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 28: Organization of the Safety Department
Jill W. Buckley, PharmD
Adjunct Assistant Professor
Rutgers, the State University of New Jersey, United States
This session will describe the various roles and responsibilities found in a typical safety organization. In addition, the quality management system required for a safety organization as well as safety outsourcing will be discussed.