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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
- GLP principles in short term studies
- Note
- Short-term studies OECD guidance documents
- The OECD definition for short-term studies
- Types of short-term studies
- In-vitro studies definition
- Study plan for short-term studies
- Supplements to study plan
- Revision of study reports
- Responsibilities in short-term studies
- Quality assurance programme (QAP)
- Types of QA inspections
- Process-based inspections
- Frequency of inspections
- Physical-chemical studies
- Physical-chemical studies: specific aspects (1)
- Physical-chemical studies: specific aspects (2)
- Physical-chemical studies: specific aspects (3)
- In vitro studies
- In-vitro studies: Study director
- In-vitro studies: Contamination
- Identification, documentation & maintenance
- Assurance of proper use of test system
- SOPs for health status evaluation of systems
- Control groups assurance
- Culture media
- Characterisation information for test items
- Test guidelines for proper performance of system
- Ad hoc SOPs
- Major safety aspects relevant to in-vitro studies
- Remark 1
- Remark 2
- Conclusions
Topics Covered
- In vitro studies
- Short-term studies
- Acute toxicity studies
- Acute ecotoxicological studies
- Genetic toxicity testing
- Standardized general study plan
- Study-specific supplement
- Standardised final report
- Process-based inspections
- Standard operating procedures
- Test item
- Reference item
- Contamination of batches
- Characterisation of culture media
- Predictive capacity of in-vitro studies
- Assessment of health effects
Talk Citation
Caroli, S. (2013, July 18). In vitro studies and short term studies [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 19, 2024, from https://hstalks.com/bs/2592/.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Sergio Caroli has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.