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DIA 2021 Global Annual Meeting
Predictive Compliance, Risk, and Quality Management Transformation: Will your Data Hold up to a Data Integrity Inspection?
- 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.
Sherri Ann Hubby
- Senior Director, GCP Quality Assurance
- Myovant Sciences , United States
Andrew Fisher, MS
- Lead Senior GCP Inspector
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Cheryl Grandinetti, PharmD
- Clinical Pharmacologist, OSI, OC, CDER
- FDA, United States
Jane von Kirchbach, MBA
- Vice President, Pfizer Digital
- Pfizer Inc, United States