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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
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
MHRA Update
Alison Cave, PhD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Effectiveness of Interventions: Successes and Challenges
Yola Moride, PhD, FISPE
YolaRX Consultants, Canada
President
Industry Update
Mamiko Kasho
Eisai Co., Ltd., Japan
Executive Director, Global PV Management Dept., Global Safety HQs
EMA Update
Priya Bahri, PhD, RPh
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
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