FDA Drug Topics: Electronic Submission of Safety Reports – Ready for Primetime? - April 30, 2024
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present our FDA Drug Topic series of educational webinars targeting the needs of all health care professionals, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health professionals. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, April 30, CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: Electronic Submission of Safety Reports – Ready for Primetime?. This webinar will review updates to requirements for submitting safety reports for investigational new drug (IND) applications, IND-exempt BA/BE studies, and approved drug and therapeutic biologic products (excluding vaccine) using the ICH E2B(R3) format; implementation status and progress; testing updates; and submitter preparedness and readiness.
Register here: https://fda.zoomgov.com/webinar/register/WN_AtitHkARTRG1sx7jZ497TQ
Download Presentation Slides: FDA Drug Topics: Electronic Submission of Safety Reports – Ready for Primetime? (PDF - 2.63 MB)
Activity Outline and Continuing Education Information: U.S. Food & Drug Administration (fda.gov)