Trial Master File Requirements and Essential Regulatory Documents 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.

Topics

• 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

Who should Attend

• 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