Publications

 

 

Library

 

Articles

PRESS RELEASE - EFGCP and MedTech Europe establish a joint Medical Technology Working Party

Ethical Challenges in Clinical Research at Both Ends of Life - a Report from the EFGCP-EUCROF Joint Workshop on Ethical Challenges in Clinical Research at both Ends of Life held at the Crowne Plaza, Antwerp, Belgium on 27 & 28 April 2010. Wrobel, Dehlinger-Kremer, Klingmann - Drug Information Journal, Vol. 45, pp. 89105, 2011 0092-8615/2011

 

Ethics Publications

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1)

World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

European Textbook on Ethics in Research - Directorate-General for Research, Science, Economy & Society, European Commission - EUR 24452 EN - 2010

 

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

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)

- 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)

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.

 

GCP-related regulations and guidelines English translations

These translated documents are provided by members of the EFGCP for mutual benefit. Whilst it is hoped that they will be useful, no responsibility can be accepted for any inaccuracies in translation, not is there any guarantee that this is a complete set of up to date documents for the relevant areas. It is essential that users of this system conduct their own research to make sure the documents meet their needs. Any updated documents of which members become aware will be gratefully received.

CHILI

CHINA

VIETNAM

SOUTH AFRICA

SOUTH AFRICA
Comparison of the SA GCP with ICH

 

Master Thesis

A Review of the Availability of Information on Ethics Committee Requirements for Clinical Trials in the EU - Master of Drug Regulatory Affairs by Ralf Rickert (2009)

 

Others

A Report from the European Commission Services on Understanding Public Debate on Nanotechnologies. Options for Framing Public Policy, EUR 24169 EN - 2010

Boyce et al. TOPS manuscript


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