SubscribeTo address some of the complex issues associated with conducting clinical research.
Drug registrations in China and India, which have emerged as centers for clinical research and development, the Drug Information Association (DIA) will host its first "Clinical Research and Drug Registration in China and India" meeting on September 17-19, 2006, in Princeton, NJ.
Sessions will focus on the unique risks, challenges, opportunities, practical aspects, and logistical problems surrounding clinical trials in China and India; Clinical Trial Applications (CTA) requirements; Good Clinical Practice expectations; acceptance of foreign data by the U.S.
Food & Drug Administration (FDA); drug registrations; and the latest government policy and environment issues, including intellectual property and pharmacovigilance.
"It appears that most of the major pharmaceutical companies are already conducting clinical studies in these two countries, and there are ambitious plans of expanding such activities over the next few years," said Program Chair Romi Singh, Ph.D. "That's why we are excited to be providing a forum to discuss the challenges associated with conducting clinical trials in these areas."
Featured speakers will include representatives from the FDA, the U.S. Department of Commerce, the China State Food and Drug Administration (SFDA), the India Central Drugs Standard Control Organization (CDSCO), and the Indian Council of Medical Research, among others.
Attendees are invited to attend both the networking reception on September 18 and a special roundtable discussion on September 19. These two events will provide an informal setting to network with regulatory and industry professionals and to discuss the latest hot topics surrounding clinical trials in China and India.
Early-bird registration runs through August 28, 2006. Register online at www.diahome.org and download the program at www.diahome.org/product/11302/06034.pdf.
For more information, contact DIA Program Manager Joanne Wallace at 215-442-6180 or Joanne.Wallace@diahome.org. Media interested in attending the event or arranging for pre- or post-event interviews should contact Heather Cable of Toplin & Associates, Inc. at 215-793-4666 or Heather@toplin.com.