Introduction to pharmacovigilance and rules for expedited reporting of individual case safety reports in Europe
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Date
- Otrdiena, 19 Maijs 2015, Visu dienu
Vieta
- European Medicines Agency, Amsterdam, the Netherlands
This one day course covers the pre-requisites for the three day training course on EudraVigilance – electronic reporting of individual case safety reports (ICSRs) and is therefore recommended to newcomers in pharmacovigilance, in particular individuals dedicated to data entry and expedited reporting. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as the rules for expedited reporting in Europe for both clinical trials and post-marketing ICSRs. Places limited.