Date: 3 April 2018
Time: 15:30 CEST
Duration: 1 hour
Speakers: Lorry Weaver from Qserve US
Neil Adams from Illumina
The IVD Directive came into force in 1998. The world was much different then. The IVDD’s regulatory framework is based on lists of products, which makes it difficult to cope with new products that do not fit into the lists.
All new innovations make a very good case for an IVD Regulation that serves the patient well today and that can adapt to changes in knowledge and technology going forward.
What we will cover in the webinar:
- A Quick History
- Why do we need the IVDR?
- What are the Regulatory Aims of the IVDR: The Recitals
- What needs to be done to meet those aims: The Articles
- How to do it: The Annexes IVDR Key Features
Interactive chat session If you want to subscribe to the webinar, please use this link.
You might also be interested in this blog: US FDA and EU IVDR diverging in regulatory approach towards genetic testing
Associate Director Regulatory Affairs EMEA, Illumina Inc
Illumina Inc., a provider of sequencing- and array-based solutions for genetic analysis. Formerly Director, Operations and Delivery for BSI Medical Devices, managing global teams of over 100 technical specialists who provide CE marking and other regulatory services to medical device, active implantable medical device and in vitro diagnostic device manufacturers across the world. Experienced product development, operations, and regulatory affairs professional who has worked in a number of global positions in a range of sectors.