Printable Handouts

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Navigable Slide Index

1. Introduction
2. MAD: background
3. MAD: objectives
4. MAD: main provision
5. The two components of MAD
6. Implementation and follow-up
7. Council acts on compliance monitoring
8. Compliance monitoring - 1983 act
9. Compliance monitoring - 1989 act
10. 1995 revision of guidance: annex I
11. 1995 revision of guidance: annex II
12. OECD working group on GLP
13. Terms of reference
14. Focus of work
15. Development of guidance documents
16. Guidance documents on compliance monitoring
17. Guidance for preparing of GLP inspection reports
18. Inspections and study audits in another country
19. Training courses
20. Working group exchanging information
21. Concluding remarks

Topics Covered

• 1981 OECD Council Act on Mutual Acceptance of Data (MAD)
• Objectives and benefits of MAD
• 1989 Council Act on Compliance Monitoring
• Guidance on compliance monitoring
• OECD Working Group on GLP
• Exchanging information across countries

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Sigman, R. (2012, March 1). Monitoring GLP compliance: history and OECD framework [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 22, 2024, from https://doi.org/10.69645/TEKY2833.
Export Citation (RIS)

Publication History

• Published on March 1, 2012

Financial Disclosures

• Mr. Richard Sigman has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.