For everything you want to know about Pharmacovigilance Programme of India:
http://www.ipc.gov.in/PvPI/pv_home.html
European Medicines Agency:
GVP Modules:
Uppsala Monitoring Centre
U.S Food And Drug Administration
WHO Safe childbirth checklist implementation guide
https://www.who.int/publications/i/item/9789241549455
Good Pharmacovigilance Practice – ICH GCP guidelines for pharmacovigilance
- E2A: Clinical safety data management: Definitions and standards for expedited reporting
- What is e2b in pharmacovigilance? E2B: Electronic reporting of adverse events: Implements electronic reporting R3 E-ICSR Implementation Guide I Link CIOMS I to E2B Guide
- E2C: Periodic benefit- risk evaluation report (PBRER): Format and content of safety updates for reporting at intervals to regulatory authorities
- E2D: Post-approval safety data management: Definitions and standards for expedited reporting: Guidance for gathering and reporting information
- E2E: Pharmacovigilance planning: Helps to make PMS plan, especially in early Phase IV
- E2F: Development Safety Update Report (DSUR): Standard for periodic reporting on drugs
- M1: Medical dictionary for Regulatory activities (MedDRA)
- M4: The Common Technical Document (CTD): Formatting of reports to regulatory bodies (M4 Organization, M4Quality, M4Safety, M4Efficacy)
- CIOMS I: The international reporting form (links with ICH E2B)
- CIOMS II: Periodic safety update reports manual
- CIOMS III: Core data sheets
- CIOMS IV: Benefit-risk assessments
- CIOMS V: Practical issues in Pharmacovigilance
- CIOMS VI: Clinical trial safety data
- CIOMS VII: Development safety update reports
- CIOMS VIII: Practical Aspects of Signal Detection in Pharmacovigilance