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Session 2A: Drug/Device Combinations
Session Chair(s)
Ursula Busse, PHD, MBA
CMC Regulatory Affairs Advisor, Self employed, France
The number, scope and complexity of Drug/Device combinations is expanding exponentially while regulations are evolving worldwide. This session will provide an overview of the challenges faced with a focus on the impact of the EU Medical Device Regulation (MDR). Speakers from industry, regulators and EU notified bodies will provide insights and point to possible solutions.
Speaker(s)
Marc Rohrschneider, PHD
Head of New Technologies, TRD Device Development and Commercialisation, Novartis, Switzerland
Drug/Device Combinations - Challenges and Opportunities
Nick Lee, PHD
Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
EU Regulatory Considerations for Drug/Device Combinations
Bassil Akra, PHD
CEO, QUNIQUE GmbH, Germany
EU MDR Implementation for Combination Products – the Role of Notified Bodies