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Breaking Down the Wall for FDA to Leverage Real World Data
Session Chair(s)
Sophie Janssens
Vice President, Global Head of Real World Evidence
UCB Pharma, Inc, Belgium
This forum will explore the use of real world evidence/big data in drug and device development, regulatory decision making under PDUFA VI and MDUFA IV, and transactional data sources.
Learning Objective : The participant will gain insight into the use of real world data among pharmaceutical and biotechnology companies with specific focus on sources of data, data integration and operational support of its use. The participant will also learn about the challenges that the industry is faced with in the use of real world evidence and how companies are implementing to meet these challenges.
Speaker(s)
A Study on the Use of Real World Evidence in Clinical Research and Postmarketing Safety Monitoring
Mary Jo Lamberti, PhD, MA
Tufts Center for the Study of Drug Development, United States
Director of Sponsored Research, Research Associate Professor
FDA Perspective
Jonathan P. Jarow, MD, PhD
FDA, United States
Chief Medical Officer, ODE, CDRH
How Are Innovators Bringing Real World Data to the Table?
John Reites
THREAD, United States
Chief Executive Officer
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