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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
- Talk outline
- Definition of GLP
- Objectives of GLP
- GLP vs. ISO 17025 (1)
- GLP vs. ISO 17025 (2)
- History of GLP (1)
- History of GLP (2)
- Legal framework of GLP in the EU (1)
- Legal framework of GLP in the EU (2)
- Legal framework of GLP in the EU (3)
- Legal framework of GLP in the EU (4)
- The role of the member states (1)
- The role of the member states (2)
- The role of the member states (3)
- GLP labs in the EU (2009)
- GLP in the EU-practicalities
- Role of the GLP commission inside the EU
- The GLP web site
- Foreign relations (1)
- Foreign relations (2)
- OECD (1)
- OECD (2)
- Relevant agencies
- EMA GLP inspections
- Cooperation with receiving authorities
- Costs and benefits of GLP
- Conclusions
- Thank you
Topics Covered
- Good Laboratory Practice
- Definition and development
- Differences and similarities to laboratory accreditation
- The role of the EU Member States, the European Commission and the OECD
- Cooperation with European agencies and regulatory authorities
Talk Citation
Schmahl, M. (2012, March 1). GLP in the European Union [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 25, 2024, from https://hstalks.com/bs/2253/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Maik Schmahl has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.