返回 Agenda
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)
Yola Moride, PHD, FISPE
President, YolaRx Consultants and Rutgers University, Canada
Evaluation of the Effectiveness of Risk Minimization Activities
Rachel Sobel, DrPH, FISPE
Vice President, Head of Pharmacoepidemiology & Risk Management Ctr of Excellence, Regeneron Pharmaceuticals, United States
Pharmacovigilance, Risk Minimization, and Evaluation of its Impact: International Perspectives and Best Practices
Meredith Yearsley Smith, MPA, FISPE
Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Therapeutic Risk Minimization: Designing for Dissemination, Sustainability, and Impact