Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: EMA and FDA Inspections: Key Differences and Similarities
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.
Video Preview
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
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
