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Session 8: Risk Management, Past, Present and Future?
Session Chair(s)
Mark Perrott, PHD
Managing Partner, Axian Consulting Ltd., United Kingdom
This session will review the evolution of risk minimization requirements and solutions since the inception of formal regulations. It will review approaches that have been, and could be used to address the objectives of risk evaluation and mitigation strategies (REMS) and additional risk minimization measures (aRMMs), particularly in the context of learnings from shared approaches for generic and biosimilar products. Current challenges to effective implementation will be examined in a global context, and the potential for a future which increases the focus on patient need and value, while still addressing compliance requirements, will be explored.
Learning Objective : - Describe the pharmaceutical industry's current approaches to REMS/aRMMs
- Express options for the management of complex risk minimization commitments by generics companies
- Discuss the improvement opportunities in the implementation of risk management programs
- Understand how digital approaches can support the development of more patient-centric approaches to improving risk management
Speaker(s)
Yasmeen Abou-Sayed, PHARMD
Team Leader, FDA, United States
The evolution of risk management in REMS, where did we start? how far have we come?
Michael Forstner, PHD, MPH, MSC
Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela-Consulting, Switzerland
Risk Management – Compliance Activity or Contributor to Benefit-Risk?
Mark Perrott, PHD
Managing Partner, Axian Consulting Ltd., United Kingdom
How have implementation approaches for REMS/aRMM developed, where do we need to go?
Sherice R Mills
Head of US, Axian Consulting Ltd., United States
On the horizon for global risk management, better value for stakeholders and better outcomes
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