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

Topics

• 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

Who should Attend

• 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