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: Clinical Trial Applications and Amendments
Upcoming Courses
Course Description
This web seminar reviews clinical trial applications and the EU single authorization process including Part I and Part II assessment reviews/reports/ determinations as well as the EU portal for sponsor and European Medicines Agency (EMA)/Member State communications. The submission and assessment of the application by the Reporting Member State and Concerned Member State(s), and their responsibilities will be reviewed along with their assessment reports and corresponding review timeline requirements. We will also examine amendments, substantial modification indications, requirements and authorization. Authorization of investigational medicinal products for use in clinical trials will also be discussed from the perspectives of manufacturing, importation and labeling. Insight and recommendations sponsors can implement to be in compliance with the EU CTR 536/2014 requirements will also be covered.
Learning Objectives
- Explain the information and language requirements in a clinical trial application (CTA) dossier
- Describe the EU single authorization process
- Identify when an amendment/substantial modification is required
Who Should Attend
- Study Managers/Directors
- Regulatory Affairs Professionals
- 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#: 0778-0000-17-064-L01-P. Released: 2/17.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
