Good laboratory practice: principles, compliance and mutual recognition, history and OECD framework

Published on March 1, 2012 Reviewed on April 19, 2018   26 min

Other Talks in the Series: Good Laboratory Practice

0:00
Hello, I'm Dian Turnheim. I'm currently Head of the Environment, Health and Safety Division. And I would like to begin by setting the framework and the history of the work of OECD on Good Laboratory Practice and compliance monitoring.
0:16
This slide is an overview slide of what my presentation today will cover. First of all, I'll give you a general overview of all the talks to be covered in this series, and then a brief discussion of the Organisation for Economic Cooperation and Development and its work on the safety of chemicals and chemical products for the past 40 years. Then I will go into the first council decision on the Mutual Acceptance of Data in the assessment of chemicals, the MAD council decision of 1981, and I will briefly touch upon the development and revision of the OECD principles of Good Laboratory Practice, which are an integral part of that decision, and finally, briefly, the role of the working group on GLP.
1:01
This slide presents an overview of all of the talks in this series which I have put together. The first section, and by far the longest, is that on the OECD principles of Good Laboratory Practice, beginning with history and framework in OECD, which I will present to you today. That is followed then by two talks on the scope of application of Good Laboratory Practice. First of all, 'What is Safety' study? Second, the relationship between Good Laboratory Practice principles and ISO standards. The third and by far the longest section is that on the OECD principles of GLP. This will begin with a long talk on the philosophy of GLP, followed by several talks on the various aspects of GLP: planning, performing, recording, reporting, archiving, quality assurance, facilities. Then: several talks on the application and interpretation of the principles of GLP, with talks on multi site studies and field studies, in vitro and term studies, the application of GLP to computerised systems, the application of GLP principles to analytical chemistry, and the role and responsibilities of the sponsor in GLP studies. The second section of talks is on monitoring for compliance with Good Laboratory Practice. Once again, we'll begin by setting out the history and the OECD framework on this work, followed by several talks on the OECD guidance for national compliance monitoring programmes, and then some specific talks on specific National Compliance Monitoring systems. The third and last section deals with the international aspects of data acceptance through OECD, starting with a talk on the history and OECD context of this work, followed by a talk on the programme for peer review of national compliance monitoring programs, and then finally on the participation of non-member economies in the OECD's system for mutual acceptance of data.
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Good laboratory practice: principles, compliance and mutual recognition, history and OECD framework

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