Risk Management and Risk Evaluation & Mitigation Strategy (REMS) Solutions
At ICON, our integrated Risk Management team forms a comprehensive risk management solution tailored to the specific nature and needs of each of our clients. Our Risk Management team operates a cross functional approach with seamless collaboration across pharmacovigilance, medical affairs, pharmacoepidemiology, regulatory affairs, and real-world solutions. Our experts, ranging from therapeutic area specialists to regulatory compliance professionals, provide unparalleled support in managing risks throughout a product’s lifecycle.
Our risk management team delivers the following end to end suite of services designed to strategically manage and mitigate risks while minimising stakeholder burden.
Design
Risk management strategy
Our risk management experts collaborate with clients to identify critical regulatory requirements. We interact effectively with regulatory authorities and key stakeholders to create a harmonised approach. Our risk management planning process starts with signal-to-risk translation and risk assessment, yielding a list of safety concerns or important risks. Once agreed, we evaluate the need for additional PV and risk minimisation.
Generation
Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS)
ICON’s experienced safety writers partner with a safety scientist and work cross functionally internally and externally to author the RMP/REMS and ensure alignment of the RMP/REMS with the submission dossier and other safety documents. Each RMP/REMS undergoes thorough medical and scientific content review and quality checks before being shared with the sponsor for review, update and approval. ICON supports clients throughout the filing process, promptly responds to all regulatory authority inquiries.
Licence application
Regulatory support
ICON's strategic regulatory affairs team will assist with the design, submission, execution and management of additional risk management activities and/or REMS programs, and ensure agency agreement throughout the program. ICON will review product benefit and risk, provide REMS design options, ensure readiness, and prepare required documents for discussions with agencies to ensure continued approval of your product. Services include risk evaluation, REMS design and modification, shared REMS project management, REMS implementation, and regulatory strategy development of REMS programs.
Implementation
Design and implement additional activities
ICON excels in developing a wide range of risk management activities, from standard communications and questionnaires to educational materials and controlled access programs. Our materials are meticulously designed, tested, and translated to meet local needs, with implementation tracked via a dedicated 3rd party platform.
CDS, our award-winning creative and digital agency, partners with you to deliver tailored solutions across the drug lifecycle. We integrate seamlessly with stakeholders and clients, ensuring excellence and innovation in every project. Driven by digital creativity, we offer comprehensive services, including web development, digital solutions, video production, and interactive eLearning modules, to help ensure effective risk minimization.
Effectiveness monitoring
Quantitative and qualitative assessments
ICON offers a range of services, from protocol through to final report, dependent on the activity implemented. Knowledge, understanding, attitudes and behaviours (KUAB) of aRMM/REMS materials can be evaluated quantitatively through customized online stakeholder surveys that can be deployed in multiple countries and in line with applicable Good pharmacovigilance Practices (GVP), REMS and Good Pharmacoepidemiological Practices (GPP) guidance. Qualitative interviews and cognitive pre-testing of survey questionnaires further assess awareness and KUAB of RMP/REMS materials and validate understanding of questionnaire items and confirm translation accuracy, respectively.
Evaluation & reporting
Effectiveness of the additional activities should be evaluated and reported, either via dedicated reporting or as part of the Periodic Benefit Risk Evaluation Report (PBRER) or Periodic Safety update Report (PSUR). Necessary changes should be made to the risk management system, as needed. ICON offers a range of services pertaining to regulatory license maintenance , authoring of aggregate safety reports or REMS assessment report.
Our Risk Management and REMS Solutions utilise the following suite of tools and technologies:
Our Creative and Digital Solutions team specialises in delivering customised digital solutions tailored to your Risk Management and REMS needs, enhancing engagement for both patients and healthcare providers. We combine innovative digital creativity with robust risk management to offer dynamic web development, interactive eLearning modules, and engaging video productions. Our solutions effectively communicate risk management strategies and REMS requirements, promoting safe medication use and ensuring regulatory compliance. Leverage our digital expertise to drive the success of your REMS initiatives with compelling, customised content that truly resonates with your audience.
Contact us for a tailored assessment of your risk management requirements and partner with us to achieve the highest standards of patient safety and regulatory compliance.