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Allgemein

FDA Guidance for Industry:

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005 (Draft) Guidance for

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ICH Topic E2F

Developmental Safety Update Report (DSUR), September 2011

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EMEA Note for Guidance

Regulatory Electronic Transmission of ICSRs in Pharmacovigilance (EMEA/H/31387/01/FINAL), March 2002

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CPMP & EudraVigilance

Technical Implementation Group (EV-TIG): Joint Pharmacovigilance Plan for the Implementation of the ICH E2B, M1 and M2 Requirements Related to the Electronic Transmission of ICSRs in the Community, March 2001

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CPMP and CVMP

Note for Guidance on electronic exchange of pharmacovigilance information for human and veterinary medicinal products in the European Union (EMEA/CXMP/PhVMP/2056/99)

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ICH M2 EWG

Electronic Transmission of ICSRs Message Specification, Final Version 2.3, 2001

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EMEA Note for Guidance

Regulatory Electronic Transmission of ICSRs in Pharmacovigilance (EMEA/H/31387/01/FINAL)

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Volume 9 – Pharmacovigilance

Medicinal Products for Human and Veterinary Use(Achtung: 323 Seiten!)

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Regulation (EC) No 540/95 of 10 March 1995

laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medical products for human or veterinary use authorized in accordance with the provisions of Council Regulations (EEC) No 2309/33

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Directive 1001/83/EC

of the European parliament and of the council of 6 November 2001 on the Community code relating to medicinal products for human use

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ICH M2(M)

Recommendations on electronic transmission of ICSRs message specification, ICH Step 5 (CPMP/ICH/285/95, modification), NOV 2000

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ICH Topic E2E

Pharmacovigilance Planning (PVP), ICH Step 4 (CPMP/ICH/5716/03), 1 DEC 2004

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E2B(R) Clinical Safety Data Management

Data Elements for Transmission of ICSRs*), Revision 2, Version 2.0, May 2005 Draft

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ICH E2BM EWG

Data Elements for Transmission of ICSRs. Revised E2B Step Four Document, Version 4.4.1, FEB 2001

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ICH Topic E2A

Clinical Safety Data Management: Definitions and Standards für Expedited Reporting (CPMP/ICH/377/95) Step 5

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Detailed Guidance

on the European Database of SUSARs (Eudravigilance – Clinical Trial Module), April 2003 - Final

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VOLUME 9A

of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use – Final March 2007

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