Drug Safety and Pharmacovigilance Across the Product Lifecycle
Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.
Session 6: FDA Guidance for Industry on Safety Reporting
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will review the FDA guidelines on safety reporting that provide recommendations for how sponsors of INDs can identify and evaluate important safety information as well as recommendations for a systematic approach to IND safety reporting.