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  • Regulatory Documentation for Clinical Trials

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Apr 18, 2014 10:00 AM
  • End Time:
  • Friday - Apr 18, 2014 11:00 AM
  • Location:
  • Online
  • This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.

    Why Should You Attend:
    Missing or incomplete clinical trial documentation is one of the leading causes of 483 audit findings and delays in regulatory approval. Not knowing about required documentation and the format of each document is not considered an excuse by reviewers.
    Regulatory agencies want consistency of documents not only within a company but between companies to help speed up review time. Regulatory documents for clinical trials not only consist of sponsor-level clinical operations and site-level documents, but also documents in the areas of data management, drug supply, biostatistics and others for which clinical operations and regulatory affairs often maintain primary responsibility. Having knowledge of required documentation not only in the operational and regulatory affairs portions but also in external areas is essential for efficient trial management and execution. It is also important to know how to close out a Trial Master File in a timely manner and prevent adverse regulatory agency findings.
    This webinar will present a detailed list of the required clinical trial documentation and it will be broken down by industry: pharmaceutical, biotechnology, medical devices and diagnostics. Documents requiring legal review such as site contracts, vendor contracts, and Informed Consent forms will also be discussed for required content from a legal and regulatory perspective. The instructor will also review many of the documents in terms of required content and structure.
    This webinar will also present additional documents for specific countries outside of the US. If you or your company have had issues finalizing the TMF in the past or have had any issues with submissions or inspections of your clinical trials, don’t miss this crucial presentation.

    Areas Covered in the Webinar:
    Specific list of required regulatory documentation for clinical trials
    Content and format review of selected documents
    Legal requirements of specific clinical regulatory documents
    Typical development and review processes of these documents
    Review of required non-clinical documents for clinical professionals
    Maintenance and quality assurance practices
    Trial Master File closure activities

    Who Will Benefit:
    This webinar will provide valuable assistance to all personnel in:
    Clinical Project Management
    Clinical Operations
    Regulatory Affairs
    Clinical Trial Assistants
    Clinical Data Management
    Legal Affairs
    Study Supply Management
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