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!
EU Clinical Trial Regulation 536/2014: Sponsor and Investigator/Institution Responsibilities as Trial Sponsor
Upcoming Courses
Course Description
This web seminar is an overview of the Investigator/Institution responsibilities as the sponsor of a clinical trial of an investigational medicinal product in the EU according to EU Clinical Trial Regulation (EU CTR) 536/2014. The new Clinical Trials Coordination and Advisory Group (CTAG) mandate will be discussed along with the tasks associated with this group. An overview of the following topics will be covered: EU CTR document structure and the importance of the content and Annexes to regulatory compliance; legal representation in the EU, clinical trial authorization, amendments; vulnerable subjects, protection of human subjects, informed consent; start, end, temporary halt, early termination; study management/monitoring, safety reporting, and serious breach reporting; substantial modifications and annual reports.
Learning Objectives
- Define “Sponsor and Investigator”
- Differentiate between “Sponsor and Investigator” and “Principal Investigator” roles for a clinical trial
- Identify the requirements for conducting clinical trials in the EU
- Describe the European Medicines Agency (EMA) expectations for mandatory adherence by trial sponsors to the EU CTR Annexes
Who Should Attend
- Sponsor-Investigator/Sponsor and Investigator
- Institutional Trial Sponsors
- Clinical Trial Office Managers/Directors
- Compliance Officers
- Study Managers/Directors
- Quality Assurance Personnel
Instructor
Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.
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#: 0778-0000-17-0263-L01-P. Released: 2/17.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
