EMA GVP Annex IV

EMA Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance

EMA Final GVP Annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance

Click on the links below for full annex details

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 A: Clinical safety data management: Definitions and standards for expedited reporting - Step...(PDF/177.91 KB)

First published: 01/06/1995, Last updated: 01/06/1995

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2B (R3): Electronic transmission of individual case safety reports (ICSRs) - data elements ...(PDF/1.49 MB)

First published: 01/09/2005, Last updated: 27/08/2013

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety repo...(PDF/480.36 KB)

First published: 01/03/2005, Last updated: 27/07/2017

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5 (PDF/476.27 KB)

First published: 31/12/2012, Last updated: 31/12/2012

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5 (PDF/181.92 KB)

First published: 30/11/2003, Last updated: 30/11/2003

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5 (PDF/225.43 KB)

First published: 31/12/2004, Last updated: 31/12/2004

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2F on development safety update report - Step 5 (PDF/352.87 KB)

First published: 30/09/2010, Last updated: 30/09/2010



EMA GVP Annex IV:

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