Back to Agenda
New Considerations in Benefit-Risk Management
Session Chair(s)
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States
Benefit-risk management continues to evolve as noted changes have been seen with ICH's M4E (R2) -Guideline on Enhancing the Format and Structure of Benefit-Risk Information along with the proposed changes to the EMA's Module V - Risk Management Systems and the FDA's draft Guidance on FDA's Application of Statutory Factors in Determining When a REMS is Necessary. This session will focus on proposed changes and the impact on MAHs. Best practices and change management efforts will be discussed.
Learning Objective : Describe how the updates and proposed revisions will impact one's pharmacovigilance organization.
Speaker(s)
Implementing Benefit-Risk Management More Effectively
Steve Mayall, PhD
Huron Consulting Group, United Kingdom
Director
The Revised ICH M4E Benefit-Risk Assessment Guidance: Update and Practical Implications
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera
Regulatory Perspective on the New ICH Guidance and the Evolving Nature of Benefit-Risk Assessment
Patrick Frey
Neurocrine Biosciences, United States
Senior Director, Regulatory Policy
Have an account?