INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH)
- E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- E2B(R3) - Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
- E2B(R3) IWG - Implementation: Electronic Transmission of Individual Case Safety Reports
- E2C(R2) - Periodic Benefit-Risk Evaluation Report
- >E2C(R2) - Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report
- E2D - Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
- E2E - Pharmacovigilance Planning
- E2F - Development Safety Update Report
GOOD PHARMACOVIGLANCE PRACTICES (GVP MODULES)
Module I – Pharmacovigilance systems and their quality systems
- Module II – Pharmacovigilance system master file
- Module III – Pharmacovigilance inspections
- Module IV – Pharmacovigilance audits
- Module V – Risk management systems
- Module VI – Management and reporting of adverse reactions to medicinal products
- Module VII – Periodic safety update report
- Module VIII – Post-authorisation safety studies
- Module VIII addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies
- Module IX – Signal management
- Module X – Additional monitoring
- Module XV – Safety communication
- Module XVI – Risk minimisation measures - Selection of tools and effectiveness indicators
FOOD & DRUG ADMINISTRATION (21 CFR Part 11)
- Subpart A--General Provisions
§ 11.1 - Scope.
§ 11.2 - Implementation.
§ 11.3 - Definitions.
- Subpart B--Electronic Records
§ 11.10 - Controls for closed systems.
§ 11.30 - Controls for open systems.
§ 11.50 - Signature manifestations.
§ 11.70 - Signature/record linking.
- Subpart C--Electronic Signatures
§ 11.100 - General requirements.
§ 11.200 - Electronic signature components and controls.
§ 11.300 - Controls for identification codes/passwords.
CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO)
COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMS)
- CIOMS Working Group I - International Reporting of Adverse Drug Reactions
- CIOMS Working Group II - International Reporting of Periodic Drug-Safety Update Summaries
- CIOMS Working Group III - Guidelines for Preparing Core Clinical-Safety Information on Drugs
- CIOMS Working Group IV - Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals
- CIOMS Working Groups V - Current Challenges in Pharmacovigilance: Pragmatic Approaches