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| Version 2013-2014 |
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| 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
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| 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
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| 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 : A Lenaers
Regulations of preclinical and clinical studies, part c : pediatric studies : Daniel Brasseur
Specific regulatory issues, part a : medicine and herbal dietary supplement : Monique Tits
Specific regulatory issues, part b : Preformulation and galenical development documentation : Francis Vanderbist
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| Coordinator : | Philippe Hubert |
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| French language |
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