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pokeyoldgram · 06-28-2009, 03:22 PM

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

Caesarea · 06-28-2009, 03:29 PM

By the same writer:
DOTmed.com - China Agrees to Harmonize Device Standards; Streamline Product Registration
China Agrees to Harmonize Device Standards; Streamline Product Registration
April 28, 2009
by Lynn Shapiro, Writer
A recent meeting of the US-China Joint Commission on Commerce and Trade's (JCCT)
Pharmaceuticals and Medical Devices subgroup, proved most fruitful, AdvaMed said.
REST of article follows
including
"The two countries will hold a follow-up workshop in Beijing in June."

SO this was the projected June follow-up.

V Interesting.

C.

pokeyoldgram · 06-28-2009, 03:45 PM

Thanks for posting that reply, I was having trouble finding anything with the keyword search. I also posted a seperate article about something similar from a different source, you might want to read..."If PVs are a drug device....." I think was the title. Would like to hear thoughts on both articles from people wiser than me.

Caesarea · 06-28-2009, 03:47 PM

Same here - I think you have found very interesting things there !!!

C.

06-28-2009, 03:22 PM	#1
pokeyoldgram Full Member Join Date: Feb 2009 Location: North East Alabama Posts: 27	FDA in China / Drugs and Devices 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

06-28-2009, 03:47 PM	#4
Caesarea ECF Veteran Join Date: Mar 2009 Location: UK Posts: 2,239	Same here - I think you have found very interesting things there !!! C. __________________

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06-28-2009, 03:29 PM	#2
Caesarea ECF Veteran Join Date: Mar 2009 Location: UK Posts: 2,239	By the same writer: DOTmed.com - China Agrees to Harmonize Device Standards; Streamline Product Registration China Agrees to Harmonize Device Standards; Streamline Product Registration April 28, 2009 by Lynn Shapiro, Writer A recent meeting of the US-China Joint Commission on Commerce and Trade's (JCCT) Pharmaceuticals and Medical Devices subgroup, proved most fruitful, AdvaMed said. REST of article follows including "The two countries will hold a follow-up workshop in Beijing in June." SO this was the projected June follow-up. V Interesting. C.

06-28-2009, 03:45 PM	#3
pokeyoldgram Full Member Join Date: Feb 2009 Location: North East Alabama Posts: 27	Thanks for posting that reply, I was having trouble finding anything with the keyword search. I also posted a seperate article about something similar from a different source, you might want to read..."If PVs are a drug device....." I think was the title. Would like to hear thoughts on both articles from people wiser than me.