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Thursday, June 18 • 8:00am - 9:00am
#401 L: Digital Risk Minimization: How Can We Advance Adoption?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-694-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will examine current challenges to the use of digital approaches to risk minimization, and explore opportunities for overcoming them to facilitate their wider adoption. Challenges and opportunities will be assessed from the perspectives of 1) regulators, including representatives from both the US and the European regulatory authorities; 2) industry sponsors at the global headquarters who plan the risk minimization strategy; and, 3) local safety officers who are responsible for coordinating the implementation of the risk minimization measures, typically in conjunction with healthcare professionals at the local country level.

Learning Objectives

Describe the state of the art in terms of the use of digital approaches for therapeutic risk minimization purposes; Discuss challenges and constraints faced by sponsors and regulators in terms of adopting digital approaches to risk minimization; Identify at least two steps that can be taken to further advance adoption of digital technologies for risk minimization purposes.


Meredith Smith, DrPH, PhD, MPA


Industry Sponsor Perspective: What are Digital Risk Minimization Measures? What are the Challenges Sponsors Face in Developing Them? How Can we Overcome Them?
Meredith Smith, DrPH, PhD, MPA

Regulatory Perspective: Opportunities and Challenges for Adopting Digital Risk-Minimization Measures
Gita Toyserkani, PharmD, MBA

Regulator Viewpoint
Fakhredin Sayed Tabatabaei, MD, PhD

Local Safety Officer Perspective: What Are the Advantages and Challenges to Implementing Digital Approaches to Risk Minimization at the Local Country Level and How Can They be Addressed?
Carla Perdun Barrett, PharmD

avatar for Carla Barrett

Carla Barrett

Sr Director, Patient Safety Risk Mgmt, PRA Health Sciences
Dr. Carla Barrett is Senior Director, Risk Management at PRA Health Sciences. Carla has over 20 years of pharmaceutical industry experience (Wyeth, Pfizer, Allergan) in the strategic and operational aspects of pharmacovigilance risk management programs for products in development... 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 →
avatar for Gita Toyserkani

Gita Toyserkani

Associate Director, Research & Strategic Initiatives, FDA
Gita A. Toyserkani, PharmD, MBA, is the Associate Director for Research and Strategic Initiatives in the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology. She has over 15 years of experience in drug safety and advises on pre and post-marketing activities... Read More →

Thursday June 18, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session