Join the RSNN session on Regulatory Readiness at the FIGON Dutch Medicines Days

01 September 2021
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We gladly invite you to join us at the RSNN session during the FIGON Dutch Medicines Days (FIGON DMD), which will be held at the Stadsgehoorzaal in Leiden on 27 and 28 September (in person). The session organized by the RSNN together with Saco de Visser (ZonMW) and Martina Teichert (KNMP) is titled “Regulatory Readiness” and will take place on Monday 27 September at 15:00.

RSNN Regulatory Readiness Session
For innovative technologies, methods, or data sources to be able to play a role in the development and authorization of medical technologies, decision-makers have to be assured that these innovations do what they say within acceptable bounds of uncertainty. This means that innovations have to go through a process that will give confidence that they are fit for purpose. An example is the qualification procedure used by EMA and other regulators. In this session we want to review what it takes for new innovations to be accepted by regulators, HTA bodies and payers for making decisions, what lessons can be drawn for innovators, and what policy makers can do to make the translation from idea to implementation as smooth as possible.

The session will focus 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.

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)

Discussion - Pieter Stolk (RSNN)

Practical Information FIGON DMD
In order to attend the Regulatory Readiness Session you will need to register for the FIGON DMD. The overall theme of the FIGON DMD is Translational Medicine and keynote speakers are Marc Kaptein (Country Medical Director, Pfizer) and Margareta Hammarlund-Udenaes, (Professor of Pharmacokinetics and Pharmacodynamics, Uppsala University of Sweden). For more information about the program and registration, please visit the FIGON DMD website.