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Enhancing Benefit-Risk Management through the Product Life Cycle
Session Chair(s)
Steve Mayall, PHD
Director
Huron Consulting Group, United Kingdom
The importance of pharmacovigilance continues to increase along with complexities in data collection, scientific methodology, technology advances and resource constraints. This session will take a look at innovative approaches to benefit/risk management, risk communication and measuring the impact of pharmacovigilance activities and discuss the experience with recently implemented elements of the Pharmacovigilance legislation.
Learning Objective : 1. To perform structured benefit-risk assessment effectively consistent with regulatory guidance; 2. To produce high quality, impactful benefit-risk information; 3. To identify and overcome the key challenges of implementing benefit-risk assessment within an organisation.
Speaker(s)
Regulator Perspectives
Jordi Llinares Garcia, MS
European Medicines Agency, Netherlands
Head of Research and Innovation
Digital Risk Management: Opportunities and Challenges
Helen Edelberg, MD, MPH, FACP
FDA, United States
Deputy Office Director for Safety, Office of New Drugs
The benefits and risks of performing structured benefit-risk assessments
Steve Mayall, PHD
Huron Consulting Group, United Kingdom
Director