Talk Medical Devices & Combination Products track
S0604 - EU COMBINE Programme
Thu, Mar 20, 2025 · 8:30–9:40 AM CET Singapore Room, Congress Center Basel
About this session
This session will present the EU COMBINE programme which supports the operational interface between the CTR, MDR and IVDR. The session will explain the structure of the programme and the scope of the different projects. There will be a special focus on the pilot of "all-in-one" coordinated assessment of applications for clinical trials involving an IVD companion diagnostic, combining the CT, device and ethics review. You will hear the views of the regulator, ethics and sponsor representatives on COMBINE activities fostering an attractive environment for clinical research in the EU.
Programme:
- 3. COMBINE in Action: A Closer Look at the Programme’s Projects — Ditte Zerlang Andersen
- 5. Industry Insights on COMBINE: Challenges, Opportunities, and Impact — Lucia D'Apote
- Panel Discussion — Monique Al, Isabelle Clamou, Ditte Zerlang Andersen, Claire Temple, Lucia D'Apote, Jana Russo
- 4. “All-in-one Coordination”: What’s Inside the Project — Claire Temple
- 2. From COMBINE Project to Programme — Isabelle Clamou
- 1. Welcome & Introduction — Olga Tkachenko
- 6. Industry Insights on COMBINE: Challenges, Opportunities, and Impact — Jana Russo
Speakers
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Clinical Trials Portfolio Lead (Executive Assessor) · Health Products Regulatory Authority
Speaker
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Executive director - Global Regulatory Policy & Intelligence · Amgen
Speaker
