Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies

This is a virtual pre-meeting Short Course in conjunction with the DIA Global Annual Meeting.

Overview

Pre-Registration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

This Short Course will be offered virtually – Join from anywhere!

This short course on real-world evidence (RWE) in regulatory decision-making offers a comprehensive exploration of how RWE is transforming the regulatory landscape for drugs and biologics. The course begins with an overview of global regulatory trends, highlighting the increasing acceptance and integration of RWE alongside randomized controlled trials to inform approvals, label expansions, and clinical development planning. Participants will learn to identify and assess diverse sources of real-world data (RWD), applying practical frameworks to determine when data are “fit for purpose” for regulatory use. Through case studies and recent regulatory guidance, the course illustrates the evolution of RWE from safety evaluation to supporting efficacy, label extensions, and population bridging, underscoring the importance of methodological rigor and early engagement with regulators. The curriculum emphasizes structured approaches and frameworks, for designing transparent and valid real-world studies, including the use of external control arms. Participants will learn that RWE generation for regulatory decision-making requires thoughtful study design and use of transparent frameworks to ensure data fitness and validity. The course will be interactive with the use of polling questions and participants are encouraged to raise scenarios they encounter for open discussion.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Learning objectives

At the conclusion of this short course, participants should be able to:

Describe how regulators across the globe are increasingly using real-world evidence (RWE) and real-world data (RWD) to inform regulatory decision-making
Identify sources of RWD and apply structured frameworks to design studies and assess RWD fitness for regulatory-quality evidence generation
Evaluate the expanding role of RWE from safety evaluation to label extensions.

Have an account?

Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.