2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference

June 15-16 + June 17-19 Training Course Series | Shanghai, China
Overview

The 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference program will bring attendees up to date with the most recent activities among stakeholders from North America, Europe and Asia to identify and implement best practices in the pharmaceutical ingredient supply chain. Leaders of the movement from regulatory agencies, industry, health organizations, and trade associations will share their personal and collective observations and ideas during eight sessions covering:
- Challenges in ensuring the quality and integrity of pharmaceutical ingredients
- Regulations and guidance on GMPs and GDPs
- The role of quality systems in Supply Chain operations
- Industry practices from the perspectives of suppliers and users of starting materials and ingredients including API manufacturers, excipient manufacturers, drug product manufacturers and distributors of these materials
- Opportunities for global cooperation, collaboration and harmonization
Take advantage of this opportunity to participate in the global initiative to ensure the integrity of the Pharmaceutical Ingredient Supply Chain. If you are involved with the pharmaceutical ingredient and ingredient starting material supply chain, you don’t want to miss this event. You won’t find this level of direct information exchange with members of industry and regulatory agencies leading the movement to promote ingredient quality and security at any other conference!
Keynote Presenters-Yi Chengdong and Rick Friedman
Yi Chengdong, Deputy Director General of Shanghai FDA and Rick Friedman, Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research (CDER), Office of Compliance, US FDA will be the Keynote Presenters.
Contact
Conference inquiries:
Wanda Neal, Vice President, Programs and Registration Services
Tel: +1 (301) 656-5900 ext. 111
Email: neal@pda.org
Registration inquiries:
Patresa Day, Assistant Manager of Registration and Customer Service
Tel: +1 (301) 656-5900 ext. 115
Email: day@pda.org
Speakers
- Eric Berg
Director of Supplier Quality, Amgen, Inc.
- Hung Chich Chang, PhD
Research Advisor, Product R&D, Eli Lilly and Company
- Nevin Chang
Technical Manager, Colorcon China and Chair, IPEC China
- Yi Chengdong, M.D., PhD
Deputy Director General of Shanghai, FDA
- Rick Friedman
Director, Division of Manufacturing & Product Quality, CDER, FDA
- Daniel Gold, Phd
President, D.H. Gold Associates, Inc.
- Dittmar K. Nerger, PhD
Head of Strategic Sourcing Healthcare, Bayer Healthcare Ltd.
- David R. Schoneker
Director of Global Regulatory Affairs, Colorcon
- Janeen Skutnik
Chair-Elect, International Pharmaceutical Excipients Council (IPEC)
- Anthony William Storey
Contract Operations Quality Assurance Manager, Pfizer
- Brenda Uratani, PhD
Senior Compliance Officer, Center for Drug Evaluation and Research, FDA
- Martin VanTrieste
Vice President Quality, Commercial Operations Amgen, Inc.
- Weibing Wang
Vice President of Quality, Zhejiang Hisun Pharmaceutical Co. Ltd.
- Neil Wilkinson
Partner, David Begg Associates
- Season Xu
Director of Manufacturing, Sigma-Aldrich (WuXi) Life Science Technology Co. Ltd.