RBQM—Better, faster insights: The keys to success

Unlocking RBQM Excellence: Discover how a holistic approach to RBQM enhances patient safety, data quality, and trial efficiency. Join our industry leaders’ roundtable discussion!

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/rbqm-in-pharma

Event overview

Challenges in today’s pharma landscape for RBQM: The clinical trial ecosystem is rapidly evolving, bringing unprecedented opportunities, challenges, and complexities. The shifting dynamics, processes, and technologies have increased the urgency to deploy modernized, more comprehensive risk-prevention strategies throughout design and delivery. However, the differing interpretations of risk-based quality management (RBQM) have posed significant challenges.

RBQM is a comprehensive and highly effective study execution strategy that ensures patient safety and data quality during a clinical trial. It comprises three components: quality by design (QbD), critical to quality (CtQ) and quality tolerance limits (QTL). These components focus on strategic study design, risk detection and prevention/mitigation during trial conduct, and setting thresholds for critical quality parameters, respectively.

This webinar is a roundtable discussion with leaders in the industry who will discuss how they are pioneering a holistic approach to RBQM, developing and implementing cross-functional study strategies to not only reduce risk and need to mitigate, but which prevent risk. This approach leverages extensive historical data, institutional knowledge and sophisticated AI algorithms to predict risks rapidly and accurately, thereby enhancing the robustness of QbD and CtQ components of RBQM.

This webinar will be the first in a series covering different aspects of RBQM, starting with the evolution of the industry and the need to improve quality through a holistic approach to monitoring studies.


Key Learnings

• Up-front strategy: Getting it right the first time for faster, better insights (QbD)
  
• An introduction to a new vision for RBQM: regulatory change, process and risk prevention
  
• Monitoring as guidance: Holistic approach to monitoring of the study and taking a risk-based approach
  
• Faster implementation: Approaches that enable quicker deployment of RBQM strategies
  

Better and faster insights: Providing approaches for improved insights at a faster rate.

Speakers:

Linda Philips
Senior Director, Clinical Operations
IQVIA
With over 20 years of experience in clinical research, Linda Philips started her career at IQVIA in the data management space supporting EDC implementation and process improvement. Based on the evolution of monitoring and the implementation of risk-based approaches to data, she moved into centralized monitoring 10 years ago, supporting teams with process implementation and technology development. She currently supports customer collaborations on RBQM in trials both fully outsourced to IQVIA and within customer FSP models.

Sabrina Steffen
Vice President and Head of Innovation and Data Strategy
Data Sciences, Safety and Medical
IQVIA

Sabrina Steffen is vice president and head of innovation and data strategy data sciences, safety and medical. She is U.S.-based and has worked in clinical research for 18 years, within data management, risk-based monitoring, data strategy, process improvement and innovation. Steffen has led the data strategy and innovation team for eight years, overseeing large-scale process and technology transformations from inception through delivery and change management to achieve fully embedded technology-enabled processes.

Danielle Oliveira
Clinical Lead Advisor, Associate Director
IQVIA

Danielle Oliveira, Pharm.D., MBA, has over 25 years of experience in clinical research, advancing from CRA to clinical project director. She has led global programs from Phase I to Phase IV across various therapeutic areas, including rare diseases, cardiovascular and metabolic diseases, respiratory, oncology and rheumatology. Oliveira is known for her expertise in quality assurance, patient recruitment and study compliance. She earned a Pharm.D. degree from Universidade Metodista de Piracicaba in Brazil, an MBA from Fundação Instituto de Administração in Brazil, and specialized in hospital pharmacy and clinical hospital pharmacy at Hospital das Clínicas da Faculdade de Medicina de São Paulo (Brazil) and Universidad de Chile (Chile), respectively. Her career includes key roles at leading pharmaceutical and CRO companies, where she has been instrumental in driving risk-based monitoring innovation and is recognized for her strong leadership.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/rbqm-in-pharma