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Navigable Slide Index

1. Introduction
2. Contents
3. Background
4. Legal framework
5. Definitions
6. GLP studies basic principle
7. Process of GLP studies
8. Communication lines - single-site study
9. Communication lines - multi site study
10. Regulatory authorities
11. Regulatory authorities requirements
12. Regulatory authorities follow up
13. Planning of reporting - overview
14. Planning of reporting - responsibility of the SD
15. Planning of reporting - data generation
16. Scientist contribution
17. Principle investigator contribution
18. Principle investigator contribution - deviations
19. Quality assurance unit (QAU) contribution
20. Study director contribution
21. Structure of the final report
22. General information
23. Final report content
24. Identification of the study
25. Identification - deviation of single study
26. Identification - deviation of multi study
27. Test and reference items identification
28. Test and reference items characterisation
29. Test and reference items deviations
30. Information on sponsor & test facility: single study
31. Information on sponsor & test facility: multi site
32. Information on sponsor & test facility: deviations
33. Experimental starting and completion dates
34. Initial starting date and reporting date
35. Dates: deviations
36. Quality assurance statement
37. GLP statement
38. Statements: deviations
39. Methods and materials used
40. Methods and materials: deviations
41. Results
42. Results: deviations (1)
43. Results: deviations (2)
44. Results: deviations (3)
45. Storage
46. Storage: deviations
47. Conclusions

Topics Covered

• Definitions and basic principles
• Legal requirements
• Integration of reporting in the whole GLP process
• Responsibilities
• Planning, structure, content and deviations related to reports
• Rejection of studies by the Regulatory Authorities if reports fail

Links

Series:

• Good Laboratory Practice

Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on March 1, 2012

Financial Disclosures

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