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