDT
Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs
8:00 AM – 9:15 AM EDT
Unlocking Opportunities for Entry-Level Positions in Regulatory AffairsModerator: – Alexion, AstraZeneca Rare Disease
Presenter:
Presenter: – Network Partners Group
Presenter: – University of Georgia
Presenter: – Elemed
Presenter: – RAPS
Skill Building
Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Moderator###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Moderator: – Alexion, AstraZeneca Rare Disease
### @@@ Brittany Caldwell ### 2122617###Presenter#########Presenter:
### @@@ Ritu Dhami – Network Partners Group ### 1967175###Presenter###Chief of Staff - Strategic Initiatives, NPG###Network Partners Group###Presenter: – Network Partners Group
### @@@ Grace Gowda, M.Pharm., PhD, RAC – University of Georgia ### 2009083###Presenter###Director, International Biomedical Regulatory Sciences###University of Georgia###Presenter: – University of Georgia
### @@@ Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: – Elemed
### she/her/hers @@@ Brian Savoie (he/him/his) – RAPS ### 1967174###Presenter###Sr. Vice President, Education & International Programs###RAPS###Presenter: – RAPS
### he/him/his
9:30 AM – 10:30 AM EDT
Plenary Session: Regulatory, Policy, and Societal Challenges of Psychedelics and the Path Forward
9:30 AM – 10:30 AM EDT
Plenary Session: Regulatory, Policy, and Societal Challenges of Psychedelics and the Path ForwardModerator: – Alexion, AstraZeneca Rare Disease
Panelist: – European Medicines Agency
Panelist: – Worldwide Clinical Trials
Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Moderator###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Moderator: – Alexion, AstraZeneca Rare Disease
### @@@ Florence Butlen – European Medicines Agency ### 2134569###Panelist######European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials ### 593742###Panelist###Vice President, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials###Panelist: – Worldwide Clinical Trials
### she/her/hers10:30 AM – 11:00 AM EDT
Coffee Break in the Exhibit Hall
10:30 AM – 11:00 AM EDT
Coffee Break in the Exhibit Hall
10:30 AM – 2:30 PM EDT
Certification Lounge Hours
10:30 AM – 2:30 PM EDT
Certification Lounge Hours
10:30 AM – 2:30 PM EDT
Exhibit Hall Hours
10:30 AM – 2:30 PM EDT
Exhibit Hall HoursNetworking Opportunity
10:30 AM – 2:30 PM EDT
Headshot Lounge
10:30 AM – 2:30 PM EDT
Regulatory Cares Community Giveback
10:30 AM – 2:30 PM EDT
Regulatory Cares Community Giveback Booth Hours
10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and Cemiplimab
10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and CemiplimabGraduate Student Presenter: – University of Southern California
Yoon Sik Jung – University of Southern California ### 2074421###Graduate Student Presenter###Student###University of Southern California###Graduate Student Presenter: – University of Southern California
### 10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab
10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab Graduate Student Presenter: – USC
Saumya Mandaokar – USC ### 2147564###Graduate Student Presenter###Student###USC###Graduate Student Presenter: – USC
### 10:45 AM – 11:10 AM EDT
Sponsored Presentation: A combination products perspective on IDMP implementation
10:45 AM – 11:10 AM EDT
Sponsored Presentation: A combination Products Perspective on IDMP Implementation
Padma Govindaiah (she/her/hers) – ArisGlobal ### 2057718###Speaker###Principal Product Manager, Regulatory Management###ArisGlobal###Speaker: – ArisGlobal
### she/her/hers
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Considerations for Successful PMCF Survey Implementation
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Considerations for Successful PMCF Survey Implementation
Marcus Torr, MSci – Purdie Pascoe ### 1550370###Speaker###PMCF / MDR Lead###Purdie Pascoe###Speaker: – Purdie Pascoe
###
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Talent Management Strategies: The Hiring and the Hired
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Talent Management Strategies: The Hiring and the HiredSpeaker: – Shurig Solutions, Inc
Darwin Shurig, RRT, MBA – Shurig Solutions, Inc ### 2042497###Speaker###CEO/Founder###Shurig Solutions, Inc###Speaker: – Shurig Solutions, Inc
###
10:45 AM – 11:15 AM EDT
"How soon can I implement this?"Navigating FDA Submissions and Review Logistics: A One-Stop Guide
10:45 AM – 11:15 AM EDT
How Soon Can I Implement This? "Navigating FDA Submissions and Review Logistics: A One-Stop GuideFacilitator: – Pharnext
Facilitator: – CMC-RX Consulting
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Abhijit P. Pangu, M. Pharm, RAC – Pharnext ### 1945629###Facilitator###VP, Regulatory Affairs###Pharnext###Facilitator: – Pharnext
### @@@ Myriam Triest, PhD (she/her/hers) – CMC-RX Consulting ### 2134415###Facilitator###Vice-President###CMC-RX Consulting###Facilitator: – CMC-RX Consulting
### she/her/hers10:45 AM – 11:15 AM EDT
A Roadmap of Expedited Pathways in Europe - the Fast for the Curious
10:45 AM – 11:15 AM EDT
A Roadmap of Expedited Pathways in Europe - The Fast for the CuriousFacilitator: – Parexel International
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Farhad Amiri, PhD, FAHA (he/him/his) – Parexel International ### 2123196###Facilitator###Principal Regulatory Consultant###Parexel International###Facilitator: – Parexel International
### he/him/his10:45 AM – 11:15 AM EDT
Biosimilar Regulations in Middle East - Challenges and Proposed Solutions
10:45 AM – 11:15 AM EDT
Biosimilar Regulations in Middle East - Challenges and Proposed SolutionsFacilitator: – Regweb Consulting Services Inc.
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Guriqbal Singh (he/him/his) – Regweb Consulting Services Inc. ### 1945633###Facilitator###Director###Regweb Consulting Services Inc.###Facilitator: – Regweb Consulting Services Inc.
### he/him/his10:45 AM – 11:15 AM EDT
eCTD Module 3, How Much Detail Do I Submit?
10:45 AM – 11:15 AM EDT
eCTD Module 3, How Much Detail Do I Submit?Facilitator: – Certara Drug Development Solutions
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Robert L. Waterland, PhD (he/him/his) – Certara Drug Development Solutions ### 1945640###Facilitator###Principal Regulatory Writer###Certara Drug Development Solutions###Facilitator: – Certara Drug Development Solutions
### he/him/his11:00 AM – 11:15 AM EDT
Student Capstone Oral Presentation: Patient-Focused Drug Development and the 21st Century Cures Act: A Qualitative Case-Control Study
11:00 AM – 11:15 AM EDT
Student Capstone Oral Presentation: Patient-Focused Drug Development and the 21st Century Cures Act: A Qualitative Case-Control StudyGraduate Student Presenter: – The George Washington University
Allison Dalton, MSHS – The George Washington University ### 2074422###Graduate Student Presenter###Student###The George Washington University###Graduate Student Presenter: – The George Washington University
###
11:00 AM – 11:30 AM EDT
RAPS BOD Roundtable: Emerging Regulatory Trends
11:00 AM – 11:30 AM EDT
RAPS BOD Roundtable: Emerging Regulatory TrendsGuest Speaker: – Planning Committee Chair Convergence 2023
Guest Speaker: – Salditt Regulatory Consulting LLC
Guest Speaker: – MEDIcept
Guest Speaker: – Candel Therapeutics
Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023 ### 535468###Guest Speaker###Global Reg Policy & Intelligence and AdPromo###Planning Committee Chair Convergence 2023###Guest Speaker: – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC ### 609884###Guest Speaker###Principal Consultant###Salditt Regulatory Consulting LLC###Guest Speaker: – Salditt Regulatory Consulting LLC
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: – MEDIcept
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: – Candel Therapeutics
### she/her/hers11:15 AM – 11:40 AM EDT
How AI will Power the Future of Proofreading in Pharma
11:15 AM – 11:40 AM EDT
Sponsored Presentation: How AI will Power the Future of Proofreading in PharmaSpeaker: – GlobalVision
Speaker: – GlobalVision
Arpad Lehoczki (he/him/his) – GlobalVision ### 2098768###Speaker###Director of Lifesciences Strategy###GlobalVision###Speaker: – GlobalVision
### he/him/his @@@ Gabriella Naguib – GlobalVision ### 2099715###Speaker###Product Marketing Manager###GlobalVision###Speaker: – GlobalVision
###
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Improve Time to Value with Integrated Product and Regulatory Data
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Improve Time to Value with Integrated Product and Regulatory DataSpeaker: – Kalypso: A Rockwell Automation Company
Speaker: – Zimmer Biomet
Cameron Carr (he/him/his) – Kalypso: A Rockwell Automation Company ### 2038836###Speaker###Manager###Kalypso: A Rockwell Automation Company###Speaker: – Kalypso: A Rockwell Automation Company
### he/him/his @@@ Mohammed Islaih – Zimmer Biomet ### 2042494###Speaker###Associate Director, RIM###Zimmer Biomet###Speaker: – Zimmer Biomet
### 11:15 AM – 11:40 AM EDT
Sponsored Presentation: Using AI/ML technology to improve regulatory efficiency by 60%
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Using AI/ML Technology to Improve Regulatory Efficiency by 60%Speaker: – Clarivate
Speaker: – Clarivate
Sam Kay – Clarivate ### 2042495###Speaker###Principle Regulatory Consultant###Clarivate###Speaker: – Clarivate
### @@@ Naushad Kapasi (he/him/his) – Clarivate ### 2042496###Speaker###Director, Consulting###Clarivate###Speaker: – Clarivate
### he/him/his11:15 AM – 12:00 PM EDT
Chapter Meet and Greet at Career Central
11:15 AM – 12:00 PM EDT
Chapter Meet and Greet at Career CentralNetworking Opportunity
11:25 AM – 11:55 AM EDT
5 ways that an RA department will be impacted by IDMP data standards
11:25 AM – 11:55 AM EDT
5 Ways that an RA Department Will be Impacted by IDMP Data StandardsSolutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Niels B. Leander, PhD – NNIT ### 1945638###Facilitator###Vice President, Global Head of R&D###NNIT###Facilitator: – NNIT
### 11:25 AM – 11:55 AM EDT
Enabling earlier access to medicines in Latin America by rationalizing legalization / apostillation requirements
11:25 AM – 11:55 AM EDT
Enabling Earlier Access to Medicines in Latin America by Rationalizing Legalization RequirementsFacilitator: – Roche
Facilitator: – Merck KGaA
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Cammilla Gomes – Roche ### 1321677###Facilitator###Regulatory Policy Lead###Roche###Facilitator: – Roche
### @@@ Pedro Franco, PhD, MSc, PharmD. – Merck KGaA ### 1321701###Facilitator###Director of Europe for Global Regulatory & Scientific Policy###Merck KGaA###Facilitator: – Merck KGaA
### 11:25 AM – 11:55 AM EDT
Q&A on the EU General Pharmaceutical Legislation Revision
11:25 AM – 11:55 AM EDT
Q&A on the EU General Pharmaceutical Legislation RevisionFacilitator: – Alexion, AstraZeneca Rare Disease
Solutions Circle
Joao Duarte, MSc MPharm (he/him/his) – Alexion, AstraZeneca Rare Disease ### 720625###Facilitator###Head of Business Planning & Operations, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Facilitator: – Alexion, AstraZeneca Rare Disease
### he/him/his11:25 AM – 11:55 AM EDT
Regulatory strategy for market entry to China for drug master filing (DMF)
11:25 AM – 11:55 AM EDT
Regulatory Strategy for Market Entry to China for Drug Master Filing (DMF)Facilitator: – Cisema
Facilitator: – Cisema
Solutions Circle
Hamish King, RAC, LLB – Cisema ### 1321685###Facilitator###CEO###Cisema###Facilitator: – Cisema
### @@@ Victoria Caldy (she/her/hers) – Cisema ### 1945635###Facilitator###Business Development & Marketing Director###Cisema###Facilitator: – Cisema
### she/her/hers11:45 AM – 12:00 PM EDT
Student Capstone oral presentation: Australia market access strategy of novel drug with companion diagnostic test kit for breast cancer
11:45 AM – 12:00 PM EDT
Student Capstone Oral Presentation: Australia Market Access Strategy of Novel Drug with Companion Diagnostic Test Kit for Breast CancerGraduate Student Presenter: – The University of Southern California
Jingrui Li – The University of Southern California ### 2074420###Graduate Student Presenter###Graduate, Master of Regulatory Science###The University of Southern California###Graduate Student Presenter: – The University of Southern California
###
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Improving Operational Excellence and Patient Safety with MDDAP
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Improving Operational Excellence and Patient Safety with MDDAP
Kim Kaplan, BS, MA (she/her/hers) – ISACA ### 2098760###Speaker###Senior Product Manager###ISACA###Speaker: – ISACA
### she/her/hers
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Steps to prepare for effective EUDAMED product Data Syndication
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Steps to Prepare for Effective EUDAMED Product Data SyndicationSpeaker: – USDM Life Sciences
Speaker: – 1WorldSync, Inc.
Jay Crowley, MS – USDM Life Sciences ### 1631712###Speaker###Vice President Medical Device Solutions and Services###USDM Life Sciences###Speaker: – USDM Life Sciences
### @@@ Scott Brown (he/him/his) – 1WorldSync, Inc. ### 2128166###Speaker###Sr. Director Global Data Standards###1WorldSync, Inc.###Speaker: – 1WorldSync, Inc.
### he/him/his11:45 AM – 12:10 PM EDT
Sponsored Presentation: UDI Essentials for Regulatory Affairs Teams
11:45 AM – 12:10 PM EDT
Sponsored Presentation: UDI Essentials for Regulatory Affairs Teams
James Gianoutsos, MBA – Rimsys ### 1328412###Speaker###Founder & CEO###Rimsys###Speaker: – Rimsys
###
11:45 AM – 12:15 PM EDT
RAPS BOD Roundtable: I Am Regulatory
11:45 AM – 12:15 PM EDT
RAPS BOD Roundtable: I Am RegulatoryGuest Speaker:
Guest Speaker: – QuidelOrtho
Guest Speaker: – Candel Therapeutics
Lawrence E. Liberti, MSc, PhD ### 1046359###Guest Speaker###Head, Regulatory Collaborations######Guest Speaker:
### @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho ### 1642067###Guest Speaker###Sr. Director, Reg. Affairs###QuidelOrtho###Guest Speaker: – QuidelOrtho
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: – Candel Therapeutics
### she/her/hers12:00 PM – 1:00 PM EDT
RAPS BOD Roundtable: Volunteering
12:00 PM – 1:00 PM EDT
RAPS BOD Roundtable: VolunteeringGuest Speaker: – CM Cooper & Associates
Guest Speaker:
Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates ### 1630469###Guest Speaker###Principal###CM Cooper & Associates###Guest Speaker: – CM Cooper & Associates
### @@@ Lawrence E. Liberti, MSc, PhD ### 1046359###Guest Speaker###Head, Regulatory Collaborations######Guest Speaker:
### 12:00 PM – 1:30 PM EDT
Networking Lunch in Exhibit Hall
12:00 PM – 1:30 PM EDT
Networking Lunch in Exhibit HallNetworking Opportunity
12:05 PM – 12:35 PM EDT
Medical Device EU MDR lessons learned with two different notified bodies
12:05 PM – 12:35 PM EDT
Medical Device EU MDR Lessons Learned with Two Different Notified BodiesFacilitator: – Abbott
Facilitator: – Abbott
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Lucy Tan, MBA (she/her/hers) – Abbott ### 1945627###Facilitator###Senior Director Regulatory Affairs###Abbott###Facilitator: – Abbott
### she/her/hers @@@ Jenny Chan, MS, RAC, PMP – Abbott ### 1945628###Facilitator###Associate Director Regulatory Affairs###Abbott###Facilitator: – Abbott
### 12:05 PM – 12:35 PM EDT
Methodologies for building a Software Predetermined Change Control Plan and Algorithm Change Plan for AI/ML
12:05 PM – 12:35 PM EDT
Methodologies for Building a Software Predetermined Change Control Plan and Algorithm Change Plan for AI/MLFacilitator: – Hogan Lovells LLP
Solutions Circle
Alex W. Smith, RAC, MBA – Hogan Lovells LLP ### 1945631###Facilitator###Director of Regulatory Sciences###Hogan Lovells LLP###Facilitator: – Hogan Lovells LLP
### 12:05 PM – 12:35 PM EDT
Sourcing Other Study Drugs for Global Clinical Trials
12:05 PM – 12:35 PM EDT
Sourcing Comparators and Other Study Drugs for Global Clinical TrialsFacilitator: – Genentech, Inc.
Solutions Circle
Jamie L. Robinson, RAC, MBA (she/her/hers) – Genentech, Inc. ### 535434###Facilitator###Technical Regulatory Director###Genentech, Inc.###Facilitator: – Genentech, Inc.
### she/her/hers12:05 PM – 12:35 PM EDT
Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource Augmentation
12:05 PM – 12:35 PM EDT
Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource AugmentationSolutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Cham Williams, MS (he/him/his) – IQVIA ### 1945636###Facilitator###Associate Director, Safety, Regulatory and Quality Solutions###IQVIA###Facilitator: – IQVIA
### he/him/his12:15 PM – 12:40 PM EDT
Sponsored Presentation: Global SSCP/SSP Implementation: Navigating the challenges, solutions, and best practices
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Global SSCP/SSP Implementation: Navigating the Challenges, Solutions, and Best PracticesSpeaker: – Acolad Life Sciences
Speaker: – Acolad Life Sciences
Nynne DeNiro (she/her/hers) – Acolad Life Sciences ### 2105794###Speaker###US Director of Account Management###Acolad Life Sciences###Speaker: – Acolad Life Sciences
### she/her/hers @@@ Stephane Millet – Acolad Life Sciences ### 2105796###Speaker###Director of Strategic Accounts – Patient Engagement Solutions###Acolad Life Sciences###Speaker: – Acolad Life Sciences
### 12:15 PM – 12:40 PM EDT
Sponsored Presentation: How to Optimize a MDSAP/EU compliant QMS, including feedback on common issues
12:15 PM – 12:40 PM EDT
Sponsored Presentation: How to Optimize a MDSAP/EU compliant QMS, including feedback on common issues
Ken Pilgrim (he/him/his) – Emergo by UL ### 2132921###Speaker###Program Manager - RA/QA###Emergo by UL###Speaker: – Emergo by UL
### he/him/his
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Reimagine Regulatory Affairs in The Era of Generative AI
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Reimagine Regulatory Affairs in The Era of Generative AI
Michelle Wu – NyquistAI ### 2101201###Speaker###Co-Founder & CEO###NyquistAI###Speaker: – NyquistAI
### 12:45 PM – 1:10 PM EDT
Sponsored Presentation: Synergies for the EU Authorised Representative, UK Responsible Person and Swiss Authorised Representative
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Synergies for the EU Authorised Representative, UK Responsible Person and Swiss Authorised Representative
Ludger Moeller (he/him/his) – MDSS GmbH ### 907125###Speaker###President###MDSS GmbH###Speaker: – MDSS GmbH
### he/him/his
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Unlocking China's Market: A Guide to Overcome Access Barriers for Medical Devices
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Unlocking China's Market: A Guide to Overcome Access Barriers for Medical DevicesSpeaker: – BradyKnows Medical Group
Jocelyn Zhu – BradyKnows Medical Group ### 1614534###Speaker###Co-founder###BradyKnows Medical Group###Speaker: – BradyKnows Medical Group
###
12:45 PM – 1:10 PM EDT
Unveiling MoCRA: Revolutionizing Cosmetics Regulation and Empowering Manufacturers
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Unveiling MoCRA: Revolutionizing Cosmetics Regulation and Empowering ManufacturersSpeaker: – The FlexPro Group
Speaker: – Network Partners
Speaker: – The FlexPro Group
Melissa Stefko, MBA, MS, RAC, ASQ CPGP & CQA – The FlexPro Group ### 2102861###Speaker###Senior Director of Quality###The FlexPro Group###Speaker: – The FlexPro Group
### @@@ Lisa Hawkins, ASQ CMQOE (she/her/hers) – Network Partners ### 2102862###Speaker###Senior Director of Regulatory###Network Partners###Speaker: – Network Partners
### she/her/hers @@@ Philipp Papadopoulos (he/him/his) – The FlexPro Group ### 2102863###Speaker###Recent Graduate of Network Partners Group Leadership Program###The FlexPro Group###Speaker: – The FlexPro Group
### he/him/his12:45 PM – 1:15 PM EDT
Annex XVI State of Play
12:45 PM – 1:15 PM EDT
Annex XVI State of PlayFacilitator: – DNV Product Assurance AS
Presenter: – BSI
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Facilitator###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Facilitator: – DNV Product Assurance AS
### @@@ jayanth K. Katta, PhD – BSI ### 907116###Presenter###Regulatory Director & Head of Medical Devices Notified Body###BSI###Presenter: – BSI
### 12:45 PM – 1:15 PM EDT
Career Central Presents: Get your Regulatory Compliance Certification (RCC): Introducing Two New Compliance Certifications
12:45 PM – 1:15 PM EDT
Career Central Stage: Get your Regulatory Compliance Certification (RCC): Introducing Two New Compliance CertificationsCareer Central Stage
Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS ### 1763591###Speaker###Director of Credentialing###RAPS###Speaker: – RAPS
###
12:45 PM – 1:15 PM EDT
Getting it right the first time - Where regulatory and design intersect; accuracy/acceptance criteria
12:45 PM – 1:15 PM EDT
Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance CriteriaFacilitator: – Qserve Group US
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Diane M. Ward, PhD (she/her/hers) – Qserve Group US ### 1945632###Facilitator###Principal Consultant###Qserve Group US###Facilitator: – Qserve Group US
### she/her/hers12:45 PM – 1:15 PM EDT
RAPS Store Stage: Meet the Authors - Regulation of Regenerative Medicines: A Global Perspective
12:45 PM – 1:15 PM EDT
RAPS Store Stage: Meet the Authors - Regulation of Regenerative Medicines: A Global PerspectiveSpeaker: – Mycovia Pharmaceuticals, Inc.
Speaker: – Lisata Therapeutics
RAPS Store Stage
Jocelyn Jennings – Mycovia Pharmaceuticals, Inc. ### 1401699###Speaker###Senior Director, Regulatory Affairs and Quality Assurance###Mycovia Pharmaceuticals, Inc.###Speaker: – Mycovia Pharmaceuticals, Inc.
### @@@ William Sietsema, PhD (he/him/his) – Lisata Therapeutics ### 573564###Speaker###Vice President, Global Regulatory Affairs###Lisata Therapeutics###Speaker: – Lisata Therapeutics
### he/him/his12:45 PM – 1:15 PM EDT
Regulatory Intelligence Campfire Chat
12:45 PM – 1:15 PM EDT
Regulatory Intelligence Solutions CircleFacilitator: – Lifescan
Facilitator: – Lifescan
Solutions Circle
Skill Building
Rosanne Middleton – Lifescan ### 1376586###Facilitator###Senior Program Lead, Regulatory Policy & Intelligence###Lifescan###Facilitator: – Lifescan
### @@@ Dinar Suleman, RAC – Lifescan ### 1374645###Facilitator###Manager Regulatory Policy, Intelligence & Ad/ Promo###Lifescan###Facilitator: – Lifescan
### 12:45 PM – 1:15 PM EDT
US Combination Products Updates: What you need to know!
12:45 PM – 1:15 PM EDT
US Combination Products Updates: What You Need to Know!Facilitator: – MEDIcept
Facilitator: – MEDIcept
Solutions Circle
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Kimberly A. Trautman, MS – MEDIcept ### 1945643###Facilitator###Managing Director and Vice President###MEDIcept###Facilitator: – MEDIcept
### @@@ Richelle Helman, RAC (she/her/hers) – MEDIcept ### 1945644###Facilitator###Senior Director###MEDIcept###Facilitator: – MEDIcept
### she/her/hers12:45 PM – 1:45 PM EDT
RAPS Fellows Speed Mentoring at Career Central (Sign-up Required)
12:45 PM – 1:45 PM EDT
RAPS Fellows Speed Mentoring at Career Central (Sign-up Required)Networking Opportunity
2:00 PM – 3:00 PM EDT
Anatomy of a Tweet in a MedDev regulatory environment
2:00 PM – 3:00 PM EDT
Anatomy of a Tweet – How to Promote on the Socials in a MedDev Regulatory Environment.Session Leader: – Abbott Laboratories
Presenter: – Abbott Laboratories
Presenter: – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Jennifer Ng Ain Kin (she/her/hers) – Abbott Laboratories ### 1946003###Session Leader###Regulatory Affairs, Ad and Promo, Project Manager###Abbott Laboratories###Session Leader: – Abbott Laboratories
### she/her/hers @@@ Hillary VanderBand, MBA – Abbott Laboratories ### 1946004###Presenter###Group Manager, Digital Marketing###Abbott Laboratories###Presenter: – Abbott Laboratories
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
###
2:00 PM – 3:00 PM EDT
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products
2:00 PM – 3:00 PM EDT
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination ProductsModerator: – Alexion, AstraZeneca Rare Disease
Moderator: – Candel Therapeutics
Panelist: – Malta Medicines Authority
Panelist: – Health Canada
Panelist: – European Medicines Agency
Panelist: – TÜV SÜD
Panelist: – Austrian Medicines and Medical Devices Agency
Panelist: – European Medicines Agency
Panelist: – United States Food and Drug Administration
Panelist: – Health Canada
Panelist: – United States Food and Drug Administration
Conversations That Matter
Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Moderator###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Moderator: – Alexion, AstraZeneca Rare Disease
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Moderator###Chief Regulatory Officer###Candel Therapeutics###Moderator: – Candel Therapeutics
### she/her/hers @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Panelist###Post-Licensing Director###Malta Medicines Authority###Panelist: – Malta Medicines Authority
### @@@ Alysha Croker, PhD (she/her/hers) – Health Canada ### 1728926###Panelist###Director, Centre for Policy, Pediatrics and International Collaboration###Health Canada###Panelist: – Health Canada
### she/her/hers @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Panelist###Global Director Regulatory Strategy###TÜV SÜD###Panelist: – TÜV SÜD
### @@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Panelist###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Panelist: – Austrian Medicines and Medical Devices Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Panelist###EMA Liaison Official to FDA###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Panelist###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Panelist: – United States Food and Drug Administration
### @@@ Kathy Soltys, MD – Health Canada ### 2133022###Panelist###Director, Office of Clinical Trials###Health Canada###Panelist: – Health Canada
### @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: – United States Food and Drug Administration
### 2:00 PM – 3:00 PM EDT
Drug Registration Pathways in China: 2023 Latest Updates
2:00 PM – 3:00 PM EDT
Drug Marketing Approval Pathways in China: 2023 Latest Updates, Accelerated Pathways & Market ChallengesSession Leader: – Cisema
Presenter: – Accestra Consulting
Presenter: – PTC Therapeutics, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Hamish King, RAC, LLB – Cisema ### 1321685###Session Leader###CEO###Cisema###Session Leader: – Cisema
### @@@ Helen Ye, n/a – Accestra Consulting ### 1946095###Presenter###Regulatory Affairs Director###Accestra Consulting###Presenter: – Accestra Consulting
### @@@ Veena CHORGHADE – PTC Therapeutics, Inc. ### 2043304###Presenter###Exec Director###PTC Therapeutics, Inc.###Presenter: – PTC Therapeutics, Inc.
###
2:00 PM – 3:00 PM EDT
FDA Expectations for Digital Health Tools in Decentralized Clinical Trials
2:00 PM – 3:00 PM EDT
FDA Expectations for using Digital Tools in Decentralized Clinical TrialsSession Leader: – EMD Serono
Presenter: – Novo Nordisk
Presenter (Remote): – FDA
Presenter (Remote): – US FDA
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Junyang Wang – EMD Serono ### 2031699###Session Leader###US Director, Global Regulatory and Scientific Policy###EMD Serono###Session Leader: – EMD Serono
### @@@ Jill Lee, JD (she/her/hers) – Novo Nordisk ### 2075482###Presenter###Senior Director###Novo Nordisk###Presenter: – Novo Nordisk
### she/her/hers @@@ Elizabeth Kunkoski, MS – FDA ### 2102867###Presenter (Remote)###Health Science Policy Analyst###FDA###Presenter (Remote): – FDA
### @@@ Andrew Potter, PhD (he/him/his) – US FDA ### 2098160###Presenter (Remote)###Mathematical Statistician###US FDA###Presenter (Remote): – US FDA
### he/him/his
2:00 PM – 3:00 PM EDT
FDA Forecast 2024: What pharmaceutical and biotech regulatory professionals can expect from FDA next year
2:00 PM – 3:00 PM EDT
FDA Forecast 2024: What Pharmaceutical and Biotech Regulatory Professionals can Expect from FDA Next YearSession Leader: – POLITICO's AgencyIQ
Moderator: – Accumulus Synergy
Presenter: – The Pink Sheet
Biopharmaceuticals (includes Biologics and Drugs)
Alexander Gaffney, MS, RAC (he/him/his) – POLITICO's AgencyIQ ### 1729641###Session Leader###Executive Director, Regulatory Policy and Intelligence###POLITICO's AgencyIQ###Session Leader: – POLITICO's AgencyIQ
### he/him/his @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Moderator###Chief Regulatory Innovation Officer###Accumulus Synergy###Moderator: – Accumulus Synergy
### @@@ Derrick Gingery (he/him/his) – The Pink Sheet ### 1946089###Presenter###Senior Writer###The Pink Sheet###Presenter: – The Pink Sheet
### he/him/his2:00 PM – 3:00 PM EDT
Seven Key Qualities of a Successful Regulatory Leader and How to Develop Them
2:00 PM – 3:00 PM EDT
Seven Key Qualities of a Successful Regulatory Leader and How to Develop ThemSession Leader: – Medtronic Endoscopy
Moderator: – Veeva Systems
Skill Building
Monika McDole-Russell, MS, RAC (she/her/hers) – Medtronic Endoscopy ### 1945991###Session Leader###Sr. Director, Global Regulatory Affairs###Medtronic Endoscopy###Session Leader: – Medtronic Endoscopy
### she/her/hers @@@ Amra Racic – Veeva Systems ### 535477###Moderator###Sr. Director Global Government Affairs###Veeva Systems###Moderator: – Veeva Systems
###
2:00 PM – 3:00 PM EDT
Transforming Patient Engagement in Medical Technologies' evolving Regulatory Landscape
2:00 PM – 3:00 PM EDT
Transforming Patient Engagement in Medical Technologies' Evolving Regulatory LandscapeModerator: – Boston Scientific
Presenter: – Abbott
Presenter: – Medtronic
Presenter: – Exact Sciences
Presenter (Remote): – U.S. Food and Drug Administration/ CDRH
Devices (includes Medical Devices and In Vitro Diagnostics)
Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific ### 1000154###Moderator###Senior Manager, Regulatory Affairs ###Boston Scientific###Moderator: – Boston Scientific
### @@@ Scott Goates, PhD. (he/him/his) – Abbott ### 1946000###Presenter###Director, Health Economics, Global Data Science and Analytics###Abbott###Presenter: – Abbott
### he/him/his @@@ Korinne Jew, PhD (she/her/hers) – Medtronic ### 1945998###Presenter###Senior Director, Enterprise Clinical Research & Medical Science###Medtronic###Presenter: – Medtronic
### she/her/hers @@@ Alexandra Massoud (she/her/hers) – Exact Sciences ### 1945999###Presenter###VP, Clinical Affairs###Exact Sciences###Presenter: – Exact Sciences
### she/her/hers @@@ Michelle Tarver, MD, PhD (she/her/hers) – U.S. Food and Drug Administration/ CDRH ### 1052823###Presenter (Remote)###Deputy Center Director, Transformation###U.S. Food and Drug Administration/ CDRH###Presenter (Remote): – U.S. Food and Drug Administration/ CDRH
### she/her/hers
2:00 PM – 3:00 PM EDT
UDI & Global Supply Chain Compliance
2:00 PM – 3:00 PM EDT
UDI & Global Supply Chain ComplianceSession Leader: – Veeva MedTech
Presenter: – USDM Life Sciences
Devices (includes Medical Devices and In Vitro Diagnostics)
Brian Scogland, MS, MBA – Veeva MedTech ### 1614542###Session Leader###Senior Director, Regulatory Strategy###Veeva MedTech###Session Leader: – Veeva MedTech
### @@@ Jay Crowley, MS – USDM Life Sciences ### 1631712###Presenter###Vice President Medical Device Solutions and Services###USDM Life Sciences###Presenter: – USDM Life Sciences
###
3:00 PM – 3:30 PM EDT
Coffee & Refreshment Break
3:00 PM – 3:30 PM EDT
Coffee & Refreshment BreakNetworking Opportunity
3:30 PM – 4:30 PM EDT
Ensuring Patient Registries Support Regulatory Decision-Making
3:30 PM – 4:30 PM EDT
Ensuring Patient Registries Support Regulatory Decision-MakingPresenter: – BioMarin Pharmaceutical Inc.
Presenter: – Austrian Medicines and Medical Devices Agency
Presenter: – World Federation of Hemophilia
Presenter (Remote): – European Medicines Agency (EMA)
Moderator: – BioMarin Pharmaceuticals, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
David Hinds, MHS (he/him/his) – BioMarin Pharmaceutical Inc. ### 2087185###Presenter###Senior Director, Epidemiology & Real World Evidence###BioMarin Pharmaceutical Inc.###Presenter: – BioMarin Pharmaceutical Inc.
### he/him/his @@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Presenter###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Presenter: – Austrian Medicines and Medical Devices Agency
### @@@ Mayss Naccache, MSc (she/her/hers) – World Federation of Hemophilia ### 2082117###Presenter###Manager, Gene Therapy###World Federation of Hemophilia###Presenter: – World Federation of Hemophilia
### she/her/hers @@@ Kelly Plueschke (she/her/hers) – European Medicines Agency (EMA) ### 2125762###Presenter (Remote)###Scientific Administrator###European Medicines Agency (EMA)###Presenter (Remote): – European Medicines Agency (EMA)
### she/her/hers @@@ Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc. ### 1946971###Moderator###Director for US Regulatory Policy###BioMarin Pharmaceuticals, Inc.###Moderator: – BioMarin Pharmaceuticals, Inc.
###
3:30 PM – 4:30 PM EDT
EU-MDR Notified Body Forum
3:30 PM – 4:30 PM EDT
EU-MDR Notified Body ForumModerator: – TÜV SÜD
Moderator: – Akra Team GmbH
Presenter: – BSI
Presenter: – DNV Product Assurance AS
Presenter: – TUV SUD
Presenter: – GMED Certification Division
Devices (includes Medical Devices and In Vitro Diagnostics)
Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###Moderator: – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: – Akra Team GmbH
### he/him/his @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: – BSI
### @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
### @@@ Andreas Stange (he/him/his) – TUV SUD ### 1187582###Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD###Presenter: – TUV SUD
### he/him/his @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: – GMED Certification Division
### 3:30 PM – 4:30 PM EDT
FDA Forecast 2024: What device and diagnostics regulatory professionals can expect from FDA next year
3:30 PM – 4:30 PM EDT
FDA Forecast 2024: What Device and Diagnostics Regulatory Professionals can Expect from FDA Next YearPresenter: – POLITICO's AgencyIQ
Moderator: – Veeva Systems
Presenter: – POLITICO's AgencyIQ
Devices (includes Medical Devices and In Vitro Diagnostics)
Alexander Gaffney, MS, RAC (he/him/his) – POLITICO's AgencyIQ ### 1729641###Presenter###Executive Director, Regulatory Policy and Intelligence###POLITICO's AgencyIQ###Presenter: – POLITICO's AgencyIQ
### he/him/his @@@ Amra Racic – Veeva Systems ### 535477###Moderator###Sr. Director Global Government Affairs###Veeva Systems###Moderator: – Veeva Systems
### @@@ Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ ### 1417843###Presenter###Director, Research###POLITICO's AgencyIQ###Presenter: – POLITICO's AgencyIQ
### she/her/hers
3:30 PM – 4:30 PM EDT
Industry Experience with Implementing ICH Q12 in US and Canada
3:30 PM – 4:30 PM EDT
Industry Experience with Implementing ICH Q12 in US and CanadaPresenter: – Genentech, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Jamie L. Robinson, RAC, MBA (she/her/hers) – Genentech, Inc. ### 535434###Presenter###Technical Regulatory Director###Genentech, Inc.###Presenter: – Genentech, Inc.
### she/her/hers
3:30 PM – 4:30 PM EDT
Lifecycle of a device, difference between SaMD & AI, pre-post market
3:30 PM – 4:30 PM EDT
Regulatory Framework of AI/ML Enabled Medical Devices in the U.S. and EU.Presenter: – Siemens Healthineers
Presenter: – TÜV SÜD GmbH
Moderator: – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Monika Bhatt, LL.M, RAC (she/her/hers) – Siemens Healthineers ### 1614394###Presenter###Chief Regulatory Healthcare Counsel###Siemens Healthineers###Presenter: – Siemens Healthineers
### she/her/hers @@@ Kenneth Fuh, PhD (he/him/his) – TÜV SÜD GmbH ### 1947083###Presenter###Product Assessment Expert###TÜV SÜD GmbH###Presenter: – TÜV SÜD GmbH
### he/him/his @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Moderator###Partner###Axon Lawyers###Moderator: – Axon Lawyers
###
3:30 PM – 4:30 PM EDT
Navigating global regulatory frameworks for cell and gene therapy development
3:30 PM – 4:30 PM EDT
Navigating Global Regulatory Frameworks for Cell and Gene Therapy DevelopmentSession Leader: – Dark Horse Consulting Group
Presenter: – POLITICO’s AgencyIQ
Presenter (Remote): – European Medicines Agency
Biopharmaceuticals (includes Biologics and Drugs)
Kimberly Benton, PhD (she/her/hers) – Dark Horse Consulting Group ### 1946107###Session Leader###Master Principal###Dark Horse Consulting Group###Session Leader: – Dark Horse Consulting Group
### she/her/hers @@@ Kirsten Messmer, PhD, RAC – POLITICO’s AgencyIQ ### 595312###Presenter###Senior Research Analyst###POLITICO’s AgencyIQ###Presenter: – POLITICO’s AgencyIQ
### @@@ Caroline Pothet (she/her/hers) – European Medicines Agency ### 1942126###Presenter (Remote)###Head of Advanced Therapies and Hematological Diseases###European Medicines Agency###Presenter (Remote): – European Medicines Agency
### she/her/hers
3:30 PM – 4:30 PM EDT
The Future of Regulatory Affairs In An Everchanging World
3:30 PM – 4:30 PM EDT
The Future of Regulatory Affairs In An Everchanging WorldSession Leader: – Worldwide Clinical Trials
Presenter: – Seagen Inc.
Skill Building
Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials ### 593742###Session Leader###Vice President, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials###Session Leader: – Worldwide Clinical Trials
### she/her/hers @@@ Linda Bowen, MSc, RAC, FRAPS (she/her/hers) – Seagen Inc. ### 1615689###Presenter###Executive Director and Head of the Regulatory Centers of Excellence###Seagen Inc.###Presenter: – Seagen Inc.
### she/her/hers
4:45 PM – 5:45 PM EDT
Challenges in implementation of IVDR requirements for CDx clinical performance studies
4:45 PM – 5:45 PM EDT
Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies Moderator: – Seagen, Inc
Presenter: – European Medicines Agency
Presenter: – Merck KGaA, Darmstadt, Germany
Presenter: – GSK
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Adriana Racolta, PhD, RAC (she/her/hers) – Seagen, Inc ### 1946002###Moderator###Director Regulatory Affairs, Companion Diagnostics Strategy###Seagen, Inc###Moderator: – Seagen, Inc
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: – European Medicines Agency
### he/him/his @@@ Christine Mayer-Nicolai, PhD (she/her/hers) – Merck KGaA, Darmstadt, Germany ### 2123255###Presenter###VP; Global Head Regulatory & Scientific Policy###Merck KGaA, Darmstadt, Germany###Presenter: – Merck KGaA, Darmstadt, Germany
### she/her/hers @@@ Mike Wierzba, PhD (he/him/his) – GSK ### 2014252###Presenter###Director, Global Regulatory Affairs, Precision Medicine and Digital Health###GSK###Presenter: – GSK
### he/him/his
4:45 PM – 5:45 PM EDT
Efficient Product Master Data Management: FDA , EUDAMED, and other Medical DeviceRegistry submission/Syndication.
4:45 PM – 5:45 PM EDT
Efficient Product Master Data Management: FDA , EUDAMED, and other Medical Device Registry submission/Syndication.Session Leader: – Item Alignment Inc.
Presenter: – USDM Life Sciences
Devices (includes Medical Devices and In Vitro Diagnostics)
Jeff Holzman (he/him/his) – Item Alignment Inc. ### 1946001###Session Leader###CEO###Item Alignment Inc. ###Session Leader: – Item Alignment Inc.
### he/him/his @@@ Jay Crowley, MS – USDM Life Sciences ### 1631712###Presenter###Vice President Medical Device Solutions and Services###USDM Life Sciences###Presenter: – USDM Life Sciences
### 4:45 PM – 5:45 PM EDT
FDA proposed ACNU NDA, a new era for patient access and commercial lifecycle management strategies
4:45 PM – 5:45 PM EDT
FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle ManagementSession Leader: – Beacon Associates, LLC
Presenter: – Food and Drug Administration
Presenter (Remote): – US Food and Drug Administration
Presenter: – Klick Consulting
Moderator: – Haleon
Biopharmaceuticals (includes Biologics and Drugs)
Paul A. Wardle, MA, MMath – Beacon Associates, LLC ### 1615713###Session Leader###Founder & Principal###Beacon Associates, LLC###Session Leader: – Beacon Associates, LLC
### @@@ Danielle Terrell, PharmD, JD, MS, RAC U.S. – Food and Drug Administration ### 2057617###Presenter###Associate Director for Strategic Initiatives###Food and Drug Administration###Presenter: – Food and Drug Administration
### @@@ Elisabeth Walther, PharmD, JD (she/her/hers) – US Food and Drug Administration ### 2057616###Presenter (Remote)###Associate Director for Strategic Initiatives###US Food and Drug Administration###Presenter (Remote): – US Food and Drug Administration
### she/her/hers @@@ Alfred Whitehead, MAs, MS (he/him/his) – Klick Consulting ### 1615714###Presenter###EVP Applied Sciences###Klick Consulting###Presenter: – Klick Consulting
### he/him/his @@@ Erin Oliver, MS, MBA, FRAPS – Haleon ### 1007343###Moderator###Vice President, Regulatory Affairs###Haleon###Moderator: – Haleon
###
4:45 PM – 5:45 PM EDT
Health Authority Forum: CBER & CDER - FDA’s Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER)
4:45 PM – 5:45 PM EDT
Health Authority Forum: CBER & CDER - FDA’s Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER)Moderator: – IAA Consulting LLC
Presenter (Remote): – United States Food and Drug Administration
Presenter (Remote): – FDA
Presenter: – US FDA
Health Authority Forum
Linda McBride, R.PH, RAC – IAA Consulting LLC ### 1946958###Moderator###Partner###IAA Consulting LLC###Moderator: – IAA Consulting LLC
### @@@ Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Presenter (Remote)###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Presenter (Remote): – United States Food and Drug Administration
### @@@ Kevin B. Bugin, PhD, MS, RAC (US) – FDA ### 2063738###Presenter (Remote)###Deputy Director###FDA###Presenter (Remote): – FDA
### @@@ Christopher Joneckis, PhD (he/him/his) – US FDA ### 601550###Presenter###Associate Director For Review Management/ Director Office of regulatory Operations, CBER###US FDA###Presenter: – US FDA
### he/him/his4:45 PM – 5:45 PM EDT
Making an impact to bring further Diversity and inclusion in Clinical Research
4:45 PM – 5:45 PM EDT
Making an Impact to Bring Further Diversity and Inclusion in Clinical ResearchSession Leader: – Worldwide Clinical Trials
Presenter: – Worldwide Clinical Trials
Biopharmaceuticals (includes Biologics and Drugs)
Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials ### 593742###Session Leader###Vice President, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials###Session Leader: – Worldwide Clinical Trials
### she/her/hers @@@ Sarah Bly (she/her/hers) – Worldwide Clinical Trials ### 2074800###Presenter###Director, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials ###Presenter: – Worldwide Clinical Trials
### she/her/hers
4:45 PM – 5:45 PM EDT
Real-world evidence and Expert Panel opinions - discussion between a consultant and 3 Notified Bodies
4:45 PM – 5:45 PM EDT
Latest Updates on Clinical Evidence – Panel Discussion with a Consultant and 3 Notified BodiesSession Leader: – Akra Team GmbH
Presenter: – TÜV SÜD Product Service GmbH
Presenter: – BSI Notified Body (NL)
Presenter: – TÜV Rheinland LGA Products GmbH
Devices (includes Medical Devices and In Vitro Diagnostics)
Matthias Fink, MD – Akra Team GmbH ### 1945993###Session Leader###Senior Clinical Consultant###Akra Team GmbH###Session Leader: – Akra Team GmbH
### @@@ Tonia Jeiter, Dr. med. (she/her/hers) – TÜV SÜD Product Service GmbH ### 1187580###Presenter###Clinical Team Lead, Global Clinical Data Trainer###TÜV SÜD Product Service GmbH###Presenter: – TÜV SÜD Product Service GmbH
### she/her/hers @@@ Richard G. Holborow, BSc (Hons) MSCST RCCP (he/him/his) – BSI Notified Body (NL) ### 1054191###Presenter###Head of Clinical Compliance###BSI Notified Body (NL)###Presenter: – BSI Notified Body (NL)
### he/him/his @@@ Christoph Ziskoven (he/him/his) – TÜV Rheinland LGA Products GmbH ### 1945994###Presenter###Global Head of Technical Competence Center###TÜV Rheinland LGA Products GmbH###Presenter: – TÜV Rheinland LGA Products GmbH
### he/him/his
4:45 PM – 5:45 PM EDT
Regulatory Opportunities and Challenges with mRNA Technology – Lessons Learned from the COVID-19 Pandemic
4:45 PM – 5:45 PM EDT
Regulatory Opportunities and Challenges with mRNA Technology – Lessons Learned from the COVID-19 PandemicPresenter: – Moderna
Presenter: – Moderna
Biopharmaceuticals (includes Biologics and Drugs)
Antonella Lozito, PharmD – Moderna ### 1946970###Presenter###Executive Director, Global Regulatory Strategy###Moderna###Presenter: – Moderna
### @@@ Immo Zdrojewski – Moderna ### 1946111###Presenter###Head Global Regulatory Policy and Regulatory Intelligence###Moderna###Presenter: – Moderna
###
4:45 PM – 5:45 PM EDT
When to “Factor” in Human Factors
4:45 PM – 5:45 PM EDT
When to “Factor” in Human FactorsPresenter: – Agilis by Kymanox
Devices (includes Medical Devices and In Vitro Diagnostics)
Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda ### 1976559###Program Committee###Director, Global Regulatory Affairs###Takeda###Program Committee: – Takeda
### she/her/hers @@@ Rita Lin (she/her/hers) – Agilis by Kymanox ### 2128307###Presenter###Dir. of Human Factors Engineering###Agilis by Kymanox###Presenter: – Agilis by Kymanox
### she/her/hers6:00 PM – 7:15 PM EDT
Honoring Excellence: RAPS 2023 Awards Celebration by Invitation Only
6:00 PM – 7:15 PM EDT
Honoring Excellence: RAPS 2023 Awards Celebration (by Invitation Only)Networking Opportunity
6:00 PM – 9:00 PM EDT
Dine-Arounds
6:00 PM – 9:00 PM EDT
Dine-AroundsNetworking Opportunity
7:30 PM – 10:00 PM EDT
Convergence Networking Party (ticket required)
7:30 PM – 10:00 PM EDT
Convergence Networking Party (ticket required)Networking Opportunity
- Thursday, October 5, 2023
12:00 AM – 5:00 PM EDT
Wellness at RAPS Convergence
12:00 AM – 5:00 PM EDT
Wellness ChallengeNetworking Opportunity
6:30 AM – 3:00 PM EDT
Registration Open
6:30 AM – 3:00 PM EDT
Registration Hours
6:30 AM – 4:30 PM EDT
Speaker Ready Room Open
6:30 AM – 4:30 PM EDT
Speaker Ready Room Hours
6:30 AM – 7:00 PM EDT
Luggage Check
6:30 AM – 7:00 PM EDT
Luggage Check
7:00 AM – 8:00 AM EDT
Community Gathering & Continental Breakfast
7:00 AM – 8:00 AM EDT
Community Gathering & Continental BreakfastNetworking Opportunity
7:30 AM – 5:00 PM EDT
RAPS Store Hours
7:30 AM – 6:00 PM EDT
Press Office Hours
7:30 AM – 6:00 PM EDT
Press Office Hours
8:00 AM – 9:15 AM EDT
Actionable Steps to Meeting Regulatory and Ethical Considerations in Clinical Trial Diversity
8:00 AM – 9:15 AM EDT
Actionable Steps to Meeting Regulatory and Ethical Considerations in Clinical Trial DiversitySession Leader: – Moderna
Presenter (Remote): – FDA
Presenter: – PhRMA
Presenter: – Moderna
Moderator: – BioMarin Pharmaceuticals, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Brittany Gerald – Moderna ### 1946110###Session Leader###Sr. Manager, Clinical Trial Diversity and Inclusion###Moderna###Session Leader: – Moderna
### @@@ Jamie Gamerman, JD (she/her/hers) – FDA ### 2123199###Presenter (Remote)###Senior Policy Advisor###FDA###Presenter (Remote): – FDA
### she/her/hers @@@ Mary Nwokedi, PharmD – PhRMA ### 2078161###Presenter###Director of Diversity in Clinical Trials ###PhRMA ###Presenter: – PhRMA
### @@@ Immo Zdrojewski – Moderna ### 1946111###Presenter###Head Global Regulatory Policy and Regulatory Intelligence###Moderna###Presenter: – Moderna
### @@@ Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc. ### 1946971###Moderator###Director for US Regulatory Policy###BioMarin Pharmaceuticals, Inc.###Moderator: – BioMarin Pharmaceuticals, Inc.
###
8:00 AM – 9:15 AM EDT
Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.
8:00 AM – 9:15 AM EDT
Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.Presenter: – American Association for the Advancement of Science/USDA
Presenter: – Allucent
Presenter: – Food and Drug Administration
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Derecka Alexander, MPH, DVM (she/her/hers) – American Association for the Advancement of Science/USDA ### 1946007###Presenter###Public Health and Agricultural Policy Fellow###American Association for the Advancement of Science/USDA###Presenter: – American Association for the Advancement of Science/USDA
### she/her/hers @@@ Marcus S. Delatte, PhD – Allucent ### 1946005###Presenter###Vice President, Regulatory Strategy###Allucent###Presenter: – Allucent
### @@@ Owen McMaster, PhD – Food and Drug Administration ### 1946008###Presenter###Senior Pharmacologist/Toxicologist###Food and Drug Administration###Presenter: – Food and Drug Administration
###
8:00 AM – 9:15 AM EDT
Conversations That Matter - Interactions with Health Authorities: Medical Devices and IVDs
8:00 AM – 9:15 AM EDT
Conversations That Matter - Interactions with Health Authorities: Medical Devices and IVDsModerator: – Alexion, AstraZeneca Rare Disease
Moderator: – Candel Therapeutics
Panelist: – European Medicines Agency
Panelist: – European Medicines Agency
Panelist: – TÜV SÜD
Panelist: – Health Canada
Conversations That Matter
Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Moderator###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Moderator: – Alexion, AstraZeneca Rare Disease
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Moderator###Chief Regulatory Officer###Candel Therapeutics###Moderator: – Candel Therapeutics
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Panelist###Head of Scientific Advice###European Medicines Agency###Panelist: – European Medicines Agency
### he/him/his @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Panelist###Global Director Regulatory Strategy###TÜV SÜD###Panelist: – TÜV SÜD
### @@@ Sally Prawdzik (she/her/hers) – Health Canada ### 2119758###Panelist###Acting Director of Policy and International Programs###Health Canada###Panelist: – Health Canada
### she/her/hers8:00 AM – 9:15 AM EDT
Device-Led Combination Products Regulatory Process – Hot Topics
8:00 AM – 9:15 AM EDT
Drug-Device Combination Products: The Why Behind the Regulatory StrategySession Leader: – Takeda
Presenter (Remote): – BSI Group
Devices (includes Medical Devices and In Vitro Diagnostics)
Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda ### 1976559###Session Leader###Director, Global Regulatory Affairs###Takeda###Session Leader: – Takeda
### she/her/hers @@@ Theresa Jeary, BSc (Hons), MSc – BSI Group ### 535537###Presenter (Remote)###Principal Technical Specialist ###BSI Group###Presenter (Remote): – BSI Group
###
8:00 AM – 9:15 AM EDT
How to Prepare Efficiently to Become IVDR-Compliant
8:00 AM – 9:15 AM EDT
What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?Session Leader: – BSI Group The Netherlands B.V.
Presenter: – Dr. Ebeling & Assoc. GmbH
Presenter: – Abbott
Presenter: – NSAI
Devices (includes Medical Devices and In Vitro Diagnostics)
Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V. ### 1945990###Session Leader###Head of IVD notified body###BSI Group The Netherlands B.V.###Session Leader: – BSI Group The Netherlands B.V.
### @@@ Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH ### 2043917###Presenter###Head of Medical Devices###Dr. Ebeling & Assoc. GmbH###Presenter: – Dr. Ebeling & Assoc. GmbH
### @@@ Robin McMillan – Abbott ### 2122612###Presenter###Senior Regulatory Affairs Specialist###Abbott###Presenter: – Abbott
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: – NSAI
### 8:00 AM – 9:15 AM EDT
Labeling - New
8:00 AM – 9:15 AM EDT
Get the 411 on 1.14 (It's More Than Just Compliant Labeling!)Session Leader: – Desai RA Consultants, LLC
Presenter: – Peay Regulatory Affairs Consulting, LLC
Presenter: – Pharming Healthcare, Inc.
Presenter: – APS Pharma Solutions, LLC
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Mona Desai (she/her/hers) – Desai RA Consultants, LLC ### 1946102###Session Leader###Owner/Principal Consultant###Desai RA Consultants, LLC###Session Leader: – Desai RA Consultants, LLC
### she/her/hers @@@ Free Peay, RAC, Global (she/her/hers) – Peay Regulatory Affairs Consulting, LLC ### 1946103###Presenter###Executive###Peay Regulatory Affairs Consulting, LLC###Presenter: – Peay Regulatory Affairs Consulting, LLC
### she/her/hers @@@ Tabitha Elmore – Pharming Healthcare, Inc. ### 1946104###Presenter###Senior Director, Global Regulatory Affairs, Labeling and Operations###Pharming Healthcare, Inc.###Presenter: – Pharming Healthcare, Inc.
### @@@ Kamana Singh, DVM, MMB, MBA, RAC(US) (she/her/hers) – APS Pharma Solutions, LLC ### 1615685###Presenter###Founder/Executive Consultant###APS Pharma Solutions, LLC###Presenter: – APS Pharma Solutions, LLC
### she/her/hers
8:00 AM – 9:15 AM EDT
Lessons on the EU-Clinical Trials Regulation
8:00 AM – 9:15 AM EDT
Lessons on the EU-Clinical Trials RegulationSession Leader: – Worldwide Clinical Trials
Presenter: – Worldwide Clinical Trials
Presenter: – European Medicines Agency
Presenter: – MMS Holdings
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials ### 593742###Session Leader###Vice President, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials###Session Leader: – Worldwide Clinical Trials
### she/her/hers @@@ Sarah Bly (she/her/hers) – Worldwide Clinical Trials ### 2074800###Presenter###Director, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials ###Presenter: – Worldwide Clinical Trials
### she/her/hers @@@ Anabela Marcal – European Medicines Agency ### 1061464###Presenter###EMA Liaison Official to FDA###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ Ben Kaspar – MMS Holdings ### 1946100###Presenter###Director, Regulatory Affairs###MMS Holdings###Presenter: – MMS Holdings
###
8:00 AM – 9:15 AM EDT
Medical Device Cybersecurity: Planning a Global Strategy
8:00 AM – 9:15 AM EDT
Medical Device Cybersecurity: Planning a Global StrategySession Leader: – MEDSEC
Presenter (Remote): – US FDA
Devices (includes Medical Devices and In Vitro Diagnostics)
Michelle Lynn Jump, MS, MSRS, ISO/TC 215 convener, RAPS instructor – MEDSEC ### 535528###Session Leader###CEO###MEDSEC###Session Leader: – MEDSEC
### @@@ Suzanne Schwartz, MD, MBA (she/her/hers) – US FDA ### 593621###Presenter (Remote)###Director – Office of Strategic Partnerships & Technology Innovation (OST) at CDRH###US FDA###Presenter (Remote): – US FDA
### she/her/hers
9:30 AM – 10:30 AM EDT
Plenary Session: RAPS Patient-Centered Health Award Presentation and Panel Discussion: Progressing Patient-Centered Health Through Collaboration: A TransCelerate Multi-Stakeholder Panel
9:30 AM – 10:30 AM EDT
Plenary Session: RAPS Patient-Centered Health Award Presentation and Panel Discussion: Progressing Patient-Centered Health Through Collaboration: A TransCelerate Multi-Stakeholder PanelKeynote Speaker: – TransCelerate BioPharma Inc.
Panelist: – Janssen Pharmaceuticals
Panelist: – European Medicines Agency
Panelist: – Merck KGaA, Darmstadt, Germany
Panelist: – United States Food and Drug Administration
Janice Chang – TransCelerate BioPharma Inc. ### 2098751###Keynote Speaker###Chief Executive Officer###TransCelerate BioPharma Inc.###Keynote Speaker: – TransCelerate BioPharma Inc.
### @@@ Ginny Beakes-Read, JD – Janssen Pharmaceuticals ### 2122616###Panelist###VP, Global Regulatory Policy and Intelligence###Janssen Pharmaceuticals###Panelist: – Janssen Pharmaceuticals
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Christine Mayer-Nicolai, PhD (she/her/hers) – Merck KGaA, Darmstadt, Germany ### 2123255###Panelist###VP; Global Head Regulatory & Scientific Policy###Merck KGaA, Darmstadt, Germany###Panelist: – Merck KGaA, Darmstadt, Germany
### she/her/hers @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: – United States Food and Drug Administration
### 10:30 AM – 11:00 AM EDT
Coffee Break in the Exhibit Hall
10:30 AM – 11:00 AM EDT
Coffee Break in the Exhibit Hall
10:30 AM – 2:30 PM EDT
Certification Lounge Hours
10:30 AM – 2:30 PM EDT
Certification Lounge Hours
10:30 AM – 2:30 PM EDT
Exhibit Hall Hours
10:30 AM – 2:30 PM EDT
Exhibit Hall HoursNetworking Opportunity
10:30 AM – 2:30 PM EDT
Headshot Lounge
10:30 AM – 2:30 PM EDT
Regulatory Cares Community Giveback
10:30 AM – 2:30 PM EDT
Regulatory Cares Community Giveback Booth Hours
10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and Cemiplimab
10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and CemiplimabGraduate Student Presenter: – University of Southern California
Yoon Sik Jung – University of Southern California ### 2074421###Graduate Student Presenter###Student###University of Southern California###Graduate Student Presenter: – University of Southern California
### 10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab
10:30 AM – 2:30 PM EDT
Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab Graduate Student Presenter: – USC
Saumya Mandaokar – USC ### 2147564###Graduate Student Presenter###Student###USC###Graduate Student Presenter: – USC
### 10:45 AM – 11:10 AM EDT
Sponsored Presentation: Drive on the Regulatory Autobahn – Stretch Your Team with No Speed Limit
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Drive on the Regulatory Autobahn – Stretch Your Team with No Speed LimitSpeaker: – Integrated Project Management Company, Inc.
Speaker: – Integrated Project Management
Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc. ### 1000086###Speaker###Principal Regulatory Consultant###Integrated Project Management Company, Inc.###Speaker: – Integrated Project Management Company, Inc.
### @@@ Rani Maloney, MBA, PMP, RAC – Integrated Project Management ### 1945637###Speaker###Senior Consultant###Integrated Project Management###Speaker: – Integrated Project Management
###
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Risk Strategy & Risk Management for Medical Devices
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Risk Strategy & Risk Management for Medical DevicesSpeaker: – Fang Consulting
Marielle Lejcher, CORe-Credential of Readiness in Business from Harvard Business School (HBS) – Fang Consulting ### 2075529###Speaker###Senior Regulatory Affairs Consultant###Fang Consulting###Speaker: – Fang Consulting
### 10:45 AM – 11:10 AM EDT
Sponsored Presentation: What’s Next: The Evolution of Regulatory Submissions and Technology
10:45 AM – 11:10 AM EDT
Sponsored Presentation: What’s Next: The Evolution of Regulatory Submissions and TechnologySpeaker: – Certara
Speaker: – Certara
Heather Graham – Certara ### 2131941###Speaker###Vice President, Regulatory Science and Medical Affairs###Certara###Speaker: – Certara
### @@@ Trevor Standish – Certara ### 2131942###Speaker###Director, Product Management###Certara###Speaker: – Certara
### 10:45 AM – 11:15 AM EDT
Lessons on the EU-Clinical Trials Regulation
10:45 AM – 11:15 AM EDT
What you need to know about the EU-Clinical Trials RegulationFacilitator: – Worldwide Clinical Trials
Facilitator: – Worldwide Clinical Trials
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials ### 593742###Facilitator###Vice President, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials###Facilitator: – Worldwide Clinical Trials
### she/her/hers @@@ Sarah Bly (she/her/hers) – Worldwide Clinical Trials ### 2074800###Facilitator###Director, Regulatory Science, Strategy & Innovation###Worldwide Clinical Trials ###Facilitator: – Worldwide Clinical Trials
### she/her/hers10:45 AM – 11:15 AM EDT
Solutions Circle - Continuing the Conversation: EU/MDR State of Play
10:45 AM – 11:15 AM EDT
EU/MDR State of PlayFacilitator: – TÜV SÜD
Facilitator: – Akra Team GmbH
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Facilitator###Global Director Regulatory Strategy###TÜV SÜD###Facilitator: – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Facilitator###Chief Executive Officer###Akra Team GmbH###Facilitator: – Akra Team GmbH
### he/him/his10:45 AM – 11:15 AM EDT
Solutions Circle - Continuing the Conversation: Pediatric Drug Development: Failure is not an Option
10:45 AM – 11:15 AM EDT
Pediatric Drug Development: Failure is not an OptionFacilitator: – IAA Consulting LLC
Facilitator: – khhconsulting
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Linda McBride, R.PH, RAC – IAA Consulting LLC ### 1946958###Facilitator###Partner###IAA Consulting LLC###Facilitator: – IAA Consulting LLC
### @@@ Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Facilitator###Consultant###khhconsulting###Facilitator: – khhconsulting
### he/him/his10:45 AM – 11:15 AM EDT
Solutions Circle - Continuing the Conversation: Regulatory Trends and Opportunities for Drug Delivery Combination Products
10:45 AM – 11:15 AM EDT
Regulatory Trends and Opportunities for Drug Delivery Combination ProductsFacilitator: – Genentech and Roche
Facilitator: – Genentech
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Chin-Wei Soo, DRSc, FRAPS (he/him/his) – Genentech and Roche ### 1946101###Facilitator###Global Regulatory Head, Devices and Combination Products###Genentech and Roche###Facilitator: – Genentech and Roche
### he/him/his @@@ Nishchay Gupta – Genentech ### 1976635###Facilitator###Senior Regulatory Program Director###Genentech###Facilitator: – Genentech
### 11:00 AM – 11:30 AM EDT
RAPS BOD Roundtable: Emerging Regulatory Trends
11:00 AM – 11:30 AM EDT
RAPS BOD Roundtable: Emerging Regulatory TrendsGuest Speaker: – Candel Therapeutics
Guest Speaker: – MEDIcept
Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: – Candel Therapeutics
### she/her/hers @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: – MEDIcept
### 11:15 AM – 11:40 AM EDT
Sponsored Presentation: Crossing the eSTAR Chasm: how to transition to FDA’s Mandatory 510(k) eSTAR submission process
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR Submission ProcessPresenter: – Essenvia
Presenter: – Essenvia
Dhritikshama Roy, PhD (she/her/hers) – Essenvia ### 2122585###Presenter###Vice President of Regulatory Affairs Transformation###Essenvia###Presenter: – Essenvia
### she/her/hers @@@ Soumya Mahapatra (he/him/his) – Essenvia ### 2122586###Presenter###CEO & Founder###Essenvia###Presenter: – Essenvia
### he/him/his11:15 AM – 11:40 AM EDT
Sponsored Presentation: FDA Forecast: The Biggest Issues Facing the FDA in 2024
11:15 AM – 11:40 AM EDT
Sponsored Presentation: FDA Forecast: The Biggest Issues Facing the FDA in 2024Speaker: – POLITICO's AgencyIQ
Speaker: – POLITICO's AgencyIQ
Alexander Gaffney, MS, RAC (he/him/his) – POLITICO's AgencyIQ ### 1729641###Speaker###Executive Director, Regulatory Policy and Intelligence###POLITICO's AgencyIQ###Speaker: – POLITICO's AgencyIQ
### he/him/his @@@ Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ ### 1417843###Speaker###Director, Research###POLITICO's AgencyIQ###Speaker: – POLITICO's AgencyIQ
### she/her/hers11:15 AM – 12:00 PM EDT
Student Mix 'n Mingle at Career Central
11:15 AM – 12:00 PM EDT
Student Mix 'n Mingle at Career CentralNetworking Opportunity
11:15 AM – 11:40 PM EDT
Sponsored Presentation: Optimizing CER and PMS document writing with technology and AI
11:15 AM – 11:40 PM EDT
Sponsored Presentation: Optimizing CER and PMS Document Writing with Technology and AI
Shruti Sharma – Celegence ### 2122587###Presenter######Celegence###Presenter: – Celegence
###
11:25 AM – 11:55 AM EDT
How to Improve Regulatory Interactions by Practicing Impromptu Speeches
11:25 AM – 11:55 AM EDT
How to Improve Your Regulatory Interactions by Practicing Speaking and Active Listening SkillsFacilitator: – Neuron23, Inc.
Facilitator: – Integrated Project Management Company, Inc.
Solutions Circle
Skill Building
Yoshiko Stowell, PhD – Neuron23, Inc. ### 1945634###Facilitator###Head of Regulatory Affairs ###Neuron23, Inc.###Facilitator: – Neuron23, Inc.
### @@@ Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc. ### 1000086###Facilitator###Principal Regulatory Consultant###Integrated Project Management Company, Inc.###Facilitator: – Integrated Project Management Company, Inc.
### 11:25 AM – 11:55 AM EDT
RAPS Store Stage: Writing for RAPS - All You Need to Know About Submitting Content for RAPS Publications
11:25 AM – 11:55 AM EDT
RAPS Store Stage: Writing for RAPS - All You Need to Know About Submitting Content for RAPS PublicationsRAPS Store Stage
11:25 AM – 11:55 AM EDT
Solutions Circle - Continuing the Conversation: FDA Expectations for Digital Health Tools in Decentralized Clinical Trials
11:25 AM – 11:55 AM EDT
FDA Expectations for Digital Health Tools in Decentralized Clinical TrialsFacilitator: – EMD Serono
Facilitator: – Novo Nordisk
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Junyang Wang – EMD Serono ### 2031699###Facilitator###US Director, Global Regulatory and Scientific Policy###EMD Serono###Facilitator: – EMD Serono
### @@@ Jill Lee, JD (she/her/hers) – Novo Nordisk ### 2075482###Facilitator###Senior Director###Novo Nordisk###Facilitator: – Novo Nordisk
### she/her/hers11:25 AM – 11:55 AM EDT
Solutions Circle - Continuing the Conversation: Get the 411 on 1.14
11:25 AM – 11:55 AM EDT
Deep Dive into Labeling OperationsFacilitator: – Desai RA Consultants, LLC
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Mona Desai (she/her/hers) – Desai RA Consultants, LLC ### 1946102###Facilitator###Owner/Principal Consultant###Desai RA Consultants, LLC###Facilitator: – Desai RA Consultants, LLC
### she/her/hers11:25 AM – 11:55 AM EDT
Trends on Orphan and Pediatric Regulatory Frameworks
11:25 AM – 11:55 AM EDT
Trends on Orphan and Pediatric Regulatory FrameworksFacilitator: – Alexion, AstraZeneca Rare Disease
Solutions Circle
Joao Duarte, MSc MPharm (he/him/his) – Alexion, AstraZeneca Rare Disease ### 720625###Facilitator###Head of Business Planning & Operations, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Facilitator: – Alexion, AstraZeneca Rare Disease
### he/him/his11:45 AM – 12:10 PM EDT
Sponsored Presentation: Pharmaceuticals, Medical Devices, OTC’s and now Cosmetics – What to watch out for when managing a Product Recall
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Pharmaceuticals, Medical Devices, OTC’s and now Cosmetics – What to watch out for when managing a Product Recall
Ryan Gooley, MBA (he/him/his) – Sedgwick ### 2131939###Speaker###Director, Business Development###Sedgwick###Speaker: – Sedgwick
### he/him/his
11:45 AM – 12:10 PM EDT
Sponsored Presentation: PMS Beyond Regulations
11:45 AM – 12:10 PM EDT
Sponsored Presentation: PMS Beyond RegulationsSpeaker: – DQS Medizinprodukte UK Ltd
Speaker: – DQS Medizinprodukte GmbH
Claire Dyson – DQS Medizinprodukte UK Ltd ### 2099571###Speaker###Regulatory Lead###DQS Medizinprodukte UK Ltd###Speaker: – DQS Medizinprodukte UK Ltd
### @@@ Szymon Kurdyn – DQS Medizinprodukte GmbH ### 2099572###Speaker###Head of Notified Body###DQS Medizinprodukte GmbH###Speaker: – DQS Medizinprodukte GmbH
### 11:45 AM – 12:10 PM EDT
Sponsored Presentation: Sustainability: potential challenges and solutions for the MedTech industry, Notified Bodies and auditing organizations.
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Sustainability: potential challenges and solutions for the MedTech industry, Notified Bodies and auditing organizations.
Linda Moon, MPhil. (she/her/hers) – BSI Group ### 2131940###Speaker###Global Quality & Accreditation Manager, Regulatory Services###BSI Group###Speaker: – BSI Group
### she/her/hers
11:45 AM – 12:15 PM EDT
Career Central Stage: The RAPS Competency Framework and Tools: What is it and what's in it for me?
11:45 AM – 12:15 PM EDT
Career Central Stage: The RAPS Competency Framework and Tools: What is it and what's in it for me?Speaker: – QRE MedTech LLC
Speaker: – Day One Biopharmaceuticals
Career Central Stage
Thomas Hutchinson, MS RAC FRAPS – QRE MedTech LLC ### 1764013###Speaker###Principal Consultant###QRE MedTech LLC###Speaker: – QRE MedTech LLC
### @@@ Lindsey Summers, MBA – Day One Biopharmaceuticals ### 802197###Speaker###Sr Talent Acquisition Partner###Day One Biopharmaceuticals###Speaker: – Day One Biopharmaceuticals
###
11:45 AM – 12:15 PM EDT
RAPS BOD Roundtable: The Futuristic Regulatory Professional
11:45 AM – 12:15 PM EDT
RAPS BOD Roundtable: The Futuristic Regulatory ProfessionalGuest Speaker: – Planning Committee Chair Convergence 2023
Guest Speaker: – NDA Partners
Guest Speaker: – Salditt Regulatory Consulting LLC
Guest Speaker: – MEDIcept
Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023 ### 535468###Guest Speaker###Global Reg Policy & Intelligence and AdPromo###Planning Committee Chair Convergence 2023###Guest Speaker: – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Guest Speaker###Partner###NDA Partners###Guest Speaker: – NDA Partners
### @@@ Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC ### 609884###Guest Speaker###Principal Consultant###Salditt Regulatory Consulting LLC###Guest Speaker: – Salditt Regulatory Consulting LLC
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: – MEDIcept
### 12:00 PM – 1:30 PM EDT
Networking Lunch in Exhibit Hall
12:00 PM – 1:30 PM EDT
Networking Lunch in Exhibit HallNetworking Opportunity
12:05 PM – 12:35 PM EDT
Notified Bodies: IVDR implementation Ask me Anything
12:05 PM – 12:35 PM EDT
Notified Bodies: IVDR implementation Ask me AnythingFacilitator: – DEKRA
Facilitator: – GMED Certification Division
Facilitator: – BSI Group The Netherlands B.V.
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Azam Khorshidi – DEKRA ### 2129976###Facilitator###Technical File Reviewer###DEKRA ###Facilitator: – DEKRA
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Facilitator###IVDMD Department Manager###GMED Certification Division###Facilitator: – GMED Certification Division
### @@@ Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V. ### 1945990###Facilitator###Head of IVD notified body###BSI Group The Netherlands B.V.###Facilitator: – BSI Group The Netherlands B.V.
### 12:05 PM – 12:35 PM EDT
Solutions Circle - Continuing the Conversation: The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
12:05 PM – 12:35 PM EDT
The eSTAR and I: Getting to Know the eSTAR Templates for FDA SubmissionsFacilitator: – DuVal & Associates, P.A.
Facilitator: – DuVal & Associates, P.A.
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Facilitator###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Facilitator: – DuVal & Associates, P.A.
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Facilitator###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Facilitator: – DuVal & Associates, P.A.
### 12:05 PM – 12:35 PM EDT
The Journy to RAC!
12:05 PM – 12:35 PM EDT
The Journey to RAC!Facilitator: – Integrated Project Management
Facilitator: – Integrated Project Management, Inc.
Facilitator: – RAPS
Solutions Circle
Skill Building
Rani Maloney, MBA, PMP, RAC – Integrated Project Management ### 1945637###Facilitator###Senior Consultant###Integrated Project Management###Facilitator: – Integrated Project Management
### @@@ Gregory L. Palagi, PMP DASM CSM (he/him/his) – Integrated Project Management, Inc. ### 2043809###Facilitator###Senior Consultant###Integrated Project Management, Inc.###Facilitator: – Integrated Project Management, Inc.
### he/him/his @@@ Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS ### 1763591###Facilitator###Director of Credentialing###RAPS###Facilitator: – RAPS
### 12:05 PM – 12:35 PM EDT
Transparent, translucent, and opaque: how global health authorities make information publicly accessible
12:05 PM – 12:35 PM EDT
Transparent, Translucent, and Opaque: How Global Health Authorities Make Information Publicly AccessibleFacilitator: – Seattle Genetics
Solutions Circle
Skill Building
Chris Whalley, cwhalley@seagen.com – Seattle Genetics ### 1000102###Facilitator###Director, Head of Global Regulatory Policy & Intelligence###Seattle Genetics###Facilitator: – Seattle Genetics
### 12:15 PM – 12:40 PM EDT
Sponsored Presentation: Managing regulatory change
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Managing regulatory change
Bridget Wiseman – IQVIA ### 2128409###Speaker###Director, Offering Management, Regulatory Intelligence###IQVIA###Speaker: – IQVIA
### 12:15 PM – 12:40 PM EDT
Sponsored Presentation: The 80/20 Rule: How Digital Transformation & AI Are Changing Regulatory Intelligence
12:15 PM – 12:40 PM EDT
Sponsored Presentation: The 80/20 Rule: How Digital Transformation & AI Are Changing Regulatory Intelligence
Immo Zdrojewski – Moderna ### 1946111###Speaker###Head Global Regulatory Policy and Regulatory Intelligence###Moderna###Speaker: – Moderna
### 12:15 PM – 12:40 PM EDT
Sponsored Presentation: Unlocking the Power of Retrospective PMCF Studies for EU MDR Compliance
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Unlocking the Power of Retrospective PMCF Studies for EU MDR ComplianceSpeaker: – RQM+
Speaker: – RQM+
Jonathan Gimbel, PhD – RQM+ ### 1071091###Speaker###Vice President, Technical###RQM+###Speaker: – RQM+
### @@@ Torrie DeGennaro – RQM+ ### 2134412###Speaker###Principal, Consulting Services###RQM+###Speaker: – RQM+
### 12:30 PM – 1:00 PM EDT
RAPS BOD Roundtable: I Am Regulatory
12:30 PM – 1:00 PM EDT
RAPS BOD Roundtable: I Am RegulatoryGuest Speaker: – MEDIcept
Guest Speaker: – NDA Partners
Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: – MEDIcept
### @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Guest Speaker###Partner###NDA Partners###Guest Speaker: – NDA Partners
### 12:45 PM – 1:15 AM EDT
Using Situational Leadership to Manage yourself and others
12:45 PM – 1:15 AM EDT
Using Situational Leadership to Manage Yourself and OthersFacilitator: – Quality and Regulatory Expert Partners, LLC
Solutions Circle
Skill Building
Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC ### 1945642###Facilitator###Partner###Quality and Regulatory Expert Partners, LLC###Facilitator: – Quality and Regulatory Expert Partners, LLC
### 12:45 PM – 1:10 PM EDT
Sponsored Presentation: Global Medical Device UDI Status and How to Best Manage Diverse Compliance Rules
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Global Medical Device UDI Status and How to Best Manage Diverse Compliance RulesSpeaker: – LexisNexis Reed Tech
Gary Saner – LexisNexis Reed Tech ### 1321700###Speaker###Sr. Manager Information Solutions###LexisNexis Reed Tech###Speaker: – LexisNexis Reed Tech
### 12:45 PM – 1:10 PM EDT
Sponsored Presentation: The Future of Change Management for Cloud-Based AI/ML Medical Software
12:45 PM – 1:10 PM EDT
Sponsored Presentation: The Future of Change Management for Cloud-Based AI/ML Medical SoftwareSpeaker: – Ketryx Corporation
Erez Kaminski, MS, MBA (he/him/his) – Ketryx Corporation ### 1764635###Speaker###Founder and CEO###Ketryx Corporation###Speaker: – Ketryx Corporation
### he/him/his12:45 PM – 1:15 PM EDT
Notified Bodies: IVDR implementation Ask me Anything
12:45 PM – 1:15 PM EDT
Notified Bodies: IVDR implementation Ask me AnythingFacilitator: – mi-CE consultancy
Facilitator: – NSAI
Facilitator: – TÜV SÜD America Inc.
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Facilitator###CEO / senior consultant###mi-CE consultancy###Facilitator: – mi-CE consultancy
### she/her/hers @@@ Tom Patten – NSAI ### 1141749###Facilitator###Certification & Inspection Officer - IVD###NSAI###Facilitator: – NSAI
### @@@ Stefan Burde, PhD – TÜV SÜD America Inc. ### 2129429###Facilitator###Director Global Focus Team IVD###TÜV SÜD America Inc.###Facilitator: – TÜV SÜD America Inc.
### 12:45 PM – 1:15 PM EDT
RAPS Store Stage: Meet the Authors - Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
12:45 PM – 1:15 PM EDT
RAPS Store Stage: Meet the Authors - Fundamentals of Pharmaceutical and Biologics Regulations: A Global PerspectiveSpeaker: – IAA Consulting LLC
RAPS Store Stage
Linda McBride, R.PH, RAC – IAA Consulting LLC ### 1946958###Speaker###Partner###IAA Consulting LLC###Speaker: – IAA Consulting LLC
### 1:15 PM – 1:45 PM EDT
Career Central Stage: Get Certified in Regulatory Affairs: Get your RAC!
1:15 PM – 1:45 PM EDT
Career Central Stage: Get Certified in Regulatory Affairs: Get your RAC!Career Central Stage
Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS ### 1763591###Speaker###Director of Credentialing###RAPS###Speaker: – RAPS
###
2:00 PM – 3:00 PM EDT
Biosimilar Regulatory Standards in the ICH Regions: Implications for Global Biosimilar Development
2:00 PM – 3:00 PM EDT
Biosimilar Regulatory Standards in the ICH Regions: Implications for Global Biosimilar DevelopmentPresenter: – Allucent
Presenter: – Amgen
Presenter: – Allucent
Presenter (Remote): – European Medicines Agency (EMA)
Biopharmaceuticals (includes Biologics and Drugs)
Antonina G. Nikolova, PhD – Allucent ### 1946964###Presenter###Vice President, CMC###Allucent###Presenter: – Allucent
### @@@ Leah Christl, PhD (she/her/hers) – Amgen ### 1459819###Presenter###Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy###Amgen###Presenter: – Amgen
### she/her/hers @@@ Marcus S. Delatte, PhD – Allucent ### 1946005###Presenter###Vice President, Regulatory Strategy###Allucent###Presenter: – Allucent
### @@@ Peter Richardson, Ph. D. – European Medicines Agency (EMA) ### 2127719###Presenter (Remote)###Scientific secretary Biosimilar Medicines Working Party###European Medicines Agency (EMA)###Presenter (Remote): – European Medicines Agency (EMA)
###
2:00 PM – 3:00 PM EDT
Health Authority Forum: Health Canada
2:00 PM – 3:00 PM EDT
Health Authority Forum: Health CanadaPanelist: – Health Canada
Panelist: – Health Canada
Panelist: – Health Canada
Health Authority Forum
Sally Prawdzik (she/her/hers) – Health Canada ### 2119758###Panelist###Acting Director of Policy and International Programs###Health Canada###Panelist: – Health Canada
### she/her/hers @@@ Kelly Robinson – Health Canada ### 2135302###Panelist###Director General, Marketed Health Products Directorate###Health Canada###Panelist: – Health Canada
### @@@ Sophie Sommerer – Health Canada ### 2135915###Panelist###Director General of the Biologic and Radiopharmaceutical Drugs Directorate###Health Canada###Panelist: – Health Canada
### 2:00 PM – 3:00 PM EDT
Importance of Building Relationships with Health Authorities: Case Study for NDA Review of Orphan ProductXYZ
2:00 PM – 3:00 PM EDT
Importance of Building Relationships with Health Authorities: Case Study for NDA Review of Orphan ProductPresenter: – Annexon Biosciences
Presenter: – Annexon Biosciences
Presenter:
Presenter: – US Food and Drug Administration
Skill Building
AJ Acker – Annexon Biosciences ### 1945988###Presenter###SVP, Regulatory Affairs, Quality Assurance & Pharmacovigilance###Annexon Biosciences###Presenter: – Annexon Biosciences
### @@@ Kunal Kanani, PharmD, MBA – Annexon Biosciences ### 1945989###Presenter###Executive Director, Head of Regulatory Affairs###Annexon Biosciences###Presenter: – Annexon Biosciences
### @@@ Sarah Rhee ### 2102886###Presenter#########Presenter:
### @@@ Mary Jo Salerno, MS PT, MPH (she/her/hers) – US Food and Drug Administration ### 1946967###Presenter###Science Policy Analyst###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### she/her/hers
2:00 PM – 3:00 PM EDT
IVDR transition and implementation: what have we learned from the MDR?
2:00 PM – 3:00 PM EDT
IVDR Transition and Implementation: What Have We Learned from the MDR?Session Leader: – BSI Group The Netherlands B.V.
Presenter:
Presenter: – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V. ### 1945990###Session Leader###Head of IVD notified body###BSI Group The Netherlands B.V.###Session Leader: – BSI Group The Netherlands B.V.
### @@@ Amélie Chollet ### 2008932###Presenter#########Presenter:
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### 2:00 PM – 3:00 PM EDT
Pediatric Drug Development: Failure is not an Option
2:00 PM – 3:00 PM EDT
Pediatric Drug Development: Failure is not an OptionPresenter: – khhconsulting
Presenter: – IAA Consulting LLC
Presenter: – Planning Committee Chair Convergence 2023
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###Presenter: – khhconsulting
### he/him/his @@@ Linda McBride, R.PH, RAC – IAA Consulting LLC ### 1946958###Presenter###Partner###IAA Consulting LLC###Presenter: – IAA Consulting LLC
### @@@ Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023 ### 535468###Presenter###Global Reg Policy & Intelligence and AdPromo###Planning Committee Chair Convergence 2023###Presenter: – Planning Committee Chair Convergence 2023
### she/her/hers
2:00 PM – 3:00 PM EDT
Strategies to Leverage Patient Preference and Perspective to Support New Indications
2:00 PM – 3:00 PM EDT
Strategies to Leverage Patient Preference and Perspective to Support Development of New Drugs and Indications Session Leader: – Bayer Pharmaceuticals
Presenter: – Organon
Presenter: – Organon
Moderator: – Bayer
Biopharmaceuticals (includes Biologics and Drugs)
Priyanka Ingle, MD (Intl), MSc, PhD – Bayer Pharmaceuticals ### 1946106###Session Leader###Director, Global Regulatory Strategy, RA###Bayer Pharmaceuticals###Session Leader: – Bayer Pharmaceuticals
### @@@ Shefali Goyal, MS, MSc – Organon ### 1946109###Presenter###Vice President and Head Global Product Regulatory Strategy, US RA and Affiliate Pharmacovigilence Lead###Organon###Presenter: – Organon
### @@@ Sandra V. Cron, MS (she/her/hers) – Organon ### 2122899###Presenter###Director, Regulatory Liaison Women’s Health, Organon###Organon###Presenter: – Organon
### she/her/hers @@@ Kathleen O'Sullivan, MS, MSL, RAC – Bayer ### 2128761###Moderator###Director Regulatory Strategy###Bayer###Moderator: – Bayer
###
2:00 PM – 3:00 PM EDT
Tackling a whirlwind of uncertainties: Lessons learned on UK market access
2:00 PM – 3:00 PM EDT
Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market AccessSession Leader: – Qserve Group BV
Presenter: – SGS North America Inc.
Presenter:
Devices (includes Medical Devices and In Vitro Diagnostics)
Daniëlle Motta, MSc. – Qserve Group BV ### 1649497###Session Leader###Head of Global Registrations###Qserve Group BV###Session Leader: – Qserve Group BV
### @@@ Balazs Bozsik – SGS North America Inc. ### 1614547###Presenter###Technical Director - MDD/MDR/UKCA###SGS North America Inc.###Presenter: – SGS North America Inc.
### @@@ Phil Brown ### 1855142###Presenter#########Presenter:
### 2:00 PM – 3:00 PM EDT
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?
2:00 PM – 3:00 PM EDT
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?Moderator: – mi-CE consultancy
Moderator: – TÜV SÜD
Presenter: – TUV Sud GmbH
Presenter: – NSAI
Presenter: – GMED Certification Division
Presenter: – DEKRA
Devices (includes Medical Devices and In Vitro Diagnostics)
Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Moderator###CEO / senior consultant###mi-CE consultancy###Moderator: – mi-CE consultancy
### she/her/hers @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###Moderator: – TÜV SÜD
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: – NSAI
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: – GMED Certification Division
### @@@ Azam Khorshidi – DEKRA ### 2129976###Presenter###Technical File Reviewer###DEKRA ###Presenter: – DEKRA
### 3:00 PM – 3:30 PM EDT
Coffee & Refreshment Break
3:00 PM – 3:30 PM EDT
Coffee & Refreshment BreakNetworking Opportunity
3:30 PM – 4:30 PM EDT
Live LinkedIn Feedback Session
3:30 PM – 4:30 PM EDT
Live LinkedIn Feedback SessionSkill Building
Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: – Elemed
### she/her/hers3:30 PM – 4:30 PM EDT
Navigating the Unique Complexities of CMC Challenges for Cell Therapies
3:30 PM – 4:30 PM EDT
Navigating the Unique Complexities of CMC Challenges for Cell TherapiesSession Leader: – Takeda Pharmaceuticals
Presenter: – Obsidian Therapuetics
Presenter: – Takeda Pharmaceuticals
Presenter: – Allucent
Biopharmaceuticals (includes Biologics and Drugs)
Olivia Ziolkowski, J.D., M.P.H. (she/her/hers) – Takeda Pharmaceuticals ### 1946121###Session Leader###US Lead (Director), Global Regulatory Policy & Innovation###Takeda Pharmaceuticals###Session Leader: – Takeda Pharmaceuticals
### she/her/hers @@@ Sanika Inamdar (she/her/hers) – Obsidian Therapuetics ### 1187607###Presenter###QA Manager###Obsidian Therapuetics###Presenter: – Obsidian Therapuetics
### she/her/hers @@@ Yoko Momonoi, M.S. (she/her/hers) – Takeda Pharmaceuticals ### 1946120###Presenter###Executive Director, Global Regulatory CMC Cell and Gene Therapy###Takeda Pharmaceuticals###Presenter: – Takeda Pharmaceuticals
### she/her/hers @@@ Antonina G. Nikolova, PhD – Allucent ### 1946964###Presenter###Vice President, CMC###Allucent###Presenter: – Allucent
###
3:30 PM – 4:30 PM EDT
Non-Clinical - New
3:30 PM – 4:30 PM EDT
Is Animal Testing Really No Longer Needed for Drug Development?Session Leader: – KC Biopharmaceutical Consulting
Presenter (Remote): – Food and Drug Administration
Presenter (Remote): – NETRI
Presenter: – Pharnext
Biopharmaceuticals (includes Biologics and Drugs)
Kamali G. Chance, PhD, MPH, RAC – KC Biopharmaceutical Consulting ### 535467###Session Leader###CEO & Executive Consultant###KC Biopharmaceutical Consulting###Session Leader: – KC Biopharmaceutical Consulting
### @@@ Paul Brown, PhD (he/him/his) – Food and Drug Administration ### 2102964###Presenter (Remote)###Associate Director for Pharmacology and Toxicology###Food and Drug Administration###Presenter (Remote): – Food and Drug Administration
### he/him/his @@@ Thibault Honegger – NETRI ### 2064600###Presenter (Remote)###CEO & Co-founder###NETRI###Presenter (Remote): – NETRI
### @@@ Abhijit P. Pangu, M. Pharm, RAC – Pharnext ### 1945629###Presenter###VP, Regulatory Affairs###Pharnext###Presenter: – Pharnext
###
3:30 PM – 4:30 PM EDT
Overview of Select PDUFA VII Innovative Meeting Programs
3:30 PM – 4:30 PM EDT
Overview of Select PDUFA VII Innovative Meeting ProgramsSession Leader: – US Food and Drug Administration
Presenter: – US Food and Drug Administration
Presenter: – US Food and Drug Administration
Moderator: – Alexion, AstraZeneca Rare Disease
Biopharmaceuticals (includes Biologics and Drugs)
CHRISTOPHER EGELEBO, DHSc, MBA, MS, RAC, PMP, RN – US Food and Drug Administration ### 1946957###Session Leader###Sr. Program Management Officer###US Food and Drug Administration###Session Leader: – US Food and Drug Administration
### @@@ Yvonne Knight, MS (she/her/hers) – US Food and Drug Administration ### 1946968###Presenter###Sr Regulatory Health Project Manager###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### she/her/hers @@@ Mary Jo Salerno, MS PT, MPH (she/her/hers) – US Food and Drug Administration ### 1946967###Presenter###Science Policy Analyst###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### she/her/hers @@@ Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Moderator###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Moderator: – Alexion, AstraZeneca Rare Disease
###
3:30 PM – 4:30 PM EDT
Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)
3:30 PM – 4:30 PM EDT
Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)Moderator: – Qserve Group
Presenter: – Elekta
Presenter: – SGS North America Inc.
Devices (includes Medical Devices and In Vitro Diagnostics)
Keith Morel, PhD (he/him/his) – Qserve Group ### 535522###Moderator###VP Regulatory Compliance###Qserve Group###Moderator: – Qserve Group
### he/him/his @@@ Leo Hovestadt (he/him/his) – Elekta ### 535504###Presenter###Director Governmental Affairs EU###Elekta###Presenter: – Elekta
### he/him/his @@@ Balazs Bozsik – SGS North America Inc. ### 1614547###Presenter###Technical Director - MDD/MDR/UKCA###SGS North America Inc.###Presenter: – SGS North America Inc.
###
3:30 PM – 4:30 PM EDT
The Art of Submission Planning: From Strategy to Filing
3:30 PM – 4:30 PM EDT
The Art of Submission Planning: From Strategy to FilingSkill Building
Cassandra T. San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM (she/her/hers) – Biogen ### 1945992###Session Leader###Director, Regulatory Submission Planning###Biogen###Session Leader: – Biogen
### she/her/hers
3:30 PM – 4:30 PM EDT
The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
3:30 PM – 4:30 PM EDT
The eSTAR and I: Getting to Know the eSTAR Templates for FDA SubmissionsSession Leader: – DuVal & Associates, P.A.
Presenter (Remote): – FDA
Presenter: – DuVal & Associates, P.A.
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Session Leader###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Session Leader: – DuVal & Associates, P.A.
### @@@ Patrick Axtell, PhD – FDA ### 1000137###Presenter (Remote)###Assistant Director, Tools and Templates Team###FDA###Presenter (Remote): – FDA
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Presenter###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Presenter: – DuVal & Associates, P.A.
###
3:30 PM – 4:30 PM EDT
The Inflation Reduction Act and Beyond: Impacts of the Evolving Reimbursement Landscape on Drug Development
3:30 PM – 4:30 PM EDT
The Inflation Reduction Act and Beyond: Impacts of the Evolving Reimbursement Landscape on Drug DevelopmentSession Leader: – Mallinckrodt
Presenter: – Model N
Moderator: – QuidelOrtho
Biopharmaceuticals (includes Biologics and Drugs)
Mallory O'Connor, MPH – Mallinckrodt ### 1000088###Session Leader###Executive Director, Public Policy###Mallinckrodt###Session Leader: – Mallinckrodt
### @@@ Jesse D. Mendelsohn (he/him/his) – Model N ### 2094361###Presenter###Senior Vice President###Model N###Presenter: – Model N
### he/him/his @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho ### 1642067###Moderator###Sr. Director, Reg. Affairs###QuidelOrtho###Moderator: – QuidelOrtho
###
3:30 PM – 4:30 PM EDT
Understand the Evolving Role of Real World Evidence
3:30 PM – 4:30 PM EDT
Understand the Evolving Role of Real World EvidencePresenter: – Boston Scientific
Presenter: – Medtronic
Presenter (Remote): – US Food and Drug Administration
Presenter: – Johnson & Johnson MedTech
Devices (includes Medical Devices and In Vitro Diagnostics)
Olga van Grol-Lawlor, MPhil (she/her/hers) – Boston Scientific ### 1534231###Presenter###Senior Global Regulatory Intelligence & Advocacy Manager###Boston Scientific###Presenter: – Boston Scientific
### she/her/hers @@@ Gina Calistro – Medtronic ### 2128676###Presenter######Medtronic###Presenter: – Medtronic
### @@@ Daniel Caños, PhD, MPH – US Food and Drug Administration ### 1083194###Presenter (Remote)###Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH###US Food and Drug Administration###Presenter (Remote): – US Food and Drug Administration
### @@@ Heather M. Colvin, MPP (she/her/hers) – Johnson & Johnson MedTech ### 1083203###Presenter###Director, Evidence & Outcomes Policy###Johnson & Johnson MedTech###Presenter: – Johnson & Johnson MedTech
### she/her/hers
4:45 PM – 5:45 PM EDT
Companion Diagnostics: Overview of the IVDR requirements and the EMA consultation process
4:45 PM – 5:45 PM EDT
Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation ProcessPresenter: – BSI
Presenter: – European Medicines Agency
Presenter: – TÜV SÜD
Presenter: – ARUP Laboratories
Moderator: – TÜV SÜD
Devices (includes Medical Devices and In Vitro Diagnostics)
Judith Prevoo (she/her/hers) – BSI ### 1523607###Presenter###Regulatory Lead###BSI###Presenter: – BSI
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: – European Medicines Agency
### he/him/his @@@ James Hewitt (he/him/his) – TÜV SÜD ### 2098107###Presenter###Business Line Manager (IVD)###TÜV SÜD###Presenter: – TÜV SÜD
### he/him/his @@@ Chelsea Welch (she/her/hers) – ARUP Laboratories ### 2128163###Presenter###Quality and Regulatory Affairs Project Manager###ARUP Laboratories###Presenter: – ARUP Laboratories
### she/her/hers @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###Moderator: – TÜV SÜD
###
4:45 PM – 5:45 PM EDT
Complex Generics - New
4:45 PM – 5:45 PM EDT
Challenges & Potential Global Convergence of the Regulatory Approval Process for Complex Generic DrugsSession Leader: – Teva Pharmaceuticals
Presenter: – United States Pharmacopeia
Presenter: – United States Pharmacopeia
Biopharmaceuticals (includes Biologics and Drugs)
Janet Vaughn – Teva Pharmaceuticals ### 1946098###Session Leader###VP North America Generics Regulatory Affairs###Teva Pharmaceuticals###Session Leader: – Teva Pharmaceuticals
### @@@ Victor S. Pribluda, PhD (he/him/his) – United States Pharmacopeia ### 1946097###Presenter###Senior International Regulatory Intelligence Manager###United States Pharmacopeia###Presenter: – United States Pharmacopeia
### he/him/his @@@ Chaitanya Koduri, MTech (he/him/his) – United States Pharmacopeia ### 1946105###Presenter###International Government & Regulatory Engagement Director###United States Pharmacopeia###Presenter: – United States Pharmacopeia
### he/him/his
4:45 PM – 5:45 PM EDT
Enabling Regulatory Environments to Deliver Better Access to Self Care Interventions – A Global Perspective ENABLING REGULATORY
4:45 PM – 5:45 PM EDT
Enabling Global Regulatory Environments to Deliver Better Self Care Interventions Presenter: – Consumer Health Products Association
Presenter: – Bayer
Presenter:
Presenter: – Haleon Canada
Biopharmaceuticals (includes Biologics and Drugs)
Jay E. Sirois, PhD – Consumer Health Products Association ### 1946961###Presenter###Vice President, Regulatory & Scientific Affairs###Consumer Health Products Association###Presenter: – Consumer Health Products Association
### @@@ Joseph Chan, RPh (he/him/his) – Bayer ### 2014522###Presenter###Senior Regulatory Affairs Manager###Bayer###Presenter: – Bayer
### he/him/his @@@ Gerry Harrington ### 2099591###Presenter#########Presenter:
### @@@ Amanda Wong, RAC – Haleon Canada ### 2099590###Presenter###Senior Director, R&D Lead and Regulatory Affairs###Haleon Canada###Presenter: – Haleon Canada
###
4:45 PM – 5:45 PM EDT
Financial Acumen for Regulatory Affairs
4:45 PM – 5:45 PM EDT
Financial Acumen for Regulatory AffairsSession Leader: – Thermo Fisher Scientific
Presenter: – Regulatory Affairs Professionals Society (RAPS)
Presenter: – UpToDate, Inc.
Skill Building
Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific ### 1083158###Session Leader###Director, Global Strategic Regulatory Affairs###Thermo Fisher Scientific###Session Leader: – Thermo Fisher Scientific
### she/her/hers @@@ Bill McMoil – Regulatory Affairs Professionals Society (RAPS) ### 1083161###Presenter###RAPS Executive Director###Regulatory Affairs Professionals Society (RAPS)###Presenter: – Regulatory Affairs Professionals Society (RAPS)
### @@@ Susan Speicher, MS (she/her/hers) – UpToDate, Inc. ### 1976561###Presenter###Director, Regulatory Affairs and Quality Compliance###UpToDate, Inc. ###Presenter: – UpToDate, Inc.
### she/her/hers
4:45 PM – 5:45 PM EDT
International Regulator Forum
4:45 PM – 5:45 PM EDT
International Regulator ForumModerator: – Veeva Systems
Presenter: – Saudi Food and Drug Authority
Presenter (Remote):
Presenter: – Emergo by UL
Health Authority Forum
Amra Racic – Veeva Systems ### 535477###Moderator###Sr. Director Global Government Affairs###Veeva Systems###Moderator: – Veeva Systems
### @@@ Razan Asally (she/her/hers) – Saudi Food and Drug Authority ### 2102871###Presenter###Head of In-vitro diagnostics evaluation section###Saudi Food and Drug Authority###Presenter: – Saudi Food and Drug Authority
### she/her/hers @@@ Abhijit Ghosh ### 2105492###Presenter (Remote)#########Presenter (Remote):
### @@@ Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL ### 1773497###Presenter###Manager, Quality & Regulatory Affairs###Emergo by UL###Presenter: – Emergo by UL
### 4:45 PM – 5:45 PM EDT
Predetermined Change Control Plans (PCCPS) are Now Codified in FDORA - What should you do?
4:45 PM – 5:45 PM EDT
Predetermined Change Control Plans (PCCPS) are Now Codified in FDORA - What should you do?Session Leader: – RQM+
Presenter: – RQM Plus
Devices (includes Medical Devices and In Vitro Diagnostics)
Nancy J. Morrison, RAC (she/her/hers) – RQM+ ### 757434###Session Leader###Vice President, Intelligence and Innovation###RQM+###Session Leader: – RQM+
### she/her/hers @@@ Hrishikesh Gadagkar, PhD (he/him/his) – RQM Plus ### 1977462###Presenter###Sr. Principal###RQM Plus###Presenter: – RQM Plus
### he/him/his
4:45 PM – 5:45 PM EDT
Regulatory Collaboration Through Cloud Platforms
4:45 PM – 5:45 PM EDT
Regulatory Collaboration Through Cloud PlatformsSession Leader: – Bayer Pharmaceuticals
Presenter: – Janssen
Presenter (Remote): – FDA Center for Biologics Evaluation and Research
Presenter: – Accumulus Synergy
Biopharmaceuticals (includes Biologics and Drugs)
Vada A. Perkins, MSc, MS, DRSc (c) – Bayer Pharmaceuticals ### 1961870###Session Leader###Executive Director, Regulatory Policy & Innovation/Head, Research & Policy-Regions###Bayer Pharmaceuticals###Session Leader: – Bayer Pharmaceuticals
### @@@ Danielle Friend – Janssen ### 1698210###Presenter###Senior Director, US Head, Regulatory Policy and Intelligence###Janssen###Presenter: – Janssen
### @@@ Virginia Hussong – FDA Center for Biologics Evaluation and Research ### 2064197###Presenter (Remote)###Branch Chief, Data Standards###FDA Center for Biologics Evaluation and Research###Presenter (Remote): – FDA Center for Biologics Evaluation and Research
### @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Presenter###Chief Regulatory Innovation Officer###Accumulus Synergy###Presenter: – Accumulus Synergy
###
4:45 PM – 5:45 PM EDT
Streamlining Conformity Assessment in Medical Device Review: the FDA's ASCA Program
4:45 PM – 5:45 PM EDT
Streamlining Conformity Assessment in Medical Device Review: the FDA's ASCA ProgramPresenter: – US Food and Drug Administration
Presenter: – US Food and Drug Administration
Devices (includes Medical Devices and In Vitro Diagnostics)
Gail M. Rodriguez, Ph.D. – US Food and Drug Administration ### 1342701###Presenter###Senior Advisor###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### @@@ Scott Colburn, MS, BSN – US Food and Drug Administration ### 805714###Presenter###Acting Director, Division of All Hazards Response, Science and Strategic Partnerships (DARSS)###US Food and Drug Administration###Presenter: – US Food and Drug Administration
### 6:30 PM – 9:30 PM EDT
SOLD OUT - RAPS Farewell Jazz Soirée: Toasting the Future Together
6:30 PM – 9:30 PM EDT
SOLD OUT - RAPS Farewell Jazz Soirée: Toasting the Future TogetherNetworking Opportunity
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