On October 4, 2017, REMS executives from various organizations met in New Orleans for a programagnostic forum discussing emerging trends such as observer status, waiver-granted REMS programs and simultaneous shared REMS development and operations. This three-part series details these emerging trends in the REMS landscape.
REMS Leadership Summit Insight Series - Part 1
Part 1 of 3: Observer Status
Part 1 of 3: Observer Status
Summary
Some shared Risk Evaluation and Mitigation Strategies (REMS) programs allow companies to “observe” in advance of joining as a program Participant. This Observer role can be helpful both to the current program Participants and to the companies with Observer status but is not without its complications. In this post, we define the Observer role, discuss considerations for potential Observers as well as program Participants, and conclude with some potential best practices that might be helpful to companies designing multiple sponsor REMS programs.
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