mindsON RBQM | Special Edition: Risk-Based Medical Monitoring Under ICH E6(R3) – Supporting Patient Safety with Technology
Registration for the webinar
Currently there are no future dates for the webinar.
Moderators
MyRBQM Academy
by Cyntegrity
Targeted education helps clinical research teams embrace the implementation process and contribute to its success, ensuring your organization's RBQM strategy has the components it needs to meet regulatory expectations.
Established in 2019, Cyntegrity's MyRBQM® Academy units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at: www.academy.cyntegrity.com
Guest Speaker:
Dusan Markovic, MD
ERGOMED Clinical Research
(VP Global Medical Affairs)
With over 20 years of experience as a licensed Radiologist, Dusan specializes in clinical development, focusing on oncology and rare diseases. He has a strong background in innovative therapies and complex designs, including First-In-Human (FIH) studies and dose escalation.
Dusan has been involved in numerous Scientific Review Committees (SRCs) and has recently co-authored nine abstracts in the field of oncology. He has also presented at prestigious conferences such as ASCO, ESMO, ESTRO, EHNO, AHNS, and other critical oncology-focused conferences.
Dusan is dedicated to pursuing knowledge and innovation in the rapidly evolving field of oncology research. Throughout his career, he has built enduring relationships with Key Opinion Leaders (KOLs) and research sites.
Julien Goncalves
Julien, a scientist with 6 years of experience in pre-clinical and clinical research, leverages his solid scientific foundation in distinct roles within marketing and business development in the healthcare and life science industries. Effectively communicating scientific content for impactful results, Julien successfully overcomes the common misalignments between sales and marketing teams. As Cyntegrity’s RBQM Solutions Architect, he adeptly translates client needs into actionable RBQM solutions tailored to each organization. With his combination of scientific training and marketing acumen, he significantly contributes to Risk-based Quality Management within Clinical Trials.
Description
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.
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.