• About
    Join us for an in-depth presentation of medical device regulations, essential for pharmacovigilance professionals seeking mastery in compliance and operational excellence. Veronika will guide participants through key regulatory requirements, integration challenges, and actionable steps for building resilient processes to support combined drug and device portfolios within primarily pharma-focused organizations. By the end of this webinar, attendees will possess the knowledge and tools necessary to navigate the complex EU device vigilance regulatory landscape, appreciate the obligations of individual entities in the device lifecycle compared to medicinal products, understand the conceptual differences in drug and device surveillance requirements, and confidently adapt their department to the change.

    Introduction to Medical Device Regulatory Requirements:
    • EU MDR overview
    • Applicable MDCG, MEDDEV and IMDRF guidelines
    • ISO 13485 quality management system 
    • Obligations of economic subjects in the device sector (e.g., MAH vs. Manufacturer)
    • Introduction to MDSAP

    Addressing practical challenges:
    • Explaining the differences between drugs and device safety surveillance 
    • Integrating medical devices into drug safety portfolios 
    • Interface between Quality, Vigilance, and Regulatory departments and other entities 
    • QPPV vs. PRRC
    • Establishing entity ownership interface agreements

    Key takeaways:
    • Understanding the differences between drug and device requirements 
    • Importance of continuous education
    • Identifying strategies to embrace and integrate products subject to a different set of regulations. 

    Q&A Session.
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