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IVDR Extension Explained: Tips & Strategies
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Agenda
00:00 – Introduction
01:45 – Understanding the proposal 2024/0021 (COD)
03:58 – Timelines
21:17 – EUDAMED
23:16 – Obligations in case of interruption of supply
24:35 – Tips & strategies
45:15 – Q&A
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Speakers
Kirsten Van Garsse
Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has amassed extensive experience in the In Vitro Diagnostic Medical Device Industry. She joined Qarad, now part of the QbD Group, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017.
In her role as Director of Authorized Representative Services & Manager of IVD Regulatory Affairs, Kirsten applies her wealth of experience to Regulatory Affairs projects, adeptly translating regulations into compliant business processes and applications. Additionally, she oversees the various Representation Services offered by Qarad, ensuring clients receive expert support in navigating regulatory requirements.
Anne Paulussen
Anne’s extensive experience in both the pharmaceutical and in vitro diagnostics (IVDs) sectors has given her a profound understanding of the interplay between pharmaceuticals and diagnostics. With expertise spanning both fields, Anne offers valuable insights that enhance her contributions to the industry, especially in the field of companion diagnostics. Prior to joining Qarad in 2022 as a Senior Regulatory Consultant for IVDs, Anne served as a Global Regulatory Device Leader at Sanofi, working on drug-device combinations. In her current role, Anne leverages her expertise to advise CROs and pharmaceutical companies on IVDR compliance, regulatory intelligence, and comprehensive training for IVD manufacturers across all facets of IVDR implementation.
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