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| Title | European Medicines Agency information day: The new individual-case-safety-report (ICSR) international standard and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B/M2 information day |
|---|---|
| Date | 05/02/2013 - 05/02/2013 |
| Location | European Medicines Agency, London, UK |
| Summary | 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. |
All documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| 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 for Human Use E2B/M2 | (English only) | 08/01/2013 | 16/01/2013 |