Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products

Wednesday, October 4, 2023

2:00 PM – 3:00 PM EDT

Location/Room: 511E

Moderator(s)

Jethro E. Ekuta

Vice President, Regulatory Affairs
Alexion, AstraZeneca Rare Disease
Susan Stewart, JD, LLM, RAC, FRAPS

Chief Regulatory Officer
Candel Therapeutics

Panelist(s)

JB

John Borg, Prof, PhD, Technical Director, Medicines Authority Malta

Post-Licensing Director
Malta Medicines Authority, Malta
Alysha Croker, PhD

Director, Centre for Policy, Pediatrics and International Collaboration
Health Canada
Sabine Haubenreisser, MSc, PhD

Principal Scientific Administrator
European Medicines Agency, Netherlands
Sabina Hoekstra-van den Bosch, PharmD FRAPS

Global Director Regulatory Strategy
TÜV SÜD
Karl-Heinz Huemer, MD, PhD

Consultant
khhconsulting, Austria
Andrea Laslop, MD

Head of Scientific Office
Austrian Medicines and Medical Devices Agency, Austria
Anabela Marcal

EMA Liaison Official to FDA
European Medicines Agency
Janet Woodcock, MD

Principal Deputy Commissioner
United States Food and Drug Administration

Presenter (Remote)(s)

Peter W. Marks, MD, PhD

Director, Center for Biologics Evaluation and Research
United States Food and Drug Administration

The way you communicate and establish your relationship with regulatory agencies could make or break your professional reputation. Every interaction with health authorities provides an opportunity to build your credibility. The panel of regulators and industry representatives from around the world, including FDA, EMA, PDMA, HC, Notified Bodies, join RAPS attendees in an interactive discussion that includes open question and answer, policy updates, information on agency collaborations, and current trends in policy, regulation and best practices.

We want to hear from you during this informal session – there is no presentation – so come prepared with your questions or discussion topics.