质量与监管可预测性：塑造USP标准 - 2025年12月11日
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研讨会 | 混合 活动标题 质量与监管可预测性：塑造USP标准 2025年12月11日 更多会议、大会和研讨会 人用药品新闻与活动 会议、大会和研讨会 重要批准 CDER对话 我们的视角 CDER科学聚焦 关于……需要了解的事项 日期： 2025年12月11日 时间： 上午9:00 - 上午10:30 美国东部时间（ET） 访问 CDER 小企业与产业援助（SBIA）主页 主题与报告 讲者 质量与监管可预测性：塑造USP标准 美国食品药品监督管理局（FDA）参与USP-NF修订过程——挑战与解决方案 录像和幻灯片 Pallavi Nithyanandan，博士 主任 药典运营与标准职员（COSS） 药品质量政策办公室（OPPQ） 药品质量办公室（OPQ） 药物评价与研究中心（CDER） | FDA 加强您的药典策略 录像和幻灯片 Matthew Vankoski 主任 | 捐赠 美国药典（USP） 行业参与USP的标准制定过程 录像和幻灯片 Scott Kuzner 高级主任 科学与监管事务 可及药物协会（AAM） 问答讨论小组 录像 Pallavi Nithyanandan、Matthew Vankoski、Scott Kuzner， 以及 Kristie Laurvick 高级监管参与经理 美国政府与监管事务 | USP 关于本次活动（由 CDER SBIA 主办） 通过举办本次研讨会，可及药品协会（AAM）、美国食品药品监督管理局（FDA）和美国药典委员会（USP）旨在提高利益相关方对USP标准制定过程的认识和参与度，最终有助于在整个药物开发、审批和产品生命周期中提高产品质量和监管可预测性。 公开质量标准被普遍认为是支持原料药和药品的设计、生产、检测和监管的重要工具。USP标准在帮助确保美国及全球上市药品的质量和安全性方面发挥着关键作用。 本次讨论将展示USP公共标准如何强化质量、精简开发流程、支持法规合规，并总体上提高药物的监管可预测性。参会者将深入了解USP标准制定过程，并学习他们如何通过公开评论来发起或参与未来标准的制定。 目标受众 监管科学与事务专业人士：来自品牌药和仿制药行业的监管科学、监管事务、质量保证和产品开发领域的专业人士，他们提交或支持IND、NDA、BLA、ANDA、NADA和ANADA申请。 监管决策者：政府监管人员——包括申请审评人员和政策制定者——有兴趣更深入地了解USP标准制定过程，以及这些标准如何支持监管决策并帮助保护公众健康。 品牌药与仿制药行业代表：来自品牌药和仿制药公司的质量管理人员、法规专员及合规官员，他们确保产品按照联邦法律（包括药品生产质量管理规范（GMP）及其他法规要求）进行市场营销，并且需要了解药品研发和审批的药典标准。 顾问：专注于药品合规、标准实施和方法验证的法规与质量顾问，他们与客户合作，运用美国药典（USP）标准处理上市许可和上市后合规事宜。 涵盖主题 FDA在USP标准制定中的职责 USP各论对FDA的价值/作用 了解标准的使用——以及所证明的合规性——如何纳入FDA的监管活动 行业在USP标准制定中的地位 生产企业在USP标准制定中的角色 USP标准在法规框架中的概述 USP修订流程的讨论 如何参与各论制定 资源 fda.gov usp.org 可及药物协会 活动材料 标题 文件类型/大小 FDA参与USP-NF修订过程——挑战与解决方案 | 演示幻灯片 pdf（573.38 KB） 加强你的药典策略 | 演示幻灯片 pdf（1.94 MB） 行业参与USP标准制定过程 | 演示幻灯片 pdf（3.41 MB） 内容更新时间： 2026年1月21日 受监管产品 药品
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Workshop | Mixed Event Title Quality and Regulatory Predictability: Shaping USP Standards December 11, 2025 More Meetings, Conferences, and Workshops News & Events for Human Drugs Meetings, Conferences, & Workshops Notable Approvals CDER Conversations From Our Perspective Spotlight on CDER Science Things to Know About... Date: December 11, 2025 Time: 9:00 a.m. - 10:30 a.m. ET Visit CDER Small Business and Industry Assistance (SBIA) Homepage Topic & Presentations Speakers Quality and Regulatory Predictability: Shaping USP Standards FDA’s Participation in USP-NF Revision Process – Challenges and Solutions Recording and Slides Pallavi Nithyanandan, PhD Director Compendial Operations and Standards Staff (COSS) Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) | FDA Strengthening Your Compendial Strategy Recording and Slides Matthew Vankoski Director | Donations United States Pharmacopeia (USP) Industry Engagement in USP’s Standards-Setting Process Recording and Slides Scott Kuzner Senior Director Science and Regulatory Affairs Association for Accessible Medicines (AAM) Q&A Discussion Panel Recording Pallavi Nithyanandan, Matthew Vankoski, Scott Kuzner, And Kristie Laurvick Senior Regulatory Engagement Manager U.S. Government and Regulatory Affairs | USP About this Event (Hosted by CDER SBIA) By hosting this workshop, the Association for Accessible Medicines (AAM), FDA, and United States Pharmacopeia (USP) aim to increase stakeholder awareness of, and participation in, the USP standards development process, ultimately contributing to product quality and regulatory predictability throughout the drug development, approval, and product lifecycle. Public quality standards are universally recognized as essential tools that support the design, manufacture, testing, and regulation of drug substances and products. USP standards play a critical role in helping ensure the quality and safety of medicines marketed in the United States and worldwide. This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards. Intended Audience Regulatory Science & Affairs Professionals: Professionals in regulatory science, regulatory affairs, quality assurance, and product development—across both brand-name and generic drug industries—who submit or support IND, NDA, BLA, ANDA, NADA, and ANADAs. Regulatory Decision-Makers: Government regulators—including application reviewers and policy makers—interested in gaining a deeper understanding of USP standards development processes and how these standards support regulatory decision-making and help protect public health. Brand-name and Generic Drug Industry Representatives: Quality managers, regulatory specialists, and compliance officers from brand-name and generic drug companies who ensure products are marketed in compliance with federal law, including GMPs and other regulatory requirements, and who need to understand compendial standards for drug development and approval. Consultants: Regulatory and quality consultants specializing in pharmaceutical compliance, standards implementation, and method validation, who work with clients to navigate USP standards for market authorization and post-market compliance. Topics Covered FDA’s responsibility in USP standards development Value/role of USP monographs for FDA Understanding how the use of standards - and demonstrated compliance - factor into FDA’s regulatory activities Industry’s position in USP standards development Manufacturers’ part in the establishment of USP standards Overview of USP standards in regulatory framework Discussion of the USP revision process How to get involved in monograph development Resources fda.gov usp.org Association for Accessible Medicines Event Materials Title File Type/Size FDA’s Participation in USP-NF Revision Process-Challenges and Solutions | Presentation Slides pdf (573.38 KB) Strengthening Your Compendial Strategy | Presentation Slides pdf (1.94 MB) Industry Engagement in USP’s Standards-Setting Process | Presentation Slides pdf (3.41 MB) Content current as of: 01/21/2026 Regulated Product(s) Drugs