Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-25-501-L04-P; CME 2.75; IACET 2.75; RN 2.75
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 will provide an overview of the current use of real-world data (RWD) and real-world evidence (RWE) for evidence generation in major markets, with a primary focus on regulatory use and how it can inform clinical development planning. Following the major points from recently released guidance documents from around the world, the course will explain how the fitness of evidence from RWD are assessed for any use case, key elements of design and analysis, and the current status for when real-world studies will be sufficient to meet regulatory evidence requirements. Specifically, the course will discuss (a) the evolving regulatory landscape; (b) the evolution of RWD, how to utilize it, and when RWD is fit-for-purpose; (c) the evolution from safety evaluation to label extensions; and (d) how to ensure design transparency and data feasibility when proposing external comparator arms. The course will feature interactive elements such as polling questions, and participants are encouraged to present their own scenarios 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!
Who should attend?Professionals involved in or interested in learning about real-world evidence, real-world data, epidemiology, clinical research, regulatory and technology development.
Learning Objectives- Discuss how regulators are using RWE for regulatory decision support and how RWD and RWE are being used to inform clinical development planning
- Describe the concept of RWD being “fit-for-purpose” including the importance of relevant data and methodologic rigor
- Identify how RWE can be assembled and integrated to generate a compelling message
