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Best Practice Database
Quality, Compliance and Regulatory » Deployment
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Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
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.
If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.