Monitoring issues and QC points from the GCP investigation, and trouble countermeasures.
S10214
While reviewing the points raised in the GCP investigation, we will elaborate on the approach to monitoring and QC!
【Speaker】 Dr. Haruhisa Hayashi, Ph.D. in Pharmacy, Representative of Hayashi Pharmaceutical Development Research Institute 【Venue】 Kawasaki City Industrial Promotion Hall, Conference Room 2 【Date and Time】 February 23, 2011 (Wednesday) 13:00-16:30
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basic information
**Course Objectives and Aims** The benchmark for the reliability of clinical trials can be said to be monitoring and quality control (QC). However, companies are struggling to determine how much monitoring and QC is sufficient. Being overly meticulous can hinder the progress of clinical trials. The goal is to pass the Good Clinical Practice (GCP) inspection and become eligible for approval review. It is essential to thoroughly understand and respond to the true intent behind the reliability assurance that regulatory authorities seek. In this seminar, we will review the points raised during GCP inspections and elaborate on the proper approach to monitoring and QC. Additionally, we will explain the key points that require particular attention due to the GCP revisions in 2008.
Price information
49,980 yen (including tax and text costs) per company for 2 people.
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. Recent Observations Regarding Monitoring in GCP Investigations 1.1 Recent Examples of Findings from GCP Field Investigations and Compliance Inspections 1.2 Specific Content of Observations Related to Article 21 of the Ordinance 1.3 Specific Content of Observations Related to Article 22 of the Ordinance 2. QC Checkpoints 2.1 Clinical Trial Process 2.2 Implementation Details (SOP/PRT) 2.3 Results (CRF) 2.4 Storage of Documents or Records 3. QC Focus Points Along the Clinical Trial Flow 4. Considerations to Keep in Mind Following the 2008 GCP Revisions 5. Where Are the Causes of Mistakes and Deviations? 6. Issues Related to QC and Over-Quality in Monitoring 6.1 Monitoring Reports from the Perspective of Regulatory Authorities 6.2 Over-Quality from the Perspective of Regulatory Authorities 6.3 Over-Quality from the Perspective of Companies 6.4 Over-Quality from the Perspective of Medical Institutions 6.5 Proposals for Resolving Over-Quality 7. Summary
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