Division of Clinical Research

Office of the Vice President and Innovation

Category results for: SBIA

Searchable Database for Training Resources on FDA’s Updated CDER SBIA Learn Webpage

FDA’s CDER Small Business and Industry Assistance (SBIA) has revamped its CDER SBIA Learn webpage to include a comprehensive, searchable, easy-to-use database containing hundreds of training resources including recordings to webinars and conferences. This searchable database includes webinar and conference recordings from SBIA’s YouTube playlists from 2021, 2020, 2019 and 2018. SBIA also posts new conferences, webinars, and recordings on the SBIA LinkedIn page.

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference 2020 Recordings

Recordings and slides are available for the 2020 REdI Annual Conference. Day One  Real-world Evidence for Drugs, Biologics, and Devices So, Your NDA Was Approved – Now What?! Post-approval Responsibilities Obligations Restructure of the Office of New Drugs (OND) Overview of Postmarketing Drug Safety Reporting Requirements Enhanced Drug Distribution Security – DSCSA Implementation Updates Drug […]

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference

August 25-28, 2020 This workshop is free of cost. Register here. Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions. Please select the track […]

Learning Library Now Available on FDA’s YouTube Channel

FDA’s CDER Small Business and Industry Assistance (SBIA) is making hundreds of recordings available via a YouTube learning library.Bookmark and share 2020, 2019, 2018, and 2017 recordings of webinar and conference presentations. New content will be posted on SBIA’s LinkedIn page. These subject matter expert presentations are intended to educate and help industry navigate FDA policies and procedures. To earn free […]

FDA Pharmaceutical Quality Symposium

Oct. 16-17, 2019 College Park, MD or Online Free and open to the public FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency. In this era of globalization, engaging stakeholders is essential to furthering the overall […]

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