MODULE 11 Pharmacovigilance March 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES

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1 MODULE 11 Pharmacovigilance March 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES

2 Robert VANDER STICHELE M.D., RUG and VUB, Senior Researcher, Health Technology Assessment, Heymans Institute of Pharmacology and Belgian Health Care Council PHARMACOEPIDEMIOLOGY AND DRUG UTILIZATION STUDIES Robert VANDER STICHELE This course will summarise the basic concepts of the epidemiological method (case control studies, cohort studies, confounding...) which must be well understood in order to perform adequate post-marketing surveillance. PHARMACOVIGILANCE IN DAILY PRACTICE Caroline DUMAS C. Dumas will present her experience of "Product Surveillance for Industries", gained within Vigilex, a company providing vigilance services for more than 15 years across the world. The practical aspects will be discussed. Caroline DUMAS M.D., MSc, Medical Executive, Vigilex, Rotterdam, Netherlands

3 Marc CEUPPENS MD, KUL, MBCPM, Therapeutic Area Safety Head Infectious diseases and Vaccines, Janssen Infectious Diseases, Belgium PHARMACOEPIDEMIOLOGY AND POST-MARKETING SURVEILLANCE Marc CEUPPENS Mr Ceuppens will describe the pharmacovigilance requirements relating to medicinal products marketed in the EU. He will explain the legal provisions relating to pharmacovigilance which are supported by a series of guidelines including those adopted in the EU under the ICH process. He will highlight the responsibilities of the Marketing Authorisation Holders, the Members States and the EMA. RECENT TRENDS IN PHARMACOVIGILANCE This course will present an overview of new concepts and tools in pharmacovigilance. Corinne JOUQUELET-ROYER MD, former clinical pharmacologist at University of Nancy and University of Bordeaux, former specialist in pharmacovigilance at the French Centre de Pharmacovigilance and at GSK Biologicals,VP, Global Phamacovigilance & Epidemiology Head PV Vaccines Regional Safety Head Europe, Sanofi Pasteur, Lyon, France

4 Wednesday 22 March 2017 Thursday 23 March Welcoming participants Robert VANDER STICHELE Basic concepts in pharmacoepidemiology Caroline DUMAS Pharmacovigilance in daily practice Coffee break Caroline DUMAS Pharmacovigilance in daily practice Robert VANDER STICHELE Basic concepts in pharmacoepidemiology Robert VANDER STICHELE Drug utilization studies, effectiveness research and risk minimization studies Coffee break Robert VANDER STICHELE Drug utilization studies, effectiveness research and risk minimization studies Lunch Marc CEUPPENS European regulation of pharmacovigilance Corinne JOUQUELET-ROYER Recent trends in pharmacovigilance

5 REGISTRATION FEES FOR THE COURSE AND EXAMINATION Attendance to the 16 modules, access to all course notes on the private domain of our web site and examination: Attendance to 4 selected modules, access to all courses notes on the private domain of our web site and examination : Attendance to one individual module, with a copy of the course notes : 600 Examination only, with access to all course notes on the private domain of our web site : Second or third attempt at the examination : 200 Registration can be done at any time during the year. Registration to a module includes two lunches and beverage breaks. A discount can be offered to candidates who are neither employed nor sponsored by a biopharmaceutical company. Register by , by sending the completed registration form to pharmed@ulb.ac.be. Download the registration form on our web site Payment should be made upon receipt of our invoice. The courses take place in Brussels, at HOTEL ERASME : Route de Lennik Brussels (Phone : 32-02/ ) For more information please contact : REGISTRATION AND INFORMATION Mrs Bahija JELLOULI PHARMED ULB CP611 Route de Lennik, 808 B 1070 Bruxelles BELGIUM pharmed@ulb.ac.be - Phone :