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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
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US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
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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 :EMEA Guidelines on Cystic Fibrosis Drug Development.. 2010-01-05 09:14:16 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,

The European Medicines Agency (EMEA) first guideline on developing products to treat cystic fibrosis advises drug makers to use forced expiratory volume (FEV) as the primary lung-function endpoint when designing clinical trials for the drugs. A clinically relevant change in FEV should be defined and justified by drug makers, as should the frequency of FEV measurements, according to the final guideline posted on the EMEA’s website last month.

Click here for this guideline

Kind regards,

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