Speaker List

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

Director, Regulatory Policy and Intelligence
AbbVie, Inc.

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

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

Associate Director, Regulatory Affairs CMC
AbbVie, Inc.

Strategic Facilitator
AFDO/RAPS Healthcare Products Collaborative

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

Director of Regulatory Affairs
Amgen

Executive Director
Association of Food and Drug Officials (AFDO)

Director, Digital Devices and Combination Products
AstraZeneca

Director, CMC Regulatory Affairs, Devices & Digital Therapeutics
AstraZeneca

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

Principal Consultant & President
Combination Products Consulting Services, LLC

Florida, United States

Special Counsel
Covington & Burling

Project Manager for CE Certification of Medical Devices
DEKRA

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

VP Regulatory and Quality Services
Edgeone Medical

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

Director, Regulatory Affairs
Enable Injections

Health Care and Life Sciences Attorney
Epstein Becker Green

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

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

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

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

Division Director, Digital Health Policy, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

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

Associate Director for Human Factors, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER)
FDA (Virtual)

Principal Regulatory Program Director
Genentech

Senior Regulatory Program Director, Devices and Combination Products
Genentech

Vice President Combination Product Quality
Genentech/Roche

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

Associate Director, CMC Devices
GSK

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

Global Regulatory Affairs, Delivery Device & Digital Health Advisor
Lilly

Executive Director, Device Quality & Regulatory
Merck

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

Senior Manager, Global Regulatory Affairs, Devices and Combination Products
Novo Nordisk

Regulatory Affairs Specialist
Novo Nordisk

Senior Usability Engineer
Novo Nordisk

Director - Regulatory Policy
Novo Nordisk

Director, Regulatory Policy
Novo Nordisk

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

Director, Human Factors
Regeneron

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

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

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

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

Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi

President & Principal Consultant
Strategic Parenteral Solutions

Director of Technical Services
Suttons Creek