Trial Master File Requirements and Essential Regulatory Documents 2019

March 19, 2019
Webinar

Trial Master File Requirements and Essential Regulatory Documents 2019 will be held on March 19, 2019.

Trial Master File Requirements and Essential Regulatory Documents 2019 is a webinar dedicated to techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.

Trial Master File Requirements and Essential Regulatory Documents 2019 covers topics such as:

  • Review the GCP requirements for essential documents
  • Define clinical research essential documentation
  • Discuss essential documentation for drugs, biologics and devices
  • Determine essential subject and non-subject specific documentation requirements per trial
  • Learn how to set up, maintain and manage a document system that meets regulatory standards
  • Describe the significance of document management in clinical research
  • Prepare for regulatory inspection: Proactive and reactive use of essential documentation
  • Understand the role of auditors, and learn how to archive documentation and prepare for a quality assurance (QA) audit or regulatory inspection

Trial Master File Requirements and Essential Regulatory Documents 2019 is intended for:

  • Medical Affairs
  • Regulatory Affairs Professionals
  • Clinical Research Associates (CRAs) involved in Planning, Monitoring, Execution of trials and Responsible for Clinical Trial Reporting
  • Project Managers
  • Principal Investigators
  • Grant Managers
200-700 US Dollar
No exhibition

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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