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Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward
Session Chair(s)
Rania Mouchantaf, PHD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
This session provides an opportunity to pause and reflect on how far we have come and discuss areas for future focus, innovation, and key influential drivers for change from a scientific, technological and patient-centric perspective.
Learning Objective : Describe the evolution in the use of risk management principles in the context of patient safety; Discuss the role of real-time information and collaboration/engagement as the catalyst for action in risk management; Identify current limitations and challenges; List specific case examples from a public health and patient safety perspective; Discuss opportunities for future innovations.
Speaker(s)
FDA Update
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
MHRA Update
Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Effectiveness of Interventions: Successes and Challenges
President, YolaRx Consultants and Rutgers University, Canada
Industry Update
Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan
EMA Update
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
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