Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 27 May 2024 to 29 May 2024

Date

Metadata

Provider: 

European Medicines Agency

URL: 

https://www.ema.europa.eu/en/events/virtual-live-hands-training-course-clinical-trials-sponsors-using-eudravigilance-system-9

Retrieved on: 

Tuesday, January 2, 2024

Information

Tags: 

Online, ICH, ICSR, European Economic Area, EMA, EudraVigilance, RP, Terminology, Location, Announcement, ISO, EV, Environment

Summary

Key Points: 

• Date
  - Monday, 27 May 2024 - Wednesday, 29 May 2024
  Location
  - Online
  Event summary
  EudraVigilance is the EU’s system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products.
• Following the Announcement of the EMA Management Board, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became mandatory on 30 June 2022 for all reporting to EudraVigilance.
• Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
• Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.

Copyright: 

2024 European Medicines Agency. All Rights Reserved.