Research and Development
Situation within FAMHP
R&D is the department 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 studies (including the declarations).
- Coordinating and conducting related GCP inspections.
- Following the authorised clinical studies
- Amendments
- Actively following any undesirable effects and / or the lack of efficacy
- Providing scientific advices in a regulative context
- national
- EMEA
- Acquiring relevant scientific knowledge
The Research & Development department consists of the following 3 sections :
1. Clinical studies
2. Good Clinical Practices (GCP)
3. Scientific advice
Workshops
To date the following workshops have been organised :
- Safety reporting (see Circulaire 460 (.PDF)) (PDF, 1.61 MB)
- General workshop about GMP (.WORD) (DOC, 93 Kb)
- GMP workshop for phase I units (.Powerpoint) (PPT, 219.5 Kb)
- International GCP workshop
- Exploratory Clinical trials (see Exploratory trials: guidance (.PDF) (PDF, 162.9 Kb) -
Exploratory CTs: info (.WORD) (DOC, 29 Kb)) - Pediatric workshop (.WORD) (DOC, 889 Kb) : the report
Subjects
Contact
Dr. Greet Musch
Federal Agency for Medicines and Healthproducts Recherche and development department
Eurostation II
8th floor Place Victor Horta 40, 40
1060 BRUSSELS