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Ottawa Marriott Hotel

Oct 30, 2018 7:00 AM - Oct 31, 2018 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Transformation with Collaboration

Session 4: Track C: Risk Minimization and Evaluation of Their Impact: Challenges and Approaches

Session Chair(s)

Rania  Mouchantaf, PhD

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


Yola  Moride, PhD, FISPE

Evaluation of the Effectiveness of Risk Minimization Activities

Yola Moride, PhD, FISPE

YolaRX Consultants, Canada


Meredith  Smith, PhD, MPA, FISPE

Therapeutic Risk Minimization: Designing for Dissemination, Sustainability, and Impact

Meredith Smith, PhD, MPA, FISPE

Evidera, Inc, United States

Senior Director, Implementation Science Pillar Lead

Rachel  Sobel, DrPH, MPH, FISPE

Pharmacovigilance, Risk Minimization, and Evaluation of its Impact: International Perspectives and Best Practices

Rachel Sobel, DrPH, MPH, FISPE

Regeneron , United States

Vice President, Head of Pharmacoepidemiology

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