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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
Nick Lee, PHD
Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Bassil Akra, PHD
CEO, QUNIQUE GmbH, Germany
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