The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are moving from a separate safety and effectiveness assessments model to requirements for combined benefit-risk assessments. This shift in approach provides challenges and opportunities in addressing these evolving regulatory requirements.With the right approach and the right partner, you can develop innovative benefit-risk programs that meet these regulatory requirements and deliver cost-effective, value-added tools for monitoring and measuring the benefit-risk of your products.
As regulatory agencies increasingly look at safety through the lens of benefit-risk balance, we continually evolve our approach to help ensure we are effectively addressing and exceeding the requirements of your stakeholders. That’s why our global safety capabilities do not reside in a REMS/RMP department, but in a Global Benefit-Risk Management Center (GBRM Center), leveraging dedicated safety and real-world and late phase resources. The GBRM Center comprises the expertise to:
- Establish current disease burden, through both primary and secondary research.
- Determine and understand the drivers of patient and prescriber behavior.
- Uncover the knowledge and attitudes of patients, caregivers, and healthcare providers.
- Build safety program materials that deliver not only information, but also the engagement/motivation requisite for participation in voluntary programs.
- Notify stakeholders of a safety initiative through multiple media, including professional journal ads.
- Develop, pilot test, refine, and field KAB surveys.
- Design world-class benefit-risk registries to track the success of your benefit-risk program via outcome indicators as well as process indicators.
- Participate in the regulatory discussions shaping the future of safety/benefit-risk management.
Our Global Benefit-Risk Management Center Leverages
- Specialized Benefit-Risk Approach: Strategies and data-driven safety and risk minimization programs that demonstrate or enhance appropriate and safe use of drugs, biologics and devices through multi-tiered programs ranging from education and behavior evaluation to PASS and safety registries to performance-linked and controlled access programs.
- Global and Local Operational and Regulatory Expertise: With 130 offices in more than 60 countries, Quintiles has extensive global reach. We have the insight to apply local solutions to help mitigate risk, and the depth and breadth of knowledge to help maximize global markets.
- Deep Therapeutic Insights: We offer 15 therapeutic centers of excellence and the expertise of more than 850 PhDs and 800 medical doctors, leading to the design of more effective and specialized programs and a greater understanding of the risks.
- Industry-Leading Adverse Event Management and Reporting Systems: We offer industry-leading and patented technologies that provide global workflow management, operational metric reports for productivity, quality and compliance analyses, full global aggregate reporting capabilities, PSUR/PBRER, expedited report submissions (E2B and paper), and signal detection and data mining.
- Collaborative Partnerships for the Future: Reflecting our deep methodological expertise and interest in shaping the future of safety and risk management, we participate in a number of collaborative initiatives, including the European Medicine Agency’s PROTECT-EU and ENCePP projects and the US FDA’s Sentinel Initiative.