Information day on the new individual case safety report international standard and ICH E2B/M2

• Date:
  Tuesday, 5 February 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

In November 2012, step 4 of ICH E2B (R3) package was signed off, including the awaited implementation guide accompanied by several technical appendices. This step opens the way for the worldwide implementation of the new ICSR, progressively replacing the current E2B (R2). This information day presents and explains the main and latest changes to E2B and its appendices as well as what, how and when they will be required in the European Union and the United States. Places limited.

Documents

Agenda - European Medicines Agency information day: The new individual-case-safety-report international standard and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals...

Summary:

In November 2012, step 4 of ICH E2B (R3) package has been signed off including the awaited

implementation guide accompanied by several technical appendices. This step opens the way for the

worldwide implementation of the new ICSR replacing progressively the current E2B (R2). This information

day will present and explain the main and latest changes to E2B and its appendices as well as what, how

and when they will be required in the EU and the US.