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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Driving Quality Through Innovative Approaches

Session Chair(s)

Jean M. Mulinde, MD

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)

Federico  Feldstein, JD

Modernizing R&D Quality and Compliance

Federico Feldstein, JD

Johnson & Johnson, United States

Vice President, Global Head of R&D Quality Compliance

MaryAnne  Rizk, PhD

Risk-Based Monitoring: An Examination of Probabilities and Rewards

MaryAnne Rizk, PhD

Rizk Management Advisors, United States

Chief Executive Officer

Laura  Galuchie

Solving Protocol Deviations Challenges: from Protocol Creation to CSR

Laura Galuchie

Merck Sharp & Dohme LLC, United States

Senior Director, Global Clinical Development

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