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DAY 1 Wednesday, July 19th 大会第一天 |
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From 7:30 AM |
Registration 注册与报到 |
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8:50 – 9:00 AM |
Welcome Speech 欢迎辞 |
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9:00 – 9:10 AM |
Introduction of IPEC Federation IPEC联盟介绍 Speaker: IPEC Federation – Patricia Rafidison |
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9:10 – 9:50 AM |
Detailed Introduction of Bundling Review & Approval of Excipient | Speaker: CFDA 药用辅料备案管理办法及关联审评审批法规详解—CFDA |
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9:50 – 10:30 AM |
Full picture of Excipient Regulation & Control in US 美国药用辅料整体监管方式 – IPEC美国 |
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10:30 – 10:50 AM |
Tea & Networking 会间休息 |
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10:50 – 11:30 AM |
The Impact of Excipient Quality on the Re-Evaluation of Generic Drugs 固体药用辅料的质量状况对仿制药质量一致性的影响 Speaker: NIFDC |
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11:30 – 12:10 PM |
Risk-based approach in assessing excipients and API in drug application – review’s perspective 辅料与API在药品关联审评时的不同考虑 — Speaker: Ben Zhao, Ph.D Ex-FDA senior reviewer of OGD 赵孝斌，原美国FDA仿制药办公室（OGD）高级审评员/博士 |
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12:10 – 1:30 PM |
Lunch & Networking 自助午餐 |
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Host主持人 |
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1:30 – 2:10 PM |
Evaluation Approach of Functional Excipients (injection) In Vivo 注射用辅料功能性体内评价方式 – Professor Gu Jingkai, Jilin University 顾景凯 吉林大学教授 |
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2:10 – 2:50 PM |
Implementation of ICH Q3D in US & EU ICH Q3D(元素杂质)在美国和欧洲的执行 Speaker: IPEC Federation – Janeen Skutnik |
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2:50 – 3:30 PM |
Sponsored Session |
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3:30 – 3:50 PM |
Tea & Networking 会间休息 |
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3:50 – 4:30 PM |
Safety Evaluation on Different Types of Excipients 各种类型辅料的安全性评估– IPEC美国 Speaker: IPEC America – Dave Schoneker |
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4:30 – 5:10 PM |
FDA Requirements for Excipient for Biological Products & New drugs 新药及生物药中辅料的审评要求 – FDA Speaker: Former FDA officer 前FDA审评主管 |
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5:10 – 5:30PM |
Networking交流 |
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DAY 2 Thursday, July 14th 大会第二天 |
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Host主持人 |
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9:00 – 9:40 AM |
Plans for Excipient Monographs & Guidances Related to ChP 中国药典辅料标准及指南的计划—ChP Speaker: Chinese Pharmacopoeia Commission |
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9:40 – 10:20 AM |
Process of Development and Revision of Excipient Monographs in Ph. Eur 欧洲药典辅料标准开发和修订的流程—EDQM 总监KEITEL Susanne Speaker: Director of EDQM – Keitel Susanne |
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10:20 – 10:40 AM |
Tea & Networking 会间休息 |
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10:40 – 11:20 AM |
Research on the Factor of Recipe and Process of Dosage forms During Generic Drug Re-evaluation 药物制剂一致性评价中的处方和工艺因素研究 Speaker: Professor He Zhonggui Shenyang Pharma University |
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11:20 – 12:00 PM |
Sponsored Session |
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12:00 – 1:30 PM |
Lunch & Networking 自助午餐 |
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Host主持人 |
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1:30 – 2:10 PM |
Review of Requirements on Excipients used in Drug Products in China 中国药品注册申请所用辅料的技术要求 Speaker: Center for Drug Evaluation, CFDA |
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2:10 – 2:50 PM |
Full picture of Excipient Regulations & Control in EU 欧洲药用辅料整体监管方式 – IPEC欧洲 Speaker: IPEC Europe – Patricia Rafidison |
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2:50 – 3:30 PM |
Comparison of US/EU/CN Excipient Regulations and Industry’s Perspective 中美欧药用辅料管理比较及行业视角视角 Speaker: IPEC China – Colin Li |
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3:30 – 3:50 PM |
Tea & Networking 会间休息 |
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3:50 – 4:30 PM |
Managing Audits Programmes of Excipient Suppliers – Current and Future Perspectives 制药企业辅料供应商审计项目管理现状及趋势
Co-Speaker – Adrian Bone, Executive Secretary of IPEC
Federation |
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4:30 – 5:10 PM |
Sponsored Session |
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