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Chinese Pharmacopoeia Commission and United States Pharmacopeial Convention

Joint Symposium III
Thursday, November 6 — Friday, November 7, 2008
Tianjin, China

Agenda

Day 1, Thursday, November 6
8:30 – 9:10 a.m. Opening and Greetings
  • Mr. Wu Zhen, Secretary General, ChP
  • Dr. Roger Williams, CEO/EVP, USP
9:10 – 9:50 a.m. 1. Collaboration between Chinese and United States Pharmacopoeias
  • Mr. Wu Zhen, Secretary General, ChP
  • Dr. Roger Williams, CEO/EVP, USP
9:50 – 10:10 a.m. Tea Break
10:10 – 10:30 a.m. 2. US FDA Perspectives
  1. Traditional Medicines as Drugs
  2. Traditional Chinese Medicine Ingredients used as Dietary Supplements
    • Dr. Jinhui Dou, Pharmacologist, U.S. FDA, DHHS/FDA/CDER/OND/ODEI
10:30 – 10:50 a.m. 3. Chinese SFDA Regulations on TCM Registration and Standards Setting
  • Mr.Yang Wei, Vice Director, Department of Drug Registration, SFDA
10:50 – 11:10 a.m. 4. Strategies to Protect and Promote TCM in China
  • Mr. Zhou Fu Cheng, Deputy Secretary General of ChP
11:10 – 11:30 noon Q&A
11:30 – 1:30 p.m. Lunch Break
1:30 – 1:50 a.m. 5. TCM Standards Setting and Collaboration between ChP and USP
  • Dr. James Griffiths, Vice President, Food and Dietary Supplement Standards, USP
1:50 – 2:10 p.m. 6. Quality Control System for the TCM Industrial Chain
  • Dr. Yan Xi Jun, President, Tianshili Group
2:10 – 2:30 p.m. 7. TCM: Modern Research
  • Prof. Guo De An, Director, Modernized TCM Center, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Professor of Pharmacy School, Beijing University
2:30 – 2:50 p.m. Q&A
2:50 – 3:10 p.m. Tea Break
3:10 – 3:30 p.m. 8. USP Perspective on Metrology
  • Dr. Roger Williams, Chief Executive Officer and EVP, USP
3:30 – 3:50 p.m. 9. USP Metals Tests: Scientific Dialogue and Next Steps
  • Dr. Darrell Abernethy, Chief Science Officer, USP
3:50 – 4:10 p.m. 10. Research on Heavy Metal Detection in TCM
  • Prof. Ji Shen, Head of TCM Division, Shanghai Institute for Food and Drug Control
4:10 – 4:30 p.m. Q&A and Adjourn

Day 2, Friday, November 7
8:30 – 8:50 a.m. 11. Drug Quality Control Requirements (Ph. Int.) and WHO Prequalification Program
  • Dr. Sabine Kopp, WHO / Ph. Int
8:50 – 9:10 a.m. 12. EP Perspectives on Drug Quality Control
  • Mr. Claude Coune, Director, Publications Department, EDQM
9:10 – 9:30 a.m. 13. British Pharmacopeia — An Update
  • Dr. Ged Lee, Secretary General, BPC
9:30 – 9:50 a.m. 14. Globalization and U.S. Department of Commerce Activities in China
  • Mr. Vince Suneja, Health Team Leader, U.S. Department of Commerce, Office of Health and Consumer Goods
9:50 – 10:00 a.m. Q&A
10:00 – 10:20 a.m. Tea Break
10:20 – 10:40 a.m. 15. Quality Control and Safety Application for Injections
  • Professor Zhou Jian Ping, Director, Dept. of Pharmacy, China Pharmaceutical University
10:40 – 11:00 a.m. 16. Application of Bio Assay and Chemical Analysis on Quality Control of Drugs sourced from Animals or Plants or Fermenters
  • Dr. Yang Liang, Chief Pharmacist, Former Deputy Director, Heibei Institute of Drug Control
11:00 – 11:20 a.m. 17. Procedures to Test for Impurities: Overview of Relevant USP General Chapters
  • Dr. James E. DeMuth, Chair, USP General Chapters Expert Committee
11:20 – 12:00 p.m. Q&A
12:00 – 1:30 p.m. Lunch Break
1:30 – 1:50 p.m. 18. USP General Chapter on Residual Solvents: Motivation, Status and Next Steps
  • Dr. Darrell Abernethy, Chief Science Officer, USP
1:50 – 2:10 p.m. 19. The Innovation and Practice on Research of TCM Identification
  • Prof. Chen Shi Lin, Director, Chinese Academy of Medical Sciences; Professor of Peking Union Medical College Institute of Medicinal Plant Development
2:10 – 2:30 p.m. 20. Research Related to Quality Control of Herbal Products
  • Dr. Ikhlas A. Khan, Professor, University of Mississippi School of Pharmacy; Director, National Center for Natural Product Research Professor of Peking Union Medical College Institute of Medicinal Plant Development
2:30 – 2:50 p.m. 21. Quality Control of TCM Preparations
  • Prof. Yao Xin Sheng, Member of Chinese Academy of Science, Professor of Shenyang Pharmaceutical University and Jinan University
2:50 – 3:10 p.m. Q&A
3:10 p.m. Closing
  • Mr. Wu Zhen
  • Dr. Roger Williams
4:00 p.m. Adjourn