Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting
Track
:
Track 14: Clinical Safety and Pharmacovigilance
Program Code:
219
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
153AB
CHAIR
:
Judith M. Kramer, MD,MS (SCHNON), Professor of Medicine, Duke University Medical Center, Duke Translational Medicine Institute, United States
Dr. Kramer is Professor of Medicine at Duke University Medical Center. She was the first Executive Director of the Clinical Trials Transformation Initiative(CTTI), a public-private partnership cofounded in 2007 by Duke and FDA to improve the quality and efficiency of clinical trials.
SPEAKER
(S):
Patrick Archdeacon, (SPKAGY), Medical Officer, Office of Medical Policy, CDER, FDA, United States
Jose M. Vega, MD (SPKNON), Vice President, Global Safety, Amgen Inc., United States
He received his A.B, A.M., and M.D. from Harvard and completed his residency in internal medicine at the Mass. General Hospital, where he then practiced emergency and internal medicine. He worked at Merck for 7 years, joining Amgen in 2003 in Early Dev followed by senior roles in Late Dev and Safety
Janet Turk Wittes, PhD (SPKNON), President, Statistics Collaborative Inc., United States
Janet Wittes is President of Statistics Collaborative, a company that consults on design of clinical trials. She has participated in many Data Safety Monitoring Committees for government and for industry. Her research deals with statistical monitoring of randomized trials.
Description
Recommendations are presented from projects of the Clinical Trials Transformation Initiative (CTTI) exploring expedited safety reporting for clinical trials conducted under an IND (Investigational New Drug) and for aligning regulatory practices for expedited safety reporting with statistical science and patient expectations.