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Tuesday, June 21 • 1:45pm - 2:45pm
#242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-565-L04-P ; CME 1.00; RN 1.00

Risk minimization measures are designed to promote patient safety. However, despite considerable advances made in this field, in some cases, the full potential of risk minimization measures has yet to be achieved.

Learning Objectives

Discuss different stakeholder perspectives with respect to key challenges encountered in risk minimization design and implementation; Describe good practices in designing and implementing risk minimization measures that allow for their optimal integration into the health care system; Identify lessons learned with the objective to minimize burden and barriers to patient access.

Chair

Rania Mouchantaf, PhD

Speaker

Identifying Undue Burden in Evaluation of REMS Both Pre and Post-Marketing
Shelly Harris, DrSc, MPH

MRisk Minimization Measures in Healthcare: The Way Forward in the EU with Qualitative and Participatory Approaches
Priya Bahri, PhD, RPh

Evaluating the Effectiveness of a Controlled Distribution Risk Minimization Program in: Designing a Mixed Methods Evaluation Study Protocol to Obtain Rich Insights on Program Implementation and Impact
Meredith Smith, PhD, MPA, FISPE



Speakers
avatar for Priya Bahri

Priya Bahri

Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
SH

Shelly Harris

REMS Assessment Team Leader, OSE, CDER, FDA, United States
Dr. Shelly Harris has over 25 years of experience in program evaluation, health policy, qualitative research, health communication, health outcomes, and health disparities. She has expertise in the evaluation of assessments and methodologies for risk evaluation and mitigation strategies... Read More →
avatar for Rania Mouchantaf

Rania Mouchantaf

A/Executive Director, Health Canada, Canada
Dr. Rania Mouchantaf has over 10 years of experience in the area of pharmacovigilance and drug safety. Her career at Health Canada has spanned a number of roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →


Tuesday June 21, 2022 1:45pm - 2:45pm CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session