*Program and presenters subject to change. Please check back frequently for updates.
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: 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
###Facilitator: Niels B. Leander, PhD – NNIT
###Facilitator: Farhad Amiri, PhD, FAHA (he/him/his) – Parexel International
### he/him/hisFacilitator: 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
###Facilitator: Guriqbal Singh (he/him/his) – Regweb Consulting Services Inc.
### he/him/hisFacilitator: Mona Desai (she/her/hers) – Desai RA Consultants, LLC
### she/her/hersFacilitator: Robert L. Waterland, PhD (he/him/his) – Certara Drug Development Solutions
### he/him/hisFacilitator: 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: 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: 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: Diane M. Ward, PhD (she/her/hers) – Qserve Group US
### she/her/hersFacilitator: 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: 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.
###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
###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: 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.
###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: Joao Duarte, MSc MPharm (he/him/his) – Alexion, AstraZeneca Rare Disease
### he/him/hisFacilitator: Rosanne Middleton – Lifescan
### @@@ Dinar Suleman, RAC – Lifescan ### 1374645###Facilitator###Manager Regulatory Policy, Intelligence & Ad/ Promo###Lifescan###Facilitator: Dinar Suleman, RAC – Lifescan
###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/hersFacilitator: 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
###Facilitator: Jamie L. Robinson, RAC, MBA (she/her/hers) – Genentech, Inc.
### she/her/hersFacilitator: Cham Williams, MS (he/him/his) – IQVIA
### he/him/hisFacilitator: 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
### @@@ 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
###Facilitator: Joao Duarte, MSc MPharm (he/him/his) – Alexion, AstraZeneca Rare Disease
### he/him/hisFacilitator: 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/hersFacilitator: Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC
###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
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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
###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/his
Speaker: Gary Saner – LexisNexis Reed Tech
###Speaker: Arpad Lehoczki (he/him/his) – GlobalVision
### he/him/his @@@ Gabriella Naguib – GlobalVision ### 2099715###Speaker###Product Marketing Manager###GlobalVision###Speaker: Gabriella Naguib – GlobalVision
###Speaker: Kim Kaplan, BS, MA (she/her/hers) – ISACA
### she/her/hersSpeaker: Bridget Wiseman – IQVIA
###Speaker: Waylon Wright – Celegence
### @@@ Joy Greidanus – Celegence ### 2159070###Speaker###Medical Device Services Director###Celegence###Speaker: Joy Greidanus – Celegence
###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: Marielle Lejcher, CORe-Credential of Readiness in Business from Harvard Business School (HBS) – Fang Consulting
###
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/his
Speaker: Immo Zdrojewski – Moderna
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Speaker: Erez Kaminski, MS, MBA (he/him/his) – Ketryx Corporation
### he/him/hisSpeaker: James Gianoutsos, MBA – Rimsys
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Speaker: Jonathan Gimbel, PhD – RQM+
### @@@ Torrie DeGennaro – RQM+ ### 2134412###Speaker###Principal, Consulting Services###RQM+###Speaker: Torrie DeGennaro – RQM+
###Speaker: Naushad Kapasi (he/him/his) – Clarivate
### he/him/his
Speaker: Heather Graham – Certara
### @@@ Trevor Standish – Certara ### 2131942###Speaker###Director, Product Management###Certara###Speaker: Trevor Standish – Certara
###Speaker: Padma Govindaiah (she/her/hers) – ArisGlobal
### she/her/hersSpeaker: Marcus Torr, MSci – Purdie Pascoe
###
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: 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/hers
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
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Speaker: Ken Pilgrim (he/him/his) – Emergo by UL
### he/him/hisSpeaker: Ryan Gooley, MBA (he/him/his) – Sedgwick
### he/him/hisSpeaker: Michelle Wu – NyquistAI
###Speaker: Linda Moon, MPhil. (she/her/hers) – BSI Group
### she/her/hersSpeaker: Ludger Moeller (he/him/his) – MDSS GmbH
### he/him/hisSpeaker: Darwin Shurig, RRT, MBA – Shurig Solutions, Inc
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Speaker: Jocelyn Zhu – BradyKnows Medical Group
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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/hisSession 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
###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
###Graduate Student Presenter: Allison Dalton, MSHS – The George Washington University
###Graduate Student Presenter: Jingrui Li – The 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
###Graduate Student Presenter: Yoon Sik Jung – University of Southern California
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