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How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance
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How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance

7/27/2015 to 7/28/2015
When: July 27-28, 2015
Where: The Hilton Los Angeles Airport (LAX)
5711 West Century Boulevard
Los Angeles, California  90045
United States
Presenter: The Center for Professional Innovation & Education, Inc.
Contact: Olivia Carlin

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How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance

By the end of this course, participants will have a detailed understanding of how to:

  • Identify and define the principles and requirements for GCPs
  • Define the roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
  • Recognize clinical trial documentation differences for drug, device, and biologic studies
  • Recognize how GCPs can impact clinical research programs
  • Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
  • Understand what happens during a GCP inspection
  • Detect and prevent fraud and misconduct in clinical trials
  • Ensure that your data and supporting documentation are accurate and in the right format for inspectors

This GCP compliance training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies.

1. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

2. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Learn more about the course and register.

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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