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- The OECD Principles of GLP
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2. Scope and application
- Mr. David Long
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3. Performing test systems and test items
- Prof. Sergio Caroli
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4. Why OECD GLP and not ISO / IEC 17025?
- Dr. Helen Liddy
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5. Principles of GLP
- Mr. David Long
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6. Performing: standard operating procedures
- Mrs. Katariina Rautalahti
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7. GLP: planning, recording, and archiving
- Mr. Phil Withers
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8. Reporting of study results
- Mr. Hedwig Beernaert
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9. Quality assurance
- Mr. David Long
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10. Facilities: buildings and equipment
- Mr. Hedwig Beernaert
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11. Multi-site studies and field studies
- Dr. Geetha Rajashekhar
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12. In vitro studies and short term studies
- Prof. Sergio Caroli
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13. Computers in a GLP environment
- Mr. John McNamee
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14. The application of the GLP principles in analytical chemistry
- Prof. Sergio Caroli
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15. Good laboratory practice: roles and responsibilities
- Mr. David Long
- Monitoring GLP Compliance
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16. Monitoring GLP compliance: history and OECD framework
- Mr. Richard Sigman
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18. Inspection procedures
- Mr. Theo Helder
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20. GLP in the European Union
- Mr. Maik Schmahl
- International Data Acceptance Through OECD
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22. International data acceptance through OECD: history and OECD context
- Mr. Richard Sigman
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24. Participation of non-OECD economies in the MAD system
- Ms. Christinah Leballo
Printable Handouts
Navigable Slide Index
- Introduction
- Mutual acceptance of data 1981 council decision
- Mutual acceptance of data
- 1989 council act on compliance monitoring
- Compliance monitoring 1989 act
- Information exchange (1)
- Information exchange (2)
- OECD working group on GLP (1)
- OECD working group on GLP (2)
- OECD working group on GLP - questionnaires
- Contents of questionnaire
- OECD working group on GLP-annual overviews
- Information provided in the annual overviews
- Notification of non-compliance
- Notification of non-compliance - facilities
- Notification of non-compliance - studies
- Peer reviews by member governments
- Peer reviews by non-member governments
- The OECD website
- Thank you
Topics Covered
- OECD Council Acts on Mutual Acceptance of Data (MAD)
- Recognizing assurance from other countries
- Collecting information on monitoring programmes via questionnaires
- Annual overviews of facilities inspected
- Notification to members of non-compliance
Talk Citation
Sigman, R. (2012, March 1). International data acceptance through OECD: history and OECD context [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 24, 2024, from https://hstalks.com/bs/2255/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Richard Sigman has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
International data acceptance through OECD: history and OECD context
Published on March 1, 2012
28 min