Duration
Economic aspects of drug development : 10h Th
Legislation and procedures applied to pharmaceutical industry : 10h Th, 5h Pr
Patents and protection : 5h Th
Macroeconomic environment and pharmaco-economics : 7h Th
CTD File (Common Technical Document) : 15h Th
Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files : 7,5h 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
Aspects réglementaires particuliers, partim b : Préformulation et documentation du développement galénique : 5h Th
Number of credits
| Advanced Master in Industrial Pharmacy | 8 crédits |
Lecturer
Economic aspects of drug development : Dominique Martin
Legislation and procedures applied to pharmaceutical industry : Catherine Druez
Patents and protection : Patrick Di Stefano
Macroeconomic environment and pharmaco-economics : Hugues Malonne
CTD File (Common Technical Document) : Walid El azab
Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files : Karen Van Malderen
Regulations of preclinical and clinical studies, part b : clinical studies : Anne Lenaers
Regulations of preclinical and clinical studies, part c : pediatric studies : Thierry Schurmans
Specific regulatory issues, part a : medicine and herbal dietary supplement : Michel Frederich
Aspects réglementaires particuliers, partim b : Préformulation et documentation du développement galénique : Francis Vanderbist
Coordinator
Language(s) of instruction
French language
Organisation and examination
All year long, with partial in January
Schedule
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, hybrid learning)
Specific regulatory issues, part a : medicine and herbal dietary supplement
Blended learning
Recommended or required readings
Specific regulatory issues, part a : medicine and herbal dietary supplement
Exam(s) in session
Any session
- In-person
written exam
Additional information:
Additional information:
Written exam
Work placement(s)
Organisational remarks and main changes to the course
Specific regulatory issues, part a : medicine and herbal dietary supplement
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Contacts
Specific regulatory issues, part a : medicine and herbal dietary supplement
Pr Michel Frédérich