戻る Agenda
Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting
Session Chair(s)
Judith M. Kramer, MD, MS
Professor of Medicine, Duke University Medical Center
Duke Translational Medicine Institute, United States
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.
Learning Objective : Describe the operational and biostatistical challenges involved in complying with the IND safety regulations for expedited reporting effective March 2011; Discuss recommendations on expedited safety reporting issued by the Clinical Trials Transformation Initiative.
Speaker(s)
Panelist
Patrick Archdeacon, MD
FDA, United States
Medical Officer, Division of Medical Policy Development, OMP, CDER
Panelist
Jose M. Vega, MD
Amgen Inc., United States
Vice President, Global Safety
Panelist
Janet Turk Wittes, PHD
Statistics Collaborative Inc., United States
President