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Driving Quality Through Innovative Approaches
Session Chair(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States
This potpourri of presentations by industry speakers will present new approaches to improve quality and compliance in clinical trials. Speakers will discuss:
• How emerging digital technologies may transform industry’s approach to risk management, clinical trial oversight and auditing
• Deploying effective and efficient risk-based monitoring in clinical trials
• Challenges in identifying, classifying, tracking and analyzing protocol deviations and the toolkit developed by the Protocol Deviations Initiative to assist with protocol deviation management.
Learning Objective : Discuss new technologies can be used to improve quality and compliance in clinical trials; Describe how risk-based monitoring impacts the conduct of clinical trials; Recognize why good protocol deviation identification, classification, tracking, and analysis methods are essential to maintaining quality in clinical trials.
Speaker(s)
Modernizing R&D Quality and Compliance
Federico Feldstein, JD
Johnson & Johnson, United States
Vice President, Global Head of R&D Quality Compliance
Risk-Based Monitoring: An Examination of Probabilities and Rewards
MaryAnne Rizk, PhD
Rizk Management Advisors, United States
Chief Executive Officer
Solving Protocol Deviations Challenges: from Protocol Creation to CSR
Laura Galuchie
Merck Sharp & Dohme LLC, United States
Sr. Director, Global Clinical Trial Operations
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