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Innovative Approaches to Trial Execution, Quality, and Compliance
Session Chair(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States
This session will provide insight from both regulatory and industry speakers on approaches to improve quality and compliance in clinical trials. Speakers will discuss: 1. Use of inspectional findings, quality data, and continuous improvement techniques to inform ongoing development of effective GxP quality systems. 2. How the COVID-19 pandemic has created opportunities to innovate and highlighted the need for quality analytics to revolutionize risk management systems, analytic auditing, and clinical trial oversight. 3. Importance of understanding unique trial design issues and emerging digital technologies to successfully execute decentralized clinical trials.
Learning Objective : Describe regulatory perspectives on effective GxP quality systems; Identify how the COVID-19 Pandemic has accelerated innovation and spurred firms to revolutionize risk management systems and use new technologies to improve quality and compliance in clinical trials; Discuss how new digital technologies and proactive stakeholder engagement in trial design discussions enhance the probability of success for decentralized clinical trials.
Speaker(s)
Using Quality Issues to your Advantage: A Regulator Perspective
Stephen Vinter
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of Compliance
R&D Quality: Enabling the Post COVID-19 Continuum of Clinical Trial Innovation Through Fit-for-Purpose, Data-Driven Quality
Federico Feldstein, JD
Johnson & Johnson, United States
Vice President, Global Head of R&D Quality Compliance
Successful Decentralized Trials: More Than Just Moving Online
Dawn Anderson, BSN
Deloitte, United States
Managing Director, Life Sciences