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Faculty of Medicine
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Advanced Master in Industrial Pharmacy
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Th
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Pr
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Au
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Programme structure
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A single year
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Renseignements
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Monsieur le Professeur Ph. HUBERT
Laboratoire de Chimie analytique
Bât. B36 - CHU - 4000 Liège
Tél : 04/366.43.16 - Fax : 04/366.43.17
Courriel : Ph.Hubert@ulg.ac.be
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Presentation
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The complementary Masters in Industrial Pharmacy is the route taken by those wishing to acquire the status of a qualified person (A.R. 14 December 2006 relating to Drugs for Human and Veterinary Use, article 84). To obtain this official recognition from the Minister for Public Health, the degree must be completed, for those holding a pharmacy degree or a degree with equivalent competences (See. Particular conditions), with 6 months of practical experience in one or more pharmaceutical companies which hold authorisation for the industrial manufacture of drugs according to the conditions set out in A.R. of 14 August 1989.
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Le Master complémentaire en pharmacie d'industrie prépare à des tâches conventionnelles de fabrication et d'analyse des médicaments. Le programme intègre également des cours dans des domaines d'actualités tels que la biotechnologie, les affaires réglementaires, l'assurance de qualité, les aspects économiques du médicament, les essais cliniques.
Un programme interuniversitaire impliquant l'ULB, L'UCL et l'ULg a été créé à cette fin en 1997.
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Conditions particulières
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A qualified person is someone who is legally responsible for the pharmaceutical activities of a permit holder; they must be registered on an up-to-date list. Request for registration on this list, accompanied by the required supporting documentation, must be addressed to the Minister.
Only those holding the legal degree of Industrial Pharmacist or the complementary Masters in Industrial Pharmacy, obtained in line with the legislation on the awarding of academic grades and the University exam programme, or those who are legally exempt, can be registered as qualified persons (without additional requirements).
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Holders of a degree in pharmacy, medicine, veterinary medicine, chemistry, biology or biomedical sciences may also be approved as qualified persons, provided they demonstrate having a theoretical and practical academic level for at least the following basic subjects :
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- Experimental physics ;
- General and inorganic chemistry ;
- Organic chemistry ;
- Analytical chemistry ;
- Pharmaceutical chemistry, including drug analysis ;
- General and applied biochemistry (medical) ;
- Physiology ;
- Microbiology ;
- Pharmacology ;
- Pharmaceutical technology ;
- Toxicology ;
- Pharmacognosy
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For further information about the basic contents, see the programme of the Bachelor in Pharmaceutical sciences :
http://progcours.ulg.ac.be/cocoon/programmes/MBPHAR01.html and the Master in Pharmaceutical sciences :
http://progcours.ulg.ac.be/cocoon/programmes/TUR_MMPHARMA.html.
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In addition, these persons have to proove that they are qualified and that they have taken theoretical and practical courses of an academic level about the following subjects :
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- In-depth knowledge in anlysis of quality control,
- In-depth knowledge in pharmaceutical biotechnology,
- In-depth knowledge in pharmaceutical technology, including validation and GMP standards,
- Specific knowledge in legislation applicable to pharmaceutical industry,
- In-depth knowledge of the grant conditions of the Regulation of therapeutic goods.
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Ces connaissances sont dispensées dans le cadre du Master complémentaire en pharmacie d'industrie.
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Reconnaissance officielle par le ministère de la Santé publique en Belgique
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- Citizens of another State of the European Union who hold an equivalent degree may also be recognized on the same criteria.
- The applicant of approval has to prove that he/she has acquired a practical experience of at least two years full time in one or several companies located in Belgium who are holders of an authorization to manufacture drugs. The experience acquired in a company established in another Member State may also be taken into account.
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- This experience must focus on the qualitative analysis of drugs, the quantitative analysis of active substances, the manufacturing of controls "in process". Its duration can be reduced by one year when the university course lasts for at least five years and by one year and a half when the training cycle lasts at least six years, that is to say, after the Advanced Master in Industry Pharmacy.
- The practice experience mus be certified by the person responsible for the placement.
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Duration
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- One year of study, with the possibility of spreading the programme over two years after a recommendation supplied by the Jury of the host university.
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Collegiality
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Coordinateur : Philippe HUBERT
Pour l'ULg : Vincent BIERLAIRE, Bruno BOULANGER, Raphaël DENOOZ, Dominique MARTIN, Laurence DENIS, Brigitte EVRARD, Marianne FILLET, Bernard PIROTTE, Eric ROZET, André SCHEEN, Monique TITS, Jean-Michel VANDERHOFSTADT, Eric ZIEMONS.
Pour l'ULB : Karim AMIGHI, Sonja BEKEN, Daniel BRASSEUR, Jean-Antoine DE MUYLDER, Patrick DI STEFANO, Pierre DUEZ, François DUFRASNES, Véronique FONTAINE, Ghanem GHANEM, Jean-Michel KAUFFMAN, A. LENAERS, Pierre VAN ANTWERPEN, Francis VANDERBIST, David VERMIJLEN.
Pour l'UCL : Catherine DRUEZ, Bernadette GOVAERTS, Philippe LEVEQUE, Xavier MARCELIS, Jacques POUPAERT, Joëlle QUETIN-LECLERCQ, Nevin SERBEST, Jean SCOUVART, Rita VAN BEVER, Roger VERBEECK, N...
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A single year
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Compulsory courses
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PHIN2004-1
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Active substances
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Substances issues de recherches pharmacochimiques, part a - Bernard Pirotte
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Substances issues de recherches pharmacochimiques, part b - Françoise Dufrasne
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Substances issues des biotechnologies - David Vermijlen
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Substances d'origine naturelle, part a - Joëlle Quetin-Leclercq
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Substances d'origine naturelle, part b - Pierre Duez
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Produits radiopharmaceutiques - Ghanem Ghanem
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PHIN2008-2
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Clinical viewpoints
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| 6
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Métabolisme des médicaments et paramètres pharmacocinétiques - Roger Verbeek
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Aspects théoriques et pratiques des études cliniques (y compris les méthodes statistiques appliquées aux études cliniques) - André Scheen
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Information et pharmacovigilance - Raphaël Denooz
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PHIN2013-2
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Quality assurance and pharmaceutical management
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| 7
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Principles of pharmaceutical management - Jean-Michel Van Der Hofstadt
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Quality assurance, part a : basic concepts and quality assurance organisation - Jean Scouvart
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Quality assurance, part b : Analytical technology of procedures and risk analysis - Xavier Marcelis
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English applied to the pharmaceutical industry - Jacques Poupaert, Nevin Serbest
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Pharmaceutical marketing - Vincent Bierlaire
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PHIN2033-1
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Industrial pharmaceutical technology
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| 8
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Industrial pharmaceutical microbiology - Véronique Fontaine
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Preformulation and selection of galenical forms - Karim Amighi
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Industrial production of galenical forms - Brigitte Evrard
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Industrial production of biomolecules - Philippe Leveque, Rita Van Bever
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Industrial aspects of technological development including packaging - Laurence Denis
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PHIN2023-1
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Drug analysis
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| 7
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Analytical methods and pharmaceutical and biopharmaceutical control, part a - Jean-Michel Kauffman, Pierre Van Antwerpen
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Analytical methods and pharmaceutical and biopharmaceutical control, part b - Marianne Fillet
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Methods in pharmaceutical and biopharmaceutical analysis, part a : Validation and qualification of equipment - Philippe Hubert, Eric Rozet
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Methods in pharmaceutical and biopharmaceutical analysis, part b : Process analytical technology - Philippe Hubert, Eric Ziemons
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Statistical methods applied to the pharmaceutical industry - Bernadette Govaerts
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Experimental planning and "quality by design" - Bruno Boulanger
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PHIN2029-2
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Regulation and the medical-social environment
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Economic aspects of drug development - Dominique Martin
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Legislation and procedures applied to pharmaceutical industry, part a : legislation - Catherine Druez
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Legislation and procedures applied to pharmaceutical industry, part b : patents and protection - Patrick Di Stefano
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Macroeconomic environment and pharmaco-economics - Pierre Duez
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CTD File (Common Technical Document) - Jean-Antoine De Muylder
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Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files - Sonia Beken
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Regulations of preclinical and clinical studies, part b : clinical studies - A Lenaers
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Regulations of preclinical and clinical studies, part c : pediatric studies - Daniel Brasseur
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Specific regulatory issues, part a : medicine and herbal dietary supplement - Monique Tits
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Specific regulatory issues, part b : Preformulation and galenical development documentation - Francis Vanderbist
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PHIN2032-1
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Visits and seminars organised in the pharmaceutical industry - Collégialité - [77,5h Vis.]
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MTFE2000-1
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Final work - Collégialité
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