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- Good_Clinical_Practice_Directive abstract "The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.The directive deals with the following items:Good clinical practice for the design, conduct, recording and reporting of clinical trials:Good Clinical Practice (GCP)The Ethics CommitteeThe sponsorsInvestigator's BrochureManufacturing or import authorisationExemption for Hospital & Health Centres and ReconstitutionConditions of Holding a Manufacturing LicenceThe trial master file and archivingFormat of Trial Master FileRetention of Essential and Medical RecordsInspectorsInspection proceduresFinal provisions".
- Good_Clinical_Practice_Directive wikiPageExternalLink LexUriServ.do?uri=CELEX:32005L0028:EN:NOT.
- Good_Clinical_Practice_Directive wikiPageExternalLink LexUriServ.do?uri=CELEX:72005L0028:EN:NOT.
- Good_Clinical_Practice_Directive wikiPageID "7482808".
- Good_Clinical_Practice_Directive wikiPageRevisionID "602145053".
- Good_Clinical_Practice_Directive hasPhotoCollection Good_Clinical_Practice_Directive.
- Good_Clinical_Practice_Directive subject Category:2005_in_law.
- Good_Clinical_Practice_Directive subject Category:2005_in_the_European_Union.
- Good_Clinical_Practice_Directive subject Category:Clinical_research.
- Good_Clinical_Practice_Directive subject Category:European_Union_directives.
- Good_Clinical_Practice_Directive subject Category:Good_practice.
- Good_Clinical_Practice_Directive subject Category:Pharmaceuticals_policy.
- Good_Clinical_Practice_Directive type Abstraction100002137.
- Good_Clinical_Practice_Directive type Communication100033020.
- Good_Clinical_Practice_Directive type Declaration106725877.
- Good_Clinical_Practice_Directive type Directive107170080.
- Good_Clinical_Practice_Directive type EuropeanUnionDirectives.
- Good_Clinical_Practice_Directive type Message106598915.
- Good_Clinical_Practice_Directive type Pronouncement106727616.
- Good_Clinical_Practice_Directive type Statement106722453.
- Good_Clinical_Practice_Directive comment "The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.The directive deals with the following items:Good clinical practice for the design, conduct, recording and reporting of clinical trials:Good Clinical Practice (GCP)The Ethics CommitteeThe sponsorsInvestigator's BrochureManufacturing or import authorisationExemption for Hospital & Health Centres and ReconstitutionConditions of Holding a Manufacturing LicenceThe trial master file and archivingFormat of Trial Master FileRetention of Essential and Medical RecordsInspectorsInspection proceduresFinal provisions".
- Good_Clinical_Practice_Directive label "Good Clinical Practice Directive".
- Good_Clinical_Practice_Directive label "Richtlinie 2005/28/EG über Grundsätze und Leitlinien der guten klinischen Praxis".
- Good_Clinical_Practice_Directive sameAs EG_über_Grundsätze_und_Leitlinien_der_guten_klinischen_Praxis.
- Good_Clinical_Practice_Directive sameAs m.02632nb.
- Good_Clinical_Practice_Directive sameAs Q2151392.
- Good_Clinical_Practice_Directive sameAs Q2151392.
- Good_Clinical_Practice_Directive sameAs Good_Clinical_Practice_Directive.
- Good_Clinical_Practice_Directive wasDerivedFrom Good_Clinical_Practice_Directive?oldid=602145053.
- Good_Clinical_Practice_Directive isPrimaryTopicOf Good_Clinical_Practice_Directive.