MASTER2 Production and Regulation of Health Products: Pharmaceutical technology, control, technical-regulatory affairs (Program B)

Programme B of the professionalizing Master 2 “Healthcare Product Production and Regulation / Health Risk Quality and Management” (Afssaps, HAS). This professionalizing course covers all aspects of the industrialization of healthcare products.
 
  • Aims
Skills acquired during the course prepare graduates to work at executive levels in the pharmaceutical industry, and more specifically in healthcare product production laboratories: conception, R&D, manufacturing, control and regulatory aspects of industrial pharmaceutics.

Sectors concerned:
- Pharmaceutical and cosmetics industries
- Bodies and institutes
- Biomedical research

Professional openings: regulatory affairs officer, galenic or control project manager
 
  • Contents or list of themes and subjects taught
Theoretical classes: 6 modules (Unités d’enseignement) = 440 hours = 30 ECTS (European Credits transfer system) including one conjointly with Programme A

Traineeship in a company or in a healthcare establishment (6 months – 850 hrs – 30 ECTS)

Trainers: teacher-researchers from the University of Tours, professionals from the pharmaceutical industry and from public bodies, trainers from the Institute for the Pharmaceutical, Cosmetics and Biotechnology Industries (IMT - Institut des Métiers et des Technologies) of Tours.
 
Details of the 6 modules
UE AB (both Master A and B programmes follow this module): Regulatory framework, communication and management (50 hrs – 5 ECTS): Legal framework, institutions and organizations, standards and frames of reference, communication and management
UE B1: Pharmaceutical technology (60 hrs lectures)
UE B2: Control (60 hrs lectures)
UE B3: Technical-regulatory affairs (80 hrs lectures, 20 hrs tutored study)
UE B4: Practical work (140 hrs)
UE B5: Case studies (30 hrs tutored study)
 
  • Prerequisites
The following students are admissible for the course: students who have validated their 5th year of pharmaceutical studies and students who hold a scientific M1 or engineering degree.