DIA 2019 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-646-L04-P; CME 1.25; IACET 1.25; RN 1.25

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?

Learning Objectives

Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson

Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE

EMA Perspective
Douwe Postmus, PhD, MSc