Results
CIOMS publications on pharmacovigilance topics
(Go to “Publications” to see all CIOMS publications, including translations)
- Patient involvement in the development, regulation and safe use of medicines, 2022
- Drug-induced liver injury (DILI), 2020
- CIOMS Guide to Vaccine Safety Communication, 2018
- CIOMS Guide to Active Vaccine Safety Surveillance, 2017
- Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA, 2016
- Evidence Synthesis and Meta-Analysis for Drug Safety (CIOMS X), 2016
- Practical Approaches to Risk Minimisation for Medicinal Products (CIOMS IX), 2014
- Definition and Application of Terms for Vaccine Pharmacovigilance, 2012
- Practical Aspects of Signal Detection in Pharmacovigilance, (CIOMS VIII), 2010
- Development Safety Update Reports (DSUR): Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials (CIOMS VII), 2006
- Management of Safety Information from Clinical Trials, (CIOMS VI), 2005
- Development and Rational Use of Standardized MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA, 2004
- Current Challenges in Pharmacovigilance: Pragmatic Approaches, (CIOMS V), 1999
- Guidelines for Preparing Core Clinical Safety Information on Drugs (second edition) , (CIOMS III and V), 1999
- Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use, 1999
- Benefit-risk balance for marketed drugs: Evaluating safety signals, (CIOMS IV), 1998
- Guidelines for Preparing Core Clinical Safety Information on Drugs, (CIOMS III and V), 1995
- International Reporting of Periodic Drug Safety Update Summaries, (CIOMS II), 1992
- International Reporting of Adverse Drug Reactions (CIOMS Working Group Report), 1987
- Monitoring and Assessment of Adverse Drug Effects (CIOMS Working Group Report), 1985
- Safety Requirements for the First Use of New Drugs and Diagnostic Agents in Man, 1983