4th Annual EU IVD Clinical and Regulatory Affairs ConferenceSeptember 2020 | Amsterdam, NL
With the IVDR compliance date rapidly approaching, diagnostic manufacturing organizations are crafting plans of action to address updated and new requirements in a timely manner. Certain areas of the regulation drastically change the way IVD performance has historically been tested and documented, in particular with the need to execute clinical trials for the proper evaluation of product efficiency in the real-life setting, and no longer solely through the literature route. Many companies face unprecedented challenges pertinent to relevant staffing, funding and budget allocation necessary to tackle the shift to IVDR, in addition to clear interpretation of the new classification regime and rules altogether.
- Deep dive into peers’ state of compliance with IVDR
- Practical insights into real-life challenges & solutions
- 100% IVD focused topics & speaker faculty
- Engaging workshops & small group discussions
- Focus on knowledge-share & participatory learning