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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 09:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 09:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
 Subject :NIH's Financial Conflict of Interest (FCOI) Proposed Rule.. 2010-05-27 11:42:00 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,
 
Partnerships between NIH-funded researchers and industry are often essential to the process of moving discoveries from the bench to the bedside. However, managing Financial Conflicts of Interest (FCOI) can be a major challenge because of the complex relationships among government, academia, and industry. A Notice of Proposed Rulemaking, which is open for public comment for the next 60 days, proposes a general revision to the existing regulations.

Information about the Notice of Proposed Rule Making is available at: http://www.gpo.gov/fdsys/pkg/FR-2010-05-21/pdf/2010-11885.pdf

A replay of the telebriefing with NIH Director Francis S. Collins, M.D., Ph.D. is available at: http://ocplmedia.od.nih.gov/nihradio/NIHtelebrifing-2010.05.20.mp3
 
Kind regards,

 

 

 
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