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| PHIN2029-1 | Regulation and the medical-social environment
- Legislation and procedures as applied to the pharmaceutical industry, part a
- Legislation and procedures as applied to the pharmaceutical industry, part b : patents and copyright
- Economic, medical and social medicine
- CTD File (Common Technical Document)
- Regulations of preclinical and clinical studies, part a : Pharmacotoxicological files
- Regulations of preclinical and clinical studies, part b : European and Belgian legislations
- Especially regulatory aspects, part a : medicines and food supplements made from plants
- Especially regulatory aspects, part b : Galenic development
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| Duration : | Legislation and procedures as applied to the pharmaceutical industry, part a : 10h Th, 5h Pr
Legislation and procedures as applied to the pharmaceutical industry, part b : patents and copyright : 5h Th
Economic, medical and social medicine : 10h Th
CTD File (Common Technical Document) : 15h Th
Regulations of preclinical and clinical studies, part a : Pharmacotoxicological files : 7,5h Th
Regulations of preclinical and clinical studies, part b : European and Belgian legislations : 7,5h Th
Especially regulatory aspects, part a : medicines and food supplements made from plants : 5h Th
Especially regulatory aspects, part b : Galenic development : 5h Th
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| Credits/ECTS : |
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| Holder(s) : | Legislation and procedures as applied to the pharmaceutical industry, part a : C. Druez
Legislation and procedures as applied to the pharmaceutical industry, part b : patents and copyright : Michel Tytgat
Economic, medical and social medicine : Alain De Wever
CTD File (Common Technical Document) : J.‑A. De Muylder
Regulations of preclinical and clinical studies, part a : Pharmacotoxicological files : J. Carleer
Regulations of preclinical and clinical studies, part b : European and Belgian legislations : A. Hepburn
Especially regulatory aspects, part a : medicines and food supplements made from plants : Monique Tits
Especially regulatory aspects, part b : Galenic development : Karim Amighi
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| Coordinator : | Philippe Hubert |
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| Language : | Langue française |
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| Course contents : |
 | | Especially regulatory aspects, part a : medicines and food supplements made from plants |
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| Comparison of manufacturing and marketing of herbal remedies are important: lists of Drugs and Foodstuffs containing plants or plant preparations published in the Belgian Law Gazette are different (lists of Royal and Ministerial Decrees).
European legislation about herbal medicinal products will be given. |
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| Course objective : |
| | Especially regulatory aspects, part a : medicines and food supplements made from plants |
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| Different ways exist to access the market of herbal medicinal products in the European Union and in Belgium.
The lists of Drugs and Foodstuffs containing plants or plant preparations published in the Belgian Law Gazette are very different (lists of Royal and Ministerial Decrees). The technical guidance on quality and thus safety and efficacy are also very different for these herbal remedies.
Description of the new European legislation on traditional herbal medicinal products (simplified procedure for access to the market).
Publication of the new Herbal Medicinal Products Committe » HMPC of the EMEA.
Specific and general monographs on herbal substances pubished in European Pharmacopea and monographs of ESCOP and WHO.
Note for guidance and specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products. |
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| Prerequisites : |
| | Especially regulatory aspects, part a : medicines and food supplements made from plants |
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| General legislation, framework of CTD |
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| Written notes : |
| | Especially regulatory aspects, part a : medicines and food supplements made from plants |
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| Lecture notes and power-point data will be distributed to students |
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| Assessment : |
| | Especially regulatory aspects, part a : medicines and food supplements made from plants |
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| Written and /or oral examination |
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| Contacts : |
| | Especially regulatory aspects, part a : medicines and food supplements made from plants |
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| Monique Tits
Laboratoire de Pharmacognosie
Av. de l'hôpital 1, B-4000 Liège
CHU Tour 4, niveau +3 (B36)
Tél 04/366 43 34 - 43 31
Fax 04/366 43 32 |
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