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SAPA Generic Drug Development 2006
Saturday, June 10, 2006
Clarion Hotel, 2055 Lincoln Highway (Route 27), Edison, NJ 08817 (Tel: 732-287-3500)
Program description
Generic pharmaceuticals have become an integral part of the growth machine of drug industry. In today's pharmaceutical world, the brand companies are facing significant challenges such as patent expiration, fewer new drug approvals, more drug recalls, price-control pressure, and cheap drug importation threat. In contrast, with equivalent quality but significant lower cost, generic drugs are mounting a robust challenge to branded medications across most pharmaceutical markets. This workshop will provide a venue for learning the generic drug development process and the current trend of generic pharmaceutical industry. Several veteran speakers will discuss business development strategy, patent litigations, product manufacturing and quality control, FDA regulations and ANDA filing.
| 12:00-1:00pm | Registration
| | 1:00pm | Current Generic Industry and Chinese Company's Opportunity and Strategy into US Market
Dr. Xiaodi Guo, CSO, Huahai US Inc.
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| 1:45pm | Generic Challenge of Brand Patent Protection for Controlled Release Products
Dr. Clifford M. Davidson, Founder and Partner, Davidson, Davidson & Kappel, LLC
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| 2:30pm | Scale-up of Oral Solid Dosage Forms in Generic Drug Development
Mr. Tahseen Chowdhury, Director, Research and Development, Barr Laboratories, Inc.
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| 3:15pm | Role of Regulatory Affairs in Successful Generic Drug Development
Mr. Sharif Ahmed, Associate Director, Regulatory Affairs, Barr Laboratories, Inc.
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| 4:00pm | United States Pharmacopeia and Its Roles in Regulating and Promoting the Quality of Pharmaceuticals
Dr. John Hu, Vice President, International, United States Pharmacopeia
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