Jonathan Newton

👉 Big regulatory changes are coming to the EU pharmaceutical sector. 🇪🇺 The EU Medicines Regulation 2025–2026 will reshape how variations are classified and managed across Europe. New definitions like Relevant Authority and Reference Authority ✅ Introduction of supergrouping and annual reporting ✅ Annexes restructured from ABCD ➝ EQCM These updates aim to simplify procedures while ensuring greater transparency and patient safety. ☀️ And since it’s August, it might just be the perfect read for a quiet summer break. Insightful, timely, and essential for everyone in the pharmaceutical field. 📖 Read the full article here: 🇪🇸 https://lnkd.in/dU-EpQVn 🇬🇧 https://lnkd.in/dfwnQKym

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The State of Clinical Trials: Charting the Path to 2030 – Executive Summary Now Available In May, 150 leaders from across the clinical research ecosystem came together to explore what’s working, what’s not, and what’s next for clinical trials. Now, we’re sharing the executive summary from that meeting, capturing the key themes, bold ideas, and actionable opportunities that emerged.    Whether you’re a sponsor, site, regulator, patient advocate, or tech partner, this summary offers important insights and next steps for advancing clinical trials.    Read the executive summary and join us in shaping a more efficient, patient-centered future for clinical research: https://ow.ly/AUBc50WyFEw

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For over two decades, the Good Clinical Data Management Practices (GCDMP©) have defined the standard for excellence in clinical data management. Shaped by experience, peer review, and the collective expertise of the CDM community, GCDMP© is more than a guideline - it’s a foundational framework that continues to evolve with the needs of our industry. Whether you're building your first data management plan or refining global processes, GCDMP© helps you: ✅ Align with regulatory expectations ✅ Standardize across teams and vendors ✅ Improve data quality and integrity ✅ Reduce risk and increase efficiency Each chapter is grounded in real-world application and designed to support professionals at every stage of their #CDM journey. 📖 Explore GCDMP©: https://scdm.org/gcdmp Dawn Kaminski, Ram Mudaliar

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Routine site visits alone won’t meet ICH E6(R3) expectations. The new EU guidance calls for risk-based, proportionate clinical trial monitoring, customized to each study’s complexity and risk. To stay compliant, sponsors and CROs should: 🔹 Focus monitoring on what’s critical to patient safety and data integrity. 🔹 Use remote monitoring tools to spot issues early. 🔹 Leverage analytics for real-time decision-making. 🔹 Maintain clear oversight of decentralized trial activities and vendors. Learn what you can do to ensure your trial protocols, monitoring strategies, and data management systems are prepared. Read the guide to ICH E6(R3) here: https://lnkd.in/eUDA5D-2

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