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New Considerations in Benefit-Risk Management
Session Chair(s)
Meredith Yearsley Smith, PHD, MPA, FISPE
Fellow and faculty member
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, 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Benefit-Risk Information along with the proposed changes to the EMA's Module V - Risk Management Systems and the FDA's draft Guidance on FDA's Application of Statutory Factors in Determining When a REMS is Necessary.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 Pharmaceuticals, United States
Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV
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