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 pharmacy | 8 crédits |
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
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
---
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