Complex REMS Require Proven Solutions

Complex REMS Require Proven Solutions

At this week's exl Risk Evaluation & Mitigation Strategies Summit, UBC's Heather Gagnier and Lee Ann Steadman will present, Balancing Regulatory and Commercial Requirements in Complex REMS Programs. 

Complex REMS, particularly those containing Elements to Assure Safe Use (ETASU), made up 55% of all REMS approvals in 2012.  Each of these programs is unique and requires experience and expertise to design, develop, and operate.  UBC's extensive experience and expertise in REMS strategy and tactical solutions is leveraged by manufacturers to reduce the likelihood of drug approval delays and increase program efficiency by working with a partner that can provide an end-to-end solution.  UBC fully understands the importance of balancing the regulatory and commercial needs of a product by minimizing patient risk, reducing healthcare stakeholder burden, and ensuring appropriate patient access.

When looking for an experienced REMS advisor, consider UBC because we:

  • Have designed, developed, and implemented more than 33 REMS programs containing ETASU
  • Operate some of the industry's most complex and rigorous REMS programs containing ETASU.  Some of our programs have been in operation since 1998 and are restricted distribution programs consistent with FDA's definition of ETASU.
  • Run Risk Management Coordinating Centers which handle more than 500,000 calls annually from physicians, pharmacies, patients, and other healthcare stakeholders
  • Have enrolled and/or tracked more than 1.2 million patients, 100,000 prescribers, and 65,000 pharmacies via our proprietary REMS technology platforms
  • Participate with manufacturers in 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 manufacturers

Look for us at the REMS Summit, or feel free to contact us any time about your product's REMS requirements.