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

Wednesday, October 8, 2025

4:30 PM - 5:30 PM EST

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Moderator(s)

Jethro E. Ekuta, DVM, PhD, EMBA, RAC, FRAPS

Chief Regulatory & Safety Officer
Ascendis Pharma, Inc.
Susan Stewart, JD, LLM, RAC, FRAPS

Chief Regulatory Officer
Rezolute Bio

Panelist(s)

Alberto Ganan, PhD

Head of Committees and Quality Assurance Department
European Medicines Agency
Sabina L. Hoekstra, PharmD, FRAPS

Global Director Regulatory Strategy
TÜV SÜD Medical Health Services, Germany
Tom Patten, n/a

International IVDR Manager
GMED, Ireland
Marta Carnielli, n/a

Head of Certification IVD
TUV Sud Product Service GmbH, Germany
Suzanne Halliday, DPhil, FRAPS

VP Regulatory, Global Regulatory Compliance
BSI, United Kingdom
Donal O'Connor, MD FEBS

Clinical Manager
HPRA
Kimberly A. Trautman, MS

Expert
RAPS BoD

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