PVpharm is pleased to inform that José Ortíz, will be a trainer in the course “Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Practical training course with the EudraVigilance system“ carried out by the European Medicines Agency (EMA).
|– Location||Virtual meeting|
|– Date and Time||11-15 October 2021, 14:00 – 18:30 CEST|
An interesting course due to the new requirements
This course is particularly relevant based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation. The EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO standard terminology for pharmaceutical forms and route of administration will also become mandatory at the same time. The use of the ICH E2B (R2) format will therefore be phased out.
The course includes a knowledge assessment for which the participants, who pass the assessment, will receive a notification from the EMA.
What you can expect from this course
According to the event information provided by the EMA, by the end of this training course, participants should be able to:
- Apply the ISO/ICH E2B(R3) format and rules to safety reporting based on practical examples for initial spontaneous and follow-up reports, amendment and nullification reports, literature and parent-child cases, and reports from interventional and non-interventional studies.
- Understand how to use EVWEB to create, send and access ICSRs and acknowledgments.
- Describe the principles of the EudraVigilance Data Analysis System (EVDAS) and access by MAHs to use electronic Reaction Monitoring Reports (e-RMRs), line listings and ICSR forms.
- Query, view, browse and download ICSRs using the EudraVigilance ICSR Download Functionality, which provides access by marketing authorisation holders (MAHs) to ICSRs from the EEA submitted by national Competent Authorities (NCAs) and MAHs.