London, UK
21.06.16 - 21.06.16
This EudraVigilance Information Day provides a forum to update stakeholders about the 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 European Medicines Agency’s pharmacovigilance programme and the planning of modifications to business processes by medicines regulatory authorities and pharmaceutical companies.
The key topics of this Information Day are:
- Adverse reaction reporting and analysis, EudraVigilance system changes to come
- Definitions, principles, processes and reporting of ICSRs in R3 format: what will change with the revision of GVP Module VI?
- Preparing for business change from a medicines regulatory authority and pharmaceutical industry perspective
- One year of medical literature monitoring performed by the Agency – achievements and lessons learned
- MedDRA - ICSR reporting and challenging coding examples
To view the full agenda, please visit the Information Day website.