Additional resources & References

• ·The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICH Harmonised Tripartite Guidelines: Pharmacovigilance Planning – E2E (2004). Available at: ICH E2E Pharmacovigilance planning (Pvp) - Scientific guideline | European Medicines Agency (europa.eu)

• EMA: Good pharmacovigilance practices –The guideline on GVP is divided into chapters that fall into two categories: 1) modules covering major pharmacovigilance processes; 2) product- or population-specific considerations. Available at:  Good pharmacovigilance practices | European Medicines Agency (europa.eu)

• Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2). Available at:  26 GVP Introductory Cover Note - M XVI Rev 3 with ADD II (europa.eu)

• The U.S. Food and Drug Administration Amendments Act of 2007 (FDAAA) and the FDA’s Guidance For Industry Format and Content for Risk Evaluation and Mitigation Strategies, REMS assessments and Proposed REMS Modifications. Available at:  Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry | FDA

• EMA ‘Risk-management plans’. Available at:  Risk management plans | European Medicines Agency (europa.eu)

• EMA ‘Medicines under additional monitoring’, including video – Available at: Medicines under additional monitoring | European Medicines Agency (europa.eu)https://www.youtube.com/watch?v=e_lcRgGcl7k