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Tuesday, June 27 • 8:30am - 9:30am
#201: Completing the Risk Management Cycle: Review of Risk Management Effectiveness

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-552-L04-P; CME 1.00; RN 1.00

This session will describe best practices for evaluating the effectiveness of additional risk minimization measures globally, and will include new models of healthcare provider and patient involvement in this effort.

Learning Objectives

Describe effectiveness measure requirements for additional risk minimization measure (aRMMs) and Risk Evaluation Mitigation Strategies (REMS; Describe the current landscape of methodologies that measure effectiveness of risk minimization strategies; Identify the best approach that overcomes challenges currently seen when measuring effectiveness of risk minimization strategies.

Chair

Lubna Merchant, PharmD, MS

Speaker

Completing the Risk Management Cycle: Review of Risk Management Effectiveness Across US and EU
Lubna Merchant, PharmD, MS

A More Perfect Union: Overcoming Challenges in Risk Minimization Evaluation via New Models of Healthcare Providers and Patient Involvement
Delphine Saragoussi, MD, MSc

EMA Update
Priya Bahri, PhD, RPh

FDA Update
Claudia Manzo, PharmD


Speakers
avatar for Priya Bahri

Priya Bahri

Senior 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 →
avatar for Claudia Manzo

Claudia Manzo

Director, Office of Medication Error Prevention and Risk Management, OSE, CDER, FDA, United States
Claudia Manzo, PharmD is the Director of the Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology (OSE), FDA. She has over 20 years of drug safety experience and in her current role she directs review staffs (~125 FTEs) that advise and... Read More →
avatar for Lubna Merchant

Lubna Merchant

Director, Risk Management Center of Excellence, Pfizer Inc , United States
Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence... Read More →
avatar for Delphine Saragoussi

Delphine Saragoussi

Executive Director, Real-World Evidence, PPD, Part of Thermo Fisher Scientific, France
Executive Director in the RWE group at Evidera, PPD, part of Thermo Fisher Scientific, in Paris, France. Dr. Saragoussi is a physician specialized in Public Health and epidemiologist. In the pharmaceutical industry during 12 years and then as a consultant for the past 5 years, she... Read More →

Tuesday June 27, 2023 8:30am - 9:30am EDT
Room 205 BC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session |   05: Patient Engagement, Session