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Session 4: Track C: Risk Minimization and Evaluation of Their Impact: Challenges and Approaches
Session Chair(s)
Rania Mouchantaf, PhD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD
Health Canada, Canada
In parallel with the global adoption of risk management planning, progress has been made in recent years in the area of risk minimization measures and evaluating effectiveness of such measures. These areas are now considered an integral part of pharmacovigilance in Canada and internationally. Moreover, in view of the broad range of pharmacovigilance activities that are now at the disposal of both the regulator and manufacturers, it is now timely to determine if such post-market processes are meeting their goals.
Learning Objective : - Identify current approaches and challenges in the implementation of risk minimization measures
- State the methodologies for measuring impact of risk minimization and pharmacovigilance activities
- Describe enablers and barriers in measuring impact
- Recognize the importance of engagement and capacity building of patient communities and healthcare professional bodies to support impact research
Speaker(s)
Evaluation of the Effectiveness of Risk Minimization Activities
Yola Moride, PhD, FISPE
YolaRX Consultants, Canada
President
Therapeutic Risk Minimization: Designing for Dissemination, Sustainability, and Impact
Meredith Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
Pharmacovigilance, Risk Minimization, and Evaluation of its Impact: International Perspectives and Best Practices
Rachel Sobel, DrPH, FISPE
Regeneron Pharmaceuticals Inc., United States
Vice President, Head of Pharmacoepidemiology