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

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

Event Categories

Health & Medicine: Pharma

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