Inside FDA's New Office in China: FDA News Webinar
June 02, 2009
It's been more than six months since the FDA set up operations in China. Direct from Beijing, get an on-the-ground report on its top priorities.
Inside the FDA's New Office in China:
Exclusive Report From Beijing
An FDAnews Webinar
Thursday, June 18, 2009 · 9:30 a.m. - 11:00 a.m. EDT
Under immense pressure from Congress and the public to increase oversight of Chinese firms that manufacture products for drug and devicemakers, the FDA established an office in Beijing last year. Since making the announcement, the FDA has provided little information about what the agency staff is doing there.
Who works in the office? What are the staff's responsibilities? How are they organized? Are they finding and correcting violations? Is it now more expensive to contract with Chinese companies? Is the FDA slowing down imports?
Direct from Beijing in this 90-minute webinar, Gordon Schatz will give you the benefit of his interactions with the FDA staff in Beijing as he explains what they do, what they inspect and what they are finding. In addition, he'll explain what it means now to outsource to, or import from, China.
The law firm Reed Smith has detailed Gordon to China for a year to work in Beijing. Working closely with FDA staff and China-based contract suppliers and manufacturers, no one is closer to the action than Gordon.
Gordon will speak about:
* The mission and organizational structure of the FDA's China office, including who, what, where, when and how the office operates
* What the responsibilities of the staff are (inspecting facilities or products ready for export?)
* Analysis of the regulatory actions and sanctions they have taken or violations they have found to date
* Drug and device firms' experiences with the new system
* Whether the FDA's actions are making outsourcing to China less cost-effective
Meet Your Instructor
Gordon Schatz, a partner with the law firm Reed Smith, is a member of the Life Sciences Health Industry Group, practicing in the area of healthcare regulatory law. He joined the firm's Washington, D.C., office in 1990. Gordon splits his time between the firm's Washington, D.C., and Beijing offices supporting the firm's Life Science medical device, drug and healthcare clients doing business in China. Gordon advises manufacturers and healthcare providers on compliance with federal and state fraud and abuse laws, including sales, promotional and marketing programs under the federal anti-kickback statute, safe harbor regulations, Office of Inspector General advisory opinions and industry guidelines.