Duration
Economic aspects of drug development : 10h Th
Belgian and European legislation and procedures applied to the pharmaceutical industry : 15h Th, 5h Pr
Organisation of social security, funding healthcare, and future developments : 5h Th
CTD file (common technical document) & qualified person duties and responsibilities : 15h Th
Regulations of preclinical and clinical studies - part A: pharmaceutical toxicological files : 7,5h Th
Belgian and European legislation on clinical trials : 5h Th
Specific regulatory environment for preclinical and clinical pediatric drugs : 2,5h Th
Specific regulatory issues, part a: medicine and herbal dietary supplements : 5h Th
Specific regulatory aspects, part b: preformulation and documentation of galenic development : 5h Th
Number of credits
| Advanced Master in Industrial Pharmacy | 8 crédits |
Lecturer
Economic aspects of drug development : Dominique Martin
Belgian and European legislation and procedures applied to the pharmaceutical industry : Catherine Druez
Organisation of social security, funding healthcare, and future developments : Hugues Malonne
CTD file (common technical document) & qualified person duties and responsibilities : Walid El azab
Regulations of preclinical and clinical studies - part A: pharmaceutical toxicological files : Karen Van Malderen
Belgian and European legislation on clinical trials : Anne Lenaers
Specific regulatory environment for preclinical and clinical pediatric drugs : Thierry Schurmans
Specific regulatory issues, part a: medicine and herbal dietary supplements : Michel Frederich
Specific regulatory aspects, part b: preformulation and documentation of galenic development : Francis Vanderbist
Coordinator
Language(s) of instruction
French language
Organisation and examination
All year long, with partial in January
If a student fails an examination during the first term:
- They are permitted to resit the assessed subject during the second term (May-June);
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 supplements
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 supplements
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Prerequisite knowledge and skills
Specific regulatory issues, part a: medicine and herbal dietary supplements
- Pharmacognosy
- Pharmaceutic legislation
Planned learning activities and teaching methods
Specific regulatory issues, part a: medicine and herbal dietary supplements
Oral lecture.
Mode of delivery (face to face, distance learning, hybrid learning)
Specific regulatory issues, part a: medicine and herbal dietary supplements
Blended learning
Course materials and recommended or required readings
Specific regulatory issues, part a: medicine and herbal dietary supplements
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 supplements
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Contacts
Specific regulatory issues, part a: medicine and herbal dietary supplements
Pr Michel Frédérich