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Virtual Event

Oct 21, 2020 10:25 AM - Oct 22, 2020 4:15 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Canadian Pharmacovigilance and Risk Management Conference

Session 4: Challenges and Opportunities in the Implementation and Evaluation of Risk Minimization Measures

Session Chair(s)

Sophie  Sommerer

Sophie Sommerer

Director General

Health Canada, Canada

Bruce  Valliant

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

Risk Management for the 21st Century: Current Status and Future Direction

Rania Mouchantaf, PhD

Health Canada, Canada

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD

Janine  Collins, MD, LLM

Real World Challenges with Evaluations

Janine Collins, MD, LLM

United BioSource Corporation, Switzerland

Executive Director Safety, Epidemiology , Registries and Risk Management

Panel  Discussion

Panel Discussion

All Session Speakers, United States

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