Study Programmes 2016-2017
WARNING : 2015-2016 version of the course specifications
PHIN2029-2  
Regulation and the medical-social environment
  • Economic aspects of drug development
  • Legislation and procedures applied to pharmaceutical industry, part a : legislation
  • Legislation and procedures applied to pharmaceutical industry, part b : patents and protection
  • Macroeconomic environment and pharmaco-economics
  • CTD File (Common Technical Document)
  • Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files
  • Regulations of preclinical and clinical studies, part b : clinical studies
  • Regulations of preclinical and clinical studies, part c : pediatric studies
  • Specific regulatory issues, part a : medicine and herbal dietary supplement
  • Specific regulatory issues, part b : Preformulation and galenical development documentation
Duration :
Economic aspects of drug development : 10h Th
Legislation and procedures applied to pharmaceutical industry, part a : legislation : 10h Th, 5h Pr
Legislation and procedures applied to pharmaceutical industry, part b : patents and protection : 5h Th
Macroeconomic environment and pharmaco-economics : 10h Th
CTD File (Common Technical Document) : 15h Th
Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files : 15h Th
Regulations of preclinical and clinical studies, part b : clinical studies : 5h Th
Regulations of preclinical and clinical studies, part c : pediatric studies : 2,5h Th
Specific regulatory issues, part a : medicine and herbal dietary supplement : 5h Th
Specific regulatory issues, part b : Preformulation and galenical development documentation : 5h Th
Number of credits :
Specialised master in industrial pharmacy8
Lecturer :
Economic aspects of drug development : Dominique Martin
Legislation and procedures applied to pharmaceutical industry, part a : legislation : Catherine Druez
Legislation and procedures applied to pharmaceutical industry, part b : patents and protection : Patrick Di Stefano
Macroeconomic environment and pharmaco-economics : Pierre Duez
CTD File (Common Technical Document) : Jean-Antoine De Muylder
Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files : Sonia Beken
Regulations of preclinical and clinical studies, part b : clinical studies : Anne Lenaers
Regulations of preclinical and clinical studies, part c : pediatric studies : Daniel Brasseur
Specific regulatory issues, part a : medicine and herbal dietary supplement : Michel Frederich
Specific regulatory issues, part b : Preformulation and galenical development documentation : Francis Vanderbist
Coordinator :
Philippe Hubert
Language(s) of instruction :
French language
Units courses prerequisite and corequisite :
Prerequisite or corequisite units are presented within each program
Learning unit contents :
Specific regulatory issues, part a : medicine and herbal dietary supplement
Overview of Belgian and European legislation on herbal medicines and herbal dietary supplements.
Learning outcomes of the learning unit :
Specific regulatory issues, part a : medicine and herbal dietary supplement
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Prerequisite knowledge and skills :
Specific regulatory issues, part a : medicine and herbal dietary supplement
- Pharmacognosy
- Pharmaceutic legislation
Planned learning activities and teaching methods :
Specific regulatory issues, part a : medicine and herbal dietary supplement
Oral lecture.
Mode of delivery (face-to-face ; distance-learning) :
Recommended or required readings :
Assessment methods and criteria :
Specific regulatory issues, part a : medicine and herbal dietary supplement
Written exam
Work placement(s) :
Organizational remarks :
Contacts :
Specific regulatory issues, part a : medicine and herbal dietary supplement
Pr Michel Frédérich
Items online :
Specific regulatory issues, part a : medicine and herbal dietary supplement
Slides and documents
slides and documents