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Predictive Compliance, Risk, and Quality Management Transformation: Will your Data Hold up to a Data Integrity Inspection?
Session Chair(s)
Kamal Biswas
President
Xybion Corporation, United States
This forum will provide information to discuss regulatory and sponsor oversight and the need to increase the communication risks to stakeholders in real-time for critical study-related activities, and how sponsors need a system that will predict and manage risk using modern digital technology platforms.
Learning Objective : Describe compliance risk prediction possibilities and how a digital technology platform, risk predictor, helps to capture, identify, mitigate, trend risk, and prioritize actions that are important to the pharma and medical device industry; Discuss how to integrate data from different data sources/platforms and shown tools.
Speaker(s)
Panelist
Sherri Ann Hubby
Myovant Sciences , United States
Senior Director, GCP Quality Assurance
Panelist
Andrew Fisher, MS
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Lead Senior GCP Inspector
FDA Update
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
Panelist
Jane von Kirchbach, MBA
Pfizer Inc, United States
Vice President, Pfizer Digital
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