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Community legislation and guidance documents General Guidance Related to Electronic Reporting of ICSRs Note for Guidance - EudraVigilance Human
version 7.0 Processing of Safety Messages and Individual Case Safety
Reports (ICSRs) (integrated in Volume 9A). Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety (ICSRs) Revision 1. Implementation Plan for the Note for Guidance EudraVigilance Human - Processing of Safety Messages and Individual Case Safety Reports (ICSRs) (Doc. Ref. EMEA/H/20665/04/Final, Revision 1). Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety (ICSRs) Revision 2. Implementation plan for the ‘Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)’ (EMA/H/20665/04/Final Rev. 2) Implementation plan revision 1. Note for Guidance on the Electronic Data Interchange (EDI) of Individual
Case Safety Reports (ICSRs) and Medicinal Products (MPRS) in
Pharmacovigilance during the pre- and post-authorisation phase
in the European economic area (EEA) (integrated in Volume 9A). Note for Guidance on Regulatory Electronic Transmission of Individual
Case Safety Reports (ICSRs) in Pharmacovigilance. ICH M2 EWG - Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1). List of Pharmaceutical Dosage Forms ICH Harmonised Tripartite Guideline - Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements of Transmission of Individual Case Safety Reports E2B(R2) E2B Implementation Working Group - Questions & Answers (R5) Clinical Trials
Volume 10 - Communication from the Commission - Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ('CT-3') , (2011/C 172/01) Volume 10 - Guidance Documents applying to Clinical Trials - Questions & Answers Specific to Adverse Reaction Reporting in Clinical Trials Version 1.0 (December 2009) Volume 10 - Guidance Documents applying to Clinical Trials - Questions & Answers version 8.0 (March 2011) Volume 10 - Guidance Documents applying to Clinical Trials - Guidance on Investigational Medicinal Products (IMPs) and 'Non Investigational Medicinal Products' (NIMPs) (Rev. 1, March 2011) Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system. EV-EWG: Volume 9A implementation Questions & Answers (version 5.4).
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General
