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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
- Outlines
- OECD guidance
- Number of GLP monitoring programs
- GLP monitoring programs in Japan
- Relationship (1)
- Relationship (2)
- Relationship (3)
- Relationship (4)
- Overview of each program
- Medical products program
- Workplace chemicals program
- Pesticides program
- Industrial chemicals program
- Compliance monitoring authority
- Monitoring authority for medical products
- Marketing approval process
- MHLW vs. PMDA
- Legal basis and regulatory requirements
- GLP standards for medical products
- Contents of GLP standards (1)
- Contents of GLP standards (2)
- Contents of GLP standards (3)
- Enforcement notices of GLP standards
- Other act, regulation, and notice concerned
- Pharmaceutical affairs act
- Enforcement regulation of pharmaceutical affairs
- Law on incorporated administrative agency
- On-site GLP inspections for drugs/devices
- Preparation of document for GLP inspections
- Unofficial publications concerned with GLP
- Normal practices of inspections
- Types of GLP inspections
- Timelines for GLP inspection
- Pre inspection (step 1)
- Pre inspection (step 2)
- Pre inspection (step 3)
- Usual inspection schedule
- Usual practice of inspection
- Pharmaceuticals
- Medical devices
- Follow-up to inspection
- Reporting to the GLP evaluation committee
- Final result of GLP inspection
- Corrective Action
- Grade B
- Grade C
- Summary
Topics Covered
- Complexity of Japanese GLP monitoring programmes
- Review and comparison of all four GLP programmes
- Detailed explanation of medical products programme
- Compliance Monitoring Authority, legal bases, and regulatory requirements of medical products programme
- Normal practices and follow-ups of GLP inspection in medical products programme
Talk Citation
Someya, H. (2012, March 1). Regulatory requirements in Japan and its compliance monitoring programmes [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved March 28, 2024, from https://hstalks.com/bs/2254/.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Hitoshi Someya has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Regulatory requirements in Japan and its compliance monitoring programmes
Published on March 1, 2012
42 min
A selection of talks on Methods
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