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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?

Session Chair(s)

Kamal  Biswas

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

Panelist

Sherri Ann Hubby

  • Senior Director, GCP Quality Assurance
  • Myovant Sciences , United States
Andrew  Fisher, MS

Panelist

Andrew Fisher, MS

  • Lead Senior GCP Inspector
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Cheryl  Grandinetti, PharmD

FDA Update

Cheryl Grandinetti, PharmD

  • Clinical Pharmacologist, OSI, OC, CDER
  • FDA, United States
Jane  von Kirchbach, MBA

Panelist

Jane von Kirchbach, MBA

  • Vice President, Pfizer Digital
  • Pfizer Inc, United States