In September of 2009, the FDA issued a draft guidance for industry on the format and content of a proposed risk evaluation and mitigation strategy (REMS), which included REMS assessments and proposed REMS modifications. Many industry experts are working to manage the detailed requirements of this new pharmacovigilence standard to include more and tighter control over drug uses.
This session provides insight into medication guides, patient package inserts, communication plans, timelines and other elements to ensure safe use. Attendees receive helpful tips about the format and contents of REMS submissions, as well as some good practices for execution of REMS strategies.
Current FDA Thinking on Risk Evaluation and Mitigation Strategies is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Thursday, February 11, 2010. For more details or to register, please visit our site at www.fxconferences.com
