EU Clinical Trial Regulation (EU-CTR) Requirements

Course Description

The EU Clinical Trial Regulation (Regulation (EU) No. 536/2014) has ushered in a transformative era for clinical trials within the European Union and is built on three fundamental pillars: Enhancing the efficiency of clinical trials in Member States Concerned (MSCs) to foster innovation and reduce duplication, increasing the transparency of clinical trials across Europe, and prioritizing participant safety. At the core of this regulatory shift is the Clinical Trial Information System (CTIS), which serves as the central hub for all submissions to the EU. This comprehensive web seminar is designed to provide participants with a thorough understanding of the EU-CTR, its objectives, and its practical implications for clinical trial conduct in the EU.

Learning Objectives

• Understand the rationale and requirements for the regulation
• Become proficient in identifying and comprehending the different types of submissions within CTIS
• Explore the critical roles and responsibilities of key stakeholders involved
• Gain a comprehensive understanding of the submission process through the CTIS, from initial registration to ongoing updates and amendments

Who Should Attend

• Clinical Trial Management, Monitors and Leads
• Regulatory Affairs
• Executive Management

Instructor

Andy Lawton

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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.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1 hours (0.1 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#: 0778-0000-24-034-L99-P. Released: 2/24. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.