mindsON RBQM | Special Edition: Risk-Based Medical Monitoring Under ICH E6(R3) – Supporting Patient Safety with Technology

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23. Januar 2025, 15:00 - 16:00
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Moderators

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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 

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Guest Speaker:
Dusan Makovic, MD

VP Global Medical Affairs (Ergomed)

Bio in preparation

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Julien Goncalves

RBQM Solutions Architect

(Cyntegrity)

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.

26. Juni 2024 Michal Helbin

A comprehensive approach to the management of risks in a clinical study. The platform is very well designed, it has been very well presented during the webinar. The platform is detailed but graphically appealing. It utilizes the smart risk categories as proposed by the TransCelerate Biopharma, uses some proprietary tools and knowledge as designed by the Cyntegrity and is easily scalable should any organization need to add more categories at any time. Its a product well done.

18. September 2024 Hanlie Bester

I thoroughly enjoyed the 'mindsON RBQM Episode 27' webinar! Dr. Johann Proeve and Keith Dorricott provided valuable insights on selection of additional risk controls. The examples were well thought out, and I found the integration of LLM responses into the presentation particularly interesting. Looking forward to the next episode!

9. Oktober 2024 Charlene Dark Dark

The content and the speakers provided informative insights on the important topic of responsible AI implementation in clinical trials. The regulatory and compliance discussions were exceptionally helpful.

Appointments

  • 23. Januar 2025, 15:00 - 16:00

Description

Join us for this special edition of mindsON, focused on the expanding role of Medical Monitoring in clinical trials. With the upcoming 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 centralized 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.

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