Pharmacovigilance

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Results

Since the CIOMS Working Group I “International Reporting of Adverse Drug Reactions” (1990) ten numbered Working Groups and several unnumbered Working Groups were launched to address hot topics of pharmacovigilance. All produced valuable reports as a result:-

  • International Reporting of Periodic Drug Safety Update Summaries (CIOMS Working Group II 1992)
  • Guidelines for Preparing Core Clinical Safety Information on Drugs (CIOMS Working Group III, 1995)
  • Benefit-risk balance for marketed drugs (CIOMS Working Group IV, 1998)
  • Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS Working Group V, 1999)
  • Development and Rational Use of Standardized MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA (CIOMS Working Group on SMQs, 2004)
  • Management of Safety Information from Clinical Trials (CIOMS Working Group VI, 2005)
  • Development Safety Update Reports  (DSUR): Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials (CIOMS Working Group VII, 2006)
  • Practical Aspects of Signal Detection in Pharmacovigilance (CIOMS Working Group VIII, 2010)
  • Definition and Application of Terms for Vaccine Pharmacovigilance (Report of CIOMS/WHO Working Group, 2012)
  • Practical Approaches to Risk Minimisation for Medicinal Products (CIOMS Working Group IX, 2014)
  • Evidence Synthesis and Meta-Analysis for Drug Safety (CIOMS Working Group X, 2016)
  • Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA (CIOMS SMQ Implementation Working Group, 2016)
  • CIOMS Guide to Active Vaccine Safety Surveillance (CIOMS Working Group on Vaccine Safety, 2017)