Subject: CORRECTION: TODAY HOTUNG ROOM 6005, O'Neill Institute: Guest Lecture by Minjie Gao, "Introduction to Good Clinical Practice in China" - 1:00pm
From: Campus Broadcast <[email-masked]>
To: Campus Broadcast <[email-masked]>
Date: Mon, 1 Dec 2014 16:21:20 +0000

O'Neill Institute Guest Lecture
by Minjie Gao, Shanghai Food and Drug Administration (SFDA)

Introduction to Good Clinical Practice in China

Monday, December 1, 2014
1:00 - 2:00 p.m.

Georgetown University Law Center
Faculty Dining Room, Hotung Room 6005
550 First Street, NW
Washington, DC 20001

Abstract
Since the standard of Good Clinical Practice (GCP) was established in China in 1998, the rights, safety, and well-being of clinical trial subjects have been better protected, and clinical trial data made more credible. China Food and Drug Administration (CFDA) has been reforming the oversight of clinical trials, has published a series of relevant guidelines, and has established the "drug clinical trial registration and information disclosure platform" to make information more accessible to the public. All these actions have been making the clinical trials conducted in China more consistent with internationally recognized principles.

Biography
Minjie Gao is a drug inspector from Center for Certification and Evaluation, Shanghai Food and Drug Administration. Ms. Gao is an expert in Chinese laws and regulations about drug registration and drug clinical trials. She works on drug applications review and on-site inspections in Shanghai. She also conducts GCP inspections for CFDA. To promote the efficacy of routine work, she and her colleagues have conducted a series of related studies on, for example, supervision of clinical trials, pharmaceutical pre-approval inspections, and regulatory policies of excipients. She graduated from Fudan University, School of Pharmacy, majoring in pharmaceutical analysis. She is currently a visiting scholar at Georgetown Law.

This event is open to all students, faculty, staff, and interested members of the public.

For more information on O'Neill Institute events, please visit: http://www.law.georgetown.edu/oneillinstitute/<http://georgetown.us5.list-manage.com/track/click?u=5556647df8c0be7cf0da07db2&id=1b03c8fbe9&e=d6f1cd8a95>

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