Richard has worked in the Pharmaceutical and Medical Device Industries for more than 35 years. He consults in such areas as Auditing, Computer Validation, Part 11, Data Management, Project Management, and Quality Assurance.
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture and standards for the Sentinel System. Prior to joining the FDA, Mitra served as the Associate Director, Health care Informatics at Novartis Pharmaceuticals Corporation.
Prior to joining CDER Jonathan worked at CDRH BIMO and co-developed the Software Education Program. Jonathan specializes in Computerized Systems used in FDA regulated Clinical Investigations. Jonathan holds an MS in Bioscience Reg. Affairs from Johns Hopkins & BS from UMCP in Cell Biology & Genetics
Description
The showcase will discuss the current status of the use of Electronic Medical Records (EMR) data in clinical research. Speakers will discuss their actual experience with the use (or non-use) of these data. Developed by the Validation (VA) SIAC.
Learning Objectives: Discuss the current status of the use of EMR data.