Navigating REMS: Article Series
Expert insights into navigating the most challenging obstacles in REMS.
Risk Evaluation and Mitigation Strategies (REMS) play a critical role in protecting patient safety, by requiring sponsors to take specific steps to ensure the benefits of a product outweigh its potential risks. However, when facing a complex web of regulatory requirements, coordination among various stakeholders, and integration with broader market strategies, sponsors may become overwhelmed by the variables and complexities that arise.
Navigating REMS: Article Series is a four-part insight series to guide sponsors through the pain points often encountered throughout the lifecycle of a REMS. Drawing on decades of REMS expertise, from launching the first REMS through today, UBC shares proven strategies that enable sponsors to prepare for and navigate some of the crucial processes, milestones, and challenges involved in REMS development, implementation, and assessment.
Read the first article, Inside REMS FDA Inspections: Insights from the Experts, for practical insights and tools to help sponsors achieve continuous inspection readiness, including:
- A summary of the REMS inspection process
- An inspection-readiness checklist
- A collection of direct takeaways from a real-world REMS inspection
- And other insights from real-world examples
Download Article 1
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Bekki Bracken Brown
President & Chief Executive Officer
Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.
With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.