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: Are You Ready?
Upcoming Courses
The effective date for the implementation of the European Union (EU) Clinical Trial Regulation of 2014, which establishes the rules for conducting clinical trials throughout the EU, is rapidly approaching. The regulation ensures that Member States, in authorizing and supervising the conduct of a clinical trial, adhere to ‘one set of rules’. The regulation also brings harmonization with the ICH GCP E6 Guideline R2 proposed addendum of 2015, various draft and final European Medicines Agency (EMA) Reflection Papers (e.g., risk-based quality management, Trial Master File and Archiving), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) serious breaches reporting requirements. In this web seminar, the instructor systematically presents select regulation requirements so learners will be able to swiftly, efficiently, and effectively perform an internal review and gap analysis of their organization’s procedures, processes and personnel training in order to be ‘ready’ by the effective implementation date.
- Distinguish between the EU Clinical Trial Regulation and the EU Clinical Directive
- Describe the EU Clinical Trial Regulation requirements for Sponsors, CROs, Investigators, Member States and Independent Ethics Committees
- Identify organizational practices requiring implementation or modification to ensure compliance by the effective date
- Managers/Directors: Clinical Operations, Quality Management, Compliance, Process Improvement, Quality Assurance
- Study Managers
- Project Managers
- Clinical Research Associates
- Investigators
- Study Coordinators
Liz Wool, R.N., B.S.N., C.C.R.A., CMT
Click here for complete trainer biographies
$795
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.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 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#: 0778-0000-16-019-L01-P. Released: 3/16.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
