Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020 скачать в хорошем качестве

Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020

FDA provides an overview of initiatives involving real-word data (RWD) and real-world evidence (RWE) and shares a regulatory frameworks for RWE with regard to drugs, biologics, and devices. Speakers discuss opportunities and challenges when using RWD focusing specifically on the use of RWE to support regulatory decisions in the FDA’s efforts to explore the potential for leveraging the vast amount of data generated in the health care system to protect and promote the public health. Presenters: John Concato, Deputy Director Office of Medical Policy Initiatives Center for Drug Evaluation and Research (CDER) Soma Kalb, Director Division of Clinical Evaluation and Analysis 1: Clinical Science and Quality Office of Clinical Evaluation and Analysis Office of Product Evaluation and Quality Center for Devices and Radiological Health (CDRH) _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367