Drug-Device Combination Products & Article 117

Are the regulatory complexities of Drug-Device Combination Products overwhelming you? Our webinar on demand might be the solution for you.

On demand

1h

Pharma

English

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This webinar will explore the latest advancements and insights regarding integral Combination Products that must be registered as drugs under the current legislation.

We will delve into complex topics such as:

Drug Device Combination Products and article 117
How to apply for a Notified Body Opinion
Data requirements to prove compliance with the relevant general safety and performance requirements (GSPR)

Speaker

Salma Michor (2)

Salma Michor, PhD

Division head Regulatory Affairs

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.