Workshop on Good Clinical Practice GCP for the Conduct of Clinical Trials for Veterinary Medicinal P

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Workshop on Good Clinical Practice (GCP) for the
Conduct of Clinical Trialsfor Veterinary
Medicinal ProductsMunich, 17 18 September 2001

• Topic Field of application of the guidelines
• V. Cracknell, Pfizer Animal Health

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VICH GCP - Some definitions

• Good Clinical Practice
• Objective
• Clinical Study
• In-use Safety v Target Animal Safety
• Veterinary Product
• Investigational Veterinary Product
• Target Animal/Study Animal

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VICH - GCP Scope - Studies

• Effectiveness clinical studies Phase III
• Intention to submit
• What about Phase IV?

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VICH - GCP Scope - People

• Sponsor
• Investigator
• Monitor
• Everyone involved with the study!

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VICH GCP vs. GLP

• VICH GCP
• studies under field conditions
• investigator remote from site
• site specific protocols SOPs
• flexible supervision by Monitor
• no legal requirement for official inspection
• independent QA audit recommended but not routine

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VICH GCP vs. GLP

• GLP
• official certification inspection of a
  permanent facility with a responsible person on
  site
• test systems are validated (SOPs)
• QA supervision built into study design
• compliance statements issued and independently
  verified

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VICH - GCP Scope - Efficacy Dossier

• Pre-clinical data
• in-vitro
• in-vivo
• laboratory animal
• target animal
• GCP or GLP?
• GLP mandatory for safety studies
• Other studies?

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VICH - GCP Scope - Efficacy Dossier

• Clinical data
• Determination of dosing regime
• Confirmation of dose
• Field studies with in-use safety component
• GCP or GLP?
• GCP by definition but.

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VICH - GCP Scope - Efficacy Dossier

• Laboratory component of clinical field studies?
• Non GLP-compliant diagnostic/support
  laboratories?
• SOPs to ensure quality
• Monitor responsibility

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VICH - GCP Scope - Efficacy Dossier

• Clinical data - from artificial challenge models
  in laboratories at GLP compliant sites?
• Sponsor to have SOPs that either
• stay with GLP process or
• modify site SOPs to meet GCP standard
• Sponsor ultimately responsible for quality and
  integrity of data

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VICH - GCP Impact

• Quality and integrity of effectiveness data
• Transparency of process
• GCP or GLP?
• Sponsors should take the pragmatic approach
• Follow GCP for animal phase data collection
• Make GLP the target for laboratory based work