Stage posture: 'AI already works in PV — we have the proof.' Vendors push end-to-end automation (intake → signal → aggregate report); IQVIA and MedGenie lead on platform, YEZA.ai represents NLP-native startups.

登台姿态：「AI 在 PV 已可用——我们有证明」。厂商推端到端自动化（摄入 → 信号 → 汇总报告），IQVIA 与 MedGenie 为平台领导者，YEZA.ai 代表 NLP 原生新势力。

• End-to-end automation: intake to aggregate report in one platform端到端自动化：从摄入到汇总报告在一个平台完成

  IQVIA and MedGenie both pitch near-touchless case processing; the emerging pitch includes AI-drafted PBRER narratives.IQVIA 与 MedGenie 均推近乎零接触的病例处理；新兴卖点包括 AI 起草 PBRER 叙述。

  • IQVIA Vigilance AI · Toward Touchless AE Processing
  • MedGenie · AI-Native PV Workflows

• GenAI narrative authoring as the new frontierGenAI 叙述撰写成为新前沿

  Multiple sessions explicitly address AI-generated PBRER/RMP narrative sections — the exact workflow AuroraPrime targets.多场明确讨论 AI 生成的 PBRER/RMP 叙述部分——正是 AuroraPrime 的目标工作流。

  • Generative AI for Periodic Safety Reports
  • YEZA.ai · Unstructured Narratives → Signal Intelligence

• GxP validation and audit trails as table stakesGxP 验证与审计轨迹是入场券

  Every AI vendor session addresses validation — recognizing that pharma safety teams won't deploy without it.每场 AI 厂商演讲都涉及验证——承认不解决这一关，药企安全团队就不会部署。

  • Masterclass · Writing PBRER/PSUR with AI Tools

Stage posture: 'How do we govern and deploy AI under regulatory scrutiny?' C-suite safety leaders dominate with AI governance, CIOMS WG XIV, and aggregate-report automation as the loudest themes.

登台姿态：「如何在监管审查下治理和部署 AI？」C 级安全领导者主导，AI 治理、CIOMS WG XIV 与汇总报告自动化是最响亮的主题。

• PBRER authoring remains the #1 operational pain pointPBRER 撰写仍是第一运营痛点

  Pharma safety leaders describe PBRER/PSUR authoring cycles of months — the white space AI document-authoring tools can address.药企安全领导者描述 PBRER/PSUR 撰写周期长达数月——AI 文档撰写工具可解决的白地带。

  • PBRER Authoring in Crisis · Why It Still Takes Months
  • Generative AI for Periodic Safety Reports

• CIOMS WG XIV governance: 'augment not replace'CIOMS WG XIV 治理：「增强而非替代」

  Pharma leaders explicitly reference CIOMS WG XIV principles for AI in PV — human oversight is non-negotiable.药企领导者明确引用 CIOMS WG XIV 的 PV AI 原则——人类监督不可或缺。

  • CIOMS WG XIV · Responsible Use of AI in PV
  • Validating AI-Powered PV Tools Under GxP

• Benefit-risk + RWE: AI accelerating the signal-to-action cycle获益-风险 + RWE：AI 加速信号到行动的循环

  Sanofi, Janssen, and Roche sessions connect real-world evidence with AI-augmented benefit-risk assessment.赛诺菲、杨森与罗氏的场次将真实世界证据与 AI 增强的获益-风险评估相结合。

  • RWE for Safety Signal Detection · From Hypothesis to Action
  • Structured Benefit-Risk Assessment

Stage posture: 'AI is here — here are the guardrails.' FDA and EMA expectations are discussed in pharma-led sessions; Uppsala/WHO adds international signal-quality context. (No agency staff present on stage — perspective carried by industry + NGOs.)

登台姿态：「AI 已来——这是护栏」。FDA 与 EMA 的期望由药企主导的场次讨论；乌普萨拉/WHO 补充国际信号质量背景。（无监管官员到场——视角由行业 + NGO 承担。）

• FDA AI validation expectations for PV tools (discussed, not presented)FDA 对 PV 工具的 AI 验证期望（被讨论，非到场）

  An FDA-invited discussion covers ICSR processing, signal detection, and — critically — aggregate report review expectations.FDA 受邀讨论涵盖 ICSR 处理、信号检测——以及关键的汇总报告审查期望。

  • FDA Perspectives on AI in Pharmacovigilance

• EMA GVP module updates: AI in GVP V (RMP) and VII (PSUR)EMA GVP 模块更新：GVP V（RMP）与 VII（PSUR）中的 AI

  Evolving EU GVP guidance explicitly addresses AI use in RMP and PSUR authoring workflows.欧盟 GVP 指南更新明确涉及 RMP 与 PSUR 撰写工作流中的 AI 使用。

  • Evolving EU GVP Guidelines · 2026

• WHO VigiBase: international signal harmonization in the AI eraWHO VigiBase：AI 时代的国际信号协调

  Uppsala Monitoring Centre presents AI's role in WHO global PV and improving reporting quality.乌普萨拉监测中心介绍 AI 在 WHO 全球药物警戒中的作用及提升报告质量的方式。

  • VigiBase & the Global Safety Signal Network