References & Additional Resources
View
 | 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)
https://www.ema.europa.eu/en/ich-e2e-pharmacovigilance-planning-pvp
- 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.
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices#
- Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
- 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 https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm441226.pdf
- EMA ‘Risk-management plans’ – available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000360.jsp&mid=WC0b01ac058067a113
- EMA ‘Medicines under additional monitoring’, including video – available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp
- EMA video ‘RMPs & new requirements, RMP summary’ available at