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EU Clinical Trial Regulation: A Fresh Take on Simplifying and Harmonizing Rules 🏥 Remember when we talked about the EU Clinical Trial Regulation 536/2014? Well, it's officially replaced the old Directive, and here's a quick refresher: 🔗 Coordinated Assessment: One decision from a reporting member state for multinational applications. 🖥️ CTIS: A shiny new portal for streamlined data submission and processing. 📅 Important Dates: Mandatory CTIS use from January 31, 2023, and compliance for existing trials by January 31, 2025. 📜 Transparency: More public insight, with protections for personal data and confidentiality. 💬 Informed Consent: Clear rules for consent procedures, with simplified options for low-risk trials. ⏰ Deadlines: Strict timelines and mandatory reporting within seven days for serious breaches. Adapting your strategies to these changes is crucial 👉 https://lnkd.in/er-iUViG #EURegulations #Law #Lawyer #clinicaltrials

Did you know Congress has the power to overturn regulations and guidance from federal agencies? The Congressional Review Act (CRA) allows lawmakers to revoke policies under specific conditions—and the upcoming Congress might use it to challenge key policies from the Biden administration. 💡 Curious about how this could impact FDA policy? AgencyIQ breaks down: ✅ How the CRA works ✅ Which FDA regulations could be affected ✅ What it means for the future of policy Read more to stay ahead of regulatory changes that could reshape the landscape. Rachel Coe Laura DiAngelo #Regulation #FDA #CongressionalReviewAct #PolicyChanges

#Globalaccess2024 panel discussion on shaping the future regulatory system - Niall MacAleenan spoke about what can be achieved within the current framework for tangible improvement. Key importance is to improve governance & infrastructure to have an effective implementation of MDR/IVDR #HPRA; #MDR/IVDR; #irishmedtech

Struggling with regulatory compliance? ClinicTracker's robust clinical records management system can help you stay compliant and stress-free. Learn more about its features: https://hubs.ly/Q02DBNQ50 #RegulatoryCompliance #EHR #MentalHealthProfessionals

Ensuring regulatory compliance is crucial for maintaining trust, accuracy, and efficiency in clinical trials. Learn about our customer-focused approach to auditing that encompasses full transparency and 24/7 access to essential documentation: https://bit.ly/3AiV58o #ClinicalTrials #ClinicalTrialCompliance #Compliance

Clinical trial audits are challenging. Find out how we give our customers a clear pathway to better audits, faster

Struggling with regulatory compliance? ClinicTracker's robust clinical records management system can help you stay compliant and stress-free. Learn more about its features: https://hubs.ly/Q02DBV__0 #RegulatoryCompliance #EHR #MentalHealthProfessionals

Regulatory compliance is a critical concern in any clinical trial, and anticipating potential regulatory queries is key to a smooth approval process. A well-constructed clinical outcome assessment strategy should include foresight into what data regulatory bodies might scrutinise. Read more insights https://ow.ly/soHW50U4nXp #ClincialTrials #ClinicalResearch #ClinicalOutcomeAssessments

✒️ Today with Oreste Pollicino commenting on the decision of the ECJ in C-21/23 (in Italian). The European Court recognised the possibility for Member States' rules allowing competitors to claim a violation of substantive provisions of the GDPR based on the prohibition of acts of unfair competition, while also underlining that the data shared by online customers to order non-prescription medicines qualifies as “health data”, and, therefore, should be treated as particular categories of personal data