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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
- Contents
- Background
- Legal framework
- Definitions
- GLP studies basic principle
- Process of GLP studies
- Communication lines - single-site study
- Communication lines - multi site study
- Regulatory authorities
- Regulatory authorities requirements
- Regulatory authorities follow up
- Planning of reporting - overview
- Planning of reporting - responsibility of the SD
- Planning of reporting - data generation
- Scientist contribution
- Principle investigator contribution
- Principle investigator contribution - deviations
- Quality assurance unit (QAU) contribution
- Study director contribution
- Structure of the final report
- General information
- Final report content
- Identification of the study
- Identification - deviation of single study
- Identification - deviation of multi study
- Test and reference items identification
- Test and reference items characterisation
- Test and reference items deviations
- Information on sponsor & test facility: single study
- Information on sponsor & test facility: multi site
- Information on sponsor & test facility: deviations
- Experimental starting and completion dates
- Initial starting date and reporting date
- Dates: deviations
- Quality assurance statement
- GLP statement
- Statements: deviations
- Methods and materials used
- Methods and materials: deviations
- Results
- Results: deviations (1)
- Results: deviations (2)
- Results: deviations (3)
- Storage
- Storage: deviations
- 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
Talk Citation
Beernaert, H. (2012, March 1). Reporting of study results [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 19, 2024, from https://hstalks.com/bs/2243/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Hedwig Beernaert has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.