Pharmacovigilance Regulatory Processes University of Bordeaux
> The aim of this course is: - To enable participants (specialists) to develop an understanding ofthe requirements of the Pharmaceutical Industry’s operationalaspects of pharmacovigilance as it relates to the preparation andassessment of documents legally required by regulatory bodies. - Focus will be on the adverse event reporting process withinIndustry, placed within the context of regulatory requirements andbest practice.
- Post-graduated leve in Health or Life Sciences. - Language prerequisites: Non-native English speakers must provide acertificate proving a minimum of English B2 level (cf. Europass[http://europass.cedefop.europa.eu/]). - Computer and internet requirement.
Assessment is a mix of continuous assessment.
> This cours consists of the following parts: - Case reporting - Periodic reporting - Product Labelling and Risk Management Plans - Contractual arrangements
Recorded and live lectures, readings, home assignments, on-line quizzes, forums, wikis, live seminars.
Online Course Requirement
- Professionals: 3,000€/year. - Students: 1,500€/year. - No additional costs and no mobility required.Duration: 12 weeksLanguage of instruction: EnglishMode of delivery: E-learning
Site for Inquiry
Please inquire about the courses at the address below.
Contact person: Karine Palinkarine.firstname.lastname@example.org