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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 :Companies to Disclose All Clinical Trials in Patients.. 2009-11-20 09:55:53 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear All,
 
The Council of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has approved an updated Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. This extends the range of clinical trials that member companies should provide information on to include all clinical trials in patients, as a minimum. The scope of this new Joint Position will include early stage safety trials of medicines for life-threatening conditions, which are typically not done in healthy volunteers. For the press release click here.
 
Best regards
IP Logged
Last Edited On: 2009-11-20 09:55:53 By GCP HelpDesk for the Reason
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