The purpose of this document is to provide recommendations arising from the Work Package 8 (WP8) – Lifecycle pharmacovigilance (PV) topic Risk Management Plan (RMP) assessment. The recommendations include the main findings, principal conclusions and practical guidance useful for PV assessments. The overall aim of these recommendations is to contribute practical advice with regard to the assessment of RMPs, as well as good practice in dealing with the parts of RMP assessment that have been found challenging for NCAs participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action.
What does this document cover?
- Assessment of the Safety Specifications
- Pharmacovigilance Plan
- Risk Minimisation Plan
- Effectiveness of RMMs
- RMP updates
Annexes - WP8 Practical Guide on RMP Assessment
The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.
14 pages PDF.
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