Companies wanting to run future interventional medicinal trials in the EU now more than ever need to ensure that their readiness programs are prioritized.
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® (Nasdaq: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.
Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.
To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.
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