WEBINAR SERIES
IVDR Extension Explained: Tips & Strategies
- In Vitro Diagnostics
- 23 May
- 4:00 pm CEST
- English
Supported by our IVD experts
SHORT EXPLAINER VIDEO
IVDR Transitional Extension: Why full speed ahead
We explores why staying on track for IVDR compliance is still the best strategy for legacy device manufacturers.
Understanding the European Commission’s proposal for extending the transitional period for IVDs
Reasons behind the extension and what it means for manufacturers.
Why start building IVDR-compliant Technical Documentation now?
This article highlights the importance of proactive action despite the proposed delay.
The Crucial Role of Clinical Evidence in IVDR Compliance
This article explores the importance of clinical evidence for IVDs under the new IVDR, and the challenges manufacturers face in meeting these new requirements.
What you'll learn
- Understanding the proposal
- Understanding the implications of the IVDR extension and the conditions to be met to make use of the new extended transitional provisions
- The impact of the gradual roll-out of EUDAMED
- Information obligation in case of interruption of supply
- Strategic planning for compliance: Learn strategies to navigate the IVDR transition effectively, including tips for adjusting your day-to-day operations and long-term planning
- Expert Q&A to address your specific questions
Speaker
Kirsten Van Garsse
More info
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.
Speaker
Anne Paulussen
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Anne Paulussen brings nearly 15 years of experience in the pharmaceutical sector.
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.