DIA CMC Workshop

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Session 2A: Drug/Device Combinations

Session Chair(s)

Ursula Busse, PhD, MBA

Head of Regulatory Affairs

Tigen Pharma SA, Switzerland

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

Marc Rohrschneider, PhD

Novartis, Switzerland

Head of New Technologies, TRD Device Development and Commercialisation

EU Regulatory Considerations for Drug/Device Combinations

Nick Lee, PhD

Health Products Regulatory Authority (HPRA), Ireland

Executive Pharmaceutical Assessor

EU MDR Implementation for Combination Products – the Role of Notified Bodies

Bassil Akra, PhD

QUNIQUE GmbH, Germany

CEO

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