×
Back to Agenda
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)
Sherri Ann Hubby
Director, Clinical Quality Assurance, Vera Therapeutics, United States
Panelist
Andrew Fisher, MS
Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Panelist
Cheryl Grandinetti
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
FDA Update
Jane von Kirchbach, MBA
Vice President, Pfizer Digital, Pfizer Inc, United States
Panelist
Have an account?