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GCP and Clinical Research Inspection
- ICH Training
- Training
APEC LSIF / Thai FDA workshop, May 27-30, 2008, Bangkok, Thailand
In May 2008, a 4-day preliminary workshop on Good Clinical Practice (GCP) and Clinical Research Inspection was held in Bangkok, Thailand. This preliminary workshop for Regulators was hosted by the Thai FDA, and supported by the APEC Life Sciences Innovation Forum. Speakers were ICH experts from US FDA.
The workshop is part of a series of two training events. The first series includes two 5-day workshops (preliminary & advanced) on the Review of Drug Development in Clinical Trials, and the second series includes two 3-4 days workshops (preliminary & advanced) on Good Clinical Practice (GCP)/Clinical Research Inspection. The advanced workshop on Good Clinical Practice (GCP)/Clinical Research Inspection was held in March 2009.
Workshop
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Day 1
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Review of GCP: Goals, Principles, Roles and Responsibilities
Dr. David Lepay and Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Regulator's Role in GCP
Dr. David Lepay, Food and Drug Administration (FDA), USA
Informed Consent
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Introduction to US FDA's Clinical Research Review Process
Dr. David Lepay, Food and Drug Administration (FDA), USA
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Day 2
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Review of Day 1
Dr. David Lepay, Food and Drug Administration (FDA), USA
Anatomy of a GCP Inspection
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Preparation for the Inspection: Protocol
Dr. David Lepay, Food and Drug Administration (FDA), USA
FDA Compliance Programs
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
The Opening Interview
Dr. David Lepay, Food and Drug Administration (FDA), USA
Auditing Clinical Data
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
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Day 3
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Review of Day 2
Dr. David Lepay, Food and Drug Administration (FDA), USA
Common GCP Deficiencies Encountered at Clinical Investigator Sites
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Misconduct in Research: Detecting Falsification
Dr. David Lepay, Food and Drug Administration (FDA), USA
Documenting an Inspection
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Assessing Sponsor and Ethics Committee Compliance from the Clinical Investigator Inspection
Dr. David Lepay, Food and Drug Administration (FDA), USA
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Day 4
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The Close-Out Discussion
Dr. David Lepay, Food and Drug Administration (FDA), USA
Summary of Clinical Investigator Inspecting
Dr. David Lepay and Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Inspecting Sponsors and Contract Research Organizations
Dr. Jean Toth-Allen, Food and Drug Administration (FDA), USA
Inspection of Ethics Committees
Dr. David Lepay, Food and Drug Administration (FDA), USA
US FDA GCP Enforcement: Strategies and Options
Dr. David Lepay, Food and Drug Administration (FDA), USA
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