Tuesday, June 20 • 2:00pm - 3:15pm
#254: New Considerations in Benefit-Risk Management

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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Benefit-Risk Information along with the proposed changes to the EMA's Module V - Risk Management Systems and the FDA's draft Guidance on FDA's Application of Statutory Factors in Determining When a REMS is Necessary.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 Objectives

Describe how the updates and proposed revisions will impact one's pharmacovigilance organization.


Meredith Y. Smith, PhD, MPA


Implementing Benefit-Risk Management More Effectively
Steve Mayall, PhD

The Revised ICH M4E Benefit-Risk Assessment Guidance: Update and Practical Implications
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Perspective on the New ICH Guidance and the Evolving Nature of Benefit-Risk Assessment
Patrick Frey

avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →

avatar for Patrick Frey

Patrick Frey

Chief of Staff, Office of New Drugs, CDER, FDA
Patrick Frey is the Chief of Staff in CDER's Office of New Drugs. He has played leadership roles in the reauthorization of PDUFA V and VI as well as BSUFA II. He was also the CDER lead in developing and implementing CDER's structured framework for benefit-risk assessment. Patrick... Read More →
avatar for Tarek Hammad

Tarek Hammad

Executive Director, Pharmacoepidemology, Merck Research Laboratories
Dr. Tarek Hammad joined Merck in 2013 as an Executive Director in the department of Pharmacoepidemiology. Prior to that, he has had a distinguished career with the FDA, most recently as Deputy Director of the Division of Epidemiology, CDER. He is nationally and internationally recognized... Read More →
avatar for Steve Mayall

Steve Mayall

Principal Consultant, Pope Woodhead & Associates Ltd
Steve Mayall is a Principal Consultant in Pope Woodhead’s Development Consulting Practice. He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management during the past 15 years. Key areas have included developing risk management plans... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616