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WGXI Patient Involvement: Workplans, drafts, TC notes ...
WGXI Patient Involvement: Background Documents
WGXI Patient Involvement: Face-to-face meetings
WGXII Benefit-risk Working Group Documents
WGXVI Development Safety Update Report Working Group Documents
WGXII Benefit-risk Working Group Documents
WGXIII Real-world Data Working Group Documents
SCAR Working Group Documents
Educational Standards Working Group Documents
Good Governance Practice for Research Institutions Working Group Documents
Pharmacoepidemiology for Public Health Working Group Documents
MedDRA Labelling Groupings Working Group Documents
Clinical Research in Resource-limited Settings Working Group Documents
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PUBLICATIONS
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Benefit-Risk Balance for Medicinal Products
2025
year
FREE
Severe cutaneous adverse reactions (SCAR)
2025
year
FREE
Glossary of ICH terms and definitions
2024
year
FREE
Chinese translation: Real-world data/evidence in regulatory decision making
2024
year
FREE
CIOMS Cumulative Glossary with a Focus on Pharmacovigilance - 75th Anniversary Edition
2024
year
FREE
Real-world data and real-world evidence in regulatory decision making
2024
year
FREE
Introduction to MedDRA Labeling Grouping (MLG)
2024
year
FREE
Patient involvement in the development, regulation and safe use of medicines
2022
year
FREE
Drug-Induced Liver Injury
2020
year
FREE
Japanese translation: Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA
2018
year
FREE
CIOMS Guide to Vaccine Safety Communication
2018
year
FREE
Chinese translation: Practical Aspects of Signal Detection in Pharmacovigilance
2018
year
FREE
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