Research and Development

Situation within FAMHP

R&D is the division at the FAMHP, which is responsible for conducting activities concerning the pre-registration phase, in parallel with the relevant organisation in the pharmaceutical industry.

Mission

During the concept phase of a medicine we make use of solid scientific knowledge to protect the user in the broadest sense, by providing a scientific opinion and by evaluating, authorising, following and controlling the clinical trials.

Key tasks

- Validating, evaluating and granting authorisation to conduct clinical trials.

- Following the authorised clinical studies

  • Amendments
  • Actively following any undesirable effects and / or the lack of efficacy

- Acquiring relevant scientific knowledge

- Treating demands for compassionate use and medical need programs

 

 

Contact

Kristof Bonnarens

Federal Agency for Medicines and Healthproducts                                                                       Recherche and development division
Eurostation II
8th floor                                                                                                                                 Place Victor Horta 40,  40
1060 BRUSSELS

Last updated on 27/04/2015