Did anyone see the webinar that this article is referencing? Or know about the content?
DOTmed.com - Inside FDA's New Office in China: FDA News Webinar
Just in case the link doesnt work right...these are the points I was wondering about.
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
DOTmed.com - Inside FDA's New Office in China: FDA News Webinar
Just in case the link doesnt work right...these are the points I was wondering about.
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