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What You'll Learn:

  • Need for harmonization of interpretation of guidelines between EU countries (Medical Device Coordination Group)
  • Increased clinical requirements and better-defined data for device approval
  • In-vitro diagnostics classified into 4 categories based on risk
  • Device database (EUDAMED)

Who Should Listen:  Trial sponsors, clinicians, R&D, medical community, device developers, Government agencies, and regulatory personnel looking to better understand the challenges of medical device development in the EU and related regulatory considerations that can affect outcomes of clinical trials.

Presenters:

  • Frank Wierckx PhD
    Senior Director, Head Regulatory Affairs, Clinipace Worldwide
  • Jurgen Frisch, MD
    Chief Medical Officer, European Operations, Clinipace Worldwide
  • Martin Cripps
    Director, Global Clinical Operations, Clinipace Worldwide

Webcast Slides:

Navigating the Challenges of the Modernization and Expansion of EU Medical Device Regulations

Download the slides today!

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