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Drug-Device Combination Products & Article 117
Are the regulatory complexities of Drug-Device Combination Products overwhelming you?
This webinar will explore the latest advancements and insights regarding integral Combination Products that must be registered as drugs under the current legislation.
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What you'll learn
- Data requirements needed to demonstrate compliance with the relevant General Safety and Performance Requirements (GSPR).
- The process for selecting and working with a Notified Body to obtain a Notified Body Opinion (NBOp).
- Dossier and Common Technical Document (CTD) requirements for combination products.
- Key development considerations for combination products.
- Quality considerations specific to combination products.
Speaker
Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.
Don’t miss the opportunity to learn and engage with professionals in the field.
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Salma Michor, PhD
Salma Michor is currently Division head Regulatory Affairs at the QbD Group. She served clients such as Johnson & Johnson, Novartis, Pfizer and CSL Behring. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH.
She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission.
Salma Michor is a member of the RAPS European Board. She holds a PhD in Bio engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University and has earned the RAC (EU and Global). She is a Chartered Manager and a fellow of the Chartered Management Institute.
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