New medicines and medical devices must be authorised before they can be marketed and made available to patients. In the European Union, the route for authorising medicines starts at the European Medicines Agency (EMA), which evaluates and authorises new medicines. 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 clinical research.

During this workshop representatives from the EMA, CBG and CCMO give insights in how and when to initiate contacts with them during pre-authorisation and authorisation settings. They will also explain how the regulatory agencies support young companies in their product development process. This workshop is meant for business developers working at Technology Transfer Offices (TTOs) in universities and medical centres. The topic will be addressed for medical devices, diagnostics and (bio) pharmaceuticals.

Programme

13:00         Welcome at VU Campus, medical faculty

13.30          Start Workshop by IXA and LifeSciences@Work

14:00         Presentation Monique Al, Coordinating/Specialist Advisor at CCMO

14:45         Presentation dr. ir. Marjon Pasmooij, Programme Manager Science at CBG

15:30         Break

15.45         Presentation Ralf Herold MD PhD, Senior Scientific Officer at EMA

16:30         Discussion and questions from participants with the experts

17.15          Drinks, bites and networking!

18.00         End of TTO Workshop Regulatory Affairs