P29: Enhancing Compliance and Improving Oversight of Additional Risk Minimization Measures by Redesigning the Process
Director, Reg Intel
Regeneron Pharmaceuticals, Inc. United States
To address process challenges of additional risk minimization measures (aRMMs) through an integrative, cross-functional approach, while improving the compliance and oversight of aRMMs, by redesigning the risk management process.
A gap analysis was performed to identify areas of improvement in risk management and aRMM. Cross-functional stakeholders convened a workshop, to determine solutions collectively and strategically, along with persons accountable, to address each of the identified needs and implement process updates.
Workshop attendees included members from Global Pharmacovigilance (EU QPPV, Risk Management, and Medical Safety), Medical Affairs, Clinical, Regulatory Affairs, and Local Country Safety colleagues, many of whom were new to the risk management process design discussions.
Local teams shared key regulations, challenges, and experiences related to the management of risks and aRMM, including specific requirements or nuances not covered by the global procedure. Considering local challenges, the teams jointly identified the need to define vital, early steps of product risk assessment, aRMM identification and evaluation, local management of aRMM materials, and central oversight and tracking of global aRMM.
Novel templates were developed to support these updates, to ensure the proper documentation for potential risks arising from safety signals, and to document the evaluation of effectiveness of aRMM. A central tracking system and process was developed to track the ongoing aRMM implementation and effectiveness evaluation at the local and regional levels. A new role, “local aRMM lead,” was also created as a single-point liaison to connect with the global team, provide accurate and timely updates on locally implemented aRMM, and to ensure oversight for aRMM preparation, translation, and tracking.
Procedural updates were both identified and led by key stakeholders from various teams and regions, with one key point of contact from the global team. That person was responsible for the coordination and oversight of all updates, and for providing guidance to contributors, facilitating global follow-up meetings, and to ensuring completion. This ensured the “buy-in” and commitment from all key stakeholders to implement the process redesign.
The cross-functional, comprehensive approach taken to redesign the risk management process led to multiple constructive changes. The new design highlights included: a) a better process for product risk assessment and documentation, b) the development of training resources and guidance on vital process steps, c) the creation of novel templates to efficiently document and communicate the product’s safety profile, and to analyze and document aRMM effectiveness evaluations, and d) clear definitions for the roles and responsibilities of local, regional, and global leads.
A centralized, global tracking system improved the oversight of aRMM implementation and streamlined the communication and alliances between Pharmacovigilance, Medical Affairs, Clinical, Regulatory, and regional teams, among others. This integrated method to process redesign strengthened the communication between functional area teams and key stakeholders and boosted the organization’s ability to track and evaluate global aRMM programs, enhanced the compliance with risk management regulations, and improved audit and inspection readiness.
This procedure redesign reinforces the significance of understanding local regulatory environments, including local affiliate teams in decision-making, and building partnerships across various functional areas, in a global organization. The development and implementation of a more integrated model for risk management as well as the centralized oversight of RMM implementation also improved the organization’s ability to minimize risks and to ensure patient safety.
It demonstrates the organization’s agility and capacity to dynamically address the challenges associated with a shifting regulatory landscape. This more inclusive and pioneering approach has proven successful, globally. Future execution of this approach will ensure constant improvement within the risk management system.