• Domaine : Masters du domaine SCIENCES, TECHNOLOGIES, SANTE
  • Diplôme : Master
  • Mention : Biologie moléculaire et cellulaire
  • Parcours : Leading international vaccinology education (ERASMUS+)
  • Unité d'enseignement : Clinical drug research
Nombre de crédits de l'UE : 3
Code APOGEE : BIO1309M
UE Obligatoire pour ce parcours
UE valable pour le semestre 2 de ce parcours
    Responsabilité de l'UE :
DELPRAT CHRISTINE
 christine.delpratuniv-lyon1.fr
04.72.68.19.54
    Type d'enseignement
Nb heures *
Cours Magistraux (CM)
30 h
Travaux Dirigés (TD)
0 h
Travaux Pratiques (TP)
0 h
Total du volume horaire
30 h
* Ces horaires sont donnés à titre indicatif.
    Programme - Contenu de l'UE :

University of Antwerp
Contact : Pierre VAN DAMME, Professor / Elke LEURIDAN, Professor
e-mail : pierre.vandamme@uantwerpen.be; elke.leuridan@uantwerpen.be
Keywords : clinical development, clinical trial

Aims of “Clinical drug research”:

-       You get an overview of the whole process of Clinical Drug Research. Using the "standard" drug development as an example, some particular other settings (paediatric clinical trials, medical device studies, vaccine trials) are also discussed. The current rules and regulations are explained and put into a historical perspective.

-       You get to know the different actors involved in clinical drug research, their respective roles and the way they interact between one another. Some standard documents and procedures are explained. This thanks to the involvement of guest speakers from the field of clinical trials (CRO-, pharma-, biotech-industry, chairman of the Ethics Committee ...).

-       Near the end of the course we look into the role of the regulating bodies, the registration of new drugs, and into some future trends in clinical research.

-       You will be allowed to get acquainted with a number of standard documents, to master clinical trial-related information and to report orally and in writing to different target audiences (= permanent evaluation during the semester)-        

Speakers: Pierre Van Damme, Elke Leuridan
Conferences concerning news items will be organized. Speakers will be invited based on their excellence.

Updated on April 9, 2019

    Compétences acquises :
Méthodologiques :

Learning outcomes:

you will have (i) gathered insight in the complex process of the clinical phase of drug development and vaccine by pharmaceutical and biotechnological companies, (ii) knowledge on the different actors involved in this process, and you are capable of describing their specific roles (CRA, sponsor, research team, investigator, Ethics Committee, Regulatory Agencies, ...), (iii)  thorough knowledge of the structure and the content of a clinical trial protocol and of the other documents involved in performing clinical trials, (iv) gained insight in the registration of (new) drugs, vaccines as well as medical devices
    Modalités de contrôle des connaissances et Compétences 2018-2019 :
TypeLibelléNatureCoef. 
CTContrôle TerminalCT : Clinical drug researcheEcrit session 1 / Ecrit session 23
    Liste des autres Parcours / Spécialité / Filière / Option utilisant cette UE :
Date de la dernière mise-à-jour : 09/04/2019
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