Electronic Submission of Adverse Event Reports to FAERS using ICH E2B(R3) Standards - Oct. 11, 2019 скачать в хорошем качестве

Electronic Submission of Adverse Event Reports to FAERS using ICH E2B(R3) Standards - Oct. 11, 2019

Suranjan De from CDER’s Office of Surveillance & Epidemiology discusses plans, progress, and technical specifications on enhancements to electronic submission of premarket and post-market Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. Find more information at https://www.fda.gov/drugs/cder-small-... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities. Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367 LinkedIn:   / cder-small-business-and-industry-assistance   Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...