Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.
Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21