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Radisson Blu

20 jun 2018 7:45 a.m. - 21 jun 2018 5:00 p.m.

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 2A: Drug/Device Combinations

Session Chair(s)

Ursula  Busse, PhD, MBA

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)

Marc  Rohrschneider, PhD

Drug/Device Combinations - Challenges and Opportunities

Marc Rohrschneider, PhD

Novartis, Switzerland

Head of New Technologies, TRD Device Development and Commercialisation

Nick  Lee, PhD

EU Regulatory Considerations for Drug/Device Combinations

Nick Lee, PhD

Health Products Regulatory Authority (HPRA), Ireland

Executive Pharmaceutical Assessor

Bassil  Akra, PhD

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

Bassil Akra, PhD

QUNIQUE GmbH, Germany

CEO

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