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Processus de découverte, de développement et de mise sur le marché du médicament [ WFARM2128 ]


3.0 crédits ECTS  30.0 h + 15.0 h  

Teacher(s) Tulkens Paul ; Dogné Jean-Michel (compensates Lambert Didier) ; Lambert Didier ; Van Bambeke Françoise (coordinator) ; Leclercq Joëlle ;
Language French
Place
of the course
Bruxelles Woluwe
Prerequisites

basic knowledge of pharmacology

Main themes

- Definition of drug targets in the context of physiopathology and in a economical and societal perspective

- Discovery methods

- Steps of preclinical and clinical development

-Registration and refund by social security

-Pharmacovigilance

Aims

Analysis and understanding of the successive steps leading to the discovery, the preclinical and clinical development, and the commercialization of drugs.

Knowledge of the process for integrating it in professional activities

Evaluation methods

- Written examination with open questions (discussion starting from practical examples)

- Individual work, aiming at proposing the development plan of a fictive drug

Content

2h sessions centered on one specific aspect, with description and analysis of the considered aspects and examples taken from drug development history.

Bibliography

supports : diaporamas and articles

Cycle et année
d'étude
> Master [120] in Pharmacy
> Master [120] in Statistics: Biostatistics
Faculty or entity
in charge
> FARM


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