PVpharm is pleased to inform that Jan Kolouch, will be participating as an co-trainer in the Eudravigilance EVWeb training, 7-11 December 2020, 14:00 – 18:30
The online course will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS.
This training course covers:
- In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR Implementation Guide
- The use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to practice examples for various reporting scenarios
- Reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products”
- How to comply with the EudraVigilance business rules and the EudraVigilance Access Policy
- Training on the transmission of ICSRs in the E2B(R3) format via the EudraVigilance Gateway (including WebTrader (EVWEB, EV Post and Gateway Traders)
- Instruction on using the ICSR download functionality for MAHs to access ICSRs
PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.