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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 :Argentina: ANMAT - new regulatory update.. 2010-05-01 01:40:32 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,

On April 15 th the new controller for ANMAT, Dr. Carlos Chiale circulated a new regulatory update, indicating that the protocols for Phase I and II with new products must be submitted directly to INAME entrance desk..

The objective of this amendment is to accelerate the time assessments for the mentioned cases.

http://www.anmat.gov.ar/medicamentos/investigacion_clinica.asp

Kind regards,
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GCP HelpDesk
 Subject :Re:Argentina: ANMAT - new regulatory update.. 2011-10-28 15:27:30 
Vishnu
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Joined: 2011-10-28 15:10:37
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The resource is very useful for regulatory issues
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 Subject :Re:Argentina: ANMAT - new regulatory update.. 2011-12-13 10:43:39 
William Cron
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Joined: 2011-12-13 10:33:10
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Regulatory issues results due to error on behalf of the accused and the resources mentioned above helped in sorting them.

 

VPN mobile

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Last Edited On: 2011-12-13 10:43:39 By William Cron for the Reason
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