Work Package 8 explored existing standards for pharmacovigilance assessments and produced reports on best practice. The reports’ aims are to ensure that NCAs are able to support the Pharmacovigilance Risk Assessment Committee (PRAC) with high-quality assessment and advice on: risk management plans, post-authorisation studies, periodic safety update reports and referral procedures.
WP8 also examined the availability and use of alternative (epidemiological) data sources for assessment in different European NCAs. Through focusing on key risk management tools to establish current assessment practices, best practice guidance documents and training in use of these tools were prepared. Competency recommendations were created to contribute to the development of PV assessors’ competencies across the EU.
WP8 Lifecycle Pharmacovigilance outputs: