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Work Package 8 – Lifecycle Pharmacovigilance

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:

Competency Recommendations

Identification of Available Data Sources Outside Spontaneous Reports: Recommendations

PASS Recommendations

Practical Guide on PASS Assessment

PASS Assessment E-learning Module

PSUR/PSUSA and Referral Recommendations

Practical Guide on PSUR/PSUSA Assessment

PSUR Assessment E-learning Module

Risk Management Plan Recommendations

Practical Guide on Risk Management Plan Assessment

Risk Management Plan Assessment E-learning Module

Practical Guide on Safety-related Referrals

Top 10 Tips on Safety-related Referrals

Safety Referrals E-learning: Practical Guidance for Assessors

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