RIC Learning Management System

This course is aimed at providing the participant with an understanding of the factors in FDA Decision Making when requiring a REMS; the elements of a REMS Program, and the Elements to Assure Safe Use (ETASU) in designing a REMS Program.

This course is aimed at providing the participant with an understanding of the internal collaborators needed to design and plan a REMS Program, including the role of the Point of Contact and the REMS Oversight Committee.

FDA Negotiations: providing the participant with an understanding of the process by which a REMS Program comes into being, and what to expect from the FDA, and when, in designing a REMS Program for New Drug Applications, Biologic License Applications,