Convened by the Robert J. Margolis, MD, Center for Health Policy at Duke University, the Second Annual Duke-Margolis Conference on Real-World Data and Evidence will bring together top experts and speakers to examine topics related to the use of real-world data (RWD) and evidence (RWE) in drug development and regulatory decision-making. Workshop sessions will highlight emerging takeaways from two working papers :
- “Characterizing the Quality and Relevancy of RWD for Regulatory Purposes”, which will be released ahead of the event, examines the process and factors that should be considered while characterizing RWD quality and relevancy for regulatory purposes
- “Meeting Regulatory Standards with Fit-For-Purpose RWE”, which is still in active development and will be informed by discussion at this event, focuses on the process for determining the regulatory acceptability of observational studies
These papers, written by multistakeholder working groups under the Duke-Margolis Center’s RWE Collaborative, further build upon core concepts in the major white paper released as part of 2017’s RWE Conference
Additional sessions will provide updates from stakeholder groups working on ways to enhance the development and use of RWD and RWE across a range of clinical and regulatory activities, as well as forward-looking discussions on actionable next steps to realize the aims of RWE provisions in PDUFA VI and the 21st Century Cures Act.
In-person and webcast registration are now open, with limited in-person seating available. Funding for this conference is made possible through the generosity of the Margolis Family Foundation, which provides core resources for the Center, as well as a combination of financial and in-kind contributions from RWE Collaborative members including Eli Lilly and Company; Genentech, a member of the Roche Group; GlaxoSmithKline; Johnson & Johnson; Novartis; and Teva.