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Session 2: Case Examples of Practical Application in Local Context, Q&A and wrap-up
Session Chair(s)
Priya Bahri, PhD, RPh
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
European Medicines Agency, Netherlands
Speaker(s)
A member state’s approach to implementing GVP Module XVI Rev 3 –
Krystyna Cegielska-Perun, PhD
Office for Registration of Medicinal Products, Poland
Head of the Unit for the Assessment of Safety Documentation
Localising additional RMM for implementation and decision making across the product lifecycle
Ryan Marshall
AstraZeneca, United Kingdom
Risk Management Director
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