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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 :Major developments in EU Clinical Trial Guidances.. 2010-04-20 19:13:23 
GCP HelpDesk
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Dear Friends,

Please find the major developments in clinical trials in Europe.

30/03/2010 :Summary of the Responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC". This document summarises the responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"

Revision of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (Version of March 2010). This Document is available in Volume 10 of EudraLex.

Guidance documents applying to clinical trials - Questions & Answers Document, Version 5.0 (March 2010). The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. This document is available in Volume 10 of EudraLex.

Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents (March 2010).

Kind regards,
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Last Edited On: 2010-04-20 19:13:23 By GCP HelpDesk for the Reason
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