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

DAY 1 Wednesday, July 19th 大会第一天

From 7:30 AM

Registration 注册与报到

 

 

8:50 – 9:00 AM

Welcome Speech

欢迎辞

9:00 – 9:10 AM

Introduction of IPEC Federation

IPEC联盟介绍

Speaker: IPEC Federation – Patricia Rafidison

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

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 

Speaker: IPEC America – Priscilla Zawislak

10:30 – 10:50 AM

Tea & Networking 会间休息

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

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

12:10 – 1:30 PM

Lunch & Networking 自助午餐

 

Host主持人

 

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

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

2:50 – 3:30 PM

Sponsored Session

3:30 – 3:50 PM

Tea & Networking 会间休息

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

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

FDA审评主管

5:10 – 5:30PM

Networking交流

 

DAY 2 Thursday, July 14th 大会第二天

 

 

Host主持人

 

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

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 

10:20 – 10:40 AM

Tea & Networking 会间休息

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

11:20 – 12:00 PM

Sponsored Session

12:00 – 1:30 PM

Lunch & Networking 自助午餐

Host主持人

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

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

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

3:30 – 3:50 PM

Tea & Networking 会间休息

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
Co-Speaker – Jack Huang, Associate QA director of Lilly Suzhou

4:30 – 5:10 PM

Sponsored Session

You might also like