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application authority bric biopharmaceuticals brazil china clinical clinical trials combination products conference course development diploma directive documentation drug global guideline india international legislation life cycle activities marketing authorisation master degree medicademy medical devices module non-clinical orphan drug designation pim paediatric investigation plans pharmaceutical law frames eu pharmacoepidemiology pharmacovigilance pharmacovigilance systems post-marketing surveilance preclinical professional quality regulation regulatory affairs role and responsibilities russia seminar strategic considerations usa variations Vis mere