Though drug approval is a major milestone for sponsors, it only marks the first step of a new and complex journey. At the post-approval stage, sponsors must conduct continuous safety monitoring, evaluate real-world effectiveness, and optimize the product through manufacturing updates. For drugs distributed across multiple global jurisdictions, the burden of ensuring global consistency alongside local regulatory compliance is a significant task that must be well coordinated across pharmacovigilance (PV); regulatory affairs; chemistry, manufacturing, and controls (CMC); quality assurance; and local affiliate teams.
Consider the key global challenges sponsors face in the post-approval phase and what innovative approaches are available to maintain speed, compliance, and consistency.
Though regulatory agencies share the same overarching goals, i.e., protecting patient safety and product quality, different countries have distinct timelines and regulatory engagement models. In many cases, sponsors lack dedicated in-country staff to manage workload peaks. When the volume of post-approval work surges, including variations, renewals, labeling updates, manufacturing changes, and risk management actions, synchronizing updates across multiple markets and coordinating with stakeholders can lead to major timeline delays. To protect their global product, sponsors must implement operating models that respect local obligations and leverage structured data to manage high volumes.
The post-approval phase requires support from both safety and regulatory teams; when these functions are disconnected, timelines slow and messages drift. The synergistic operating model is a solution that brings PV and regulatory functions under a unified operating model and governance structure. Teams align decision cycles, templates, and evidence within a single coordinated workflow. As a result, sponsors can submit a single aligned package for local submissions and ensure consistency across global updates. The synergistic model also enables the following actions:
Though sponsors may worry that a synergistic operating model will require a major organizational overhaul or technology investment, flexible, plug-and-play approaches like adaptive resourcing and applied AI allow them to seamlessly tailor the model to fit their existing organizational structure.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
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