This special edition of mindsON focuses on Risk Management and effective Sponsor Oversight in Clinical Trials. Our experts, guest speaker Jessica Cordes (Clinical Excellence GmbH, Clinical Operations Expert) and Dr. Johann Proeve (Cyntegrity, Chief Scientific Officer), provide practical insights into how a strategic oversight and risk management framework can help ensure data quality and patient safety. Using real-world case studies and interactive discussions, participants will learn how to successfully integrate risk-based monitoring measures into daily trial operations to uphold the highest quality standards.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Donnerstag, 21. November 2024 16:00 – 17:00

Eventort: Online

Der Beitrag mindsON RBQM Special Edition | Risk Management and Sponsor Oversight (Webinar | Online) erschien zuerst auf Event Kreis.

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. 

Eventdatum: Dienstag, 19. November 2024 16:00 – 17:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Risk-Based Medical Monitoring Under ICH E6(R3) – Supporting Patient Sa (Webinar | Online) erschien zuerst auf Event Kreis.

Proud and pleased, we at Cyntegrity’s MyRBQM Academy celebrate another milestone:

Our five-year anniversary of transferring RBQM knowledge and expertise!

We’re grateful for the 1,630 participants from 385 organizations who have trusted us with their RBQM goals. To show our appreciation, we’ll grant all learners a 50% DISCOUNT on our entire RBQM training portfolio during the anniversary week in September! Visit our Academy website from Sept. 23 to 29, 2024, and take advantage of this great learning opportunity!

A big hand and a heartfelt thank you goes to our fabulous RBQM experts, trainers, and mindsON workshop speakers, whose contributions have been instrumental in making the past five years such a success:

Johann Proeve (Chief Scientific Officer), Keith Dorricott (Lead Instructor), Tamara Beck (MyRBQM Academy Operations Manager), Jo Burmester (Senior Instructor), Sibel Köklü (Lead Instructor), Artem Andrianov (Chief Executive Officer), and Linda Bunschoten (Chief Marketing Officer). 

We look forward to welcoming you to our MyRBQM Academy!

Eventdatum: 23.09.24 – 29.09.24

Eventort: Online

Der Beitrag Cyntegrity’s MyRBQM Academy celebrates 5 years of Excellence in Education (Schulung | Online) erschien zuerst auf Event Kreis.

Join us for an insightful webinar highlighting how Risk-Based Quality Management (RBQM) can empower M&A and investment decisions in the pharmaceutical industry. Discover how RBQM enhances clinical due diligence processes, supporting areas like data integrity and risk assessment. We’ll explore methodologies and potential findings that drive data-driven decision-making, ultimately showcasing the benefits of gaining actionable insights for informed M&A and investment strategies. Don’t miss out on this opportunity to navigate the deal-making complexities with clarity, confidence, and speed.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Dienstag, 04. Juni 2024 16:00 – 17:00

Eventort: Online

Der Beitrag mindsON RBQM | Special Edition – M&A Efficiency: RBQM supported Clinical Due Diligence (Webinar | Online) erschien zuerst auf Event Kreis.

We will share an example of output that a central monitor might see and work together to investigate to determine if there is an issue and then try to determine the root causes. We will use the D-I-G-R root cause analysis method and show how it is more effective than the overly simplified „Five Whys.“ Come along to take part – or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well.  

Eventdatum: Mittwoch, 11. Dezember 2024 17:00 – 18:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Episode 30: Test your Central Monitoring Skills (Webinar | Online) erschien zuerst auf Event Kreis.

Some companies have been early adopters of RBQM methodology, and others have been laggards. What evidence is there of added value to the early adopters?

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Mittwoch, 13. November 2024 17:00 – 18:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Episode 29: Does Centralized Monitoring add value? (Webinar | Online) erschien zuerst auf Event Kreis.

We will share a simplified example of a protocol outline, along with high-risk items that we want to reduce. How would you define KRIs to monitor the high-risk items? How would you determine the metric definition and thresholds? Will you get the same answers as our RBQM experts? Come along to take part – or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Mittwoch, 23. Oktober 2024 17:00 – 18:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Episode 28: Can you define KRIs to monitor key risks? (Webinar | Online) erschien zuerst auf Event Kreis.

We will share a simplified example of a protocol outline, along with high-risk items that we want to reduce. How should you go about reducing risks? What is a mitigation, a risk control and a contingency? Will you get the same answers as our RBQM experts? Come along to take part – or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well.

Eventdatum: Dienstag, 17. September 2024 17:00 – 18:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Episode 27: Can you determine the best risk controls for risks you want to r (Webinar | Online) erschien zuerst auf Event Kreis.

We will share a simplified example of a protocol outline, brainstorm, and evaluate risks. Will you get the same answers as our RBQM experts? Come along to take part—or just listen and learn.

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Donnerstag, 27. Juni 2024 17:00 – 18:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Episode 26: Can you identify and evaluate key risks in a protocol? (Webinar | Online) erschien zuerst auf Event Kreis.

An area of much debate (and confusion) is the differences, similarities, and overlaps between Risk-Based Quality Management, Quality by Design, Centralized Monitoring, Centralized Statistical Monitoring, Remote Monitoring, and Risk-Based Monitoring. Or, in the alphabet soup of our industry, RBQM, QbD, CM, CSM, RM and RBM. At this workshop, our industry experts will provide their perspectives and get the perspectives of those in the audience. Is the industry settling on definitions for these terms, or will the confusion persist?

ABOUT „mindsON RBQM“ WORKSHOPS

mindsON RBQM is a series of workshops by Cyntegrity’s MyRBQM Academy that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your experiences and participate in the interactive dialog with our well-known industry experts, Johann Proeve (PhD) and Keith Dorricott (MBB). If you prefer to listen and observe, that’s okay as well. 

Eventdatum: Mittwoch, 29. Mai 2024 17:00 – 18:00

Eventort: Online

Der Beitrag mindsON RBQM Workshop | Episode 25: RBQM, RBM, QbD, CM, CSM – So many terms but what are they,? (Webinar | Online) erschien zuerst auf Event Kreis.