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Check out our free eBook which will guide you around the upcoming g EU JCA & local HTA processes 📖

Navigating the EU JCA & Local HTA Processes Just Got Simpler! Are you facing challenges with EU Joint Clinical Assessments (JCAs) and local HTA decision-making? 🌍 The evolving landscape of health technology assessments (HTAs) in Europe demands clarity and strategy. Our free eBook is here to guide you! 📖 What you’ll learn: ✅ Step-by-step strategies for navigating EU JCA submissions ✅ How to align with local HTA requirements seamlessly ✅ Insights to streamline your processes and improve decision-making Whether you’re in market access, regulatory affairs, or clinical development, this is a must-read! 📥 Download the eBook now and stay ahead: https://hubs.ly/Q02ZN2PT0 #EUJCA #HTA #MarketAccess #Pharma #RegulatoryAffairs #HealthcareInnovation

Are you facing challenges with EU Joint Clinical Assessments (JCAs) and local HTA decision-making? Navigating the EU JCA & Local HTA processes just got easier! 🌍 The evolving landscape of health technology assessments (HTAs) in Europe demands clarity and strategy. Our free e-book is here to guide you! 📖 What you’ll learn: ✅ Step-by-step strategies for navigating EU JCA submissions ✅ How to align with local HTA requirements seamlessly ✅ Insights to streamline your processes and improve decision-making Whether you’re in market access, regulatory affairs, or clinical development, this is a must-read! 📥 Download the e-book now and stay ahead: https://hubs.ly/Q032rGkh0 #EUJCA #HTA #MarketAccess #Pharma #RegulatoryAffairs #HealthcareInnovation

There are a lot of "what if's": What if a member state requests a different assessment scope during the national #HTA? Do they have to provide justification for this? Let's see how this is implemented on the national level.

🚨 FDA's Final Guidance: Enhancing Bioresearch Monitoring (BIMO) Inspections 🚨 The FDA has issued its final guidance for Standardized electronic submission of key data to aid Bioresearch Monitoring (BIMO) inspections for NDAs, BLAs, and clinical supplements submitted to CDER. 🎯 💡 Key Takeaways: ✔️Purpose: Streamline and enhance inspection planning by ensuring timely access to critical data, enabling efficient site selection and preparation for FDA inspections. ✔️Applicability: Covers pivotal studies supporting safety and efficacy claims in NDAs, BLAs, and certain INDs submitted prior to applications. ✔️Standardization: Sponsors are required to provide: ▶️ A table of all clinical sites, their investigators, and contact details. ▶️Listings of all contracted entities and their responsibilities. ▶️Subject-level data and summary datasets for clinical sites. ✔️Compliance Timeline: Starting December 2026, electronic submission in the specified format becomes mandatory. 🔎 Why This Matters: ✔️Facilitates a risk-based model for earlier and more efficient site selection. ✔️Enables FDA to verify data integrity, prioritize human subject protection, and support informed regulatory decisions. ✔️Aligns with the FDA's commitment to enhancing transparency and reliability in clinical research. 📈 As the industry moves towards greater digital standardization, this guidance marks a step forward in ensuring clinical research integrity and efficiency. How do you see this impacting your submission processes or inspection planning? Share your thoughts! #FDA #BIMO #ClinicalResearch #RegulatoryAffairs #DigitalHealth

STAY TUNED on EU HTA - 4 ******************************** 🚀 Third Implementing Act for JCA: New #Consultation Open! 🚀 The European Commission has launched a public consultation on the third draft implementing act. This draft outlines rules for exchanging information between the Member State Coordination Group, the Health Technology Assessment (#HTA) secretariat and the European Medicines Agency (#EMA) and includes: 📊 Planning and Forecasting: Establishes detailed procedures for sharing information about planning and forecasting joint #clinical #assessments and scientific consultations for both medicinal products and medical devices, enhancing strategic foresight. 👥 #Expert Identification: Provides guidelines for sharing information about identifying and involving patients, clinical experts, and other relevant professionals in joint clinical assessments and scientific consultations, ensuring the inclusion of diverse perspectives. 🔒 Robust #Confidentiality Measures: introduces strong safeguards to protect commercially sensitive and personal data throughout the process, including advanced IT platform integration for secure data exchange. 💬 Have Your Say! The consultation is open until July 24, 2024. We invite all stakeholders to participate and share their insights. Get involved and help shape the future of health technology assessment in the EU! 🌟 Stay updated with our latest insights on this evolving regulatory landscape. With our expertise and extensive experience, we are well-equipped to support our clients. #HealthTechnology #PublicConsultation #JCA #IA #Pharmaceuticals #Innovation #HTA #EMA #FutureOfHealth

The new EU HTA regulation demands more from drug developers—regulatory and HTA processes will now run in parallel. This presents a critical challenge: how do you optimize your teams to manage both without compromising efficiency? In our last webinar, Chantal W.M. van Gils and Maxwell Craig discuss why breaking down silos between clinical development, regulatory, and market access teams is vital for success. Watch the full webinar to learn how to stay ahead. https://lnkd.in/d9B74_Zq At SSI Strategy, we partner with you to develop an evidence and value strategy that meets these new requirements head-on. Don’t let resource misalignment slow your path to market. Let's talk! letstalk@ssistrategy.com

🔮 𝗪𝗵𝗮𝘁 𝗺𝗮𝗸𝗲𝘀 𝗮 𝘀𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗳𝗿𝗼𝗺 𝗮 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲? RQM+ Senior Vice President of Scientific Affairs Amie Smirthwaite, PhD, FRAPS and former FDA lead reviewer Ryan Randall take a shot at answering this question in the first of 𝘵𝘩𝘳𝘦𝘦 videos on the topic. We'll publish the next two in the next two weeks. 𝗞𝗲𝘆 𝗮𝘀𝗽𝗲𝗰𝘁𝘀 𝗰𝗼𝘃𝗲𝗿𝗲𝗱 𝗶𝗻 𝘁𝗵𝗶𝘀 𝗼𝗻𝗲* 👇 – Essential stakeholders in the clinical trial approval process for both US and EU markets – The importance of early engagement with regulatory bodies and payers – Reviewer approaches to clinical data sets and benefit-risk analyses – Strategies for navigating failed primary endpoints – The balance between statistical and clinical significance in regulatory decision-making – Differences in approach between MDD and #MDR in the EU – The impact of study design and protocol adherence on regulatory review *𝘛𝘩𝘪𝘴 15-𝘮𝘪𝘯𝘶𝘵𝘦 𝘓𝘪𝘯𝘬𝘦𝘥𝘐𝘯 𝘤𝘶𝘵 𝘪𝘴 𝘱𝘢𝘤𝘬𝘦𝘥 𝘸𝘪𝘵𝘩 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯, 𝘣𝘶𝘵 𝘥𝘰𝘯'𝘵 𝘮𝘪𝘴𝘴 𝘵𝘩𝘦 𝘧𝘶𝘭𝘭 21-𝘮𝘪𝘯𝘶𝘵𝘦 𝘷𝘦𝘳𝘴𝘪𝘰𝘯 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘰𝘯 𝘰𝘶𝘳 𝘠𝘰𝘶𝘛𝘶𝘣𝘦 𝘤𝘩𝘢𝘯𝘯𝘦𝘭 𝘢𝘯𝘥 𝘱𝘰𝘥𝘤𝘢𝘴𝘵, 𝘸𝘩𝘪𝘤𝘩 𝘢𝘳𝘦 𝘣𝘰𝘵𝘩 𝙡𝙞𝙣𝙠𝙚𝙙 𝙞𝙣 𝙩𝙝𝙚 𝙘𝙤𝙢𝙢𝙚𝙣𝙩𝙨. 𝘠𝘰𝘶 𝘤𝘢𝘯 𝘧𝘪𝘯𝘥 𝘵𝘩𝘦 𝘳𝘦𝘴𝘵 𝘰𝘧 𝘵𝘩𝘦 𝘷𝘪𝘥𝘦𝘰𝘴 𝘪𝘯 𝘰𝘶𝘳 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭𝘴 𝘦𝘥𝘶𝘤𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘷𝘪𝘥𝘦𝘰 𝘴𝘦𝘳𝘪𝘦𝘴 𝘵𝘩𝘦𝘳𝘦, 𝘵𝘰𝘰. ▶️ #RegulatoryAffairs #ClinicalTrials #MedTech #FDA #EURegulation #EUMDR

ICH News!! (Good Clinical Practice Guideline E6(R3)) The International Council for Harmonisation (ICH) has today (14 January) announced the adoption of the final version of its Guideline for Good Clinical Practice E6(R3). This update is a major milestone in global clinical research, reflecting the latest thinking in ethics, science, and quality standards. The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. This update replaces E6(R2) and aligns with ICH E8(R1) principles to foster quality by design, making clinical trials more adaptable to emerging technologies and diverse participant populations. Next Steps: The ICH E6(R3) guideline is now recommended for adoption by regulatory bodies across ICH regions, setting the stage for harmonized global implementation in clinical trial practices. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevice #medicaldevices #automation #regulatoryintelligence #fda #medtech #pharma #gcp #ich #ema #clinicaltrials

🚀 The Future of Clinical Trials: Risk-Based Monitoring (RBM) 🚀 Traditional monitoring methods can be resource-intensive and inefficient. Risk-Based Monitoring (RBM) is transforming the landscape by prioritizing data quality, patient safety, and regulatory compliance through a smarter, more efficient approach. 🔍 What is RBM? RBM identifies, assesses, and mitigates risks in clinical trials, focusing efforts where they matter most. Instead of routine site visits, it leverages centralized monitoring and targeted on-site visits based on risk indicators. 💡 Why RBM? ✅ Improves trial efficiency & reduces costs ✅ Enhances data integrity & patient safety ✅ Detects risks early with real-time monitoring ✅ Aligns with FDA & EMA guidelines As clinical research evolves, RBM is the way forward! Are you leveraging RBM in your trials? Let’s discuss! 👇 #ClinicalResearch #RiskBasedMonitoring #RBM #ClinicalTrials #Pharma #DataQuality #PatientSafety #Innovation