REMS
Risk Evaluation and Mitigation Strategy: REMS
A Risk Evaluation and Mitigation Strategy (REMS) is the new legal framework for risk management plans, specifying timelines and procedures for submission and review under the Food and Drug Administration Amendments Act of 2007 (FDAAA). REMS can range from periodic assessment of a product's post-marketing safety profile to strict limitations on prescribing.
Sentrx implemented and operates the first REMS program with the “Elements to Assure Safe Use” required under the FDAAA. Our experts understand the details and nuances associated with the FDAAA; we have a proven ability to manage the components of both traditional and emerging REMS solutions.
Our firm foundation of success includes a technology-enabled infrastructure to integrate multiple databases. We have extensive expertise in all levels of REMS from the periodic assessment of safety profile, medication guide, and the controlled distribution program plus periodic assessments.
Turn to an expert in risk management; turn to Sentrx.
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REMS At A Glance
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Doreen Lechner, PhD EVP Pharmacovigilance Client Services |
