EFGCP - European Forum for Good Clinical Practice

🌟 The EFGCP Better Medicines for Children Conference 2024 has concluded, wrapping up two intense days of insightful discussions and collaboration. A heartfelt thank you to all the delegates and participants who made this event a success. Your engagement and expertise truly enriched our conversations! Looking forward to continuing the dialogue and driving progress in paediatric medicine in October 2025. #EFGCP #BetterMedicinesForChildren #Conference2024 #PaediatricHealth

📢 SAVE THE DATE! 📢 EFGCP Better Medicines for Children Conference 2025 Join us as we explore "Innovation in Paediatric Drug Development as a Driver for Change" 🚀 In an evolving regulatory and scientific landscape, this year’s conference will highlight how innovative approaches and solutions can drive greater efficiencies in paediatric drug development—across Europe, the US, and globally. Stay tuned for more details! 🔎 #PediatricMedicine #DrugDevelopment #Innovation #EFGCP

Week FIVE – Safe at the top. We continue with a short discussion on a GCP-critical topic i.e., “clinical trial safety”, and its integration into the Quality Management System. A common pitfall in clinical quality management systems we’ll look at case studies for compliance. 📝 For more information or to register click here: https://lnkd.in/esFJHaUf #QMS #QualityManagementSystem #webinars #academicresearch

A recent EFPIA blog highlights the need to remove barriers that prevent patients from accessing clinical trials across borders. 🌍 ❌Regulatory and logistical challenges continue to limit participation, delaying access to new treatments and slowing medical progress. 🤝EFPIA, along with EFGCP, is leading the EUXCT initiative to address these challenges and improve cross-border clinical trial access in Europe. As part of this effort, EU-X-CT has launched a public consultation on draft recommendations to create a more coordinated and efficient process. 👉See draft recommendations and send us your comments: https://lnkd.in/eG769Jrf 📖 Read the EFPIA blog here: https://lnkd.in/dihaUQjV 🙏 Thank you EFPIA - European Federation of Pharmaceutical Industries and Associations for drawing attention to this important issue. #ClinicalTrials #CrossBorderTrials #PatientAccess #EUXCT #EFPIA #EFGCP

Week FOUR – Building Stamina In this session we reflect on the effectiveness of our quality management system, how it can be continuously or continually improved using a risk and process-driven approach, and ensure our systems are raising flags and alerts at the operational level. 📝For more information or to register, please click the following link: https://lnkd.in/esFJHaUf #QMS #QualityManagementSystem #webinars #academicresearch

Exciting news! As the head of the EFGCP - European Forum for Good Clinical Practice eConsent initiative, I’m proud to share that the work of our Study Documents Workstream has been referenced in the updated Swissmedic & Swissethics position paper on Decentralized Clinical Trials (DCT) with medicinal products (published Feb 10, 2025)! A huge congratulations to the incredible team behind this achievement! Your dedication is driving real impact in shaping the future of eConsent. Special thanks to some of the key contributors of the Study Documents Workstream: Silvia C., Tina Caruana, Manuela Ghielli, Wendy Frye, Holly Robertson, PhD, Reamonn Madden, Nora Meskini, Svetlana Litvak, Petra Ochabova, Jana Devine RN, BSN. And a big thank you to the entire EFGCP eConsent initiative team for your continued contributions! #eConsent #ClinicalTrials #DCT #RegulatoryUpdates #EFGCP

Week THREE – Relax into the mind-stretch Establishing the framework on which to build our improvements, we’ll look at getting the right documents in place at the right time, making sure bureaucracy burdens and we’re all fit for purpose. 📝For more information or to register, please click the following link: https://lnkd.in/esFJHaUf #QMS #QualityManagementSystem #webinars #academicresearch

Academic Quality Management System Bootcamp Week TWO – Rehydration station! Inspired by Week One we’ll absorb the basic requirements of the quality management system and critically review your situation in 5 key points, following from week one’s homework. Share your pain so we all gain. For more information or to register, please reach out to the sign up here: https://lnkd.in/esFJHaUf #academicbootcamp #QMS

Trying to make sense of eConsent amidst the complexities, disconnects, and uncertainties? Or having questions about the suite of tools developed by the European Forum GCP eConsent initiative? Join Katrin Ong and me on January 29 at 16 CEST as we demystify eConsent and provide insights to help bridge the gaps. Want to explore the tools in advance? They’re publicly available here: https://lnkd.in/e_bnzgQt

Academic Quality Management System Bootcamp Week ONE – Checking you have the right kit to get started! Laces tied, focussed mind… In this session, we’ll work together to set our six-week objectives, based on quality fundamentals. Your case studies will contribute to our success For more information or to register, please click here: https://lnkd.in/esFJHaUf #QMS #QualityManagementSystem #webinars #academicresearch