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Session 4: Challenges and Opportunities in the Implementation and Evaluation of Risk Minimization Measures
Session Chair(s)
Sophie Sommerer
Director General, Marketed Health Products Directorate, Health Canada, Canada
Bruce Valliant
Head of Pharmacovigilance and Medical Information, Pharmascience Inc., Canada
This session will focus on some of the challenges and opportunities in designing, implementing and evaluating the effectiveness of risk minimization measures in healthcare settings. The session will include a presentation from Health Canada about best practices in the design, implementation and evaluation of risk minimization measures. An industry presenter will discuss options for risk mitigation and the application of evaluation methods to assess their effectiveness. Both presentations will use real world examples to highlight lessons learned.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify Options Available to them for Assessing Risk Mitigation Measures Included in their Risk Management Plan
- Understand the Benefits and Shortcomings of Various Methods of Evaluation
- Make Decisions about Revisions to RMPs Based on the Outcome of the Evaluations
Speaker(s)
Rania Mouchantaf, PHD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Janine Collins, MD, LLM
Executive Director Safety, Epidemiology , Registries and Risk Management , United BioSource Corporation, Switzerland
Panel Discussion
, All Session Speakers, United States
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