Enhancing Regulatory Science and Expediting Drug Development: eClinical and eHealth Tools
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
308
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
252AB
CHAIR
:
Ron Fitzmartin, PhD,MBA (SPKAGY), Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER, FDA, United States
Ron Fitzmartin is Sr Advisor, Office of Planning and Informatics, CDER, FDA. Ron held positions at Decision Analytics, Daiichi Sankyo, & Purdue Pharma. Degrees: PhD in statistics; Univ of Maryland, MBA; Univ of New Haven; and MS / BS - So. Conn. State Univ. DIA President, 2007-09.
SPEAKER
(S):
Leonard V. Sacks, MD (SPKAGY), Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Mitra Rocca, MS (SCHAGY), Senior Medical Informatician, Office of Translational Science, CDER, FDA, United States
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.
Jonathan S. Helfgott, (SPKAGY), Operations Research Analyst, OSI, OC, CDER, FDA, United States
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
This session will be an interactive FDA panel focused on eClinical and eHealth tools and guidance to enhance regulatory science and expedite drug development. The audience will actively participate throughout the session.