This learning unit is not open to incoming exchange students!
Teacher(s)
Language
French
Learning outcomes
At the end of this learning unit, the student is able to : | |
| 1 | The aim is to provide pharmacists with knowledge of pharmaceutical legislation, and in particular internationally-imposed Good Manufacturing Practices (GMP) and the conditions for granting marketing authorization for medicines. |
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.
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
