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SAPA 13th Annual Conference Program
On-site registration
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Direction to Rutgers University
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Building a Better Future for Public Health and Pharmaceutical Industry through Innovation and Global Collaboration
Friday, August 12th
1:30-5:30 pm
The Clarion Hotel & Towers
2055 Lincoln Highway (Rt. 27), Edison, NJ 08817
Directions
Pre-conference Workshop
Workshop Chair: Dr. John Jiangbin Hu
Lecture/Tutorial and Interactive Session
FDA Pre-approval Inspection and 483's: How to Establish a Quality System for API and Dosage Form Manufacturers Overseas?
In this workshop, three veteran professionals in the field of Pre-Approval Inspection (PAI) will provide a tutorial and lectures on how to successfully prepare for the PAI and avoid the most common mistakes. Real case studies will be examined and discussed.
Pre-Approval Inspection Preparation & ConductionVictor Ma Associate Director, Quality Systems Novartis Corporation
Establishing A Quality Dialog Between Your Company and Foreign Pharmaceutical ManufacturersRonald Connolly Senior Vice President Frontage Laboratories, Inc
Overview of Pre-approval Inspection Process
Zi Qiang Gu
CDER Compliance
US Food and Drug Administration
Speaker and Sponsor ReceptionFriday, August 12, 6:30 - 9:30 pm
China Chalet (Tian Fu) Restaurant
184 Columbia Turnpike
Florham Park, NJ 07932
Directions
Saturday, August 13th
Busch Campus Center, Rutgers University, Piscataway, NJ 08854 (Directions)
Registration and Breakfast - 7:30am to 8:30am
Morning Session - 8:30 am to 12:30 pm
Morning Session
John Hu, Ph.D., SAPA President & Conference Chair
Keynote Speaker:
Opportunities and Challenges in a Fast Moving Market -China
James Liu President and CEO Beijing Novartis Pharma, Ltd
Speakers:
Trends of FDA cGMP and Risk-Based Approach
Nicholas Buhay Deputy Director, Office of Compliance CDER, FDA
How the US Department of Commerce Assists Firms in Accessing Asian Healthcare Markets
Jay Biggs Analyst, Department of Commerce's Office of Health and Consumer Goods United States Department of Commerce
East Meets West: Roles of Traditional Chinese Medicine in Modern Pharmaceutical Industry
Yong Ming Li President Traditional Chinese Medicine Association
From Marijuana to Modern Medicines: Recent Advances in Cannabinoid Receptor Ligands
Dr. Neng-Yang Shih Sr. Director, Drug Discovery Schering-Plough Research Institute
Afternoon Session - 1:30 pm to 5:30 pm
Afternoon Session 1
China Pharmaceutical Forum
(Bilingual: Either in English or Chinese)
海归的成功创业故事和制药业在中国的崛起
Chair: Dr. Mingde Xia
Biotech Entrepreneurship in China
海归怎样在中国创业 Jack Liu CEO of TEDA Watson Biopark, Tianjing
Succeed in China through BiogenericsDr. Lei Jin CEO, GenSci Pharmaceutical Corp.
Outsourcing and In-licensing - An Alternative Pathway of Industry Building
Michael Hui Managing Director, Shanghai ChemPartner Co., Ltd
Kewen Jin CEO, Shanghai BioExplorer
Sino-American Collaboration in Academic Research: Impact on Public HealthDr. Yufang Shi Professor R.W. J. Medical School, University of Medicine & Dentistry of New Jersey
Bridging the Gap between A Huge Talent Pool in China and Advanced Drug Research in USADr. W. Paul Mar CEO of SynChem, Inc
Innovation Drug R&D based on Traditional Chinese HerbsDr. Ke Liu CEO of Research Institute of Luye Pharmacy (RILP)
Part A: A New Perspective of Drug Discovery in China
Part B: Career Opportunities Dr. Li Chen Head of Research and Chief Scientific Officer at Roche R&D Center (China) Ltd.
Afternoon Session 2
Exploring Traditional Chinese Herbal Medicine- from Bedside to Test TubeChairs: Dr. Yong Ming Li and Jerry X. Huang
This Symposium is co-sponsored by Traditional Chinese Medicine Association & Alumni (TCMAA.org) and Association
of Chinese Physician (ACAPonline.org). TCMAA members may received 4 continue education hours (NCCAOM PDA)
Challenges and Opportunities in the Standardization of Botanical Raw Materials and Preparations - USP's Approach V. (Srini) Srinivasan, PhD Vice President, Verification Program United States Pharmacopeia
Regulatory Review of Botanical Drugs: A Drug Development PerspectiveJohn Duan, PhD Pharmacokineticist/Senior Reviewer Botanical Review Team, ODE-I, CDER, FDA
Anti-cancer Activity in Chinese Herbs David Zhang, MD, PhD Associate Professor Mount Sinai Medical Center
Investigation of Chinese Herbal Therapy for AsthmaXiu-min Li, MD Associate Professor Mount Sinai Medical School
Identification of Confusable Chinese Materia Medica in the MarketZhongzheng Zhao, PhD Professor Hong Kong Baptist University
The First Anticancer Herbal Mix from Lab to a NIH-funded and FDA-supervised Phase III Clinical Trial on Non-Small Cell Lung CancerAlexander Sun, PhD Director, Medical Sciences Connecticut Institute for Aging and Cancer
Funding Opportunities for TCM Research at NIH-NCCAMYong Ming Li, MD, PhD Attending Physician, Warren Hospital, President of TCMAA
Afternoon Session 3
OutsourcingChairs: Drs. Gui-Bai Liang, Bin Li and Lihu Yang
Can CRO make complex molecules? Shuhui Chen and Ge Li Chief Scientific Officer/Chairman Wuxi PharmaTech
Basic Chemistry Outsourcing in China: Current and Future Work Ellen Crawford Senior Contract Synthesis Coordinator Merck Research Labs
CRO, Not Only Clinical Trials, But Also R&D in ChinaFeng Gao Executive Director and General Manager Beijing Mediking Pharmaceutical Co.
Bridging the "Valley of Death": New Approaches and Models for "Virtual" Drug
Development Outsourcing and Management in the US and Asia
Glenn Rice
CEO
Bridge Pharmaceuticals
Clinical Trial Outsourcing Strategy and ManagementDan Zhang Head of Clinical Development Sigma Tau Research Inc.
Banquet
Saturday, August 13th, 2005, 6:30-9:30 pm
Busch Campus Center, Rutgers University
Piscataway, NJ 08854
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