Presentation slides from the RSNN session at FIGON Dutch Medicines days now available
27 October 2021
During the FIGON Dutch Medicines days, which were held on 27 and 28 September, the RSNN together with ZonMw and KNMP organized a successful session around the topic of regulatory readiness.
The session focused on the “readiness” of registry data for the purpose of medicine development and authorisation as well as the accompanying experiences, problems, and solutions from the perspective of the regulator, academics, and industry.
Several speakers shared their thoughts on the topic. The PDF files of their presentations are now available and can be downloaded through the links below:
- Introduction en relevance Regulatory Readiness - Pieter Stolk (RSNN)
- Regulatory Readiness Levels as a tool to drive regulatory innovation - Sjaak Bot (RSNN, Janssen)
- The impact and use of quality registries - Can real-world data complement post-approval clinical trials?” - Rawa Ismail (DICA, UU) en Michel Wouters (DICA, NKI)
- An academia-led registry for metachromatic leukodystrophy – the MLD initiative - Daphne Schoenmakers (AmsterdamUMC)
- Perspective of the regulator on readiness of registry data –Marjon Pasmooij (RSNN, MEB)
The RSNN will continue to discuss the topic of regulatory readiness regarding registry data and other regulatory innovations in future activities.