FDA ADVERSE EVENT REPORTING FOR PHARMACEUTICALS 2011 is a course that covers categories such as:
- The Concepts of Seriousness, Expectedness and Causality
- Adverse Event Reporting to the FDA
- Safety Issues and Reporting Obligations
- Describe, Characterize and Document Adverse Events
- Identify Key Concepts Related to Electronic Records
- Associated with Clinical Trials and Marketed Products
- The Evolving Role of the FDA in Drug and Biologic Development
FDA ADVERSE EVENT REPORTING FOR PHARMACEUTICALS brings together clinical personnel, Safety personnel, Regulatory personnel, Safety personnel and Quality personnel.
