Speaker List

Director, Product Classification, Products Classification Department
Saudi Food and Drug Authority (SFDA) (Virtual)

Global Regulatory Affairs, Delivery Device & Digital Health Advisor
Lilly

Vice President Combination Product Quality
Genentech/Roche

Associate Director - Global Regulatory Device Lead , Global Regulatory Affairs, Devices and Combination Products
Novo Nordisk

Strategic Facilitator
AFDO/RAPS Healthcare Products Collaborative

Executive Director, Device Quality & Regulatory
Merck

Director of the Office of Combination Products (OCP)
FDA (Virtual)

Director, Office of Policy for Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER)
FDA (Virtual)

Maryland, United States

Health Care and Life Sciences Attorney
Epstein Becker Green

Associate Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi

Massachusetts, United States

Global Head, Medical Device Regulatory Affairs
Novartis

Not Applicable

Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products
AbbVie, Inc

Associate Director, CMC Devices
GSK

North Carolina, United States

Principal Regulatory Program Director
Genentech

President & Principal Consultant
Strategic Parenteral Solutions

Vice President, Solution Engineering
Suttons Creek

Digital Health Policy Team Lead, Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Director, CMC Policy and Advocacy
GSK

District of Columbia, United States

Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER)
FDA (Virtual)

Associate Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi

Regulatory Group Director, Devices and Combination Products
Genentech

California, United States

Director, Regulatory Policy and Intelligence
AbbVie, Inc.

Project Manager for CE Certification of Medical Devices
DEKRA

Regulatory Affairs Specialist
Novo Nordisk

Global Regulatory Lead - NPD Wearable Injectors and Innovation
Becton Dickinson & Co

Chief, Project Management Staff, Office of Regulatory Operations, Office of New Drugs, Office of New Drugs, Center for Drug Evaluation and Research (CDER)
FDA (Virtual)

Special Counsel
Covington & Burling

Director of Regulatory Affairs
Amgen

Senior Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi

Deputy Director, Office of Combination Products
FDA (Virtual)

Executive Director
Association of Food and Drug Officials (AFDO)

Senior Usability Engineer
Novo Nordisk

Executive Director, Head of GRS Combination Products and Medical Devices
Pfizer

Senior Director, Devices and Digital Therapeutics
AstraZeneca

Director, CMC Regulatory Affairs, Devices & Digital Therapeutics
AstraZeneca

Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products
Johnson & Johnson

Assistant Director, Injection Devices Team, Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Principal Consultant & President
Combination Products Consulting Services, LLC

Florida, United States

Director, Regulatory Affairs
Enable Injections

Associate Vice President, Global Regulatory Affairs, Drug Delivery and Combination Products
Eli Lilly

Director, Human Factors
Regeneron

Associate Vice President, Head of GRA Devices
Sanofi

Associate Director - MDCP QA
Gilead Sciences

Senior Vice President, Education & International Programs
Regulatory Affairs Professionals Society (RAPS)

Associate Director - Head of Device Development and Support
ALK A/S

Executive Director, Medical Device and Combination Product Development, Regulatory and Quality
Merck

Vice President, Global Regulatory Head, Devices and Combination Products
Genentech/Roche

California, United States

Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices
AbbVie, Inc.

Technical Director, Medical Devices Certification
DEKRA Certification B.V.

Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi

Global Head, Regulatory Affairs (CoE) - Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow - Regulatory Science,
AbbVie, Inc.

Member
Barr Consulting LLC

Associate Director, Regulatory Affairs CMC
AbbVie, Inc.

VP Regulatory and Quality Services
EdgeOne Medical

Director - Regulatory Policy
Novo Nordisk

Director, Regulatory Policy
Novo Nordisk

Senior Program Manager, Medicines Licensing & Pharmacovigilance
Danish Medicines Agency