The Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application 2016 is a webinar that covers topics such as:
- Minimum data elements for a Serious Adverse Event Report
- Overview of Dietary Supplement and Nonprescription Drug Consumer Act of 2006
- How to adhere to the reporting timeframes
- Label submission guidelines are reviewed
- FDA expectations for reporting submissions
- Various mechanisms for receiving a report of an adverse event
The Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application 2016 is intended for:
- Senior Management
- Quality Assurance Professionals
- Quality Project Managers
- Regulatory Affairs Professionals
- Pharmacovigilance Professionals
- Auditors
