CHAIR
:
SPEAKER
(S):
Keith Chan, PhD, President & CEO , Globoasia LLC
Maria Freire, PhD, Director , Thywill, Argentina
Mukesh Kumar, PhD, Senior Director, Regulatory Affairs , Amarex Clinical Research
Description
"Asia and South America are traditionally viewed as destinations for outsourcing clinical product development due to the promise of cost saving and speed. Often overlooked is the robust infrastructure in these regions for innovative drug discoveries, particularly from natural products. Very few biomedical products have successfully been transferred from these regions to the Western markets because there is a lack of regulatory infrastructure, lack of innovative product development training and a business environment highly tilted toward providing quality service to Western sponsors vs. developing original products."
Objective1: Compare regulatory processes and business policies in Asia and South America with those in the United States and EU.
Objective2: Discuss strategies for developing products based on technologies invented in Asia and South America for U.S. and EU markets.
Objective3: Suggest outsourcing models for companies in Asia and South America.