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Best Practice Database
Quality, Compliance and Regulatory » Deployment
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Given the complexity of balancing regulatory imperatives and commercial objectives, Best Practices, LLC conducted a benchmarking study to explore how pharmaceutical companies develop and execute effective Risk Evaluation and Mitigation Strategy (REMS) plans for newly-approved drugs in the U.S. market.
The report provides leading insights and benchmarks around the structure and responsibilities of REMS teams, use of market research teams to support and benefit REMS programs, physician/ distributor compliance on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.
This study engaged 19 healthcare executives and leaders supporting REMS programs at 17 leading life sciences and medical device companies. More than 50% of research participants work at the level of director or senior director. Roughly one-fifth of participants serve either as president or CEO.