Bioequivalence and Bioavailability Forum

No GCP “certificate” for BE-centers issued by EU countries [GxP / QC / QA]

posted by Helmut  – Vienna, Austria, 2012-10-07 15:21 (4997 d 04:23 ago) – Posting: # 9331
Views: 8,017

Hi CK!

Click the icon: (Hint: 4^th hit).
If BE studies are of concern, no European member state runs a facility inspection program. MHRA has established an accreditation program on a national basis – but only for CROs performing FIM studies.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

• Facility inspection by UKMHRA/EU cakhatri 2012-10-07 11:30 
  • Facility inspection by UKMHRA/EU ElMaestro 2012-10-07 12:50
    • Facility inspection by UKMHRA/EU cakhatri 2012-10-09 06:57
  • No GCP “certificate” for BE-centers issued by EU countriesHelmut 2012-10-07 13:21
    • No GCP “certificate” for BE-centers issued by EU countries Dr_Dan 2012-10-08 13:07
      • (Bad) experiences… Helmut 2012-10-08 13:56
      • No GCP “certificate” for BE-centers issued by EU countries ElMaestro 2012-10-08 16:22
    • No GCP “certificate” for BE-centers issued by EU countries cakhatri 2012-10-09 07:16