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

Thursday, September 19, 2024

9:15 AM – 10:30 AM PDT

Location/Room: 104 A

Moderator(s)

Jethro Ekuta, DVM, PhD, RAC, FRAPS

Vice President, Regulatory Affairs
Alexion, AstraZeneca Rare Disease

Panelist (Remote)(s)

Peter W. Marks, MD, PhD

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

Panelist(s)

Sabine Haubenreisser, MSc, PhD

Principal Scientific Administrator
European Medicines Agency, Netherlands
Anabela Marcal

EMA Liaison Official to FDA
European Medicines Agency
Tshetsana Senau

Research Officer- Clinical Trials and Research
Botswana Medicines Regulatory Authority, Botswana

This session is an open forum where participants can engage in interactive and informal conversations with a broad set of panelists representing different health authorities around the world. During the session, participants are encouraged to ask the panelists any questions of interest pertaining to the regulation of drugs, biologics and combination products, except questions seeking advice or guidance on products under a regulatory agency review. Such questions should be the subject of formal engagements with applicable regulatory agencies. As these sessions are informal, it should be understood by participants regarding any issues discussed, that all opinions expressed by health authority panelists are those of the panelists and should not be construed as formal positions of the agencies they represent.

Learning Objectives:

Engage with health authoritiy representatives in an informal setting
Ask any relevant questions of interest
Obtain feedback from health authority panelists on any relevant questions of interest