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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 GCP HelpDesk on 2010-08-20 12:12:20
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by GCP HelpDesk on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by GCP HelpDesk on 2010-06-13 10:07:59
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by GCP HelpDesk on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by GCP HelpDesk on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by GCP HelpDesk on 2010-05-01 01:40:32
Major developments in EU Clinical Trial Guidances   by GCP HelpDesk on 2010-04-20 19:10:55
CONSORT III (2010)   by GCP HelpDesk on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by GCP HelpDesk on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by GCP HelpDesk on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data   by GCP HelpDesk on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by GCP HelpDesk on 2010-02-06 12:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by GCP HelpDesk on 2010-01-27 11:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by GCP HelpDesk on 2010-01-22 10:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by GCP HelpDesk on 2010-01-21 11:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by GCP HelpDesk on 2010-01-13 20:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by GCP HelpDesk on 2010-01-12 12:15:13
EMEA Guidelines on Cystic Fibrosis Drug Development   by GCP HelpDesk on 2010-01-05 09:14:16
US-FDA' proposed rule on Informed Consent regulations   by GCP HelpDesk on 2010-01-02 22:22:47
International Compilation of Human Research Protections 2010 Edition   by GCP HelpDesk on 2009-12-23 14:59:39
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by GCP HelpDesk on 2009-12-17 19:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by GCP HelpDesk on 2009-12-04 18:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by GCP HelpDesk on 2009-11-30 10:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by GCP HelpDesk on 2009-11-21 07:57:50
Companies to Disclose All Clinical Trials in Patients   by GCP HelpDesk on 2009-11-19 09:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by GCP HelpDesk on 2009-11-09 09:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by GCP HelpDesk on 2009-11-08 22:28:30
PhRMA's New Clinical Trial Guidelines   by GCP HelpDesk on 2009-10-05 10:21:30
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 Ethics, GCP, Quality Assurance and Regulatory Affairs
Topics Replies Views Last Post
Argentina: ANMAT - new regulatory update
by GCP HelpDesk on 2010-05-01 01:40:32 		2 308718 by William Cron
on 2011-12-13 10:43:39
EFGCP–EUCROF Joint Workshop Final Report
by GCP HelpDesk on 2010-08-20 12:12:20 		0 10766 by GCP HelpDesk
on 2010-08-20 12:12:20
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification
by GCP HelpDesk on 2010-06-13 10:11:41 		0 8669 by GCP HelpDesk
on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)
by GCP HelpDesk on 2010-06-13 10:07:59 		0 8215 by GCP HelpDesk
on 2010-06-13 10:07:59
NIH's Financial Conflict of Interest (FCOI) Proposed Rule
by GCP HelpDesk on 2010-05-27 11:42:00 		0 1864 by GCP HelpDesk
on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population
by GCP HelpDesk on 2010-05-13 11:39:54 		0 1732 by GCP HelpDesk
on 2010-05-13 14:55:29
EFGCP:Procedure for the Ethical Review of Protocols in Turkey
by GCP HelpDesk on 2010-04-30 22:35:05 		0 338 by GCP HelpDesk
on 2010-04-30 22:35:05
Major developments in EU Clinical Trial Guidances
by GCP HelpDesk on 2010-04-20 19:10:55 		0 1254 by GCP HelpDesk
on 2010-04-20 19:13:23
Deming's 14 Principles-Aricle from BARQA
by Leon on 2010-04-18 22:32:54 		0 324 by Leon
on 2010-04-18 23:04:59
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