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