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
Past Events
Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices 2016 - 14-15 Jul 2016, Four Points By Sheraton San Diego Downtown, California, United States (59827)
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
Health & Medicine: Medical device, Medical laboratories, Pharma
