DOCUMENTS


Bureau of Quality Assurance documents

- Belgian GLP Compliance Monitoring Programme Manual (third edition, revised Dec 2009)

- Standard Form to fill in the GLP Activities

- Standard Form to notify a non-GLP phase in a study

Belgian Legislation

Royal Decree of March 6, 2002 : part 1, part 2

European Legislation

English

Directive 2004/10/EC replacing Directive 87/18/CEE

Directive 2004/09/EC replacing Directive 88/320/CEE

Nederlands

Richtlijn 2004/10/EG

Richtlijn 2004/09/EG

Français

Directive 2004/10/CE

Directive 2004/09/CE

The Product Oriented Directives

See Vademecum on the application of the GLP Principles in the EU

OECD documents

External link: OECD official website on Good Laboratory Practice

Number 1: OECD Principles on Good Laboratory Practice (as revised in 1997)

Number 2: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (1995)

Number 3: Revised Guidance for the Conduct of Laboratory Inspections and Study Audit (1995)

Number 4: Consensus Document: Quality Assurance and GLP (revised 1999)

Number 5: Consensus Document: Compliance of Laboratory Suppliers with GLP Principles (revised 1999)

Number 6: Consensus Document: The Application of the GLP Principles to Field Studies (revised 1999)

Number 7: Consensus Document: The Application of the GLP Principles to Short Term Studies (revised 1999)

Number 8: Consensus Document: The Role and Responsibilties of the Study Director in GLP Studies (revised 1999)

Number 9: Guidance for the Preparation of GLP Inspection Reports (1995)

Number 10: Consensus Document: The Application of the Principles of GLP to Computerised Systems (1995)

Number 11: Advisory Documents of the Working Group on GLP: The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP (1998)

Number 12: Advisory Documents of the Working Group on GLP: Requesting and Carrying Out Inspections and Study Audits in Another Country (2002)

Number 13: Consensus Document of the Working Group on Good Laboratory Practice: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002)

Number 14: Advisory Documents of the Working Group on GLP: The Application of the Principles of GLP to in vitro Studies (2004)

<Number 16: Advisory Documents of the Working Group on GLP: Guidance on the GLP Requirements for Peer Review of Histopathology(2014)

OECD position paper: The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994)

OECD position paper: Outsourcing of inspection functions by GLP Compliance Monitoring Authorities (2006)

Presentations

13th GLP Annual Meeting, Brussels, 16 October 2008

Drug Registration and GLP, Dr. Sonja Beken - FAMHP

The application of the OECD principles at the OECD level and in non-member countries, Dr. Dian Turnheim - OECD

REACH information requirements and compliance with the GLP principles, Maarten Roggeman - FPS Health, Food Chain Safety and Environment

14th GLP Annual Meeting, Brussels, 22 October 2009

GLP Annual Meeting 2009 syllabus

15th GLP Annual Meeting, Brussels, 17 November 2010

GLP Annual Meeting 2010 syllabus

16th GLP Annual Meeting, Brussels, 9 November 2011

GLP Annual Meeting 2011 syllabus

17th GLP Annual Meeting, Brussels, 16 May 2013

GLP Annual Meeting 2013 syllabus

18th GLP Annual Meeting, Brussels, 27 October 1015

GLP Annual Meeting 2015 syllabus

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