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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
- An acknowledgement
- The GLP panel
- OECD
- Countries adherent to OECD MAD decisions
- The OECD MAD decision C(81)30 (final)
- OECD decision-recommendation C(89)87(final) (1)
- OECD decision-recommendation C(89)87(final) (2)
- OECD council decision-recommendation: Annex I
- OECD council decision-recommendation: Annex II
- Annex III to council decision C(89)87(final)
- Mutual acceptance of data
- The mutual joint visit (MJV) pilot project (1)
- The mutual joint visit (MJV) pilot project (2)
- Parties involved in the MJV pilot project
- MJV steering group
- Working group on GLP
- Outcome of the MJV report
- MJV pilot project (1)
- MJV pilot project (2)
- The whole project
- Programme of on-site evaluation visits (1)
- Programme of on-site evaluation visits (2)
- Pre-visit documentation review
- On-site evaluation visit (1)
- On-site evaluation visit (2)
- Programme of on-site evaluation visits (3)
- Progress of the on-site evaluation program
- Concluding remarks
Topics Covered
- Countries with a GLP monitoring program (1989): the GLP panel
- OECD
- The OECD MAD decision C(81)30 (final)
- OECD council decision-recommendation C(89)87(final)
- Annex I, II and III
- Mutual acceptance of data
- Objective of the mutual joint visit (MJV) pilot project
- Working group on GLP
- MJV pilot project
- Programme of on-site evaluation visits
Talk Citation
Helder, T. (2012, September 13). History and rationale for the development of an international evaluation programme [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 24, 2024, from https://hstalks.com/bs/2393/.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Theo Helder has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
History and rationale for the development of an international evaluation programme
Published on September 13, 2012
17 min
A selection of talks on Pharmaceutical Sciences
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