Our CEO, José Alberto Ayala Ortiz participated as an intructor in the EVWEB and XEVMPD training. The course was offered by The European Medicines Agency (EMA) and took place in Madrid from 20th to 24th May.
The EVWEB hands-on training course “The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B (R3) format” was held from the 20th to the 22nd May. This training covered the functionalities of the new EudraVigilance web application (EVWEB) and it included practical examples for creating, sending and accessing individual case safety reports (ICSRs) in the new ISO/ICH E2B (R3). It also includes reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.
On the other hand, The EMA aslo provided a XEVMPD “Extended EudraVigilance medicinal product dictionary” training. This training explained how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary.
PVpharm is also organizing in-house trainings for pharmaceutical companies and CROs, please contact us for further information.