ExcipientFest Asia
Excipient Industry’s Leading Expo and Conference for Regulatory, Science and Supply Chain Education
ExcipientFest Asia brings together experts from the excipients suppliers and users community. The program is designed to share practical experience about topics related to the manufacture, use, regulatory compliance and future technologies of pharmaceutical excipients. The presentations and workshops will provide solutions based on guidelines and tools elaborated by IPEC Federation. Technical and scientific subjects will be discussed by various industry experts..
ExcipientFest 2017
July 19-20, 2017
Jingdu Xinyuan Hotel Beijing
REGISTER NOW !
SCHEDULE
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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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