Schulungen, praktische Hilfen

Institut für Arzneimittelsicherheit

Gutachten, Klinische Studien, Statistik und Epidemiologie

Detailed Guidance

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


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


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

ICH Topic E2A

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

ICH Topic E2E

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

E2B(R) Clinical Safety Data Management

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

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


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

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

Volume 9 – Pharmacovigilance

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

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