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Best Practice Database
Quality, Compliance and Regulatory » Structure,Staffing and Execution
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New regulatory requirements have created ever greater compliance hurdles for pharmaceutical organizations. One of the outgrowths of these new regulations is that pharmaceutical companies need to develop innovative Risk Evaluation & Mitigation (REMS) program strategies to help achieve both
compliance and commercial objectives.
Best Practices, LLC conducted this research study to identify the most suitable structure and roles to support REMS programs. In addition to exploring how pharmaceutical organizations approach issues around the structure and roles for supporting REMS programs, this study evaluates the role of market research in supporting REMs programs.
Biopharmaceutical leaders who are involved with REMS programs can use this study to compare their structure and roles for supporting REMS programs with the approach used by other leading organizations.