QbD Group
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    Drug-Device Combination Products and Article 117

    Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

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    1h
    Regulatory Affairs · Combination Products
    Chinese

    Did you know that MDR has amended the drug legislation regarding Combination Products?

    Specifically, Article 117 requires manufacturers who are placing integral drug-device combination products on the market as “medicinal products” to seek a Notified Body Opinion (NBOp).

    Additionally, an integral drug device without CE marking needs to be registered as a pharmaceutical drug under the drug legislation. The Notified Body must also assess the conformity of the device with the relevant general safety and performance requirements (GSPR) outlined in Annex I.

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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.

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    演讲者

    Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.

    SM

    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.

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