Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 25, 8:00AM - 9:30AM

Session Number:
219

Room Number:
153AB

Level:
Intermediate

Type:
Forum

Title:
Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting

Chair(s):
Judith M. Kramer, MD,MS
Professor of Medicine, Duke University Medical Center
Duke Translational Medicine Institute, 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.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Panelist
Patrick Archdeacon
Medical Officer, Office of Medical Policy, CDER
FDA, United States

Panelist
Jose M. Vega, MD
Vice President, Global Safety
Amgen Inc., United States

Panelist
Janet Turk Wittes, PhD
President
Statistics Collaborative Inc., United States