Event: US FDA GCP Workshop Shanghai
Dates: March 18 and April 15, 2011
Venue: TBD, Shanghai, China
Weblink: www.csrpharmsvcs.com/training

Contact: Mabel Ong

Tel: +86 21 6149 8049

Email: mong@csrpharmsvcs.com

 

The CSR Training Center will be conducting a series of one-day FDA GCP WORKSHOPS. The FDA Workshops will be focused on different and important topics concerning "Clinical Trials and GCP" from a US FDA perspective. The goal of these training events is to help professionals to understand the key issues and concerns, as well as to reinforce key concepts and regulatory perspectives in the conduct of GCP Clinical Trials.

 

The Workshop organizer/presenter is the former US FDA Investigator/ FDA Pre-Approval Manager 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 Workshops course materials will be available in English and Chinese.