Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices 2016

  • 16-17 Jun 2016
  • Philadelphia, PA, United States

Description

Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices 2016 is a course that covers topics such as:

  • The importance of the Food, Drug and Cosmetic Act (FDCA)
  • The role, structure what the Food and Drug Administration (FDA) regulates
  • Various safety management practices employed during clinical studies
  • How to setup a data safety monitoring plan and when to use a data safety monitoring board
  • How to create an adverse event database
  • The importance of the training requirements of safety monitors (investigators)
  • How to troubleshooting safety events with site principal investigators
  • The submitting process for IND/IDE safety reporting
  • How to survive an FDA audit for safety management practices and what Bioresearch Monitoring

Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices 2016 brings together:

  • Quality professionals
  • Quality managers
  • Compliance professionals
  • Regulatory professionals
  • Biotechnology and pharmaceutical professionals
  • Medical device professionals
  • Study Monitors
  • Clinical Investigators
  • Data analysis specialist
  • Quality auditors
  • Record retention specialists
  • Document control specialists
  • Marketing Staff
  • Medical affairs

Past Events

Important

Please, check "Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Quality assurance
Health & Medicine: Medical device, Medical laboratories, Medical technology
Science: Life Sciences & Biology
Technology: Biotechnology

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