Global Risk Management and REMS
Providing benefit-risk solutions for medicinal products
Global regulatory authorities may require pharmaceutical companies to include risk management activities as part of their pharmacovigilance system to obtain, or retain, marketing authorization for their medicinal product. The risk management system plays a critical role in positively impacting the benefit-risk ratio and enabling patients to access these life-enhancing therapies.
In the United States, the FDA applies risk management controls through Risk Evaluation and Mitigation Strategy (REMS) programs. Whereas in Europe, and most other countries, the regulators require Risk Management Plans (RMP) with additional risk minimization measures (aRMMs) to apply the necessary controls.
Your expert partner for efficient, effective risk management design and implementation
Regardless of the terms used, designing and implementing REMS or aRMMs to address the benefit-risk profile is a complex topic and requires skilled experts to help ensure controls are balanced, effective and appropriate.
Syneos Health is here to help and has the experts, solutions and capabilities to address the global risk management challenges you may have.
For example:
- Do you have an asset in clinical development that may require risk management controls?
- Are you planning on including risk management activities as part of your marketing application?
- Have the regulators indicated that you may need a REMS or aRMMS to obtain marketing approval?
- Are you currently operating a REMS or aRMM program and are looking to transition away from your current vendors?
- Are you considering migrating your brand risk management system to a multi-sponsor shared program?
Three core offerings, customized to your needs
Our Global Risk Management Solutions team is dedicated to helping sponsors plan, implement, and assess measures to positively impact the risk-benefit balance of medicinal products.
We provide three core risk management services:
- Full-Service REMS: Providing a comprehensive single vendor solution for US brand and generic manufacturers across the entire REMS lifecycle
- Global Risk Management: Supporting global biopharma by implementing additional risk minimization measures to optimize the safe and effective use of medicinal products
- Risk & Program Management: Providing a best-in-class framework to support multi-sponsor engagements
Our Experience:
- Supporting REMS programs since 2010
- Our leadership team has worked on 90% of all currently approved REMS programs
- Extensive experience preparing REMS and RMP submissions
Want to learn more?
Leadership Team
Michael Carr
Global Risk Management & REMS Lead
Over a decade of global risk management and REMS experience. Having led the strategy, development, implementation and operations of several risk management plans/additional risk minimization measures, as well as over half the currently approved REMS on the market, both as a manufacturer and a REMS administrator.
Lindsay Crampton
Risk & Program Management Lead
More than two decades of patient safety experience focused on safety surveillance, real world evidence, data analytics, risk minimization action plans, REMS, and observational patient and pregnancy registries.
