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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)
Drug/Device Combinations - Challenges and Opportunities
Head of New Technologies, TRD Device Development and Commercialisation, Novartis, Switzerland
EU Regulatory Considerations for Drug/Device Combinations
Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
EU MDR Implementation for Combination Products – the Role of Notified Bodies
CEO, QUNIQUE GmbH, Germany
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