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JLpiccard
Junior

Argentina,
2018-07-13 20:35

Posting: # 19051
Views: 806
 

 BE/BA centers [Study As­sess­ment]

Hello everybody

I would like to know id there is an FDA or EMA list of clinical stage centerd for conducting BE for generics.

Thanks

Jean
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-07-13 22:42

@ JLpiccard
Posting: # 19056
Views: 715
 

 BE/BA centers

Salut Jean-Luc,

great nick! Are you a trekkie of TNG flavor?

» I would like to know id there is an FDA or EMA list of clinical stage centerd for conducting BE for generics.

No. Any center following the rules of GCP and observes local medicines laws is in principle qualified.

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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JLpiccard
Junior

Argentina,
2018-07-16 18:16

@ Helmut
Posting: # 19068
Views: 594
 

 BE/BA centers

» great nick! Are you a trekkie of TNG flavor?

Dear Helmut

Greetings earthling!!
Indeed a TNG fan.... but also Jean-Luc is my terrestrial name....:-D:-D

many thanks for your fast response, i asked in order to contact good reputation centers, i saw in different Agencies that they publish a list of approved CRO for BA/BE.

So, based on your answer, i will look for FDA or EMA GCP inspected centers.

Again many thanks

Best

Jean-Luc


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-07-16 18:51

@ JLpiccard
Posting: # 19070
Views: 588
 

 BE/BA centers

Salut Jean-Luc,

» […] i saw in different Agencies that they publish a list of approved CRO for BA/BE.

Where? As ElMaestro wrote, the WHO maintains a list of inspected sites.
On the other hand, navigate to the FDA’s Clinical Investigator Inspection Search and select Country IND (India). Gives me 61 hits and none of the well-known CROs.
“Approved CRO” is a term often misunderstood. There are a few countries certifying CROs (e.g., Brazil, Turkey, Russia). You can only hope that a CRO (generally a study / studies) was inspected by a reputable* agency. This means that on the date of inspection these studies were performed according to the rules of GCP. Doesn’t mean that all are or will be in the future (yes, yours!)…
Another story is GLP. Under its rules the site is inspected and the certificate is valid for 2–3 years (depending on the issuing authority).


  • As of today 1,386 (!) “medical institutions entitled to conduct clinical trials of medicinal products for medical use” are accredited in Russia. Gimme a break.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
ElMaestro
Hero

Denmark,
2018-07-13 22:42

@ JLpiccard
Posting: # 19057
Views: 719
 

 BE/BA centers

Hi JLPiccard,

I am not aware of such a list from EMA or FDA (as far as I know the topic was debated in the past. Publishing a list might create more problems than solutions).

WHO keep a little list of the last CROs that were inspected by them with positive outcome. Check it out via the prequalification website.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
JLpiccard
Junior

Argentina,
2018-07-16 18:17

@ ElMaestro
Posting: # 19069
Views: 590
 

 BE/BA centers

» WHO keep a little list of the last CROs that were inspected by them with positive outcome. Check it out via the prequalification website.

Hi ElMaestro!

I was not aware of such WHO list.

I will look into it...

Thank you!

Best

Jean-Luc


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
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