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A Proactive and Systematic Approach to Managing Product Risk Across the Life Cycle
Session Chair(s)
Brian Edwards, DrMed
Vice President
International Society of Pharmacovigilance, United Kingdom
It will be nearly seven years since CIOMS VI published their recommendations for developmental risk management planning. But what has happened to systematic life cycle management? How good are we at assimilating all the evidence about a medicine? Are we better at determining how to balance risks against benefit at all phases? There is a mass of evidence concerning systems or organizational science such as human factors engineering. How has our sector implemented this evidence? The time to apply organizational science to systematically manage the risks of medicines is overdue. This session will assess what current best practice is from industry and regulatory perspectives and how this might be improved by applying the principles of organizational science.
Learning Objective : Identify a practical process for arranging risk management during all phases of the product life cycle; Describe how systems science can be practically applied in the design of more efficient risk management systems.
Speaker(s)
Safety Engineering: A Systems Approach For Analyzing Product Hazards
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President
Once Size Does Not Fit All! Risk Management by Product Life Cycle Stage
Linda Quinn, PharmD
Janssen Pharmaceuticals, Inc., United States
Director, Risk Management Scientific Lead
The FDA REMS Program: A Work in Progress
Syed Rizwanuddin Ahmad, MD, MPH, FISPE
Drug Safety Consultant, United States
Ex-Consultant/Safety Reviewer, FDA, Assoc Prof (adjunct), Rutgers, Georgetown
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