通过整合LQPPV和生命周期管理与应用人工智能，为审批后合规性做好未来准备

Futureproofing Post-ApprovalCompliance by IntegratingLQPPV and Lifecycle Managementwith Applied AI Align local pharmacovigilance and regulatory changeunder one governance model. JAY GANDECHA, Senior Director, Regulatory AffairsANA PEDRO JESUÍNO, Director, Marketed Product Safety Table of contents Introduction1The global-scale compliance challenges sponsors face2A synergistic operating model3Adaptive resourcing4Applied AI5An effective AI governance approach6Support models with strategic partnerships6A unified system without reorganization7One operating model with integrated PV and regulatory functions7Conclusion7About IQVIA8About the authors9 Introduction All approved drugs follow the same product lifecycle: discovery and development;clinical trials; evaluation and authorization; and finally, post-approval and safetymonitoring. Though a drug’s approval is a major achievement, it is only thebeginning of an ongoing journey with no set finish line. Post-approval and safetyfunctions require significant ongoing work that ebbs and flows as labels evolve,and safety signals emerge. The post-approval environment is where globalgovernance, legal obligations, volume variations,and market-specific expectations converge, makingthe operating model that sponsors adopt critical tomaintaining speed and compliance. As this environmentbecomes more complex and globally interconnected,regulatory expectations are evolving alongside it. of the International Organization for Standardization —Identification of Medicinal Products (ISO IDMP) via thesubstance, product, organization, and referential data(SPOR) program, and the move toward electronic commontechnical document (eCTD 4.0), both of which underpinstructured data, interoperability, and end-to-endtraceability. In parallel, continuous signal management,as set out in GVP Module IX, has become the acceptedregulatory standard for pharmacovigilance (PV). Regulators now expect high-quality, traceable,data-driven submissions with fewer inconsistenciesacross markets. This is reflected in the EMA’s adoption The global-scale compliancechallenges sponsors face Country-specific hurdles include translation nuances,health authority communication preferences, andexpectations for local qualified persons for PV (LQPPVs).These micro-requirements compound to slow downeven relatively simple updates. Furthermore, manysponsors lack dedicated in-country expertise and havedifficulty managing workload peaks related to post-approval activities. Manufacturing, distributing, and monitoring an approvedtherapeutic at a global scale is inherently complex. Theburden is further complicated by managing complianceand consistency across a variety of jurisdictions. Localrequirements and regulatory interpretations are notalways consistent with global regulation, and though allregulatory agencies share similar goals, translating globalprinciples into local realities, i.e., different timelines,templates, and regulatory engagement models, is achallenge. These distinctions can create friction anddelays across markets. The volume of post-approval work keeps increasingand includes variations, renewals, labeling updates,manufacturing changes, and risk management actions,which are meant to run in parallel. While these activitiesare manageable individually, their collective volume atscale is high risk due to fragmented data and decision-making across PV, regulatory affairs, and local teams.If a single labeling change or safety update is pushedthrough 20+ regulatory systems, minor processdifferences create major coordination workloads. Sponsor teams must coordinate across PV; regulatoryaffairs; chemistry, manufacturing and controls (CMC);quality assurance (QA); and local affiliate teams tomaintain alignment on evidence and rationale. It oftentakes more time to synchronize updates than to producethem. To ensure speed and global compliance, operatingmodels must respect local obligations, leveragestructured data and shared governance, and deftlymanage high volumes. The volume of post-approval workkeeps increasing and includesvariations, renewals, labelingupdates, manufacturing changes,and risk management actions,which are meant to run in parallel. A synergistic operating model This structure delivers several additionaloperational benefits: The post-approval stage requires work from both safetyand regulatory teams. For example, a safety signal canaffect labeling, and the labeling change will triggera variation that requires coordinated submissions.When safety and regulatory functions are disconnected,time is lost and messages drift. A synergistic operatingmodel brings PV and regulatory functions under oneumbrella: a single governance structure with shareddecision cycles, templates, and evidence. Instead ofhandoffs between teams, there is one coordinatedworkflow where both functions have access to the sameinformation simultaneously. As a result, sponsors avoidduplicate work and miscommunication. •Affiliates rec