Bioanalytical Community

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Hi Eric,

I am happy to participate in the discussion and learn about the recent changes. 

Best regards,

Mark

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Hi Eric,

I am happy to participate in the discussion and learn about the recent changes. 

Best regards,

Mark

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Several companies, including our have had success even before the rules were changed.  With the new rules, other companies are attempting export and those that have had success in the past are considering increased exporting.  There is active discussion on this topic at the monthly calls for the AAPS China BA discussion group.  Send me a note if you are interested in participating.

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Thanks, Thomas! Hope things work out for you.

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Regarding some specifics of requirements for sample export from China to the US, I have been asked by others at Gilead, including Kinjal Satasiya in the Biomarker and Bioanalytical Operations (Sample Management) ,who is a member of the China BA discussion group organized by Eric Woolf, to post the following questions to this Community:

1. A new request for China Customs for the shipping of such samples is:  "Description of the foreign recipient/ the recipient's qualification/ sample risk recognition and acceptance statement."  This would be the US CRO lab that is to receive the samples, correct?  Any tips on providing the description?  Does anyone know any logistic vendor in China with experience on  how to draft the description of the foreign recipient?
2. Does anyone have any CIQ application experience to share (tips for success, lessons learned)?

-Tom

Thomas L. Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

[email protected]

Thanks, Thomas! Hope things work out for you.

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Regarding some specifics of requirements for sample export from China to the US, I have been asked by others at Gilead, including Kinjal Satasiya in the Biomarker and Bioanalytical Operations (Sample Management) ,who is a member of the China BA discussion group organized by Eric Woolf, to post the following questions to this Community:

1. A new request for China Customs for the shipping of such samples is:  "Description of the foreign recipient/ the recipient's qualification/ sample risk recognition and acceptance statement."  This would be the US CRO lab that is to receive the samples, correct?  Any tips on providing the description?  Does anyone know any logistic vendor in China with experience on  how to draft the description of the foreign recipient?
2. Does anyone have any CIQ application experience to share (tips for success, lessons learned)?

-Tom

Thomas L. Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

[email protected]

Thanks, Thomas! Hope things work out for you.

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Hi Thomas

I wanted to follow up if you are successful with setting up CIQ application from China central Lab.

Thanks

Regarding some specifics of requirements for sample export from China to the US, I have been asked by others at Gilead, including Kinjal Satasiya in the Biomarker and Bioanalytical Operations (Sample Management) ,who is a member of the China BA discussion group organized by Eric Woolf, to post the following questions to this Community:

1. A new request for China Customs for the shipping of such samples is:  "Description of the foreign recipient/ the recipient's qualification/ sample risk recognition and acceptance statement."  This would be the US CRO lab that is to receive the samples, correct?  Any tips on providing the description?  Does anyone know any logistic vendor in China with experience on  how to draft the description of the foreign recipient?
2. Does anyone have any CIQ application experience to share (tips for success, lessons learned)?

-Tom

Thomas L. Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

[email protected]

Thanks, Thomas! Hope things work out for you.

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Hi Thomas

I wanted to follow up if you are successful with setting up CIQ application from China central Lab.

Thanks

Regarding some specifics of requirements for sample export from China to the US, I have been asked by others at Gilead, including Kinjal Satasiya in the Biomarker and Bioanalytical Operations (Sample Management) ,who is a member of the China BA discussion group organized by Eric Woolf, to post the following questions to this Community:

1. A new request for China Customs for the shipping of such samples is:  "Description of the foreign recipient/ the recipient's qualification/ sample risk recognition and acceptance statement."  This would be the US CRO lab that is to receive the samples, correct?  Any tips on providing the description?  Does anyone know any logistic vendor in China with experience on  how to draft the description of the foreign recipient?
2. Does anyone have any CIQ application experience to share (tips for success, lessons learned)?

-Tom

Thomas L. Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

[email protected]

Thanks, Thomas! Hope things work out for you.

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti

Hi Thomas

I wanted to follow up if you are successful with setting up CIQ application from China central Lab.

Thanks

Regarding some specifics of requirements for sample export from China to the US, I have been asked by others at Gilead, including Kinjal Satasiya in the Biomarker and Bioanalytical Operations (Sample Management) ,who is a member of the China BA discussion group organized by Eric Woolf, to post the following questions to this Community:

1. A new request for China Customs for the shipping of such samples is:  "Description of the foreign recipient/ the recipient's qualification/ sample risk recognition and acceptance statement."  This would be the US CRO lab that is to receive the samples, correct?  Any tips on providing the description?  Does anyone know any logistic vendor in China with experience on  how to draft the description of the foreign recipient?
2. Does anyone have any CIQ application experience to share (tips for success, lessons learned)?

-Tom

Thomas L. Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

[email protected]

Thanks, Thomas! Hope things work out for you.

------------------------------
Preeti Dhawan
Associate Director Biomarker and Bioanalytical
Terns Pharma
Foster City CA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 01-10-2024 01:14
From: Thomas Tarnowski
Subject: New HGRAC Regs in China and suicee in exporting plasma/serum samples out of China?

Hi Preeti-

We have only begun the process of trying to export human plasma/ serum samples from clinical studies from China, which is why I had posted the original message.  Right now we have been asked for verification that the US lab is qualified to analyze such samples and are trying to understand what that means.  We often get a somewhat similar query from foreign health authorities asking for a certification of our us CRO for a bioanalytical method, and provide an official  statement from our QA group explaining that the CRO has been audited and deemed qualified.  I don't know if that is what China is seeking, or something else.  

Tom

Thomas Tarnowski, Ph.D.

Executive Director, Gilead Sciences 

Hi Thomas,

I would like to follow up with you regarding your question about the success of exporting plasma/serum samples out of China. I haven't seen any responses from others regarding their success in exporting these samples. Could you share if you have succeeded in exporting the clinical study samples? I am interested in understanding any obstacles you encountered and how you overcame them, if you were successful. If not, could you elaborate on the challenges you are currently facing?

thanks

Preeti