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JLpiccard ☆ Argentina, 2018-07-13 22:35 (2110 d 18:20 ago) Posting: # 19051 Views: 5,153 |
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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 |
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Helmut ★★★   Vienna, Austria, 2018-07-14 00:42 (2110 d 16:13 ago) @ JLpiccard Posting: # 19056 Views: 4,565 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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JLpiccard ☆ Argentina, 2018-07-16 20:16 (2107 d 20:38 ago) @ Helmut Posting: # 19068 Views: 4,524 |
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❝ 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....  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] |
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Helmut ★★★ Vienna, Austria, 2018-07-16 20:51 (2107 d 20:04 ago) @ JLpiccard Posting: # 19070 Views: 4,441 |
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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, Chile, 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).
2018-10-16: 1,399 2019-10-05: 1,461 — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2018-07-14 00:42 (2110 d 16:13 ago) @ JLpiccard Posting: # 19057 Views: 4,581 |
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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. — Pass or fail! ElMaestro |
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JLpiccard ☆ Argentina, 2018-07-16 20:17 (2107 d 20:38 ago) @ ElMaestro Posting: # 19069 Views: 4,446 |
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❝ 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] |
Ing. Helmut Schütz