EudraVigilance Information Day
This EudraVigilance Information Day provides a forum to update stakeholders about latest developments with regard to EudraVigilance in the context of the implementation of the pharmacovigilance legislation. It further aims to facilitate change management as part of the Agency’s pharmacovigilance programme and the planning of modifications to business processes by medicines regulatory authorities and pharmaceutical companies.
Other topics to be addressed include the revision of the Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products with main focus on the transition to the ISO/ICH E2B(R3) format as well as updates on MedDRA provided by the Maintenance Support Service Organisation (MSSO).
The Information Day will conclude with a summary of the first year of the operation of the medical literature monitoring and ICSR reporting by the Agency.
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