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Monday, June 20 • 4:00pm - 5:00pm
#139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-532-L04-P ; CME 1.00; RN 1.00

An expert panel will review the EMA and FDA benefit-risk frameworks and how to optimize these processes, including the addition of sponsor input to highlight critical considerations in the submission; and offer suggestions for effective public communications.

Learning Objectives

Compare and contrast FDA and EMA benefit-risk (BR) assessments and how they drive or factor into regulatory decisions for marketing authorizations; Discuss how these decisions are communicated to the public; Explore how sponsors may provide input on benefit-risk to EMA and FDA to better inform regulatory review and decision making and contribute to review modernization.


Julie Anne Zawisza, MA, MT


FDA Guidance on Benefit-Risk Assessment for New Drug and Biological Products
Graham Thompson

EMA Update
Francesco Pignatti, MD

Industry Update
Pujita Vaidya, MPH

Industry Update
Ellis Unger, MD

avatar for Francesco Pignatti

Francesco Pignatti

Head of Oncology and Hematology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Staff (DSAS) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and... Read More →
avatar for Ellis Unger

Ellis Unger

Principal Drug Regulatory Expert, Hyman, Phelps & McNamara, P.C., United States
Dr. Ellis Unger is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara. A cardiologist with 24 years of FDA experience in drug regulation, safety, clinical trial design, and analysis, he started as a Medical Officer in CBER, ultimately serving 8 years as the Director, Office... Read More →
avatar for Julie Anne Zawisza

Julie Anne Zawisza

Senior Director, Global Regulatory Policy, MRL GRACS, Merck & Co., Inc., United States
Ms. Zawisza leads regulatory policy for Merck’s oncology business. She is active on PhRMA and BIO committees for biosimilars, new drug clinical development, CDx, adaptive trial design, and other key FDA policy initiatives. She is a Board member of The Alliance for a Stronger FDA... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum |   01: ClinSafety-PV, Forum