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Role of Real-World Evidence in Regulatory Decision-Making Before, During, & After COVID + The Use of Real-World Data for Prescription Drug Regulatory Questions

Wednesday, December 2, 2020 9:00am to 10:30am

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American Course on Drug Development and Regulatory Sciences (ACDRS)

University of California, San Francisco

W e b i n a r    A n n o u n c e m e n t

Role of Real-World Evidence in Regulatory Decision-Making Before, During, and After COVID

Nirosha Mahendraratnam Lederer, PhD, MSPH

Director, RWE Strategy

Aetion

COVID-19 has disrupted drug development, evidence generation, and care-delivery. This presentation will provide an overview of how COVID-19 has accelerated the generation and adoption of RWD/RWE for drug development and its potential for the future.

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The Use of Real-World Data for Prescription Drug Regulatory Questions

Mark Levenson, PhD

Director, Division of Biometrics VII

Office of Biostatistics

US Food and Drug Administration

Emerging sources of digital health data, including electronic medical records, app-based data, and wearable device data, may be leveraged to address regulatory questions concerning prescription drugs. FDA has extensive experience using digital health data to address questions on the safety of drugs. More recently, FDA has initiated efforts to explore the use of these data sources, known as real-world data, to address questions on the efficacy of drugs. This talk will review these efforts and apply the regulatory standard for the demonstration of efficacy to the evaluation of studies based on real-world data.

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