Publications

EFGCP Publications

EFGCP Guidelines

EFGCP Audit Working Party Notes on Clinical Trials Insurance Issues (2009)

Guidance for Auditing Quality Systems of Independent Ethics Committees in Europe (2008)

The Role of the Quality Assurance Unit (2008)

Guideline for Auditing Clinical Laboratories (2005)

Revision of the ENGAGE Auditing Guideline. An Optional Guideline for GCP Compliance and Quality Management Systems Auditing (2005)

EFGCP Guidelines for Auditing Independent Ethics Committees (2002)

International Guidelines on Bioethics - Informal listing of selected International Codes, Declarations, Guidelines, etc. on medical Ethics/Bioethics/Health Care Ethics/Human Rights Aspects of Health (2000)

EFGCP Engage Guideline - Optional Guideline for Good Clinical Practice Compliance and Quality Systems Auditing (1998)

EFGCP Guidelines and Recommendations for European Ethics Committees (1997)

Surveying and Evaluating Ethical Review Practices (2002)

Operational Guidelines for Ethics Committees That Review Biomedical Research (2000)

EFGCP News

The EFGCP News - Spring 2010

The EFGCP News - Autumn 2009

The EFGCP News - Spring 2009

The EFGCP News - Autumn 2008

The EFGCP News - Spring 2008

The EFGCP News - Autumn 2007

The EFGCP News – Spring 2007

The EFGCP News – Winter 2006

The EFGCP News – Summer 2006

The EFGCP News – Winter 2005

The EFGCP News – Autumn 2005

The EFGCP News – Summer 2002

EFGCP Reports and Submissions

EFGCP Written Submission to the European Commission and EMEA on The Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future (2007)

EFGCP Comments on the Guideline on Requirements for First in Man Clinical Trials for Potential High Risk Medicinal Products (EMEA/CHMP/SWP28367/2007)

EFGCP Report on: The Procedure for the Ethical Review of Protocols for Clinical Research Projects in the European Union

EFGCP Reports of Activities

Report of Activities 2009

Report of Activities 2008