Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs

Wednesday, September 18, 2024

1:00 PM – 2:00 PM PDT

Location/Room: 104 A

Moderator(s)

Jethro Ekuta, DVM, PhD, RAC, FRAPS

Vice President, Regulatory Affairs
Alexion, AstraZeneca Rare Disease

Slides

Panelist(s)

Judith Arcidiacono, MS

Advanced Therapies Regulatory Expert
US Food and Drug Administration
Suzanne Halliday, PhD

VP Regulatory
BSI, United Kingdom
Sabine Haubenreisser, MSc, PhD

Principal Scientific Administrator
European Medicines Agency, Netherlands
Sabina Hoekstra, PharmD FRAPS

Global Director Regulatory Strategy
TÜV SÜD Medical Health Services, Netherlands
Andrea Laslop, MD

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

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 medical devices and in-vitro diagnostics (IVDs), 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 authority representatives in an informal setting
Ask any questions of interest
Obtain feedback from health authority panelists on any relevant questions of interest