mindsON RBQM | Special Edition: Risk-based Medical Monitoring under ICH E6(R3) скачать в хорошем качестве

mindsON RBQM | Special Edition: Risk-based Medical Monitoring under ICH E6(R3)

Join us for this special edition of mindsON, focused on the expanding role of Medical Monitoring in clinical trials. With the recent release of ICH E6(R3) guidelines, trial oversight professionals now encounter fresh requirements in risk management, patient safety, and data quality. This session will explore how these guidelines shape risk-based Medical Monitoring practices and show how AI-enhanced technology can assist medical monitors, pharmacovigilance teams, clinical operations, and data managers meet these enhanced responsibilities. Meet the Speakers: Dusan Markovic - Vice President, Global Medical Affairs, ERGOMED Julien Nunes Goncalves - Head of Growth, Cyntegrity Key Topics: ICH E6(R3) Guidelines: Essential updates for medical monitors and clinical trial professionals concerning safety oversight, risk management, and protocol compliance. Practical Approaches to New Requirements: Approaches to efficiently manage and support expanded roles across various trial stages. Technology in Action: How a digital Subject Profiles tool simplifies workflows, enables medical monitoring, and enhances patient safety efforts. Who Should Attend: Medical Monitors, Pharmacovigilance Specialists, Clinical Operations Managers, Data Managers, Quality Assurance Teams, CRO Teams, and others involved in ensuring patient safety and compliance in clinical trials. ABOUT "mindsON RBQM" WORKSHOPS The mindsON RBQM workshops provide practical, system-agnostic guidance on the challenges of implementing and executing Risk-Based Quality Management (RBQM) in day-to-day clinical trial operations. These sessions emphasize interactive dialogue and problem-solving, offering a collaborative space to share experiences, explore strategies, and tackle real-world challenges. Rooted in Quality by Design (QbD) principles, mindsON RBQM focuses on concepts and strategies without being tied to any specific system. For those looking to see these principles applied through technology, the actON QbD series offers complementary workshops with live demonstrations of use cases powered by the MyRBQM Portal. Whether you choose to participate or simply observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively. Ready to explore smarter Medical Monitoring? 🔗 Register here: https://academy.cyntegrity.com/upcomi... 🔗 For a demo of AI-augmented RBQM: https://cyntegrity.com/contact-us/