The Quality Issue – May 2024
Welcome to the May edition of our Quality Issue newsletter! This month, we’re excited to bring you a wealth of resources and events designed to elevate your expertise in clinical trial risk management. Whether you’re looking to join our complimentary virtual event, catch up on our latest webinar, or gain insights from industry leaders, we’ve got you covered.
Elevate Your Expertise in Clinical Trial Risk Management – Join Our Complimentary Virtual Event!
We are excited to invite you to our complimentary virtual event designed for professionals looking to advance their expertise in clinical trial risk management.
Join us for “Mastering Clinical Trial Risk Management” on 27th June at 10 am EDT/3 pm BST. This event will last less than 2 hours, offering a concise yet comprehensive exploration of clinical trial risk management.
Why Attend?
Learn from renowned Quality Management Experts as they guide you through the protocol risk assessment process per ICH E6. Our five concise sessions will provide essential tools and insights to effectively navigate and mitigate risks in clinical trials.
Sessions Include:
- Part One: Defining Critical Variables
- Part Two: Risk Identification
- Part Three: Risk Evaluation
- Part Four: Risk Controls
- Part Five: Risk Communication
This event is complimentary and open to all professionals who work at Sponsors and CROs. Please feel free to invite your colleagues to join you.
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:
Insights from Industry Leaders: Quality Management Expert Interviews
Over the last six weeks, we have had the privilege of interviewing some of the foremost experts in quality management. These insightful conversations cover a range of topics crucial to advancing clinical trial risk management. Each expert brings unique perspectives and actionable advice that can help you navigate the complexities of clinical trial quality management.
- Brian Barnes, Director, Risk Management Strategy Process Excellence and Oversight, BIONTECH
- Jenny Christal, AD RBQM, Global Clinical Development Operations, Jazz Pharmaceuticals
- Jennifer Stewart, Exec Director, Clinical Data Sciences, Premier Research
- Suzanne Kincaid, Consultant, Research Consulting LLC
- Alec Vardy, Independent RBQM Consultant
- Kelly Holladay, Associate Director, RBQM, Worldwide Clinical Trials
- Molly Peterson, Manager, Risk Management, Worldwide Clinical Trials
Until next month!