NEU
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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Detailed Guidance on the European Database of SUSARs (Eudravigilance
– Clinical Trial Module), April 2003 - Final
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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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ICH E2BM EWG Data Elements for Transmission of ICSRs.
Revised E2B Step Four Document, Version 4.4.1, FEB 2001
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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 Topic E2E Pharmacovigilance Planning (PVP), ICH Step
4 (CPMP/ICH/5716/03), 1 DEC 2004 |
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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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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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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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Volume 9 – Pharmacovigilance. Medicinal Products for Human
and Veterinary Use
(Achtung: 323 Seiten!)
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EMEA Note for Guidance: Regulatory Electronic Transmission
of ICSRs in Pharmacovigilance (EMEA/H/31387/01/FINAL)
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ICH M2 EWG Electronic Transmission of ICSRs Message Specification, Final Version 2.3, 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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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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EMEA Note for Guidance: Regulatory Electronic Transmission
of ICSRs in Pharmacovigilance (EMEA/H/31387/01/FINAL), March
2002
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FDA Guidance for Industry: Good Pharmacovigilance Practices
and Pharmacoepidemiologic Assessment, March 2005 (Draft)
Guidance for
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