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DIA 2013 49th Annual Meeting
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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
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
 Janet Turk Wittes, PhD (SPKNON), President, Statistics Collaborative Inc., United States
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.

Session Recording
(Code: 219)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Handout Online
(Code: 219)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON3 Comp Access: Tuesday Online Access Package - June 25, 2013
Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting