Regulatory Affairs

All medicines and medical devices must be authorised before they can be marketed and made available to patients. In the European Union (EU), there are two main routes for authorising medicines: a centralised route were the European Medicines Agency (EMA) evaluates and authorises new medicines and a national route were the ‘College ter Beoordeling van Geneesmiddelen (CBG)’ is responsible for giving approval for the Dutch market. In addition you need approval from the ´Central Committee on Research Involving Human Subjects’ (CCMO) to start your clinical research.

During this expert class representatives from the EMA, CBG and CCMO give insights in how and when a company needs to initiate contacts with them during pre-authorisation and authorisation settings. They also will explain how the regulatory agencies support young and SME companies in their product development process. The topic will be addressed for medical devices, diagnostics and (bio) pharmaceuticals.

The expert class program is set up in an interactive way such that the participants have also the possibility to bring their own questions and discuss issues they encounter in their own (start-up) company. The experts will give you feedback on your questions. We ask all participants to send their questions not later than October 3rd to ">.

Programme

13.00 hrs. Welcome at Loyens and Loeff central hall

13.30 hrs. Start Expert Class by Leon Mur (moderator)
Pitch participants (2 min. per participant):
– Company presentation
– Share questions and/or issues on the topic

14.00 hrs. Presentation Ralf Herold MD PhD, Senior scientific officer at European Medicines Agency (EMA)

14:45 hrs. Presentation dr. ir. Marjon Pasmooij, Programme manager Science at College ter Beoordeling van Geneesmiddelen (CBG)

15.30 hrs. Presentation Monique Al, Head National Clinical Trial Office at the Central Committee on Research Involving Human Subjects

16.15 hrs. Discuss questions and issues from participants with the experts

17.15 hrs. Drinks, bites and networking!

18.00 hrs. End of Expert Class LifeSciences@Work

Expert Classes are a series of targeted (virtual) workshops organized in close collaboration with industry and academic experts
• The small-scale and personalized Expert Classes welcome Venture Challenge Alumni, Value Centre Alumni and NWO Take off Alumni.
• New early startups not (yet) part of our LS@W community but interested to join are also very welcome, provided there is a match with the LS@W community profile.
• Participation is free-of-charge for startup teams.