*Program and presenters subject to change. Please check back frequently for updates.
Presenter: Purvi S. Patel, PhD, CEng, MIMechE – BSI Group
Presenter: Vishal Thakker, MEng – BSI Group
Presenter: Rachel Mead, BEng MIET – BSI Group
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Gareth Enright, MEng – National Standards Authority of Ireland
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: Purvi S. Patel, PhD, CEng, MIMechE (she/her/hers) – 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: Vishal Thakker, MEng (he/him/his) – BSI Group
### he/him/his @@@ Rachel Mead, BEng MIET (she/her/hers) – BSI Group ### 2016362###Presenter###Clinical Regulatory Lead###BSI Group ###Presenter: Rachel Mead, BEng MIET (she/her/hers) – 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: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
### @@@ Gareth Enright, MEng – National Standards Authority of Ireland ### 2074276###Presenter###Certification & Inspection Officer ###National Standards Authority of Ireland###Presenter: Gareth Enright, MEng – National Standards Authority of Ireland
###
Presenter: Corinne Delorme, MS, RAC – nexialist
Presenter: Vincent Castéras, PhD – nexialist
Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: Corinne Delorme, MS, RAC – nexialist
### @@@ Vincent Castéras, PhD – nexialist ### 1543942###Presenter###CEO and Founder###nexialist###Presenter: Vincent Castéras, PhD – nexialist
### @@@ Florianne Torset-Bonfillou, MS, RAC – GMED North America ### 579831###Presenter###Senior International Regulatory Project Manager ###GMED North America###Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America
###
Workshop Leader: Hagit Marchaim, PhD MBA – HMC-Regulation
Presenter: Lina Jamis, MS – Synthego Corporation
Presenter: Tyler C. Vandivort, PhD, RAC, DABT – Amplicore Inc
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Workshop Leader: Hagit Marchaim, PhD MBA (she/her/hers) – HMC-Regulation
### she/her/hers @@@ Lina Jamis, MS (she/her/hers) – Synthego Corporation ### 2099003###Presenter###Associate Director, Regulatory Affairs###Synthego Corporation###Presenter: Lina Jamis, MS (she/her/hers) – 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: Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – Amplicore Inc
### he/him/hisPresenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting
Presenter: Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices
Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
Presenter (Remote): Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH
Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
### @@@ Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###Presenter: Karl-Heinz Huemer, MD, PhD (he/him/his) – 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: Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Presenter###Principal Scientific Administrator###European Medicines Agency###Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Presenter###Post-Licensing Director###Malta Medicines Authority###Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
### @@@ Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH ### 573390###Presenter (Remote)###Principal Consultant###Granzer Regulatory Consulting & Services GmbH###Presenter (Remote): Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH
### @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Presenter###Partner###NDA Partners###Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Tom Patten – NSAI
Presenter: Catherine Holzmann – GMED Certification Division
Presenter: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: Catherine Holzmann – 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: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
###
Workshop Leader: Bassil Akra, phD – Akra Team GmbH
Presenter: Danielle Giroud, MSci – MD-CLINICALS SA
Presenter: Keith Morel, PhD – Qserve Group
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Erik R. Vollebregt – Axon Lawyers
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Workshop Leader: Bassil Akra, phD (he/him/his) – Akra Team GmbH
### he/him/his @@@ Danielle Giroud, MSci (she/her/hers) – MD-CLINICALS SA ### 1187621###Presenter###CEO###MD-CLINICALS SA###Presenter: Danielle Giroud, MSci (she/her/hers) – MD-CLINICALS SA
### she/her/hers @@@ Keith Morel, PhD (he/him/his) – Qserve Group ### 535522###Presenter###VP Regulatory Compliance###Qserve Group###Presenter: Keith Morel, PhD (he/him/his) – 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: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: Erik R. Vollebregt – Axon Lawyers
###Presenter: David Chadwick, PhD, RAC, FRAPS – Independent
Presenter: Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A.
Presenter: Etienne Nichols, PMP, CSM – Greenlight Guru
Presenter: Tony Blank – AtriCure, Inc.
Presenter: Christie Hughes, MPH, MLS(ASCP) – Qserve Group
Presenter (Remote): Larry Pool – Cook Incorporated
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: David Chadwick, PhD, RAC, FRAPS – Independent
### @@@ Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A. ### 535473###Presenter###President & CEO,###DuVal & Associates, P.A.###Presenter: Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A.
### @@@ Etienne Nichols, PMP, CSM – Greenlight Guru ### 1397975###Presenter###Medical Device Guru###Greenlight Guru###Presenter: Etienne Nichols, PMP, CSM – Greenlight Guru
### @@@ Tony Blank – AtriCure, Inc. ### 1036809###Presenter###Senior Director, Regulatory Affairs###AtriCure, Inc.###Presenter: Tony Blank – AtriCure, Inc.
### @@@ Christie Hughes, MPH, MLS(ASCP) – Qserve Group ### 1389439###Presenter###Principal Consultant, IVD Expert###Qserve Group###Presenter: Christie Hughes, MPH, MLS(ASCP) – Qserve Group
### @@@ Larry Pool (he/him/his) – Cook Incorporated ### 1397977###Presenter (Remote)###Dir, Post Market Surveillance###Cook Incorporated###Presenter (Remote): Larry Pool (he/him/his) – Cook Incorporated
### he/him/hisPresenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Presenter: Elena Kyria – Elemed
Presenter: Daniëlle Motta, MSc. – Qserve Group BV
Presenter: Kimberly A. Trautman, MS – MEDIcept
Presenter: Susan Bain, DRSc – University of Southern California
Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
### @@@ Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: Elena Kyria (she/her/hers) – Elemed
### she/her/hers @@@ Daniëlle Motta, MSc. – Qserve Group BV ### 1649497###Presenter###Head of Global Registrations###Qserve Group BV###Presenter: Daniëlle Motta, MSc. – Qserve Group BV
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Presenter###Managing Director and Vice President###MEDIcept###Presenter: Kimberly A. Trautman, MS – MEDIcept
### @@@ Susan Bain, DRSc – University of Southern California ### 2125647###Presenter###Assistant Professor, Department of Regulatory and Quality Sciences###University of Southern California###Presenter: Susan Bain, DRSc – University of Southern California
###Networking Opportunity
Facilitator: Sarah T. Michel, CSP – Velvet Chainsaw Consulting
Guest Speaker: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
Guest Speaker: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023
Moderator: Megha Iyer, MS, RAC – Thermo Fisher Scientific
Guest Speaker: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Panelist: Iordanis Gravanis, MD, PhD – European Medicines Agency
Panelist: Amin Osmani, MSc – Cedience Inc.
Panelist: Amrit Ray, MD, MBA – Principled Impact
Panelist: Kelly Robinson – Health Canada
Panelist: Janet Woodcock, MD – United States Food and Drug Administration
Facilitator: Sarah T. Michel, CSP (she/her/hers) – Velvet Chainsaw Consulting
### she/her/hers @@@ Bill McMoil – Regulatory Affairs Professionals Society (RAPS) ### 1083161###Guest Speaker###RAPS Executive Director###Regulatory Affairs Professionals Society (RAPS)###Guest Speaker: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
### @@@ 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: Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific ### 1083158###Moderator###Director, Global Strategic Regulatory Affairs###Thermo Fisher Scientific###Moderator: Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific
### she/her/hers @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Guest Speaker###CSO###Qserve Group###Guest Speaker: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
### @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Panelist###Head of Scientific Advice###European Medicines Agency###Panelist: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ Amin Osmani, MSc – Cedience Inc. ### 2098346###Panelist###CEO###Cedience Inc.###Panelist: Amin Osmani, MSc – Cedience Inc.
### @@@ Amrit Ray, MD, MBA (he/him/his) – Principled Impact ### 2098157###Panelist###CEO###Principled Impact###Panelist: Amrit Ray, MD, MBA (he/him/his) – Principled Impact
### he/him/his @@@ Kelly Robinson – Health Canada ### 2135302###Panelist###Director General, Marketed Health Products Directorate###Health Canada###Panelist: Kelly Robinson – Health Canada
### @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: Janet Woodcock, MD – United States Food and Drug Administration
###Networking Opportunity
Networking Opportunity
Networking Opportunity
.png)
Presenter: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
Presenter: Courtney Evans
Presenter: Douglass S. Mead, III, RAC – CP Pathways LLC
Q&A Presenter: Nishchay Gupta – Genentech
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Presenter: Chin-Wei Soo, DRSc, FRAPS (he/him/his) – Genentech and Roche
### he/him/his @@@ Courtney Evans ### 2113017###Presenter#########Presenter: Courtney Evans
### @@@ Douglass S. Mead, III, RAC – CP Pathways LLC ### 1946088###Presenter###Principal Consultant and President###CP Pathways LLC###Presenter: Douglass S. Mead, III, RAC – CP Pathways LLC
### @@@ Nishchay Gupta – Genentech ### 1976635###Q&A Presenter###Senior Regulatory Program Director###Genentech###Q&A Presenter: Nishchay Gupta – Genentech
###Session Leader: Luis Rocha, PhD – Allucent
Presenter (Remote): Kristina Larsson, MSc – European Medicines Agency
Presenter: Punam Sandhu, PhD – Jazz Pharmaceuticals
Presenter: Rivka Zaibel – ADRES, Advanced Regulatory Services Israel Ltd.
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Luis Rocha, PhD – Allucent
### @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Presenter (Remote)###Head of Orphan Drugs###European Medicines Agency###Presenter (Remote): Kristina Larsson, MSc – European Medicines Agency
### @@@ Punam Sandhu, PhD – Jazz Pharmaceuticals ### 1946099###Presenter###Head of Oncology, Global Regulatory Affairs###Jazz Pharmaceuticals###Presenter: Punam Sandhu, PhD – 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: Rivka Zaibel (she/her/hers) – ADRES, Advanced Regulatory Services Israel Ltd.
### she/her/hersModerator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Moderator: Bassil Akra, phD – Akra Team GmbH
Presenter (Remote): Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety
Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: Bassil Akra, phD (he/him/his) – 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): Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Presenter###CSO###Qserve Group###Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
###Moderator: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Presenter: Anabela Marcal – European Medicines Agency
Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
Presenter (Remote): Caroline Pothet – European Medicines Agency
Health Authority Forum
Moderator: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Presenter###EMA Liaison Official to FDA###European Medicines Agency###Presenter: Anabela Marcal – 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: Andrea Laslop, MD – 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: Iordanis Gravanis, MD, PhD (he/him/his) – 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): Caroline Pothet (she/her/hers) – European Medicines Agency
### she/her/hersModerator: Maria A. Apostolaros, JD, PharmD, MS, BSc, RPh, CCEP – PhRMA
Presenter: Robyn Bent, RN, MS – FDA
Presenter: Josh Coulter, MA – Pfizer
Presenter (Remote): Claire Espinasse
Presenter: Nicholas Langevin – Sumitomo Pharma America, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Moderator: Maria A. Apostolaros, JD, PharmD, MS, BSc, RPh, CCEP – PhRMA
### @@@ Robyn Bent, RN, MS (she/her/hers) – FDA ### 1724460###Presenter###FDA/CDER/OCD, Supervisory General Health Scientist###FDA###Presenter: Robyn Bent, RN, MS (she/her/hers) – FDA
### she/her/hers @@@ Josh Coulter, MA (he/him/his) – Pfizer ### 2098133###Presenter###Director, Preference Elicitation###Pfizer###Presenter: Josh Coulter, MA (he/him/his) – Pfizer
### he/him/his @@@ Claire Espinasse ### 2132791###Presenter (Remote)#########Presenter (Remote): Claire Espinasse
### @@@ Nicholas Langevin – Sumitomo Pharma America, Inc. ### 2045398###Presenter###Director, Regulatory Affairs###Sumitomo Pharma America, Inc.###Presenter: Nicholas Langevin – Sumitomo Pharma America, Inc.
###Session Leader: Kimberly A. Trautman, MS – MEDIcept
Presenter: Brian Siroka – MEDIcept Inc.
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Kimberly A. Trautman, MS – MEDIcept
### @@@ Brian Siroka (he/him/his) – MEDIcept Inc. ### 1981335###Presenter###Associate Consultant###MEDIcept Inc.###Presenter: Brian Siroka (he/him/his) – MEDIcept Inc.
### he/him/hisModerator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
Presenter: Brittany Caldwell
Presenter: Ritu Dhami – Network Partners Group
Presenter: Grace Gowda, M.Pharm., PhD, RAC – University of Georgia
Presenter: Elena Kyria – Elemed
Presenter: Brian Savoie – RAPS
Skill Building
Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
### @@@ Brittany Caldwell ### 2122617###Presenter#########Presenter: Brittany Caldwell
### @@@ Ritu Dhami – Network Partners Group ### 1967175###Presenter###Chief of Staff - Strategic Initiatives, NPG###Network Partners Group###Presenter: Ritu Dhami – Network Partners Group
### @@@ Grace Gowda, M.Pharm., PhD, RAC – University of Georgia ### 2009083###Presenter###Director, International Biomedical Regulatory Sciences###University of Georgia###Presenter: Grace Gowda, M.Pharm., PhD, RAC – University of Georgia
### @@@ Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: Elena Kyria (she/her/hers) – Elemed
### she/her/hers @@@ Brian Savoie (he/him/his) – RAPS ### 1967174###Presenter###Sr. Vice President, Education & International Programs###RAPS###Presenter: Brian Savoie (he/him/his) – RAPS
### he/him/hisModerator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
Panelist: Florence Butlen – European Medicines Agency
Panelist: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
### @@@ Florence Butlen – European Medicines Agency ### 2134569###Panelist######European Medicines Agency###Panelist: Florence Butlen – 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: Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials
### she/her/hersNetworking Opportunity
Graduate Student Presenter: Yoon Sik Jung – University of Southern California
Graduate Student Presenter: Yoon Sik Jung – University of Southern California
###Graduate Student Presenter: Saumya Mandaokar – USC
Graduate Student Presenter: Saumya Mandaokar – USC
###Speaker: Padma Govindaiah – ArisGlobal
Speaker: Padma Govindaiah (she/her/hers) – ArisGlobal
### she/her/hersSpeaker: Marcus Torr, MSci – Purdie Pascoe
.png)
Speaker: Marcus Torr, MSci – Purdie Pascoe
###Speaker: Darwin Shurig, RRT, MBA – Shurig Solutions, Inc
.png)
Speaker: Darwin Shurig, RRT, MBA – Shurig Solutions, Inc
###Facilitator: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
Facilitator: Myriam Triest, PhD – CMC-RX Consulting
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
### @@@ Myriam Triest, PhD (she/her/hers) – CMC-RX Consulting ### 2134415###Facilitator###Vice-President###CMC-RX Consulting###Facilitator: Myriam Triest, PhD (she/her/hers) – CMC-RX Consulting
### she/her/hersFacilitator: Farhad Amiri, PhD, FAHA – Parexel International
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Farhad Amiri, PhD, FAHA (he/him/his) – Parexel International
### he/him/hisFacilitator: Guriqbal Singh – Regweb Consulting Services Inc.
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Guriqbal Singh (he/him/his) – Regweb Consulting Services Inc.
### he/him/hisFacilitator: Robert L. Waterland, PhD – Certara Drug Development Solutions
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Robert L. Waterland, PhD (he/him/his) – Certara Drug Development Solutions
### he/him/hisGraduate Student Presenter: Allison Dalton, MSHS – The George Washington University
Graduate Student Presenter: Allison Dalton, MSHS – The George Washington University
###Guest Speaker: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023
Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS – Candel Therapeutics
Guest Speaker: Kimberly Belsky, MS, FRAPS (she/her/hers) – 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: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hersSpeaker: Arpad Lehoczki – GlobalVision
Speaker: Gabriella Naguib – GlobalVision
Speaker: Arpad Lehoczki (he/him/his) – GlobalVision
### he/him/his @@@ Gabriella Naguib – GlobalVision ### 2099715###Speaker###Product Marketing Manager###GlobalVision###Speaker: Gabriella Naguib – GlobalVision
###Speaker: Cameron Carr – Kalypso: A Rockwell Automation Company
Speaker: Mohammed Islaih – Zimmer Biomet
.png)
Speaker: Cameron Carr (he/him/his) – Kalypso: A Rockwell Automation Company
### he/him/his @@@ Mohammed Islaih – Zimmer Biomet ### 2042494###Speaker###Associate Director, RIM###Zimmer Biomet###Speaker: Mohammed Islaih – Zimmer Biomet
###Speaker: Naushad Kapasi – Clarivate
Speaker: Naushad Kapasi (he/him/his) – Clarivate
### he/him/hisNetworking Opportunity
Facilitator: Niels B. Leander, PhD – NNIT
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Niels B. Leander, PhD – NNIT
###Facilitator: Cammilla Gomes – Roche
Facilitator: Pedro Franco, PhD, MSc, PharmD. – Merck KGaA
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Cammilla Gomes – Roche
### @@@ Pedro Franco, PhD, MSc, PharmD. – Merck KGaA ### 1321701###Facilitator###Director of Europe for Global Regulatory & Scientific Policy###Merck KGaA###Facilitator: Pedro Franco, PhD, MSc, PharmD. – Merck KGaA
###Facilitator: Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease
Solutions Circle
Facilitator: Joao Duarte, MSc MPharm (he/him/his) – Alexion, AstraZeneca Rare Disease
### he/him/hisFacilitator: Hamish King, RAC, LLB – Cisema
Facilitator: Victoria Caldy – Cisema
Solutions Circle
Facilitator: Hamish King, RAC, LLB – Cisema
### @@@ Victoria Caldy (she/her/hers) – Cisema ### 1945635###Facilitator###Business Development & Marketing Director###Cisema###Facilitator: Victoria Caldy (she/her/hers) – Cisema
### she/her/hersGraduate Student Presenter: Jingrui Li – The University of Southern California
Graduate Student Presenter: Jingrui Li – The University of Southern California
###Speaker: Kim Kaplan, BS, MA – ISACA
Speaker: Kim Kaplan, BS, MA (she/her/hers) – ISACA
### she/her/hersSpeaker: Jay Crowley, MS – USDM Life Sciences
Speaker: Scott Brown – 1WorldSync, Inc.
Speaker: Jay Crowley, MS – USDM Life Sciences
### @@@ Scott Brown (he/him/his) – 1WorldSync, Inc. ### 2128166###Speaker###Sr. Director Global Data Standards###1WorldSync, Inc.###Speaker: Scott Brown (he/him/his) – 1WorldSync, Inc.
### he/him/hisSpeaker: James Gianoutsos, MBA – Rimsys
Speaker: James Gianoutsos, MBA – Rimsys
###Guest Speaker: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Guest Speaker: Lawrence E. Liberti, MSc, PhD
Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS – Candel Therapeutics
Guest Speaker: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Lawrence E. Liberti, MSc, PhD ### 1046359###Guest Speaker###Head, Regulatory Collaborations######Guest Speaker: Lawrence E. Liberti, MSc, PhD
### @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho ### 1642067###Guest Speaker###Sr. Director, Reg. Affairs###QuidelOrtho###Guest Speaker: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Guest Speaker###Chief Regulatory Officer###Candel Therapeutics###Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hersGuest Speaker: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Guest Speaker: Lawrence E. Liberti, MSc, PhD
Guest Speaker: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Lawrence E. Liberti, MSc, PhD ### 1046359###Guest Speaker###Head, Regulatory Collaborations######Guest Speaker: Lawrence E. Liberti, MSc, PhD
###Networking Opportunity
Facilitator: Lucy Tan, MBA – Abbott
Facilitator: Jenny Chan, MS, RAC, PMP – Abbott
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Facilitator: Lucy Tan, MBA (she/her/hers) – Abbott
### she/her/hers @@@ Jenny Chan, MS, RAC, PMP – Abbott ### 1945628###Facilitator###Associate Director Regulatory Affairs###Abbott###Facilitator: Jenny Chan, MS, RAC, PMP – Abbott
###Facilitator: Alex W. Smith, RAC, MBA – Hogan Lovells LLP
Solutions Circle
Facilitator: Alex W. Smith, RAC, MBA – Hogan Lovells LLP
###Facilitator: Jamie L. Robinson, RAC, MBA – Genentech, Inc.
Solutions Circle
Facilitator: Jamie L. Robinson, RAC, MBA (she/her/hers) – Genentech, Inc.
### she/her/hersFacilitator: Cham Williams, MS – IQVIA
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Facilitator: Cham Williams, MS (he/him/his) – IQVIA
### he/him/hisSpeaker: Nynne DeNiro – Acolad Life Sciences
Speaker: Stephane Millet – Acolad Life Sciences
Speaker: Nynne DeNiro (she/her/hers) – Acolad Life Sciences
### she/her/hers @@@ Stephane Millet – Acolad Life Sciences ### 2105796###Speaker###Director of Strategic Accounts – Patient Engagement Solutions###Acolad Life Sciences###Speaker: Stephane Millet – Acolad Life Sciences
###Speaker: Ken Pilgrim – Emergo by UL
.png)
Speaker: Ken Pilgrim (he/him/his) – Emergo by UL
### he/him/hisSpeaker: Michelle Wu – NyquistAI
Speaker: Michelle Wu – NyquistAI
###Speaker: Ludger Moeller – MDSS GmbH
.png)
Speaker: Ludger Moeller (he/him/his) – MDSS GmbH
### he/him/hisSpeaker: Jocelyn Zhu – BradyKnows Medical Group
.png)
Speaker: Jocelyn Zhu – BradyKnows Medical Group
###Speaker: Melissa Stefko, MBA, MS, RAC, ASQ CPGP & CQA – The FlexPro Group
Speaker: Lisa Hawkins, ASQ CMQOE – Network Partners
Speaker: Philipp Papadopoulos – The FlexPro Group
Speaker: Melissa Stefko, MBA, MS, RAC, ASQ CPGP & CQA – The FlexPro Group
### @@@ Lisa Hawkins, ASQ CMQOE (she/her/hers) – Network Partners ### 2102862###Speaker###Senior Director of Regulatory###Network Partners###Speaker: Lisa Hawkins, ASQ CMQOE (she/her/hers) – 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: Philipp Papadopoulos (he/him/his) – The FlexPro Group
### he/him/hisFacilitator: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: jayanth K. Katta, PhD – BSI
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Facilitator: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
### @@@ jayanth K. Katta, PhD – BSI ### 907116###Presenter###Regulatory Director & Head of Medical Devices Notified Body###BSI###Presenter: jayanth K. Katta, PhD – BSI
###Speaker: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
Career Central Stage
Speaker: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
###Facilitator: Diane M. Ward, PhD – Qserve Group US
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Facilitator: Diane M. Ward, PhD (she/her/hers) – Qserve Group US
### she/her/hersSpeaker: Jocelyn Jennings – Mycovia Pharmaceuticals, Inc.
Speaker: William Sietsema, PhD – Lisata Therapeutics
RAPS Store Stage
Speaker: Jocelyn Jennings – Mycovia Pharmaceuticals, Inc.
### @@@ William Sietsema, PhD (he/him/his) – Lisata Therapeutics ### 573564###Speaker###Vice President, Global Regulatory Affairs###Lisata Therapeutics###Speaker: William Sietsema, PhD (he/him/his) – Lisata Therapeutics
### he/him/hisFacilitator: Rosanne Middleton – Lifescan
Facilitator: Dinar Suleman, RAC – Lifescan
Solutions Circle
Skill Building
Facilitator: Rosanne Middleton – Lifescan
### @@@ Dinar Suleman, RAC – Lifescan ### 1374645###Facilitator###Manager Regulatory Policy, Intelligence & Ad/ Promo###Lifescan###Facilitator: Dinar Suleman, RAC – Lifescan
###Facilitator: Kimberly A. Trautman, MS – MEDIcept
Facilitator: Richelle Helman, RAC – MEDIcept
Solutions Circle
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Facilitator: Kimberly A. Trautman, MS – MEDIcept
### @@@ Richelle Helman, RAC (she/her/hers) – MEDIcept ### 1945644###Facilitator###Senior Director###MEDIcept###Facilitator: Richelle Helman, RAC (she/her/hers) – MEDIcept
### she/her/hersNetworking Opportunity
Session Leader: Jennifer Ng Ain Kin – Abbott Laboratories
Presenter: Hillary VanderBand, MBA – Abbott Laboratories
Presenter: Erik R. Vollebregt – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Jennifer Ng Ain Kin (she/her/hers) – Abbott Laboratories
### she/her/hers @@@ Hillary VanderBand, MBA – Abbott Laboratories ### 1946004###Presenter###Group Manager, Digital Marketing###Abbott Laboratories###Presenter: Hillary VanderBand, MBA – Abbott Laboratories
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: Erik R. Vollebregt – Axon Lawyers
###Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
Moderator: Susan Stewart, JD, LLM, RAC, FRAPS – Candel Therapeutics
Panelist: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
Panelist: Alysha Croker, PhD – Health Canada
Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Panelist: Karl-Heinz Huemer, MD, PhD – khhconsulting
Panelist: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Panelist: Anabela Marcal – European Medicines Agency
Panelist: Janet Woodcock, MD – United States Food and Drug Administration
Presenter (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration
Conversations That Matter
Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Moderator###Chief Regulatory Officer###Candel Therapeutics###Moderator: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – 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: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
### @@@ Alysha Croker, PhD (she/her/hers) – Health Canada ### 1728926###Panelist###Director, Centre for Policy, Pediatrics and International Collaboration###Health Canada###Panelist: Alysha Croker, PhD (she/her/hers) – Health Canada
### she/her/hers @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Panelist###Global Director Regulatory Strategy###TÜV SÜD###Panelist: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Panelist###Consultant###khhconsulting###Panelist: Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting
### he/him/his @@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Panelist###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Panelist: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Panelist###EMA Liaison Official to FDA###European Medicines Agency###Panelist: Anabela Marcal – European Medicines Agency
### @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: Janet Woodcock, MD – United States Food and Drug Administration
### @@@ 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): Peter W. Marks, MD, PhD – United States Food and Drug Administration
###Session Leader: Hamish King, RAC, LLB – Cisema
Presenter: Helen Ye, n/a – Accestra Consulting
Presenter: Veena CHORGHADE – PTC Therapeutics, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Hamish King, RAC, LLB – Cisema
### @@@ Helen Ye, n/a – Accestra Consulting ### 1946095###Presenter###Regulatory Affairs Director###Accestra Consulting###Presenter: Helen Ye, n/a – Accestra Consulting
### @@@ Veena CHORGHADE – PTC Therapeutics, Inc. ### 2043304###Presenter###Exec Director###PTC Therapeutics, Inc.###Presenter: Veena CHORGHADE – PTC Therapeutics, Inc.
###Session Leader: Junyang Wang – EMD Serono
Presenter: Jill Lee, JD – Novo Nordisk
Presenter (Remote): Elizabeth Kunkoski, MS – FDA
Presenter (Remote): Andrew Potter, PhD – US FDA
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Session Leader: Junyang Wang – EMD Serono
### @@@ Jill Lee, JD (she/her/hers) – Novo Nordisk ### 2075482###Presenter###Senior Director###Novo Nordisk###Presenter: Jill Lee, JD (she/her/hers) – Novo Nordisk
### she/her/hers @@@ Elizabeth Kunkoski, MS – FDA ### 2102867###Presenter (Remote)###Health Science Policy Analyst###FDA###Presenter (Remote): Elizabeth Kunkoski, MS – FDA
### @@@ Andrew Potter, PhD (he/him/his) – US FDA ### 2098160###Presenter (Remote)###Mathematical Statistician###US FDA###Presenter (Remote): Andrew Potter, PhD (he/him/his) – US FDA
### he/him/hisSession Leader: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
Moderator: Khushboo Sharma, MBA – Accumulus Synergy
Presenter: Derrick Gingery – The Pink Sheet
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Alexander Gaffney, MS, RAC (he/him/his) – POLITICO's AgencyIQ
### he/him/his @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Moderator###Chief Regulatory Innovation Officer###Accumulus Synergy###Moderator: Khushboo Sharma, MBA – Accumulus Synergy
### @@@ Derrick Gingery (he/him/his) – The Pink Sheet ### 1946089###Presenter###Senior Writer###The Pink Sheet###Presenter: Derrick Gingery (he/him/his) – The Pink Sheet
### he/him/hisSession Leader: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy
Moderator: Amra Racic – Veeva Systems
Skill Building
Session Leader: Monika McDole-Russell, MS, RAC (she/her/hers) – Medtronic Endoscopy
### she/her/hers @@@ Amra Racic – Veeva Systems ### 535477###Moderator###Sr. Director Global Government Affairs###Veeva Systems###Moderator: Amra Racic – Veeva Systems
###Moderator: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific
Presenter: Scott Goates, PhD. – Abbott
Presenter: Korinne Jew, PhD – Medtronic
Presenter: Alexandra Massoud – Exact Sciences
Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific
### @@@ Scott Goates, PhD. (he/him/his) – Abbott ### 1946000###Presenter###Director, Health Economics, Global Data Science and Analytics###Abbott###Presenter: Scott Goates, PhD. (he/him/his) – Abbott
### he/him/his @@@ Korinne Jew, PhD (she/her/hers) – Medtronic ### 1945998###Presenter###Senior Director, Enterprise Clinical Research & Medical Science###Medtronic###Presenter: Korinne Jew, PhD (she/her/hers) – Medtronic
### she/her/hers @@@ Alexandra Massoud (she/her/hers) – Exact Sciences ### 1945999###Presenter###VP, Clinical Affairs###Exact Sciences###Presenter: Alexandra Massoud (she/her/hers) – 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): Michelle Tarver, MD, PhD (she/her/hers) – U.S. Food and Drug Administration/ CDRH
### she/her/hersSession Leader: Brian Scogland, MS, MBA – Veeva MedTech
Presenter: Jay Crowley, MS – USDM Life Sciences
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Brian Scogland, MS, MBA – Veeva MedTech
### @@@ Jay Crowley, MS – USDM Life Sciences ### 1631712###Presenter###Vice President Medical Device Solutions and Services###USDM Life Sciences###Presenter: Jay Crowley, MS – USDM Life Sciences
###Networking Opportunity
Moderator: Amra Racic – Veeva Systems
Presenter: Sally Prawdzik – Health Canada
Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Amra Racic – Veeva Systems
### @@@ Sally Prawdzik (she/her/hers) – Health Canada ### 2119758###Presenter###Acting Director of Policy and International Programs###Health Canada###Presenter: Sally Prawdzik (she/her/hers) – Health Canada
### 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): Michelle Tarver, MD, PhD (she/her/hers) – U.S. Food and Drug Administration/ CDRH
### she/her/hersPresenter: David Hinds, MHS – BioMarin Pharmaceutical Inc.
Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Presenter: Mayss Naccache, MSc – World Federation of Hemophilia
Presenter (Remote): Kelly Plueschke – European Medicines Agency (EMA)
Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Presenter: David Hinds, MHS (he/him/his) – 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: Andrea Laslop, MD – 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: Mayss Naccache, MSc (she/her/hers) – 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): Kelly Plueschke (she/her/hers) – 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: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
###Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Moderator: Bassil Akra, phD – Akra Team GmbH
Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Andreas Stange – TUV SUD
Presenter: Catherine Holzmann – GMED Certification Division
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: Bassil Akra, phD (he/him/his) – Akra Team GmbH
### he/him/his @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
### @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
### @@@ Andreas Stange (he/him/his) – TUV SUD ### 1187582###Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD###Presenter: Andreas Stange (he/him/his) – TUV SUD
### he/him/his @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: Catherine Holzmann – GMED Certification Division
###Presenter: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
Moderator: Amra Racic – Veeva Systems
Presenter: Laura DiAngelo, MPH – POLITICO's AgencyIQ
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: Alexander Gaffney, MS, RAC (he/him/his) – POLITICO's AgencyIQ
### he/him/his @@@ Amra Racic – Veeva Systems ### 535477###Moderator###Sr. Director Global Government Affairs###Veeva Systems###Moderator: Amra Racic – Veeva Systems
### @@@ Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ ### 1417843###Presenter###Director, Research###POLITICO's AgencyIQ###Presenter: Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ
### she/her/hersPresenter: Jamie L. Robinson, RAC, MBA – Genentech, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Presenter: Jamie L. Robinson, RAC, MBA (she/her/hers) – Genentech, Inc.
### she/her/hersPresenter: Monika Bhatt, LL.M, RAC – Siemens Healthineers
Presenter: Kenneth Fuh, PhD – TÜV SÜD GmbH
Moderator: Erik R. Vollebregt – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: Monika Bhatt, LL.M, RAC (she/her/hers) – Siemens Healthineers
### she/her/hers @@@ Kenneth Fuh, PhD (he/him/his) – TÜV SÜD GmbH ### 1947083###Presenter###Product Assessment Expert###TÜV SÜD GmbH###Presenter: Kenneth Fuh, PhD (he/him/his) – TÜV SÜD GmbH
### he/him/his @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Moderator###Partner###Axon Lawyers###Moderator: Erik R. Vollebregt – Axon Lawyers
###Session Leader: Kimberly Benton, PhD – Dark Horse Consulting Group
Presenter: Kirsten Messmer, PhD, RAC – POLITICO’s AgencyIQ
Presenter (Remote): Caroline Pothet – European Medicines Agency
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Kimberly Benton, PhD (she/her/hers) – Dark Horse Consulting Group
### she/her/hers @@@ Kirsten Messmer, PhD, RAC – POLITICO’s AgencyIQ ### 595312###Presenter###Senior Research Analyst###POLITICO’s AgencyIQ###Presenter: Kirsten Messmer, PhD, RAC – 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): Caroline Pothet (she/her/hers) – European Medicines Agency
### she/her/hersSession Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
Presenter: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.
Skill Building
Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – 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: Linda Bowen, MSc, RAC, FRAPS (she/her/hers) – Seagen Inc.
### she/her/hersModerator: Adriana Racolta, PhD, RAC – Seagen, Inc
Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
Presenter: Christine Mayer-Nicolai, PhD – Merck KGaA, Darmstadt, Germany
Presenter: Mike Wierzba, PhD – GSK
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Moderator: Adriana Racolta, PhD, RAC (she/her/hers) – 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: Iordanis Gravanis, MD, PhD (he/him/his) – 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: Christine Mayer-Nicolai, PhD (she/her/hers) – 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: Mike Wierzba, PhD (he/him/his) – GSK
### he/him/hisSession Leader: Jeff Holzman – Item Alignment Inc.
Presenter: Jay Crowley, MS – USDM Life Sciences
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Jeff Holzman (he/him/his) – 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: Jay Crowley, MS – USDM Life Sciences
###Session Leader: Paul A. Wardle, MA, MMath – Beacon Associates, LLC
Presenter: Danielle Terrell, PharmD, JD, MS, RAC U.S. – Food and Drug Administration
Presenter (Remote): Elisabeth Walther, PharmD, JD – US Food and Drug Administration
Presenter: Alfred Whitehead, MAs, MS – Klick Consulting
Moderator: Erin Oliver, MS, MBA, FRAPS – Haleon
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Paul A. Wardle, MA, MMath – 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: Danielle Terrell, PharmD, JD, MS, RAC U.S. – 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): Elisabeth Walther, PharmD, JD (she/her/hers) – 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: Alfred Whitehead, MAs, MS (he/him/his) – Klick Consulting
### he/him/his @@@ Erin Oliver, MS, MBA, FRAPS – Haleon ### 1007343###Moderator###Vice President, Regulatory Affairs###Haleon###Moderator: Erin Oliver, MS, MBA, FRAPS – Haleon
###Moderator: Linda McBride, R.PH, RAC – IAA Consulting LLC
Presenter (Remote): Kevin B. Bugin, PhD, MS, RAC (US) – FDA
Presenter (Remote): Christopher Joneckis, PhD – US FDA
Presenter (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration
Health Authority Forum
Moderator: Linda McBride, R.PH, RAC – IAA Consulting LLC
### @@@ Kevin B. Bugin, PhD, MS, RAC (US) – FDA ### 2063738###Presenter (Remote)###Deputy Director###FDA###Presenter (Remote): Kevin B. Bugin, PhD, MS, RAC (US) – FDA
### @@@ Christopher Joneckis, PhD (he/him/his) – US FDA ### 601550###Presenter (Remote)###Associate Director For Review Management/ Director Office of regulatory Operations, CBER###US FDA###Presenter (Remote): Christopher Joneckis, PhD (he/him/his) – US FDA
### he/him/his @@@ 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): Peter W. Marks, MD, PhD – United States Food and Drug Administration
###Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
Presenter: Sarah Bly – Worldwide Clinical Trials
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – 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: Sarah Bly (she/her/hers) – Worldwide Clinical Trials
### she/her/hersSession Leader: Matthias Fink, MD – Akra Team GmbH
Presenter: Tonia Jeiter, Dr. med. – TÜV SÜD Product Service GmbH
Presenter: Richard G. Holborow, BSc (Hons) MSCST RCCP – BSI Notified Body (NL)
Presenter: Christoph Ziskoven – TÜV Rheinland LGA Products GmbH
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Matthias Fink, MD – 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: Tonia Jeiter, Dr. med. (she/her/hers) – 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: Richard G. Holborow, BSc (Hons) MSCST RCCP (he/him/his) – 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: Christoph Ziskoven (he/him/his) – TÜV Rheinland LGA Products GmbH
### he/him/hisPresenter: Antonella Lozito, PharmD – Moderna
Presenter: Immo Zdrojewski – Moderna
Biopharmaceuticals (includes Biologics and Drugs)
Presenter: Antonella Lozito, PharmD – Moderna
### @@@ Immo Zdrojewski – Moderna ### 1946111###Presenter###Head Global Regulatory Policy and Regulatory Intelligence###Moderna###Presenter: Immo Zdrojewski – Moderna
###Presenter: Rita Lin – Agilis by Kymanox
Devices (includes Medical Devices and In Vitro Diagnostics)
Program Committee: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda
### she/her/hers @@@ Rita Lin (she/her/hers) – Agilis by Kymanox ### 2128307###Presenter###Dir. of Human Factors Engineering###Agilis by Kymanox###Presenter: Rita Lin (she/her/hers) – Agilis by Kymanox
### she/her/hersNetworking Opportunity
.png)
Networking Opportunity
Networking Opportunity
Networking Opportunity
Networking Opportunity
Session Leader: Brittany Gerald – Moderna
Presenter (Remote): Jamie Gamerman, JD – FDA
Presenter: Mary Nwokedi, PharmD – PhRMA
Presenter: Immo Zdrojewski – Moderna
Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Brittany Gerald – Moderna
### @@@ Jamie Gamerman, JD (she/her/hers) – FDA ### 2123199###Presenter (Remote)###Senior Policy Advisor###FDA###Presenter (Remote): Jamie Gamerman, JD (she/her/hers) – FDA
### she/her/hers @@@ Mary Nwokedi, PharmD – PhRMA ### 2078161###Presenter###Director of Diversity in Clinical Trials ###PhRMA ###Presenter: Mary Nwokedi, PharmD – PhRMA
### @@@ Immo Zdrojewski – Moderna ### 1946111###Presenter###Head Global Regulatory Policy and Regulatory Intelligence###Moderna###Presenter: Immo Zdrojewski – Moderna
### @@@ Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc. ### 1946971###Moderator###Director for US Regulatory Policy###BioMarin Pharmaceuticals, Inc.###Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
###Presenter: Derecka Alexander, MPH, DVM – American Association for the Advancement of Science/USDA
Presenter: Marcus S. Delatte, PhD – Allucent
Presenter: Owen McMaster, PhD – Food and Drug Administration
Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)
Presenter: Derecka Alexander, MPH, DVM (she/her/hers) – American Association for the Advancement of Science/USDA
### she/her/hers @@@ Marcus S. Delatte, PhD – Allucent ### 1946005###Presenter###Vice President, Regulatory Strategy###Allucent###Presenter: Marcus S. Delatte, PhD – Allucent
### @@@ Owen McMaster, PhD – Food and Drug Administration ### 1946008###Presenter###Senior Pharmacologist/Toxicologist###Food and Drug Administration###Presenter: Owen McMaster, PhD – Food and Drug Administration
###Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
Moderator: Susan Stewart, JD, LLM, RAC, FRAPS – Candel Therapeutics
Panelist: Iordanis Gravanis, MD, PhD – European Medicines Agency
Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Panelist: Sally Prawdzik – Health Canada
Panelist: Kimberly A. Trautman, MS – MEDIcept
Conversations That Matter
Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Moderator###Chief Regulatory Officer###Candel Therapeutics###Moderator: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – 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: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Panelist###Global Director Regulatory Strategy###TÜV SÜD###Panelist: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Sally Prawdzik (she/her/hers) – Health Canada ### 2119758###Panelist###Acting Director of Policy and International Programs###Health Canada###Panelist: Sally Prawdzik (she/her/hers) – Health Canada
### she/her/hers @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Panelist###Managing Director and Vice President###MEDIcept###Panelist: Kimberly A. Trautman, MS – MEDIcept
###Session Leader: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA – Takeda
Presenter (Remote): Theresa Jeary, BSc (Hons), MSc – BSI Group
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda
### she/her/hers @@@ Theresa Jeary, BSc (Hons), MSc – BSI Group ### 535537###Presenter (Remote)###Principal Technical Specialist ###BSI Group###Presenter (Remote): Theresa Jeary, BSc (Hons), MSc – BSI Group
###Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Presenter: Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH
Presenter: Robin McMillan – Abbott
Presenter: Tom Patten – NSAI
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
### @@@ Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH ### 2043917###Presenter###Head of Medical Devices###Dr. Ebeling & Assoc. GmbH###Presenter: Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH
### @@@ Robin McMillan – Abbott ### 2122612###Presenter###Senior Regulatory Affairs Specialist###Abbott###Presenter: Robin McMillan – Abbott
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
###Session Leader: Mona Desai – Desai RA Consultants, LLC
Presenter: Free Peay, RAC, Global – Peay Regulatory Affairs Consulting, LLC
Presenter: Tabitha Elmore – Pharming Healthcare, Inc.
Presenter: Kamana Singh, DVM, MMB, MBA, RAC(US) – APS Pharma Solutions, LLC
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Session Leader: Mona Desai (she/her/hers) – 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: Free Peay, RAC, Global (she/her/hers) – 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: Tabitha Elmore – 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: Kamana Singh, DVM, MMB, MBA, RAC(US) (she/her/hers) – APS Pharma Solutions, LLC
### she/her/hersSession Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
Presenter: Sarah Bly – Worldwide Clinical Trials
Presenter: Anabela Marcal – European Medicines Agency
Presenter: Ben Kaspar – MMS Holdings
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – 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: Sarah Bly (she/her/hers) – Worldwide Clinical Trials
### she/her/hers @@@ Anabela Marcal – European Medicines Agency ### 1061464###Presenter###EMA Liaison Official to FDA###European Medicines Agency###Presenter: Anabela Marcal – European Medicines Agency
### @@@ Ben Kaspar (he/him/his) – MMS Holdings ### 1946100###Presenter###Director, Regulatory Affairs###MMS Holdings###Presenter: Ben Kaspar (he/him/his) – MMS Holdings
### he/him/hisSession Leader: Michelle Lynn Jump, MS, MSRS, ISO/TC 215 convener, RAPS instructor – MEDSEC
Presenter (Remote): Suzanne Schwartz, MD, MBA – US FDA
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Michelle Lynn Jump, MS, MSRS, ISO/TC 215 convener, RAPS instructor – 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): Suzanne Schwartz, MD, MBA (she/her/hers) – US FDA
### she/her/hersKeynote Speaker: Janice Chang – TransCelerate BioPharma Inc.
Panelist: Ginny Beakes-Read, JD – Janssen Pharmaceuticals
Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Christine Mayer-Nicolai, PhD – Merck KGaA, Darmstadt, Germany
Panelist: Janet Woodcock, MD – United States Food and Drug Administration
Keynote Speaker: Janice Chang – TransCelerate BioPharma Inc.
### @@@ Ginny Beakes-Read, JD – Janssen Pharmaceuticals ### 2122616###Panelist###VP, Global Regulatory Policy and Intelligence###Janssen Pharmaceuticals###Panelist: Ginny Beakes-Read, JD – Janssen Pharmaceuticals
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: Sabine Haubenreisser, MSc, PhD – 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: Christine Mayer-Nicolai, PhD (she/her/hers) – 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: Janet Woodcock, MD – United States Food and Drug Administration
###Networking Opportunity
Graduate Student Presenter: Yoon Sik Jung – University of Southern California
Graduate Student Presenter: Yoon Sik Jung – University of Southern California
###Graduate Student Presenter: Saumya Mandaokar – USC
Graduate Student Presenter: Saumya Mandaokar – USC
###Speaker: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
Speaker: Rani Maloney, MBA, PMP, RAC – Integrated Project Management
Speaker: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
### @@@ Rani Maloney, MBA, PMP, RAC – Integrated Project Management ### 1945637###Speaker###Senior Consultant###Integrated Project Management###Speaker: Rani Maloney, MBA, PMP, RAC – Integrated Project Management
###Speaker: Marielle Lejcher, CORe-Credential of Readiness in Business from Harvard Business School (HBS) – Fang Consulting
Speaker: Marielle Lejcher, CORe-Credential of Readiness in Business from Harvard Business School (HBS) – Fang Consulting
###Speaker: Heather Graham – Certara
Speaker: Trevor Standish – Certara
Speaker: Heather Graham – Certara
### @@@ Trevor Standish – Certara ### 2131942###Speaker###Director, Product Management###Certara###Speaker: Trevor Standish – Certara
###Facilitator: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
Facilitator: Sarah Bly – Worldwide Clinical Trials
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Facilitator: Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – 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: Sarah Bly (she/her/hers) – Worldwide Clinical Trials
### she/her/hersFacilitator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Facilitator: Matthias Fink, MD – Akra Team GmbH
Facilitator: Bassil Akra, phD – Akra Team GmbH
Facilitator: GERRIT WILLEM BOS, FRAPS – Qservegroup
Facilitator: Suzanne Halliday, MSc. D.Phil. – BSI
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Facilitator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Matthias Fink, MD – Akra Team GmbH ### 1945993###Facilitator###Senior Clinical Consultant###Akra Team GmbH###Facilitator: Matthias Fink, MD – Akra Team GmbH
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Facilitator###Chief Executive Officer###Akra Team GmbH###Facilitator: Bassil Akra, phD (he/him/his) – Akra Team GmbH
### he/him/his @@@ GERRIT WILLEM BOS, FRAPS – Qservegroup ### 1187552###Facilitator###Executive director & partner###Qservegroup###Facilitator: GERRIT WILLEM BOS, FRAPS – Qservegroup
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Facilitator###VP Regulatory###BSI###Facilitator: Suzanne Halliday, MSc. D.Phil. – BSI
###Facilitator: Linda McBride, R.PH, RAC – IAA Consulting LLC
Facilitator: Karl-Heinz Huemer, MD, PhD – khhconsulting
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Facilitator: Linda McBride, R.PH, RAC – IAA Consulting LLC
### @@@ Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Facilitator###Consultant###khhconsulting###Facilitator: Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting
### he/him/hisFacilitator: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
Facilitator: Nishchay Gupta – Genentech
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Facilitator: Chin-Wei Soo, DRSc, FRAPS (he/him/his) – Genentech and Roche
### he/him/his @@@ Nishchay Gupta – Genentech ### 1976635###Facilitator###Senior Regulatory Program Director###Genentech###Facilitator: Nishchay Gupta – Genentech
###Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS – Candel Therapeutics
Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
Guest Speaker: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hers @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
###Presenter: Dhritikshama Roy, PhD – Essenvia
Presenter: Soumya Mahapatra – Essenvia
Presenter: Dhritikshama Roy, PhD (she/her/hers) – Essenvia
### she/her/hers @@@ Soumya Mahapatra (he/him/his) – Essenvia ### 2122586###Presenter###CEO & Founder###Essenvia###Presenter: Soumya Mahapatra (he/him/his) – Essenvia
### he/him/hisSpeaker: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
Speaker: Laura DiAngelo, MPH – POLITICO's AgencyIQ
.png)
Speaker: Alexander Gaffney, MS, RAC (he/him/his) – POLITICO's AgencyIQ
### he/him/his @@@ Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ ### 1417843###Speaker###Director, Research###POLITICO's AgencyIQ###Speaker: Laura DiAngelo, MPH (she/her/hers) – POLITICO's AgencyIQ
### she/her/hersNetworking Opportunity
Speaker: Waylon Wright – Celegence
Speaker: Joy Greidanus – Celegence
Speaker: Waylon Wright – Celegence
### @@@ Joy Greidanus – Celegence ### 2159070###Speaker###Medical Device Services Director###Celegence###Speaker: Joy Greidanus – Celegence
###Facilitator: Yoshiko Stowell, PhD – Neuron23, Inc.
Facilitator: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
Solutions Circle
Skill Building
Facilitator: Yoshiko Stowell, PhD – 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: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
###RAPS Store Stage
Facilitator: Junyang Wang – EMD Serono
Facilitator: Jill Lee, JD – Novo Nordisk
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Facilitator: Junyang Wang – EMD Serono
### @@@ Jill Lee, JD (she/her/hers) – Novo Nordisk ### 2075482###Facilitator###Senior Director###Novo Nordisk###Facilitator: Jill Lee, JD (she/her/hers) – Novo Nordisk
### she/her/hersFacilitator: Mona Desai – Desai RA Consultants, LLC
Solutions Circle
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Facilitator: Mona Desai (she/her/hers) – Desai RA Consultants, LLC
### she/her/hersFacilitator: Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease
Solutions Circle
Facilitator: Joao Duarte, MSc MPharm (he/him/his) – Alexion, AstraZeneca Rare Disease
### he/him/hisSpeaker: Ryan Gooley, MBA – Sedgwick
Speaker: Ryan Gooley, MBA (he/him/his) – Sedgwick
### he/him/hisSpeaker: Claire Dyson – DQS Medizinprodukte UK Ltd
Speaker: Szymon Kurdyn – DQS Medizinprodukte GmbH
Speaker: Claire Dyson – DQS Medizinprodukte UK Ltd
### @@@ Szymon Kurdyn – DQS Medizinprodukte GmbH ### 2099572###Speaker###Head of Notified Body###DQS Medizinprodukte GmbH###Speaker: Szymon Kurdyn – DQS Medizinprodukte GmbH
###Speaker: Linda Moon, MPhil. – BSI Group
Speaker: Linda Moon, MPhil. (she/her/hers) – BSI Group
### she/her/hersSpeaker: Thomas Hutchinson, MS RAC FRAPS – QRE MedTech LLC
Speaker: Lindsey Summers, MBA – Day One Biopharmaceuticals
Career Central Stage
Speaker: Thomas Hutchinson, MS RAC FRAPS – QRE MedTech LLC
### @@@ Lindsey Summers, MBA – Day One Biopharmaceuticals ### 802197###Speaker###Sr Talent Acquisition Partner###Day One Biopharmaceuticals###Speaker: Lindsey Summers, MBA – Day One Biopharmaceuticals
###Guest Speaker: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023
Guest Speaker: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
Guest Speaker: Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023
### she/her/hers @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Guest Speaker###Partner###NDA Partners###Guest Speaker: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
### @@@ Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC ### 609884###Guest Speaker###Principal Consultant###Salditt Regulatory Consulting LLC###Guest Speaker: Diana Salditt, FRAPS – Salditt Regulatory Consulting LLC
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Guest Speaker###Managing Director and Vice President###MEDIcept###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
###Networking Opportunity
Facilitator: Azam Khorshidi – DEKRA
Facilitator: Catherine Holzmann – GMED Certification Division
Facilitator: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Facilitator: Azam Khorshidi – DEKRA
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Facilitator###IVDMD Department Manager###GMED Certification Division###Facilitator: Catherine Holzmann – 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: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
###Facilitator: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Facilitator: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Facilitator###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Facilitator: Kathy Herzog, BSME – DuVal & Associates, P.A.
###Facilitator: Rani Maloney, MBA, PMP, RAC – Integrated Project Management
Facilitator: Gregory L. Palagi, PMP DASM CSM – Integrated Project Management, Inc.
Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
Solutions Circle
Skill Building
Facilitator: Rani Maloney, MBA, PMP, RAC – 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: Gregory L. Palagi, PMP DASM CSM (he/him/his) – Integrated Project Management, Inc.
### he/him/his @@@ Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS ### 1763591###Facilitator###Director of Credentialing###RAPS###Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
###Facilitator: Chris Whalley, cwhalley@seagen.com – Seattle Genetics
Solutions Circle
Skill Building
Facilitator: Chris Whalley, cwhalley@seagen.com – Seattle Genetics
###Speaker: Bridget Wiseman – IQVIA
Speaker: Bridget Wiseman – IQVIA
###Speaker: Immo Zdrojewski – Moderna
Speaker: Immo Zdrojewski – Moderna
###Speaker: Jonathan Gimbel, PhD – RQM+
Speaker: Torrie DeGennaro – RQM+
Speaker: Jonathan Gimbel, PhD – RQM+
### @@@ Torrie DeGennaro – RQM+ ### 2134412###Speaker###Principal, Consulting Services###RQM+###Speaker: Torrie DeGennaro – RQM+
###Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
Guest Speaker: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
Guest Speaker: Kimberly A. Trautman, MS – MEDIcept
### @@@ Daniela Drago, PhD, RAC, FRAPS – NDA Partners ### 535534###Guest Speaker###Partner###NDA Partners###Guest Speaker: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
###Speaker: Gary Saner – LexisNexis Reed Tech
Speaker: Gary Saner – LexisNexis Reed Tech
###Speaker: Erez Kaminski, MS, MBA – Ketryx Corporation
.png)
Speaker: Erez Kaminski, MS, MBA (he/him/his) – Ketryx Corporation
### he/him/hisFacilitator: Anja Wiersma, PhD – mi-CE consultancy
Facilitator: Tom Patten – NSAI
Facilitator: Stefan Burde, PhD – TÜV SÜD America Inc.
Solutions Circle
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Facilitator: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
### she/her/hers @@@ Tom Patten – NSAI ### 1141749###Facilitator###Certification & Inspection Officer - IVD###NSAI###Facilitator: Tom Patten – NSAI
### @@@ Stefan Burde, PhD – TÜV SÜD America Inc. ### 2129429###Facilitator###Director Global Focus Team IVD###TÜV SÜD America Inc.###Facilitator: Stefan Burde, PhD – TÜV SÜD America Inc.
###Speaker: Linda McBride, R.PH, RAC – IAA Consulting LLC
RAPS Store Stage
Speaker: Linda McBride, R.PH, RAC – IAA Consulting LLC
###Facilitator: Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC
Solutions Circle
Skill Building
Facilitator: Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC
###Networking Opportunity
Speaker: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
Speaker: Emily Nesbitt
Career Central Stage
Speaker: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
### @@@ Emily Nesbitt ### 2160140###Speaker#########Speaker: Emily Nesbitt
###Presenter: Antonina G. Nikolova, PhD – Allucent
Presenter: Leah Christl, PhD – Amgen
Presenter: Marcus S. Delatte, PhD – Allucent
Presenter (Remote): Peter Richardson, Ph. D. – European Medicines Agency (EMA)
Biopharmaceuticals (includes Biologics and Drugs)
Presenter: Antonina G. Nikolova, PhD – Allucent
### @@@ Leah Christl, PhD (she/her/hers) – Amgen ### 1459819###Presenter###Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy###Amgen###Presenter: Leah Christl, PhD (she/her/hers) – Amgen
### she/her/hers @@@ Marcus S. Delatte, PhD – Allucent ### 1946005###Presenter###Vice President, Regulatory Strategy###Allucent###Presenter: Marcus S. Delatte, PhD – Allucent
### @@@ Peter Richardson, Ph. D. – European Medicines Agency (EMA) ### 2127719###Presenter (Remote)###Scientific secretary Biosimilar Medicines Working Party###European Medicines Agency (EMA)###Presenter (Remote): Peter Richardson, Ph. D. – European Medicines Agency (EMA)
###Panelist: Sally Prawdzik – Health Canada
Panelist: Kelly Robinson – Health Canada
Panelist: Sophie Sommerer – Health Canada
Health Authority Forum
Panelist: Sally Prawdzik (she/her/hers) – Health Canada
### she/her/hers @@@ Kelly Robinson – Health Canada ### 2135302###Panelist###Director General, Marketed Health Products Directorate###Health Canada###Panelist: Kelly Robinson – Health Canada
### @@@ Sophie Sommerer – Health Canada ### 2135915###Panelist###Director General of the Biologic and Radiopharmaceutical Drugs Directorate###Health Canada###Panelist: Sophie Sommerer – Health Canada
###Presenter: AJ Acker – Annexon Biosciences
Presenter: Kunal Kanani, PharmD, MBA – Annexon Biosciences
Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration
Presenter: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
Skill Building
Presenter: AJ Acker – Annexon Biosciences
### @@@ Kunal Kanani, PharmD, MBA – Annexon Biosciences ### 1945989###Presenter###Executive Director, Head of Regulatory Affairs###Annexon Biosciences###Presenter: Kunal Kanani, PharmD, MBA – Annexon Biosciences
### @@@ 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: Mary Jo Salerno, MS PT, MPH (she/her/hers) – US Food and Drug Administration
### she/her/hers @@@ Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Presenter###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Presenter: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
###Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Presenter: Amélie Chollet
Presenter: Erik R. Vollebregt – Axon Lawyers
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
### @@@ Amélie Chollet ### 2008932###Presenter#########Presenter: Amélie Chollet
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: Erik R. Vollebregt – Axon Lawyers
###Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting
Presenter: Linda McBride, R.PH, RAC – IAA Consulting LLC
Presenter: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023
Biopharmaceuticals (includes Biologics and Drugs)
Conversation Starters
Presenter: Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting
### he/him/his @@@ Linda McBride, R.PH, RAC – IAA Consulting LLC ### 1946958###Presenter###Partner###IAA Consulting LLC###Presenter: Linda McBride, R.PH, RAC – 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: Kimberly Belsky, MS, FRAPS (she/her/hers) – Planning Committee Chair Convergence 2023
### she/her/hersSession Leader: Priyanka Ingle, MD (Intl), MSc, PhD – Bayer Pharmaceuticals
Presenter: Shefali Goyal, MS, MSc – Organon
Presenter: Sandra V. Cron, MS – Organon
Moderator: Kathleen O'Sullivan, MS, MSL, RAC – Bayer
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Priyanka Ingle, MD (Intl), MSc, PhD – 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: Shefali Goyal, MS, MSc – Organon
### @@@ Sandra V. Cron, MS (she/her/hers) – Organon ### 2122899###Presenter###Director, Regulatory Liaison Women’s Health, Organon###Organon###Presenter: Sandra V. Cron, MS (she/her/hers) – Organon
### she/her/hers @@@ Kathleen O'Sullivan, MS, MSL, RAC – Bayer ### 2128761###Moderator###Director Regulatory Strategy###Bayer###Moderator: Kathleen O'Sullivan, MS, MSL, RAC – Bayer
###Session Leader: Daniëlle Motta, MSc. – Qserve Group BV
Presenter: Balazs Bozsik – SGS North America Inc.
Presenter: Phil Brown – ABHI
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Daniëlle Motta, MSc. – Qserve Group BV
### @@@ Balazs Bozsik – SGS North America Inc. ### 1614547###Presenter###Technical Director - MDD/MDR/UKCA###SGS North America Inc.###Presenter: Balazs Bozsik – SGS North America Inc.
### @@@ Phil Brown (he/him/his) – ABHI ### 1855142###Presenter###Director, Regulatory and Compliance###ABHI###Presenter: Phil Brown (he/him/his) – ABHI
### he/him/hisModerator: Anja Wiersma, PhD – mi-CE consultancy
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Tom Patten – NSAI
Presenter: Catherine Holzmann – GMED Certification Division
Presenter: Azam Khorshidi – DEKRA
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
### she/her/hers @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: Catherine Holzmann – GMED Certification Division
### @@@ Azam Khorshidi – DEKRA ### 2129976###Presenter###Technical File Reviewer###DEKRA ###Presenter: Azam Khorshidi – DEKRA
###Networking Opportunity
Presenter: Elena Kyria – Elemed
Skill Building
Presenter: Elena Kyria (she/her/hers) – Elemed
### she/her/hersSession Leader: Olivia Ziolkowski, J.D., M.P.H. – Takeda Pharmaceuticals
Presenter: Sanika Inamdar – Obsidian Therapuetics
Presenter: Yoko Momonoi, M.S. – Takeda Pharmaceuticals
Presenter: Antonina G. Nikolova, PhD – Allucent
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Olivia Ziolkowski, J.D., M.P.H. (she/her/hers) – Takeda Pharmaceuticals
### she/her/hers @@@ Sanika Inamdar (she/her/hers) – Obsidian Therapuetics ### 1187607###Presenter###QA Manager###Obsidian Therapuetics###Presenter: Sanika Inamdar (she/her/hers) – 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: Yoko Momonoi, M.S. (she/her/hers) – Takeda Pharmaceuticals
### she/her/hers @@@ Antonina G. Nikolova, PhD – Allucent ### 1946964###Presenter###Vice President, CMC###Allucent###Presenter: Antonina G. Nikolova, PhD – Allucent
###Session Leader: Kamali G. Chance, PhD, MPH, RAC – KC Biopharmaceutical Consulting
Presenter (Remote): Paul Brown, PhD – Food and Drug Administration
Presenter (Remote): Thibault Honegger – NETRI
Presenter: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Kamali G. Chance, PhD, MPH, RAC – 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): Paul Brown, PhD (he/him/his) – Food and Drug Administration
### he/him/his @@@ Thibault Honegger – NETRI ### 2064600###Presenter (Remote)###CEO & Co-founder###NETRI###Presenter (Remote): Thibault Honegger – NETRI
### @@@ Abhijit P. Pangu, M. Pharm, RAC – Pharnext ### 1945629###Presenter###VP, Regulatory Affairs###Pharnext###Presenter: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
###Session Leader: CHRISTOPHER EGELEBO, DHSc, MBA, MS, RAC, PMP, RN – US Food and Drug Administration
Presenter: Yvonne Knight, MS – US Food and Drug Administration
Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration
Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: CHRISTOPHER EGELEBO, DHSc, MBA, MS, RAC, PMP, RN – 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: Yvonne Knight, MS (she/her/hers) – 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: Mary Jo Salerno, MS PT, MPH (she/her/hers) – 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: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
###Moderator: Keith Morel, PhD – Qserve Group
Presenter: Leo Hovestadt – Elekta
Presenter: Balazs Bozsik – SGS North America Inc.
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Keith Morel, PhD (he/him/his) – Qserve Group
### he/him/his @@@ Leo Hovestadt (he/him/his) – Elekta ### 535504###Presenter###Director Governmental Affairs EU###Elekta###Presenter: Leo Hovestadt (he/him/his) – Elekta
### he/him/his @@@ Balazs Bozsik – SGS North America Inc. ### 1614547###Presenter###Technical Director - MDD/MDR/UKCA###SGS North America Inc.###Presenter: Balazs Bozsik – SGS North America Inc.
###Session Leader: Cassandra T. San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM – Biogen
Skill Building
Session Leader: Cassandra T. San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM (she/her/hers) – Biogen
### she/her/hersSession Leader: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
Presenter (Remote): Patrick Axtell, PhD – FDA
Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
Devices (includes Medical Devices and In Vitro Diagnostics)
Conversation Starters
Session Leader: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
### @@@ Patrick Axtell, PhD – FDA ### 1000137###Presenter (Remote)###Assistant Director, Tools and Templates Team###FDA###Presenter (Remote): Patrick Axtell, PhD – FDA
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Presenter###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
###Session Leader: Mallory O'Connor, MPH – Mallinckrodt
Presenter: Jesse D. Mendelsohn – Model N
Moderator: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Mallory O'Connor, MPH – Mallinckrodt
### @@@ Jesse D. Mendelsohn (he/him/his) – Model N ### 2094361###Presenter###Senior Vice President###Model N###Presenter: Jesse D. Mendelsohn (he/him/his) – Model N
### he/him/his @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho ### 1642067###Moderator###Sr. Director, Reg. Affairs###QuidelOrtho###Moderator: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
###Moderator: Olga van Grol-Lawlor, MPhil – Boston Scientific
Presenter (Remote): Daniel Caños, PhD, MPH – US Food and Drug Administration
Presenter: Heather M. Colvin, MPP – Johnson & Johnson MedTech
Speaker: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
Speaker: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Olga van Grol-Lawlor, MPhil (she/her/hers) – Boston Scientific
### she/her/hers @@@ 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): Daniel Caños, PhD, MPH – 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: Heather M. Colvin, MPP (she/her/hers) – Johnson & Johnson MedTech
### she/her/hers @@@ Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 574720###Speaker###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###Speaker: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
### @@@ Monika McDole-Russell, MS, RAC (she/her/hers) – Medtronic Endoscopy ### 1945991###Speaker###Sr. Director, Global Regulatory Affairs###Medtronic Endoscopy###Speaker: Monika McDole-Russell, MS, RAC (she/her/hers) – Medtronic Endoscopy
### she/her/hersPresenter: Judith Prevoo – BSI
Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency
Presenter: James Hewitt – TÜV SÜD
Presenter: Chelsea Welch – ARUP Laboratories
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
Devices (includes Medical Devices and In Vitro Diagnostics)
Presenter: Judith Prevoo (she/her/hers) – BSI
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ James Hewitt (he/him/his) – TÜV SÜD ### 2098107###Presenter###Business Line Manager (IVD)###TÜV SÜD###Presenter: James Hewitt (he/him/his) – TÜV SÜD
### he/him/his @@@ Chelsea Welch (she/her/hers) – ARUP Laboratories ### 2128163###Presenter###Quality and Regulatory Affairs Project Manager###ARUP Laboratories###Presenter: Chelsea Welch (she/her/hers) – ARUP Laboratories
### she/her/hers @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
###Session Leader: Janet Vaughn – Teva Pharmaceuticals
Presenter: Victor S. Pribluda, PhD – United States Pharmacopeia
Presenter: Chaitanya Koduri, MTech – United States Pharmacopeia
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Janet Vaughn – Teva Pharmaceuticals
### @@@ Victor S. Pribluda, PhD (he/him/his) – United States Pharmacopeia ### 1946097###Presenter###Senior International Regulatory Intelligence Manager###United States Pharmacopeia###Presenter: Victor S. Pribluda, PhD (he/him/his) – 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: Chaitanya Koduri, MTech (he/him/his) – United States Pharmacopeia
### he/him/hisPresenter: Jay E. Sirois, PhD – Consumer Health Products Association
Presenter: Joseph Chan, RPh – Bayer
Presenter: Gerry Harrington
Presenter: Amanda Wong, RAC – Haleon Canada
Biopharmaceuticals (includes Biologics and Drugs)
Presenter: Jay E. Sirois, PhD – Consumer Health Products Association
### @@@ Joseph Chan, RPh (he/him/his) – Bayer ### 2014522###Presenter###Senior Regulatory Affairs Manager###Bayer###Presenter: Joseph Chan, RPh (he/him/his) – Bayer
### he/him/his @@@ Gerry Harrington ### 2099591###Presenter#########Presenter: Gerry Harrington
### @@@ Amanda Wong, RAC – Haleon Canada ### 2099590###Presenter###Senior Director, R&D Lead and Regulatory Affairs###Haleon Canada###Presenter: Amanda Wong, RAC – Haleon Canada
###Session Leader: Megha Iyer, MS, RAC – Thermo Fisher Scientific
Presenter: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
Presenter: Susan Speicher, MS – UpToDate, Inc.
Skill Building
Session Leader: Megha Iyer, MS, RAC (she/her/hers) – Thermo Fisher Scientific
### she/her/hers @@@ Bill McMoil – Regulatory Affairs Professionals Society (RAPS) ### 1083161###Presenter###RAPS Executive Director###Regulatory Affairs Professionals Society (RAPS)###Presenter: Bill McMoil – Regulatory Affairs Professionals Society (RAPS)
### @@@ Susan Speicher, MS (she/her/hers) – UpToDate, Inc. ### 1976561###Presenter###Director, Regulatory Affairs and Quality Compliance###UpToDate, Inc. ###Presenter: Susan Speicher, MS (she/her/hers) – UpToDate, Inc.
### she/her/hersModerator: Amra Racic – Veeva Systems
Presenter: Razan Asally – Saudi Food and Drug Authority
Presenter (Remote): Abhijit Ghosh
Presenter: Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL
Health Authority Forum
Moderator: Amra Racic – 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: Razan Asally (she/her/hers) – Saudi Food and Drug Authority
### she/her/hers @@@ Abhijit Ghosh ### 2105492###Presenter (Remote)#########Presenter (Remote): Abhijit Ghosh
### @@@ Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL ### 1773497###Presenter###Manager, Quality & Regulatory Affairs###Emergo by UL###Presenter: Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL
###Session Leader: Nancy J. Morrison, RAC – RQM+
Presenter: Hrishikesh Gadagkar, PhD – RQM Plus
Devices (includes Medical Devices and In Vitro Diagnostics)
Session Leader: Nancy J. Morrison, RAC (she/her/hers) – RQM+
### she/her/hers @@@ Hrishikesh Gadagkar, PhD (he/him/his) – RQM Plus ### 1977462###Presenter###Sr. Principal###RQM Plus###Presenter: Hrishikesh Gadagkar, PhD (he/him/his) – RQM Plus
### he/him/hisSession Leader: Vada A. Perkins, MSc, MS, DRSc (c) – Bayer Pharmaceuticals
Presenter: Danielle Friend – Janssen
Presenter (Remote): Virginia Hussong – FDA Center for Biologics Evaluation and Research
Presenter: Khushboo Sharma, MBA – Accumulus Synergy
Biopharmaceuticals (includes Biologics and Drugs)
Session Leader: Vada A. Perkins, MSc, MS, DRSc (c) – Bayer Pharmaceuticals
### @@@ Danielle Friend – Janssen ### 1698210###Presenter###Senior Director, US Head, Regulatory Policy and Intelligence###Janssen###Presenter: Danielle Friend – 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): Virginia Hussong – FDA Center for Biologics Evaluation and Research
### @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Presenter###Chief Regulatory Innovation Officer###Accumulus Synergy###Presenter: Khushboo Sharma, MBA – Accumulus Synergy
###Moderator: Kimberly A. Trautman, MS – MEDIcept
Presenter: Gail M. Rodriguez, Ph.D. – US Food and Drug Administration
Presenter: Scott Colburn, MS, BSN – US Food and Drug Administration
Devices (includes Medical Devices and In Vitro Diagnostics)
Moderator: Kimberly A. Trautman, MS – MEDIcept
### @@@ Gail M. Rodriguez, Ph.D. – US Food and Drug Administration ### 1342701###Presenter###Senior Advisor###US Food and Drug Administration###Presenter: Gail M. Rodriguez, Ph.D. – 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: Scott Colburn, MS, BSN – US Food and Drug Administration
###Networking Opportunity