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Archive: EMA and FDA Inspections: Key Differences and Similarities

October 25, 2016
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Course Description

In this web seminar, key differences and similarities between the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) inspection procedures and processes will be discussed, including their collaborations on official joint Good Clinical Practice (GCP) inspections of sponsors, CROs, and investigational sites. The published results of the Pilot EMA-FDA GCP Initiative will also be reviewed using recent examples of joint inspections. Clarification will be provided for reporting of Serious Breaches in the United Kingdom along with a review of common inspection findings.

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Learning Objectives

  • Describe the EMA and FDA inspection processes
  • Clarify reporting of Serious Breach requirements
  • Review inspection findings of FDA-EMA joint inspections

Who Should Attend

  • Quality Assurance Personnel (Auditors, Compliance Officers)
  • Clinical Trial Managers
  • Clinical Research Associates
  • Project Managers
  • Drug Safety Personnel
  • Post-Marketing Pharmacovigilance Personnel

Instructor

The course will be led by one of the following instructors:

Vaska Tone

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.