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Certificates of Confidentiality Part 1: General Overview

Part one of this two-part webinar series discusses the purpose of a Certificate of Confidentiality (CoC), identifiable/sensitive information, applicable laws, disclosure protections & exceptions, and application of a CoC. Timestamps 00:49 – Overview 01:37 – Certificate of Confidentiality 02:29 – Applicable Laws 03:38 – Identifiable, Sensitive Information 05:23 – Disclosure Protections & Exceptions 07:38 – Types of CoCs 08:51 – FDA Guidance Document Speaker: Irene Rwakazina, Pharm.D., CCRP Consumer Safety Officer Office of Scientific Investigations Office of Compliance | CDER | FDA FDA Guidance Document: https://www.fda.gov/media/132966/down... Learn more at: NEED TO INSERT WEBPAGE HERE ONCE IT’S CREATED ----------------------- 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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367