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EU Legislation and Guidance

Good Clinical Practice : Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 - adopted July 96) EudraLex Volume 3C Efficacy 3CC1A

- Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Official Journal L 91, 9/4/2005 p. 13 - 19)

Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p. 34 - 44)

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006amending Regulation 1901/2006 on medicinal products for paediatric use

Procedure for coordinating GCP inspections requested by the EMEA

Procedure for preparing GCP inspections requested by the EMEA

Procedure for conducting GCP inspections requested by the EMEA

Annex I to procedure for conducting GCP inspections requested by the EMEA: investigator site

Annex II to procedure for conducting GCP inspections requested by the EMEA: clinical laboratories

Annex III to procedure for conducting GCP inspections requested by the EMEA: computer systems

Annex IV to procedure for conducting GCP inspections requested by the EMEA: sponsor site and/or Contract Research Organisations (CRO)

Annex V to procedure for conducting GCP inspections requested by the EMEA: phase I units

Annex VI to procedure for conducting GCP inspections requested by the EMEA: file structure and archiving of documents relating to CHMP requested inspections - in Member State and at EMEA

Procedure for reporting of GCP inspections requested by the EMEA

Principal documents taken into account for the preparation of procedures for GCP inspections requested by the EMEA

EMEA draft reflection paper on e-source document

Pharmacovigilance inspection procedures for the coordination, conduct and reporting of Pharmacovigilance inspections carried out in the context of the Centralised Procedure. These procedures have been developed by the pharmacovigilance inspectors in conjunction with the GCP Inspectors Working Group and are now published for the first time. They will be revised and updated, as necessary, in the light of experience.


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