University of California, San Francisco - Webinar Announcement - Role of Real-World Evidence in Regulatory Decision-Making Before, During, and After COVID and The Use of Real-World Data for Prescription Drug Regulatory Questions

Free Webinar

American Course on Drug Development and Regulatory Sciences, University of California, San Francisco
Role of Real-World Evidence in Regulatory Decision-Making Before, During, and After COVID

and

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

Speakers

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.

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.

Further information on the ACDRS Webinar Series can be found at https://pharm.ucsf.edu/acdrs/webinar.

Date and Time

December 2, 2020
6:00 - 7:30 pm CET/noon - 1:00 pm eastern

Registration

There is no registration fee, but advanced registration is required for planning purposes.
Registration:  https://ucsf.zoom.us/webinar/register/WN_jG8H70QyRGq-IGr60HRA4w

Enrollment is open for the 2021 ACDRS (course #13). Given the pandemic, we are launching the 2021 ACDRS online in March 2021 and hope to transition to in-person in late September for the remainder of the course through December 2021. ACDRS is great for those interested in having their skills sharpened and their drug development horizons expanded. This course is of high-value not only for people from industry, but also for people in regulatory agencies, academia or other organizations who focus on drug development. For further information, please see https://pharm.ucsf.edu/acdrs/course.