Date: Saturday, 1:00 - 5:00 pm, March 19, 2005
Location: Clarion Hotel, 2055 Lincoln Highway (Route 27), Edison, NJ 08817 (Tel: 732-287-3500)
Organizer: : Sino-American Pharmaceutical Professional Association
Committee: Dr. Xiaohui Mei, Dr. Mingde Xia

Online Registration

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 from generic industry, patent law firms and API sourcing agency will discuss formulation development, patent litigations, FDA regulations, ANDA filing, and API sourcing from China.

12:30 pm - 1:00 pm
Registration
SAPA member: $10
Non-member: $25
Student: Free

1:00 pm
Generic Drug Development and Patent Challenge
Dr. Clifford M. Davidson
Founder and Partner
Davidson, Davidson & Kappel, LLC

1:45 pm
Generic Drug Development and Bioequivalence
Dr. Prakash Kulkarni
Sr. Director, Pharmaceutical Research & Development
TEVA Pharmaceuticals

2:30 pm
Current Trends in the Chinese Pharmaceutical Industry-Opportunities for Sourcing
Ms. Sue Capie
General Manager
PharmaVantage

3:15 pm
Product Development for ANDA vs. NDA Projects
Dr. Sanjeev K. Gupta
Director, Research and Development
Barr Laboratories, Inc.

4:00 pm
Generic Drugs and the FDA
Ms. Seema Gadkari
Independent Consultant

4:45 pm
David vs Goliath: A Rematch in the 21st Century Pharmaceutical Industry
Dr. Albert W.K. Chan
Principle of the Law Offices
Albert Wai-Kit Chan, LLC