REMS with Elements to Assure Safe Use

Risk management, including risk assessment and risk mitigation strategies, are core business offerings supported by our depth and breadth of experience and capabilities in clinical medicine and epidemiology, information technology, regulatory practice, trade relations and distribution logistics, Coordinating Center operations, and project management. Since 1998, UBC has designed and managed some of the industry’s most complex risk management programs including many programs to meet post-approval regulatory commitments for risk assessment and risk minimization. UBC has designed, implemented and evaluated more RiskMAPs and REMS than any other REMS provider, having been involved in more than 80 such programs. In addition to developing Medication Guides and evaluating their effectiveness, UBC has content and graphics experts to develop materials for education and outreach in Communication Plans. We have designed more than 20 programs with one or more elements to assure safe use, with many currently in the marketplace and others under review at FDA.

  • Our REMS Coordinating Center handles more than 500,000 calls annually from physicians, retail pharmacies and patients and has been operating risk management programs since 1998.
  • Our proprietary REMS technology platforms have enrolled and/or tracked more than 1.2 million patients, 100,000 prescribers, and 65,000 pharmacies.
  • We have enrolled and monitored almost every national distributor and regional distributor in the United States (US) for REMS programs.
  • We participate with Sponsors in multiple Food and Drug Administration (FDA) meetings and teleconferences about designing and implementing REMS, particularly those with ETASU, and are often asked to address complex analytical and surveillance issues related to REMS on behalf of Sponsors.
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