Lunch and Learn: EU Clinical Trial Regulation 536/2014

If you currently operate or plan to operate clinical trials in Europe, you will be impacted by the European Union Clinical Trial Regulation 536/2014 (EU-CTR), effective January 2022. The new regulation aims to standardize and harmonize interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency.

With little time left to prepare, companies need to mobilize all stakeholders to analyze current business processes, upgrade information technology systems, and restructure operations to avoid disruptions to
start-up, conduct, and maintenance of ongoing and new clinical trials. And since it is lunchtime somewhere in the world, grab a bite to eat take a short break, and learn about the new regulation and how it might impact you and your company.

This short session will cover:

• Overview of the new EU-CTR regulation
• Understanding the new Clinical Trial Information System (CTIS)
• Impact of the new regulation on clinical trials
• Top tips for operationalizing the new changes

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