References

CIOMS (1990) International Reporting of Adverse Drug Reactions: Final Report of CIOMS Working Group. Geneva: Council for International Organisations of Medical Sciences.

CIOMS (1992) International Reporting of Periodic Drug-Safety Update Summaries: Final Report of CIOMS Working Group II. Geneva: Council for International Organisations of Medical Sciences.

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.

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.

CIOMS (1999) Guidelines for Preparing Core Clinical-Safety Information on Drugs, 2nd edn. Report of CIOMS Working Groups III and V. Geneva: Council for International Organisations of Medical Sciences.

CIOMS (2001) Current Challenges in Pharmacovigi-lance: Pragmatic Approaches: Report of CIOMS Working Group V. Geneva: Council for International Organisations of Medical Sciences.

ICH (1994) E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Step 4; October)

ICH (1997) E2B: Clinical Safety Data Management: Data Elements for Transmission of ADR Reports (Step 4; July)

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).

ICH (1996) E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Step 4; November).

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. 2B. December.

Notice to Marketing Authorisation Holders: Pharma-covigilance Guidelines (January 1999).

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