Risk Evaluation & Mitigation Strategies
Positively Impact and Control Your Product’s Safety
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Fulfill Your Regulatory Obligations With Confidence
Regulatory requirements for new and existing products can be complex and require proven methods, extensive knowledge, and technical expertise. Having a trusted partner who can provide guidance on meeting FDA mandates to ensure the benefits of a drug or biologic product outweigh its risk can make all the difference.
REMS Consulting & Design
Whether a REMS may be on the horizon, or you are currently in discussion with the FDA, UBC offers consulting on all aspects of your REMS program and FDA interactions. Regardless of your timing requirements, we can partner at any point to review product benefit and risk, provide REMS design options, and ensure you are ready for REMS discussions as you move through product development and approval.
With over 150 years of combined industry experience rooted in evidence generation, our REMS consultants provide strategic guidance to support customers in securing the safe and appropriate use of their products. Our epidemiology-led approach supports regulatory authority interactions regarding effective strategies for mitigating specific product risks.
REMS Implementation & Evaluation
Partner with a trusted advisor for full-service REMS delivery
With experience delivering more than 120 risk management programs across multiple therapeutic areas with varied risks, UBC is the leading provider of integrated, comprehensive REMS services. Led by our team of epidemiologists, safety scientists, clinicians, data analysts, software developers, psychometricians, and project managers, UBC has established a reputation among sponsors and the FDA as the leader in full-service REMS delivery.
- REMS Implementation
- UBC Knowledge Survey System
- Coordinating Center Operations (REMS Center of Excellence)
- REMS Evaluation
- FDA Assessment Report Analysis and Preparation
Configurable, Scalable Solutions
When a multi-sponsor REMS consortium is considered, it is important to establish consensus on imperatives among the sponsors in the single, shared system REMS program. By relying our deep REMS experience and our experience serving as a project management organization (PMO), sponsors are assured that individual company’s requirements are acknowledged in a professional, confidential, and fiscally sound manner.
UBC As PMO:
- Governance & Program Charter
- Sponsor & Third-party Vendor Onboarding
- Regulatory Reporting Oversight
- Document Repository Management
- Financial Planning & Management
REMS Experience
EU Risk Management Plans & Effectiveness Evaluations
Your guide to understanding, evaluating, and mitigating product risk
With an increasing regulatory focus on the importance of evaluating the effectiveness of risk minimization activities, UBC is uniquely skilled at
designing and implementing evaluation studies with maximum efficiency and minimal burden to healthcare professionals, patients, and sponsors.
UBC is unequaled in its mastery of Risk Management Plan (RMP) requirements, leveraging experts who have created complex RMPs, not only in the EU, but also in other territories worldwide where an RMP is required for regulatory approval. We are well-versed in local regulatory requirements, and we understand the nuances of these regulations and how RMP content is interpreted. UBC partners with you to develop an RMP that will meet regulatory expectations and
minimize questions during the regulatory review period.
EU Risk Management Services:
- Developmental RMPs
- Assessment of Effectiveness of Additional Risk Minimization Measures (aRMMs)
- RMPs for Regulatory Submission
- Protocol Development for Post-Authorization Safety Studies
- Risk Minimization Activities and Educational Materials
EU Risk Management Experience
Learn More About UBC's REMS
Interested in learning more about how UBC’s REMS can help you make more informed decisions earlier and meet regulatory requirements?
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What You Can Expect Next
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Get Ready to Change Your Business
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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.