S0503 - Understanding Changing European Regulatory Landscape: Combined Clinical Trials and COMBINE Solutions

Wed, Mar 19, 2025 · 8:30–9:40 AM CET Kairo 1-2 Room, Congress Center Basel

About this session

'In this session, we will revisit the challenges encountered in conducting clinical research in Europe at the interface of IVDR and CTR, highlighting the potential solutions proposed by the various stakeholders. We will explore the evolving European regulatory landscape for combined clinical trials and the planned implementation of COMBINE project recommendations, fostering a fit-for-purpose and attractive European CT ecosystem.

Programme:
- 1. Global Regulatory Landscape Overview: Case Examples and the Role of the COMBINE Program — Mike Wierzba, Adriana Racolta
- Panel Discussion — Ditte Zerlang Andersen, Ana Trullás Jimeno, Thomas Sudhop, Dario Trapani

Speakers

Dario Trapani

Medical Oncologist · European Oncology Institute

Panelist
Adriana Racolta

Sr Director, Global Regulatory Leader IVD · Bayer

Speaker
Mike Wierzba

Senior Director, GRA, Precision Medicine and Digital Health · GSK

Speaker
Thomas Sudhop

Senior Regulatory Expert · BfArM

Panelist
Ana Trullás Jimeno

Senior Scientific Specialist · European Medicines Agency

Panelist
Ditte Zerlang Andersen

Strategic business program manager · Danish Medicines Agency (DKMA)

Panelist
Lucia D'Apote

Executive director - Global Regulatory Policy & Intelligence · Amgen

Chair
Claudia Popp

Head EU Regulatory Science & EMA Liaison · Roche

Chair