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
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It is very important the actions that have been taken for training all stakeholders on the new regulatory procedures according to the recently approved law (14.784/2024) for Clinical Trials in Brazil. The new law will provide more protection for participants, predictable regulatory timeline approvals and less bureaucratic procedures.
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🔍Ever wondered who ensures the safety and rights of clinical trial participants? Meet the Legal Representatives and European Authorized Representatives, the guardians of compliance in clinical research. Swipe to discover their pivotal role in upholding ethical standards and regulatory compliance! Need help? Contact us: info@gcp-service.com or schedule your FREE 1:1 consultation here: https://lnkd.in/d6siPERm #ClinicalResearch #EthicalStandards #ComplianceGuardians #EULegalRepresentatives #ClinicialTrials
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Why should you translate informed consent forms? Informed consent is a fundamental ethical principle in research that ensures that participants or the subjects fully understand the study and voluntarily agree to participate. Translating these forms is crucial to ensuring and confirming that the participants have understood all the nuances of the study. Additionally, it builds trust, limits liability, and ensures regulatory compliance. To know more about ICF translation, read: https://bit.ly/3IFH1qq
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Additional Perspective on the LifeLabs Case: Building on Kris Klein’s Insights As Kris Klein, CIPP/C, CIPM, FIP highlighted, the LifeLabs Medical Laboratory Services LP v. Information and Privacy Commissioner of Ontario decision underscores the limits of solicitor-client and litigation privilege in regulatory investigations. Expanding on his points, here are some additional perspectives: Key Takeaways for Privacy Professionals: Privilege Isn’t Absolute: Facts about breaches (e.g., root causes, remediation) cannot be shielded simply by involving legal counsel or embedding them in privileged reports. Clear Incident Response Protocols: Ensure breach response plans distinguish legal advice from operational or factual investigations to avoid weakened privilege claims. Joint Investigations & Global Influence: Regulators increasingly collaborate across borders, and courts may reference international cases like Capital One for guidance. Reputation Costs of Delays: Efforts to block transparency can backfire, eroding public trust, inviting harsher scrutiny, and worsening reputational harm. Bottom Line: Organizations must align breach response strategies with regulatory transparency while ensuring privilege claims are specific and defensible. Building on Kris Klein’s insights, this case reminds us that accountability and cooperation matter — delays or obstruction carry real risks. Are organizations truly prepared to manage the balance between privilege and transparency?
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FDA Law Blog has an excellent post today going over some of the ongoing concerns regarding the recent LDT rule, along with considerations a clinical laboratory needs to account for. Definitely worth a read. https://lnkd.in/gxYaG638
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LDT rule - broken down in an excellent post in the link below. It is one of the most readable ones I have seen and has beautiful examples.
FDA Law Blog has an excellent post today going over some of the ongoing concerns regarding the recent LDT rule, along with considerations a clinical laboratory needs to account for. Definitely worth a read. https://lnkd.in/gxYaG638
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🚀 Happy to announce that Gert Bos, PhD, FRAPS, will be joining us during our upcoming seminar in Brussels, Sept 24-26! Gert Bos will dive into the latest developments of the EU MDR legal framework. Get the inside scoop on implementation status, evolving guidance, and future directions for legislation and governance. Don't miss out— discover our full program and secure your spot today! https://lnkd.in/eru4KEH9 #EUMDR #RegulatoryUpdate #MedTech #Compliance #LabTesting #Sterilization
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Partner - Data, Tech and Cybersecurity - Helping Businesses Thrive in the Digital Age
The Q1 2024 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy. #lifesciences #healthcare #EU https://lnkd.in/eHWRY2-W
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A big thank you to all who joined our webinar on key regulatory aspects & legal challenges! We appreciate your participation and engagement. We trust you found the insights on navigating complex guidelines for clinical testing in Europe from our experts, Vlada Injac and Istvan Horvath, valuable. For those who couldn't make it, reach out for access to the recording. Stay tuned for more events and resources! #webinar #clinicaltrials #clinicalresearch #legal #regulatory
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The Q1 2024 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy. #lifesciences #healthcare #EU https://lnkd.in/dp8Cc7gi
Life Science Law Update – Key developments for pharma & device companies in EU
