Affaires réglementaires et environnement médico-social

wfari2105  2025-2026  Bruxelles Woluwe

Affaires réglementaires et environnement médico-social
The version you’re consulting is not final. This course description may change. The final version will be published on 1st June.
8.00 credits
72.0 h
Q1

  This learning unit is not open to incoming exchange students!

Language
French
Content
GMP (good manufacturing practices) and International Standards in the engineering of pharmaceutical and related plants. Impact on plant construction, premises, personnel and production equipment. Circuit analysis. Harmonization of pharmaceutical legislation within the European Union. International technical harmonization (ICH: International Conference of Harmonisation). Drug marketing authorization (AMM) procedures. Intellectual property and patents.
Evaluation methods
The module exam could be placed outside the official June session.
Written exam including questions proposed by each speaker.
In the event of exceptional circumstances, examination arrangements may be reviewed.
Faculty or entity


Programmes / formations proposant cette unité d'enseignement (UE)

Title of the programme
Sigle
Credits
Prerequisites
Learning outcomes
Advanced Master in Industrial Pharmacy