2013 Schedule

WS DAY

Tue. November 19
  • Exhibitors Preregistration
  • Workshops I & II

DAY 1

Tue. November 20
  • Key-Note Speaker
  • Educational Sessions
  • Pharma Expo
  • Poster Sessions
  • Lunch
  • Speakers’ Roundtable

DAY 2

Wed. November 21
  • Key-Note Speaker AM
  • Half Day Workshop
  • Educational Sessions
  • Pharma Expo
  • Poster Sessions
  • Lunch
  • Key-Note Speaker PM
  • ExcipientFest Cocktail
DAY 1: Tuesday - November 19th
I  IPEC Regulatory Considerations (3 sessions)
(Conference Room: 1) - limited to 25 participants. 
  Topic Speakers
  IPEC Certificate of Analysis
IPEC 检测分析报告指南和IPEC重大变更指南
Mr, Colin Li
  IPEC Significant Change Guide
IPEC 检测分析报告指南和IPEC重大变更指南
Mr. Dale Carter (IPEC Americas),
Mr. Martin Tao (IPEC China)
   IPEC Excipient Information Package Guide
IPEC辅料信息文件(EIP)指南
 Ms. Priscilla Zawislak (IPEC Americas),
Ms. Meredith Ge (IPEC China)
   Hot topics dicussion: Excipient Import inspection; Excipient Registration; Injectable Excipients related requirement.
专题讨论:辅料进口检验;辅料注册;注射用辅料相关要求
Mr. Daniel Liu; Mr. Martin Tao; Ms. Julia Zhu;
Ms. Nicol Feng; Ms. Jenny Feng. (IPEC China)

Abstract: More than a decade has elapsed since the IPEC-Americas® Certificate of Analysis Guide for Bulk Pharmaceutical Excipients (CoA Guide 2000) was published. Since then, important changes in the global pharmaceutical industry and regulatory area have occurred, which have necessitated development of the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients, 2013 (CoA Guide).
The 2013 CoA Guide incorporates current best practices from industry and regulatory sources and it is critical tool for manufacturers, distributors and excipient users by providing clarity on regulatory and industry requirements related to supply chain transparency, authenticity of the CoA and testing requirements to name a few and by providing a suggested format that includes all necessary information.
Objective of this workshop is to give an inside on this new guide and share best practices from a manufacturer, distributors and users point of view.


 

The Revised Excipient Information Package Guidance has been published in 2013. The revised guide updates the originally published 2005 version and can be used by excipient suppliers to provide a standardized set of documents to exchange data between suppliers and their customers.

This workshop will discuss how usage of the EIP documents can help streamline information and data in a simple formalized and consistent manner to reduce the volume of questionnaires and surveys needed to obtain similar information from multiple customers.


 

Hot Topics Discussion: The use and quality control of excipient has been drawing an increasing attention accompanying with the strengthening management of excipient. This workshop will focus on hop topics of excipient import inspection, injectable excipients, shelf life and retest period of excipient, excipient registration and quality agreement etc.  to discuss and share experience.

Presented by IPEC Federation