RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > EMA Begins Pharmacovigilance Training Courses

EMA Begins Pharmacovigilance Training Courses

Posted 08 April 2016 | By Zachary Brennan 

EMA Begins Pharmacovigilance Training Courses

The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA).

At least one user from each national competent authority, marketing-authorization holder or sponsor of clinical trials in the EEA should complete the training to ensure the information collected in EudraVigilance is of the highest quality and integrity, EMA said.

Those who successfully complete the currently available EudraVigilance training courses and the subsequent registration process will be able to start the electronic submission of individual case safety reports (ICSRs) and ICSR acknowledgements to meet their reporting obligations in relation to pharmacovigilance or clinical trials authorized in the EEA.

Currently there are two sets of three-day training courses. One set will help participants understand ICH rules for safety reporting; understand EudraVigilance better; understand how to electronically transmit ICSRs, as well as how to search and download safety reports, among other tasks. In addition to this week’s course in Madrid, the next courses are occurring:

EMA is also holding a set of EudraVigilance Data Analysis System (EVDAS) training courses for national competent authorities in EEA member states.

Later this year and next year, the EMA will release a set of training modules focusing on pharmacovigilance. EMA has developed the new curriculum to prepare stakeholders for the changes introduced by the 2010 pharmacovigilance legislation regarding adverse reaction reporting and signal detection.

EMA advises stakeholders to start their training around six months before the agency implements the new EudraVigilance functionalities, and to plan regular refresher training sessions in the run-up to implementation.

EudraVigilance Training


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.