艾昆纬-超越自动化：人工智能时代战略性LQPPV外包如何证明光伏合规性（英）

White PaperBeyond Automation: How Strategic LQPPV Outsourcing Future-proofs PV Compliance in the AI Era ANA PEDRO JESUÍNO, Associate Marketed Product Safety Director DOMINIQUE COLEMAN, Senior Director, Operations Lifecycle Safety BARRY MULCHRONE, Head of Safety Science & Strategy, Lifecycle SafetyTable of contentsIntroduction 1What regulatory changes are impacting the PV climate? 2Where does AI fit into PV workflows? 2Why is outsourcing LQPPV work worthwhile? 3How do I enhance my PV offerings? 4About IQVIA 4About the authors 5 iqvia.com | 1The field of pharmacovigilance (PV) continues to rapidly evolve due to changing regulations, increased adverse event reporting across multiple platforms, and the global expansion of pharmaceutical development. In response, Marketing Authorization Holders (MAHs) are exploring how to integrate artificial intelligence (AI) into their workflows to increase efficiency and lessen the burden on human experts. Yet, despite growing AI usage across PV, the role of Local Qualified Persons for PV (LQPPVs) — who serve as the MAH representatives and primary contacts for local health authorities in their designated country — remains essential and pivotal. Amid this delicate landscape, the question of whether to outsource LQPPV responsibilities is top of mind. Recent European Medicine Agency (EMA) guidance updates have emphasized the importance of robust vendor oversight and, in response, MAHs are considering which partnerships will best facilitate streamlined vendor management. Strategically selecting an outsourcing partner with a wide array of PV services, advanced technology offerings, and ample regulatory knowledge will allow you to leverage their expertise to ease operational burdens, align with industry best practices, and maintain consistent compliance with evolving PV and AI guidelines.IntroductionStrategically selecting an outsourcing partner with a wide array of PV services, advanced technology offerings, and ample regulatory knowledge will allow you to leverage their expertise to ease operational burdens.2 | Beyond Automation: How Strategic LQPPV Outsourcing Future-proofs PV Compliance in the AI EraWhat regulatory changes are impacting the PV climate? Both the EMA good pharmacovigilance practices (GVP) and Commission Implementing Regulation (EU) 520/2012 guidelines have undergone recent updates that address the importance of an MAH’s commitment to strengthening their protocols for vendor oversight and management. MAHs typically employ a broad array of vendors across functions, including aggregate reporting, risk mitigation, social media monitoring, market research, and various other functions, which adds complexity to the vendor oversight process. Both documents implore MAHs to establish rigorous vendor management protocols that ensure a vendor is compliant, their workload is under control, and an MAH is apprised of any issues that arise throughout a partnership. Satisfying these goals requi