Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application 2016
25 May 2016
Webinar
Description
Topics
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
Who should Attend
Senior Management
Quality Assurance Professionals
Quality Project Managers
Regulatory Affairs Professionals
Pharmacovigilance Professionals
Auditors
Past Events
Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application 2016 - 25 May 2016, Webinar (59607)
Important
Please, check "Post-marketing Adverse Event Reporting for Non-prescription Human Drug Products Marketed Without an Approved Application" official website for possible changes, before making any traveling arrangements