The Quality Issue – June 2024
We are excited to bring you the latest updates and insights in our June newsletter. This edition features a new white paper release, a reminder about our upcoming virtual event, and highlights from our recent travels and engagements. We hope you find the information valuable and look forward to your continued participation and support.
New White Paper Release: "Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry"
We are pleased to inform our readers about the release of PHUSE Global’s highly anticipated white paper, “Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry,” authored by industry experts Mireille Lovejoy, PMP PSM of GE Healthcare and Chris Wells of Roche.
Highlights of the White Paper:
Historical Context and Evolution: The paper traces the evolution of RBQM and QbD principles, illustrating how the industry’s understanding and implementation have matured over the past decade.
Identification of Critical-to-Quality Factors (CtQs): The authors detail the importance of CtQs in the planning phase of clinical trials, highlighting how these factors are pivotal to ensuring participant safety and data integrity.
Application and Monitoring of QTLs: The white paper discusses how QTL parameters are used to monitor risks associated with CtQs, identifying systemic issues that could compromise trial endpoints.
Industry Survey Insights: Drawing on an extensive industry survey, the paper provides valuable insights into the current use and perception of QTLs across various organizations, shedding light on best practices and common challenges.
Future Directions in RBQM: The authors explore the future trajectory of QTL implementation within the evolving regulatory landscape, offering guidance on how stakeholders can adapt to ensure ongoing compliance and quality.
This white paper is an invaluable resource for professionals engaged in clinical trial management and quality assurance, offering deep insights into the effective use of QTLs to enhance trial outcomes.
We highly recommend accessing and reviewing this comprehensive analysis to stay abreast of the latest advancements and practices in RBQM.
Read the full white paper here: WP-084.pdf (phuse.s3.eu-central-1.amazonaws.com)
Operationalizing RBQM in Clinical Trials – Insights and Actions for Enhanced Efficiency [recording]
Missed our recent webinar? Don’t worry! The recording of “Operationalizing RBQM: Insights and Actions for Enhanced Efficiency” is now available for you to watch at your convenience. Join Duncan Hall, CEO of TRI, and Amandeep Sonik, Senior Director of RBQM at Worldwide Clinical Trials, as they delve into transforming the theoretical concepts of Risk-Based Quality Management (RBQM) into practical, actionable strategies.
Discussion Points Covered:
- RBQM Operationalization: Understand what RBQM operationalization entails and the characteristics of effective implementation.
- Proactive Risk Mitigation: Learn about the nuanced assessment of potential risks and the strategic actions designed to neutralize the most critical risks.
- Change Management: Explore the attributes of stakeholders involved in RBQM and the technological advancements necessary to drive its successful operationalization.
- Real-World Evidence: Discover real-life case studies where RBQM principles have been successfully applied, resulting in significant improvements in trial management and outcomes.
Watch the recording now to gain valuable insights and practical actions to enhance your clinical trial efficiency:
Reminder: Register for Our Virtual Event on June 27th - "Mastering Clinical Trial Risk Management"
We are excited to welcome you to our complimentary virtual event, “Mastering Clinical Trial Risk Management,” designed for professionals looking to advance their expertise in clinical trial risk management at an intermediate level. The event will take place on June 27th and will last less than 2 hours, with short breaks between each session. Delivered by renowned Quality Management Experts, this focused event will guide you through the complete protocol risk assessment process, as laid out in ICH E6, in bite-sized chunks. You’ll learn what is essential to ensure the safety, rights, and well-being of clinical trial subjects, as well as the integrity and reliability of clinical trial data.
With over 300 professionals already registered, this is an event you won’t want to miss. Elevate your expertise and contribute to the success and safety of clinical trials.
Register for the event: https://event.gotowebinar.com/event/01a22fb2-2c96-4686-93c6-442dc3f26f6f
On the Road: Thank You for Your Support!
We’ve been busy traveling to various events and are grateful for the incredible engagement we’ve received. A big thank you to everyone who stopped by our booth, attended our presentations, and interacted with us. Your support and enthusiasm drive our mission forward.
We’re excited to share a teaser from our recent activities. Our CEO, Duncan Hall , delivered a highly attended presentation at OCT UK titled “How RBQM Creates Trust Between Sponsors and CROs.” With over 100 attendees, the session sparked significant interest, and we’ve received numerous requests for the slides.
In response to this overwhelming demand, we’re thrilled to announce that Duncan will be delivering the session as a webinar.
Stay tuned for the dates and details of this and future events, coming soon!