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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