All Regulatory Rapporteur articles in December 2021 – Page 2

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    A regulatory revolution – driven by data


    On occasions it felt like time was standing still in 2021, with further restrictions and lockdowns taking us out of our ‘normal’ routines and nothing much seeming to happen day-to-day, yet it still feels like the year has come around quickly to the Annual Symposium issue!

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    Meeting Report

    IVD5: How do I Implement IVDR? Some key practicalities


    This session looked at the practicalities of IVDR implementation and considered how to prepare application documents, the expectations for performance evaluation (PE) and postmarketing clinical follow-up (PMCF).

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    Meeting Report

    Listening is only the first step


    From ‘Knocking on the door’ to co-creation: 25 Years of patient engagement in R&D: Virginie Hivert, Therapeutic Development Director, EURORDIS, reflects on the evolution of patient engagement in the rare diseases field, emphasising the importance of collaboration between stakeholders and patients.