EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area

• Date:
  Wednesday, 18 June 2014, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This training course is intended for people in charge of pharmacovigilance and medicine safety in marketing-authorisation holders and national competent authorities with legal reporting obligations in the EEA, who wish to acquire a robust knowledge in the fundamentals of the electronic reporting of ICSRs, familiarise themselves with the electronic transmission of ICSRs and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications, understand and apply the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices as well as the current EudraVigilance business rules and get hands-on experience with the EudraVigilance reporting capabilities and query functions. Places limited.

Documents

Overview of the EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area: 18-20 June 2014, London, UK