What ICH E2E - Pharmacovigilance Planning: Safety Specification and Pharmacovigilance Plan (2004) requires
ICH E2E (Step 4, November 2004) requires a Safety Specification and Pharmacovigilance Plan to be submitted with marketing authorisation applications, defining…
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Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://www.ich.org/products/guidelines/efficacy/article/e2e.html
SHA-256 integrity: 0223921866ecc31d2b81513b0b7c0e6e2c2f7dec3a64b486d243e4b44d3ee698
Primary Citations — 6 traced to source
- ICH E2E - Pharmacovigilance Planning (Step 4, November 2004)
- ICH E2C(R2) - Periodic Benefit-Risk Evaluation Report (PBRER) (2012)
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