The purpose of this document is to provide practical guidance for National Competent Authority (NCA) assessors arising from WP8 – Lifecycle Pharmacovigilance, Benefit/Risk assessment in the context of Periodic Safety Update Report (PSUR) / Single assessment of Periodic Safety Update Reports (PSUSA) and Referral procedures.
What does this document cover?
2. Practical guidance
- Planning and organisation
- Support for overcoming challenges during evaluation of risks/risk characterisation or for benefit/risk decision making
- Different approaches to assessment according to the lifecycle of the medicine
- Support for the drafting of questions to be addressed by the MAH
- Support for better delivery of procedure recommendations and final outcomes
The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.
18 pages PDF.
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