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Risk Minimization in the EU: New Guidance, New Collaborations
Session Chair(s)
Priya Bahri, PhD, RPh
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
European Medicines Agency, Netherlands
Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.
Learning Objective : Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.
Speaker(s)
Industry Update
Meredith Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
Patient Update
Regina Mariam Kamoga, MPA
Community Health And Information Network ( CHAIN), Uganda
Executive Director
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