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| EPID0721-1 | Pharmaco-epidemiology and clinical epidemiology
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| Duration : | 30h Th, 30h Pr |
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| Credits/ECTS : |
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| Holder(s) : | Jean‑Yves Reginster |
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| Language : | Langue française |
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| Course contents : | - Good Clinical Practices (GCP)
- Performance of clinical studies
- Analysis of Belgian regulatory requirements for registration and reimbursement
- Handling of electronic databases in research
- Basis for economic modelisation |
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| Course objective : | The student will be able, after this course, to be part of a multidisciplinary CRA team, to understand and to participate in the appropriate management of clinical trials. He/She will be able to collect all data requested for the submission of a file to an IRB and to prepare the appropriate administrative documentation. He should understand, from the pharmaceutical industry point of view, the way to interact with the Belgian Regulatory Authorities. He will be able to contribute in the preparation of a filing for regulatory application. |
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| Prerequisites : | Having successfully completed the course Basic principles of Epidemiology, Health Economics and Econometry |
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| Workshops : | No |
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| Organization : | Following a brief theoretical introduction, the students will benefit from two external stages. The first stage will be organized within an hospital unit specialized in the Management of clinical trials. Following this first part, they will be invited to interact with pharmaceutical companies based in Belgium. At this time, they will benefit for exchanges with CRA developing new studies protocol and preparing regulatory files. |
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| Written notes : | Available at the Department of Public Health, Epidemiology and Health Economics. |
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| Assessment : | A brief report (maximum 3 pages) for each of the two stages should be remitted to the administrative assistant of the Department of Public Health, Epidemiology and Health Economics at least one month before the date chosen for the first or second session deliberation. |
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| Contacts : | Jean-Yves REGINSTER, Professor
Public Health, Epidemiology and Health Economics
CHU SART-TILMAN
Bât. B23
Tél. : +32 4 366 25 01 - Fax : +32 4 366 28 12
E-mail : episp@ulg.ac.be
Secreatry: Vanessa STRAUVEN |
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