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Baltimore Marriott Waterfront

05 feb 2024 7:00 a.m. - 07 feb 2024 1:00 p.m.

700 Aliceanna Street , Baltimore, MD 21202

Global Pharmacovigilance and Risk Management Strategies Conference

Register for 2 or more short courses and save $150 off your registration fee!

Session 8: Risk Management, Past, Present and Future?

Session Chair(s)

Mark  Perrott, PhD

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

The evolution of risk management in REMS, where did we start? how far have we come?

Yasmeen Abou-Sayed, PharmD

FDA, United States

Team Leader

Michael  Forstner, PhD, MPH, MSc

Risk Management – Compliance Activity or Contributor to Benefit-Risk?

Michael Forstner, PhD, MPH, MSc

SOBI, Switzerland

Head of Global Safety Science

Mark  Perrott, PhD

How have implementation approaches for REMS/aRMM developed, where do we need to go?

Mark Perrott, PhD

Axian Consulting Ltd., United Kingdom

Managing Partner

Sherice  Mills

On the horizon for global risk management, better value for stakeholders and better outcomes

Sherice Mills

Adroit Risk Management, LLC, United States

President and CEO

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