Are You Ready for EU CTR? The Challenges, Lessons Learned and Innovations Surrounding the New Regulation, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn about the significant changes that the new European Union Clinical Trial Regulation (EU CTR) will bring to how clinical trials are conducted in the EU. The featured speakers will discuss how companies can adapt their processes and systems to these new systems in order to comply. Attendees will learn which innovative process and technology solutions can help them achieve readiness success.

TORONTO (PRWEB) May 26, 2022

The European Union Clinical Trial Regulation (EU CTR) is the largest change in the EU clinical trial landscape in 20 years. This year marks the beginning of a three-year transition period during which companies need to implement updated processes and assess systems to enable compliance and effective Clinical Trials Information System (CTIS) interfacing. Companies wanting to run future interventional medicinal trials in the EU now more than ever need to ensure that their readiness programs are prioritized.

The following six major changes mandated by CTR are significant and require processes and systems across sponsors and CROs to be adapted to ensure compliance:

Clinical Trial Application (CTA) submission to all member states is now done through CTIS, with 12-day request for information (RFI) response times and new constraints to submission modifications; new labelling requirements for Investigational Medicinal Product (IMP); increased transparency requirements that impact disclosure of commercial confidential information and protected personal data; increased clinical trial notifications requirements; new safety reporting requirements and timelines; and CTIS interaction.

Join this webinar as EU CTR experts discuss these challenges and the innovative process design, technology and outsourcing solutions available.

Join experts from Syneos Health®, Fabienne Lekaim, PhD, Director, Regulatory Advice and Delivery (RAD) Team – SSU Early Engagement; Peter Sargent, PhD, Director, R&D Advisory; Charlie Bergqvist, Senior Engagement Manager, R&D Advisory; Sherry Merrifield, Senior Director, Global Operations Management; and Fatima Pimentel, Associate Director, Site Start-Up & Regulatory, for the live webinar on Tuesday, June 14, 2022, at 9am EDT North America (2pm BST/UK).

For more information, or to register for this event, visit Are You Ready for EU CTR? The Challenges, Lessons Learned and Innovations Surrounding the New Regulation.

ABOUT SYNEOS HEALTH

Syneos Health® SYNH is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs and commercial capabilities to address modern market realities.

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To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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