Regulators & Standards Drivers监管方与标准驱动力
14 regulator / NGO speakers from 7 agencies — plus the 7 regulatory and standards drivers (CIOMS, ICH, EMA GVP, FDA) shaping PV technology in 2025–2026.
来自 7 家机构的 14 位监管 / NGO 演讲人——以及塑造 2025–2026 年 PV 技术的 7 项监管与标准驱动力（CIOMS、ICH、EMA GVP、FDA）。
Regulator speakers
监管演讲人
Including NGO / foundation voices
含 NGO / 基金会代表
Agencies
机构数
FDA · EMA · MHRA · AMA · Saudi FDA · …
FDA · EMA · MHRA · AMA · 沙特 FDA · …
Highlighted
重点关注
Senior PV / safety policy voices
资深 PV / 安全政策声音
Standards drivers
标准驱动力
CIOMS · ICH · GVP · FAERS · MedDRA
CIOMS · ICH · GVP · FAERS · MedDRA
Regulator & NGO speakers监管与 NGO 演讲人
Grouped by agency. These are the policy and surveillance voices defining what a compliant PV operation must do — and increasingly, how AI may be used within it.
按机构分组。这些是界定合规 PV 运营底线、并日益规范其中 AI 用法的政策与监测声音。
Duke University / ex-FDA
FDA- Robert M. Califf ★Duke University; former FDA Commissioner (keynote)杜克大学；前 FDA 局长（主旨）
FDA
FDA- Gerald Dal Pan ★Director, Office of Surveillance and Epidemiology (OSE), CDERCDER 监测与流行病学办公室（OSE）主任
- Scott JaniczakTeam Leader, Division of Pharmacovigilance-I, OSE, CDERCDER OSE 药物警戒一处组长
- Richard ForsheeAssociate Director of Benefit-Risk Assessment, OSE, CDERCDER OSE 获益-风险评估副主任
- Nakissa SadriehSenior Advisor for New Approach Methodologies, CDERCDER 新方法学高级顾问
EMA
EMA- Priya Bahri ★Senior Lead, PV and Risk Management Guidance and Policy药物警戒与风险管理指南及政策高级负责人
- Georgy Genov ★Head of Pharmacovigilance Office药物警戒办公室主任
- Andrej SegecScientific Administrator科学事务管理专员
MHRA
MHRA- Stephanie Millican ★Deputy Director, Benefit-Risk Evaluation, Safety and Surveillance获益-风险评估、安全与监测副主任
- Jenn MatthissenHead of GI System, Nutrition, Endocrine and Fertility消化系统、营养、内分泌与生殖科主管
African Medicines Agency
AMA- Delese Mimi DarkoDirector General, African Medicines Agency非洲药品管理局总干事
Saudi FDA
SaudiFDA- Fadi A. AlanaziSenior Expert, Pharmaceuticals Safety药品安全高级专家
Gates Foundation
Gates- Deirdre McCarthyPV Lead, Regulatory System Strengthening监管体系强化 PV 负责人
Reagan-Udall Foundation for the FDA
Reagan-Udall- Carla Rodriguez-WatsonDirector of Research研究总监
Regulatory & standards drivers shaping PV tech塑造 PV 技术的监管与标准驱动力
The frameworks every AI-in-PV claim at this conference is measured against — from CIOMS WG XIV's 'augment not replace' guardrail to the ICH/EMA/FDA interoperability and reporting backbone.
本届会议所有 AI-in-PV 论述的衡量标尺——从 CIOMS WG XIV「增强而非替代」护栏，到 ICH/EMA/FDA 的互操作与报告骨架。
CIOMS Working Group XIV — AI in PharmacovigilanceCIOMS 第十四工作组——药物警戒中的 AI
CIOMSMulti-stakeholder working group defining principles for using AI/ML in PV.
界定在 PV 中使用 AI/ML 原则的多方工作组。
Why it matters: Sets the 'augment not replace' guardrail — AI should support, not remove, human expertise from causality and benefit-risk decisions. The reference point for every AI-in-PV claim at this conference.
为何重要：确立「增强而非替代」的护栏——AI 应辅助而非取代人类在因果与获益-风险决策中的专业判断。是本届会议所有 AI-in-PV 论述的参照系。
Final report published 4 Dec 2025 (after 12 meetings since 2022).
终版报告于 2025 年 12 月 4 日发布（自 2022 年起共 12 次会议）。
ICH E2B(R3)ICH E2B(R3)
ICHStandard for electronic transmission of individual case safety reports (ICSRs), built on HL7 / ISO 27953.
个例安全报告（ICSR）电子传输标准，基于 HL7 / ISO 27953。
Why it matters: Every safety system needs an E2B(R3) gateway to submit ICSRs to FAERS, EudraVigilance, PMDA, etc. The interoperability backbone of PV tech.
为何重要：每个安全系统都需要 E2B(R3) 网关，才能向 FAERS、EudraVigilance、PMDA 等递交 ICSR。是 PV 技术的互操作骨架。
A US Federal Register notice (Apr 2026) updates electronic postmarketing ICSR submission to FDA.
美国《联邦公报》（2026 年 4 月）更新了向 FDA 电子递交上市后 ICSR 的要求。
ICH E2C(R2) — PBRERICH E2C(R2)——PBRER
ICHStandard format and content for the Periodic Benefit-Risk Evaluation Report.
定期获益-风险评估报告的标准格式与内容。
Why it matters: Underpins the aggregate-reporting capability — and the document-authoring white space, since PBRER/PSUR narratives remain largely manual.
为何重要：支撑汇总报告能力——也是文档撰写的空白地带，因为 PBRER/PSUR 叙述仍以人工为主。
Established standard; periodic reporting workload keeps growing with portfolios.
成熟标准；随着产品组合扩大，定期报告工作量持续增长。
EU Good Pharmacovigilance Practices (GVP)欧盟良好药物警戒规范（GVP）
EMAModules I–XVI covering PV systems & QA, risk management, ADR collection, signal management, PASS, and safety communication.
模块 I–XVI，涵盖 PV 体系与质量保证、风险管理、ADR 收集、信号管理、PASS 与安全沟通。
Why it matters: The functional backbone of EU PV obligations — defines what a compliant PV platform must support.
为何重要：欧盟 PV 义务的功能骨架——界定合规 PV 平台必须支持的范围。
Ongoing; module revisions track AI and RWE developments.
持续更新；模块修订紧跟 AI 与 RWE 发展。
FDA FAERSFDA FAERS
FDAUS postmarketing adverse-event and medication-error database feeding CDER/CBER safety review.
支撑 CDER/CBER 安全审查的美国上市后不良事件与用药错误数据库。
Why it matters: Primary US signal source; its known limits (underreporting, no proven causality) are exactly what RWE and smarter signal tools aim to offset.
为何重要：美国主要信号来源；其已知局限（漏报、无法证明因果）正是 RWE 与更智能信号工具试图弥补的。
Operational; volume drives demand for automated triage.
持续运行；数据量推动对自动化分诊的需求。
EMA EudraVigilanceEMA EudraVigilance
EMAEU system for ICSR reporting and evaluation (EVCTM clinical-trial + EVPM post-authorization modules).
欧盟 ICSR 报告与评估系统（EVCTM 临床试验 + EVPM 上市后两个模块）。
Why it matters: Consumes ICH E2B ICSRs and supports EEA-wide signal detection — the EU counterpart to FAERS.
为何重要：接收 ICH E2B ICSR 并支持欧洲经济区范围的信号检测——FAERS 的欧盟对应系统。
Operational; central to EU signal management.
持续运行；是欧盟信号管理的核心。
MedDRAMedDRA
ICH / MSSOMedical Dictionary for Regulatory Activities — standardized adverse-event terminology.
监管活动医学词典——标准化的不良事件术语。
Why it matters: Core to ICSR coding, signal detection, and aggregate analysis; auto-coding is a top AI/automation target (e.g. ArisGlobal NavaX, Veeva agents).
为何重要：ICSR 编码、信号检测与汇总分析的核心；自动编码是 AI/自动化的首要目标（如 ArisGlobal NavaX、Veeva agents）。
Versioned twice yearly; dictionary updates are a platform table-stake.
每年更新两次；词典更新是平台的入场券。