Lessons Learned When Implementing a REMS Program

Don’t lose efficiency with REMS implementation. Leverage our lessons learned from over 120 REMS programs to help seamlessly navigate your product through regulatory and commercial requirements.

Download our white paper Lessons Learned When Implementing a REMS Program to gain insights into how a past REMS can be the best indicator of a future REMS program. From the first REMS  launched in the industry, our extensive experience working with many stakeholders and patient populations has taught us valuable lessons about REMS and product safety, including how to:     

• Align REMS with the healthcare system
• Plan early for proactive risk management
• Approach multi-stakeholder communication to determine benefit-risk balance
• Aim for innovative education test strategies

UBC’s Chief Scientific Officer, Annette Stemhagen, DRPH, FISPE, and Senior Director of Risk Management & Scientific Consulting, Rachel Bonfanti, discuss key insights learned over more than a decade of designing and implementing RiskMAPs and REMS for products in various therapeutic areas.

Explore ways to apply the lessons we have learned. Complete the form to access our Lessons Learned When Implementing a REMS Program white paper.

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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.