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DIA 2021 Global Annual Meeting
Innovative Approaches to Trial Execution, Quality, and Compliance
Jean M. Mulinde, MD
- Medical Officer, Policy Advisor, 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 : Identify why COVID-19 has been proving the importance of accelerating drug development and providing innovative, life-saving treatments or vaccines to patients in need; Discuss why vaccines are much needed for those working at the frontline; Describe how digital technologies have been playing an increasingly important role in the drug development process - to accelerate, to modernize and to continuously enhance patient-centrity.
Using Quality Issues to your Advantage: A Regulator Perspective
- Operations Manager GLPMA and Laboratories Group
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
R&D Quality: Enabling the Post COVID-19 Continuum of Clinical Trial Innovation Through Fit-for-Purpose, Data-Driven Quality
Federico Feldstein, JD
- Vice President, Global Head of R&D Quality Compliance
- Johnson & Johnson, United States
Successful Decentralized Trials: More Than Just Moving Online
Dawn Anderson, BSN
- Managing Director, Life Sciences
- Deloitte Consulting, United States