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Digital Risk Minimization: How Can We Advance Adoption?
Session Chair(s)
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States
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 Objective : 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.
Speaker(s)
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, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
Regulatory Perspective: Opportunities and Challenges for Adopting Digital Risk-Minimization Measures
Gita Toyserkani, PharmD, MBA
FDA, United States
Associate Director, Research & Strategic Initiatives
Regulator Viewpoint
Fakhredin Sayed Tabatabaei, MD, PhD
MEB, Netherlands
Senior Assessor
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 Barrett, PharmD
Novavax, United States
Vice President, Global Risk Management
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