Pharmacovigilance Guidelines

• Signal Detection

  • EMA - GVP Module IX - Signal Management (Rev 1)​

  • EMA - GVP Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

  • EMA - Signal Management

  • EMA - IME List

  • EMA - DME List

  • EMA - PRAC Recommendations on signals

  • CIOMS WG VIII -  ​Practical Aspects of Signal Detection in Pharmacovigilance

  • MedDRA  - Standardized MedDRA Queries (SMQs)

​​

• Risk Management

  • EMA - GVP Module XVI - Risk Minimisation Measures (Rev 3)

  • EMA - GVP Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures​

​

• Additional Monitoring

  • EMA - GVP Module X – Additional monitoring

​

• Benefit-Risk Evaluation​

  • CIOMS WG IV - Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals

  • CIOMS WG VIII - Practical Aspects of Signal Detection in Pharmacovigilance

  • CIOMS WG IX - Practical Approaches to Risk Minimisation for Medicinal Products

  • CIOMS WG X - Evidence Synthesis and Meta-Analysis for Drug Safety

​​

• ICSR Management

  • EMA - GVP Module​ VI - Collection, management and submission of reports of suspected AR

  • EMA - GVP Module VI Addendum I – Duplicate management of suspected adverse reaction reports

  • ICH E2D - Post-approval safety data management - definitions and standards for expedited reporting

  • ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

  • CIOMS WG V - ​Current Challenges in Pharmacovigilance: Pragmatic Approaches

  • Duplicate Manegement:

    • EMA - GVP Module VI Addendum I – Duplicate management of suspected adverse reaction reports

  • Coding of Adverse Drug Reactions:

    • ​MedDRA Points to Consider

  • Causality Assessment:​

    • The WHO Causality Assessment​

​​

• PBRER, PSUR

  • EMA - GVP Module​ VII - Periodic Safety Update Reports

  • ICH E2C (R2) - Periodic Benefit-Risk Evaluation Report

​​

• DSUR​

  • ICH E2F - DSUR

  • CIOMS VII - DSUR Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials: Report of CIOMS Working Group VII

​​

• Investigator Brochure

  • ICH E6(R2) - Good Clinical Practice​

  • ICH E2F - DSUR

  • CIOMS III and V - Guidelines for Preparing Core Clinical-Safety Information on Drugs Second Edition – Report of CIOMS Working Groups III and V

​​

• CCSI, CCDS Concept

  • EMA - GVP Module​ VII - Periodic Safety Update Reports

  • ICH E2C (R2) - Periodic Benefit-Risk Evaluation Report

  • CIOMS III and V - Guidelines for Preparing Core Clinical-Safety Information on Drugs Second Edition – Report of CIOMS Working Groups III and V