From the 16th to the 20th September, José Alberto Ayala Ortiz will be participating as an instructor on the EVWEB and XEVMPD training courses provided by the European Medicines Agency (EMA) in Amsterdam.
From the 16th to the 18th September, a hands-on Training Course using the EudraVigilance System will be provided.
This training course covers:
-Explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B (R3).
-The use of EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3).
-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 Gateway, including WebTrader.
-Instruction on using the ICSR download functionality for MAHs to access ICSRs.
On the other hand, a face-to-face training course on eXtended EudraVigilance Medicinal Product Dictionary is provided on the days 19th and 20th September.
This training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB).
PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.