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.

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