A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
EMA and FDA Inspections: Key Differences and Similarities
Upcoming Courses
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.
Learning Objectives
- Describe the EMA and FDA inspection processes
- Explain 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
Vaska Tone
Click here for complete trainer biographies
Registration Fees
$735
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Accreditation Information
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-17-087-L01-P. Released: 11/17.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
