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Real-World Evidence in External Control Arms: Driving Innovation in Drug Development (in person)
LEVEL: Advanced
TRACK: Real World Data & Information Systems
LENGTH: 4 Hours | Course runs 1 day
This short course is offered in-person at the ISPOR Europe 2024 conference. Separate registration is required. Visit the ISPOR Europe 2024 Program page to register and learn more.
Sunday, 17 November 2024 | Course runs 1 Day
08:00-12:00 Central European Time (CET)
DESCRIPTION
Separate registration required.
Gain new skills in the use of real-world evidence (RWE) in external control arms (ECAs) – an advanced application that has become critical in drug development. During this course you will learn more about the history and regulatory landscape of the application of ECAs and how to analyze the current regulatory and payer landscape for ECA acceptance and application in drug development and market access. You will explore the relevant data sources and sourcing methodologies for ECAs and learn how to develop external control arms using synthetic data and data from multiple data sources. End the course by designing and developing an external control arm with your peers.
PREREQUISITE: To get the most out of the course, students should be familiar with basic definitions and concepts of RWE including regulatory applications.
Registrants receive a digital course book. Copyright, Trademark and Confidentiality Policies apply.
FACULTY MEMBERS
Leanne Larson, MHA
Principal
ZS Associates
Wilmette, IL, USA
Doug Foster, MBA
Partner
Advanced Data Sciences LLC
San Francisco, CA, USA
Ulka Campbell, PhD, MPH
Head of Scientific Strategy
Aetion, Inc.
New York, NY, USA
Aaron Kamauu, MPH, MS, MD
Managing Director
Navidence LLC
Bountiful, UT, USA
4 Hours | Course runs 1 Day