CIOMS Working Groups and their Contribution to Pharmacovigilance

Pharmacovigilance: Second Edition

Volumn , Issue , 2007, Pages 287-305

  Roden, Sue ^a   Gibbs, Trevor ^a  

^a G1axoSmithKline Research and Development Ltd   (United Kingdom)

Author keywords

CIOMS 11 periodic safety updates; CIOMS IV benefit risk evaluation; CIOMS working groups and pharmacovigilance contribution; Council for International Organisations of Medical Sciences (CIOMS); Development Risk Management Plan (DRMP)

Indexed keywords

EID: 79954435668     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470059210.ch23     Document Type: Chapter

References (17)

1. CIOMS (1990) International Reporting of Adverse Drug Reactions: Final Report of CIOMS Working Group. Geneva: Council for International Organisations of Medical Sciences.
2. CIOMS (1992) International Reporting of Periodic Drug-Safety Update Summaries: Final Report of CIOMS Working Group 77. Geneva: Council for International Organisations of Medical Sciences.
3. CIOMS (1995) Guidelines for Preparing Core Clinical-Safety Information on Drugs: Report of CIOMS Working Group III. Geneva: Council for International Organisations of Medical Sciences.
4. CIOMS (1998) Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals: Report of CIOMS Working Group IV. Geneva: Council for International Organisations of Medical Sciences.
5. CIOMS (1999) Guidelines for Preparing Core Clinical-Safety Information on Drugs: Report of CIOMS Working Groups III and V, 2nd edn. Geneva: Council for International Organisations of Medical Sciences.
6. CIOMS (2001) Current Challenges in Pharmacovigilance: Pragmatic Approaches: Report of CIOMS Working Group V. Geneva: Council for International Organisations of Medical Sciences.
7. CIOMS VI (2005) Management of Safety Information from Clinical Trials: Report of CIOMS Working Group VI. Geneva: Council for International Organisations of Medical Sciences.
8. ICH (1994) E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Step 4; October).
9. ICH (1996) E2C. Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Step 4; November).
10. ICH (1997) E2B: Clinical Safety Data Management: Data Elements for Transmission of ADR Reports (Step 4; July).
11. ICH (2000) E2B (M): Maintenance of the ICH Guideline on Clinical Safety Data Management Including the Maintenance of the Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1) (Step 4; July 1997, amended November).
12. ICH (2003a) E2D: Post-approval Safety Data Management: Definitions and Standards for Expedited Reporting (Step 4; November).
13. ICH (2003b) Addendum to ICH E2C: Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs (Step 4 February).
14. ICH (2004) E2E: Pharmacovigilance Planning (Step 4; November).
15. 'A guideline on the summary of product characteristics' (1999) In: The Rules Governing Medicinal Products in the European Union, Vol. 2A, and The Notice to Applicants, Vol. 213, December.
16. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
17. Notice to Marketing Authorisation Holders: Pharmacovigilance Guidelines (1999).