Focus on Impact of Chinese and Indian Markets on US Industry
Tuesday, March 15, The Waldorf-Astoria, New York City

The regulatory challenges faced by generic pharmaceutical companies seeking drug approvals and the business environment for chemicals and pharmaceuticals produced in India and China will be the focus of the Generic Pharmaceutical Association's (GPhA) 2005 Active Pharmaceutical Ingredient (API) Conference on March 15 in New York City.

"This conference will provide the generic pharmaceutical industry with insight on critical topics, such as drug master file issues that may slow down product approvals," said Kathleen Jaeger, GPhA President and CEO. "It also will provide a perspective on the regulatory challenges facing generic pharmaceutical companies on API issues and examine the growing Indian and Chinese API markets."

The 2005 API Conference will be held on Tuesday, March 15 at the Waldorf-Astoria, located at 301 Park Avenue in New York City. The conference begins at 8:15 a.m. and is being hosted in conjunction with the Drug, Chemical and Associated Technologies (DCAT) Week.

Following is the agenda:

8:15 a.m.-8:30 a.m.
Welcoming Remarks
Patrick Vazquez, Alpharma, DCAT President
Kathleen Jaeger, President and CEO, GPhA

8:30 a.m.-9:10 a.m.
Drug Master File Issues at the Office of Generic Drugs: How to Prepare Acceptable DMFs
Paul Schwartz, Ph.D., Deputy Director, Division of Chemistry I, Office of Generic Drugs

9:10 a.m.-9:40 a.m.
The USP Monograph: New Approaches and Update
Roger Williams, Executive Vice President and Chief Executive Officer,
U.S. Pharmacopeia

9:40 a.m.-10:15 a.m.
China: Regulatory & Compliance, Today and Tomorrow
Steven Beagle, Vice President of Sales, Chemwerth, Inc.

10:15 a.m.-10:30 a.m.
Break

10:30 a.m.-11:15 a.m.
APIs: Global Financial Outlook
Simon Thompson, Group Director, Publications, IMS Health

11:15 a.m.-Noon
The Chinese Pharmaceutical Revolution: Impact on the Generic Industry
2005-2010
Sue Capie, Director, Pharma Vantage

Noon-1:15 p.m.
Lunch

1:15 p.m.-2:10 p.m.
API Changes: Dose Deals, India, and China Rising
Jean Hoffman, President, Q Street Advisors

2:10 p.m.-3:00 p.m.
APIs: Post 2005 Overview of India
Dilip Shah, Secretary General, Indian Pharmaceutical Alliance

3:00 p.m.-3:15 p.m.
Break

3:15 p.m.-4:00 p.m.
China's Healthcare System, Obstacles and Opportunities for the Pharmaceutical Industry in China, and an Overview of the Department of Commerce's Global Pharmaceutical Activities Jeffrey Gren, Director, Department of Commerce, Office of Health and Consumer Goods

4:15 p.m.
DCAT/GPhA Reception, to follow

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