Talk Medical Devices & Combination Products track
S0603 - Global Harmonization of Combination Products Regulation
Wed, Mar 19, 2025 · 4:50–6:00 PM CET Boston 1-2 Room, Congress Center Basel
About this session
Regulation for drug-device combinations faces challenges in international alignment. This session, in interactive panel format, will explore the progress made in this area. Representatives from several regulators across the globe will highlight relevant developments undertaken from their region to achieve international regulatory reliance and alignment. Representatives from international (pharmaceutical) industry will give their perspective. The panellists will highlight some elements of their vision for the future and what actions they see as necessary to bring their vision closer to reality.
This panel session will also include interactive Q&As with the audience.
Programme:
- 2. Progress towards International Regulatory Alignment for Combination Products — Kevin Klein
- Panel Discussion — Virginia Acha
- 3. EU Regulatory Perspective — Donal O'Connor
- 1. Setting the Scene — Sabina Hoekstra-van den Bosch
Speakers
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Global Director Regulatory Strategy · TÜV SÜD
Chair
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AVP, Science and Regulatory Policy · MSD
Panelist
