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Freelance Senior Consultant Clinical Regulatory Affairs & Study Start-Up, Founder, CTR/CTIS Master Trainer, Speaker and your Rock in the surf

🚨 Important Update for Sponsors: New Resource for CTR 536/2014 Transition 🚨 As a Regulatory Affairs & Study Start-up consultant, I stay up-to-date on the latest developments impacting clinical trials. Recently, the European Commission published a new resource to assist sponsors with transitioning ongoing clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) 536/2014. Key Point: 📚 New Resource: The European Commission published on EudraLex Vol. 10 the "Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation" to aid sponsors in the CTR transition process. You can access the guidance here: https://lnkd.in/e6AEgF5K What this means for Sponsors: ⏰ Deadline Approaching: It's crucial to remember that only the CTR and its delegated acts will be applicable from January 31, 2025. This means sponsors of ongoing clinical trials under the CTD need to transition their trials to the CTR by this deadline to remain compliant. 🚀 Action Required: Sponsors should review the new guidance to understand their obligations and the steps involved in transitioning their trials. 🔍 Seek Expert Advice: Given the complexity of the transition process, consulting with a qualified regulatory affairs professional is highly recommended. Feel free to connect with me to discuss your specific needs and explore how I can assist you in navigating the CTR transition process. #RegulatoryRocks #CTISrocks #TransitionalTrials #CTIS #CTR #ClinicalTrials #SSU #regulatory #regaffairs #RegulatoryAffairs #StudyStartUp

10c83e6b-2587-420d-9204-d49c2f75f476_en

10c83e6b-2587-420d-9204-d49c2f75f476_en

health.ec.europa.eu

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