Regulatory & NGO perspectives at WPSC Americas 2026WPSC 美洲 2026 的监管与 NGO 视角
WPSC has no FDA/EMA staff presenting on stage — unlike DIA. The regulatory perspective is carried by (1) pharma/CRO-led sessions discussing FDA & EMA expectations, and (2) NGO / standards bodies actually on stage (Uppsala Monitoring Centre / WHO, ASA, Personalized Medicine Coalition). KPIs below count agencies discussed, not agencies present.
与 DIA 不同，WPSC 没有 FDA/EMA 官员上台演讲。监管视角由两部分承担：（1）药企/CRO 主导、讨论 FDA 与 EMA 期望的场次；（2）真实到场的 NGO / 标准机构（乌普萨拉监测中心 / WHO、ASA、个性化医疗联盟）。下方 KPI 统计「被讨论的机构」，而非「到场的机构」。
FDA discussed
FDA 被讨论
Sessions discussing this agency's PV expectations
讨论该机构 PV 期望的场次
EMA discussed
EMA 被讨论
Sessions discussing this agency's PV expectations
讨论该机构 PV 期望的场次
NGO / standards bodies
NGO / 标准机构
Uppsala/WHO · ASA · PMC
乌普萨拉/WHO · ASA · 个性化医疗联盟
Regulatory-track sessions
监管轨道场次
Regulatory + NGO + cross-border
监管 + NGO + 跨境
Sessions discussing FDA
讨论 FDA 的场次
FDA position on AI in PV, intelligence, consumer-product PV
FDA 对 PV 中 AI 的立场、情报、消费品 PV
Sessions discussing EMA
讨论 EMA 的场次
EU GVP module updates, regulatory intelligence
欧盟 GVP 模块更新、监管情报
NGO-led sessions
NGO 主导场次
Real NGO / standards-body speakers on stage
真实到场的 NGO / 标准机构讲者
Trending Topics from Regulatory & NGO Sessions监管与 NGO 场次关键词趋势
Keywords extracted from regulatory & NGO session titles and abstracts. Chip size reflects how many sessions mention the topic.
从监管与 NGO 场次的标题和摘要中提取的关键词。芯片大小反映提及该主题的场次数量。
Based on 6 regulatory & NGO sessions at WPSC 2026 · chip size = frequency · hover for context基于 WPSC 2026 6 场监管与 NGO 场次 · 芯片大小 = 频次 · 悬停查看上下文
Sessions — regulatory expectations & NGO perspectives场次 — 监管期望与 NGO 视角
6 WPSC 2026 sessions covering FDA/EMA expectations for AI in PV, EU GVP updates, global regulatory intelligence, and WHO/NGO safety-signal perspectives.
共 6 场 WPSC 2026 场次，涵盖 FDA/EMA 对 PV 中 AI 的期望、欧盟 GVP 更新、全球监管情报，以及 WHO/NGO 的安全信号视角。
Oct 15, 2026 · 9:00 AM – 9:45 AM · TBA
FDA Perspectives on AI in Pharmacovigilance: Current Position and Future Expectations
An FDA-invited discussion on where the agency stands on AI and machine learning tools used in pharmacovigilance operations — covering AI in ICSR processing, signal detection, aggregate report review, and risk management plan generation. The session clarifies current FDA expectations for validation, transparency, and documentation of AI tools in regulated PV environments.
Speakers演讲人
- Rohan Nanda — Director, Global Pharmacovigilance, Eli Lilly
Oct 15, 2026 · 11:00 AM – 11:45 AM · TBA
Evolving EU GVP Guidelines: What Pharma Safety Teams Need to Know in 2026
An update on evolving European Medicines Agency Good Pharmacovigilance Practice module updates, including GVP Module VII (PSUR), GVP Module V (RMP), and new guidance on AI use in pharmacovigilance operations. Speakers cover practical compliance implications and how to update SOPs and pharmacovigilance system master files.
Speakers演讲人
- Galyna Cordero — Head of Pharmacovigilance Department, QPPV, JSC Farmak
- Adriana Aristizabal — Medical Director, Vitalis
Oct 14, 2026 · 3:00 PM – 3:45 PM · TBA
VigiBase and the Global Safety Signal Network: Lessons from 55 Years of International PV
The Uppsala Monitoring Centre shares perspectives from the WHO global pharmacovigilance database and its work harmonizing international safety signals. The session covers how VigiBase data informs global signal assessment, the evolving role of AI in the WHO Programme for International Drug Monitoring, and strategies for improving quality and completeness of national reporting.
Speakers演讲人
- Peter Hjelmstrom — Director / CEO, Uppsala Monitoring Centre (WHO PV Collaborating Centre)
Oct 15, 2026 · 2:00 PM – 2:45 PM · TBA
Global Regulatory Intelligence for PV: Tracking 130+ Country Requirements in Real Time
Qinecsa presents its Observia platform for tracking pharmacovigilance regulatory requirements across 130+ countries — how to stay current with changing ICSR reporting timelines, aggregate report submission schedules, signal assessment requirements, and local literature monitoring mandates. The session demonstrates AI-powered regulatory intelligence for compliance monitoring.
Speakers演讲人
- Qinecsa Presenter — VP, Regulatory Intelligence, Qinecsa Solutions
Oct 15, 2026 · 11:00 AM – 11:45 AM · TBA
Pharmacovigilance for Consumer Products: OTC, Cosmetics, and Dietary Supplements
The unique challenges of pharmacovigilance beyond prescription drugs — monitoring safety for OTC medicines, cosmetics, dietary supplements, and animal health products. The session covers consumer product PV regulations across FDA, EU, and international frameworks, data collection approaches, and AI tools being applied to consumer safety surveillance.
Speakers演讲人
- James Buchanan — Co-Lead, Biopharmaceutical Safety Working Group Interactive Safety Graphics, American Statistical Association (ASA)
Oct 14, 2026 · 2:00 PM – 2:45 PM · TBA
Patient-Reported Safety: Direct Adverse Event Reporting and Social Media PV
Placing patients at the center of safety data collection — direct patient reporting portals, mobile-first adverse event reporting tools, and AI-powered social media pharmacovigilance from platforms including patient forums and health apps. The session covers quality of patient-reported data and its integration with spontaneous reporting systems.
Speakers演讲人
- Dennis Van Liew — Board Member Emeritus, Personalized Medicine Coalition
Source: WPSC Americas 2026 agenda (terrapinn.com). Unlike DIA, no regulatory-agency staff are listed as speakers; “discussed” badges mark agencies whose expectations the session covers, and NGO badges mark standards/industry bodies actually on stage. Cross-conference regulatory landscape is available in Industry Trends.数据来源：WPSC 美洲 2026 议程（terrapinn.com）。与 DIA 不同，无监管机构官员列为讲者；「被讨论」徽章标注该场涉及其期望的机构，NGO 徽章标注真实到场的标准 / 行业机构。跨会议监管全景请前往行业趋势页。