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admission conditions
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Advanced Master in Industrial Pharmacy
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Au
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Information
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Professor Ph. HUBERT
Analytical Chemistry Laboratory
Build. B36 - CHU - 4000 Liege
Phone : 04/366.43.16 - Fax : 04/366.43.17
e-mail address : 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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The complementary Masters in Industrial Pharmacy prepares students for standard tasks in drug manufacture and analysis. The programme also integrates courses in contemporary areas such as biotechnology, regulations, quality assurance, economic aspects of drugs, and clinical trials.
An inter-university programme involving the ULB, UCL and ULg was created to this end in 1997.
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Particular requierements
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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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These courses are taught in the Advanced Master in Industrial Pharmacy.
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Official recognition by the Department of Public Health in Belgium
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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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Coordinator : Philippe HUBERT
For the ULg : Vincent BIERLAIRE, Bruno BOULANGER, Corinne CHARLIER, Dominique MARTIN, Laurence DENIS, Brigitte EVRARD, Marianne FILLET, Bernard PIROTTE, André SCHEEN, Monique TITS, Jean-Michel VANDERHOFSTADT.
For the ULB : Karim AMIGHI, Sonja BEKEN, Daniel BRASSEUR, Jean-Paul DEHAYE, Jean-Antoine DE MUYLDER, Alain DE WEVER, Pierre DUEZ, François DUFRASNES, Véronique FONTAINE, Ghanem GHANEM, Jean-Michel KAUFFMAN, A. LENAERS, Pierre VAN ANTWERPEN, Francis VANDERBIST.
For the UCL : Catherine DRUEZ, Jean GILLARD, Didier LAMBERT, Xavier MARCELIS, Sylvie PONCHAUT, Joëlle QUETIN-LECLERCQ, Nevin SERBEST, Jean SCOUVART, Roger VERBEEK, 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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| 6
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- Substances issues de recherches pharmacochimiques, part a - Bernard Pirotte
| 10
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- Substances issues de recherches pharmacochimiques, part b - Françoise Dufrasne
| 5
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- Substances issues des biotechnologies - Jean‑Paul Dehaye
| 15
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- Substances d'origine naturelle, part a - Joëlle Quetin‑Leclercq
| 5
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- Substances d'origine naturelle, part b - Pierre Duez
| 5
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- Produits radiopharmaceutiques - Ghanem Ghanem
| 10
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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
| 20
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- Aspects théoriques et pratiques des études cliniques (y compris les méthodes statistiques appliquées aux études cliniques) - André Scheen
| 15
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- Information et pharmacovigilance - Corinne Charlier
| 10
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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
| 10
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- Quality assurance, part a : basic concepts and quality assurance organisation - Jean Scouvart
| 20
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- Quality assurance, part b : Analytical technology of procedures and risk analysis - Xavier Marcelis
| 7,5
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- English applied to the pharmaceutical industry - Jennifer Moreman, Jacques Poupaert, Nevin Serbest
| 20
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- Pharmaceutical marketing - Vincent Bierlaire
| 7,5
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PHIN2022-1
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Industrial pharmaceutical technology
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| 8
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- Microbiologie pharmaceutique industrielle - Véronique Fontaine
| 15
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- Préformulation et sélection des formes galéniques - Karim Amighi
| 15
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- Production industrielle des formes galéniques - Brigitte Evrard
| 15
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- Génie pharmaceutique - Jean Gillard
| 15
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- Aspects industriels du développement technologique y compris le conditionnement - Laurence Denis
| 10
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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
| 10
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- Analytical methods and pharmaceutical and biopharmaceutical control, part b - Marianne Fillet
| 10
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- Methods in pharmaceutical and biopharmaceutical analysis, part a : Validation and qualification of equipment - Philippe Hubert, Eric Rozet
| 15
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- Methods in pharmaceutical and biopharmaceutical analysis, part b : Process analytical technology - Philippe Hubert, Eric Ziemons
| 5
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- Statistical methods applied to the pharmaceutical industry - Bernadette Govaerts
| 15
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- Experimental planning and "quality by design" - Bruno Boulanger
| 10
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PHIN2029-2
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Regulation and the medical-social environment
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| 8
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- Aspects économiques du développement du médicament - Dominique Martin
| 10
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- Legislation and procedures applied to pharmaceutical industry, part a : legislation - Catherine Druez
| 10
| 5
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- Legislation and procedures applied to pharmaceutical industry, part b : patents and protection - Patrick Di Stefano
| 5
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- Environnment macro-économique et pharmaco-économie - Alain De Wever
| 10
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- CTD File (Common Technical Document) - Jean‑Antoine De Muylder
| 15
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- Regulations of preclinical and clinical studies, part a : pharmaceutical toxicological files - Sonia Beken
| 15
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- Regulations of preclinical and clinical studies, part b : clinical studies - A Lenaers
| 5
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- Regulations of preclinical and clinical studies, part c : pediatric studies - Daniel Brasseur
| 2,5
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- Specific regulatory issues, part a : medicine and herbal dietary supplement - Monique Tits
| 5
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- Aspects réglementaires particuliers, partim b : Préformulation et documentation du développement galénique - Francis Verbist
| 5
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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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| 15
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