Event: FDA GCP Workshop Shanghai 23-25 June 2010
Dates: June 23-25, 2010
Venue: Shanghai, China
Weblink: http://www.csrpharmsvcs.com

Contact: Mabel Ong

Tel: +86 21 6149 8049

CSR Pharma's Training Services will be conducting a 3-day FDA WORKSHOP in cooperation with the Shanghai FDA Institute for Food and Drug Safety from 23-25 June 2010.  The FDA Workshop will be focused on "Clinical Trials and GCP", and will train as to how to conduct clinical trials in CHINA to GCP standards.

The presenter will be the former US FDA BIMO Specialist / Investigator Andrews, who has over 20 years of compliance experience, including foreign inspections in Asia, Canada and Europe.  In 1992, she began to specialize in the FDA BIMO (Bioresearch Monitoring) Compliance Program that inspects GCP clinical trials, non-clinical (animal) GLP studies, and bioequivalence studies anywhere in the world.  In 2001, she was promoted to Pre-Approval Manager and supervised pre-approval inspections of drugs, devices and food products that are regulated by US FDA.

The FDA Workshop's course materials will be in Chinese and English. Simultaneous interpretation will be available.