This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 330
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307585
Title: Prospective Safety Analysis Plans: Critical Elements and Principles
Author(s): George Rochester*+
Companies: FDA
Address: Bldg 21 Room 4626, Silver Spring, MD, 20903, USA
Keywords: Safety-analysis ; risk-management ; guidances
Abstract:

The Program Safety ANalysis Plan (PSAP) is an important tool for communication between sponsors and regulators on prospective safety planning during product, drug or biologic, developemnt. This presentation focuses on prospective planning from data collection, submission, analysis and presentation in a new product application. The critical elements that are expected in preparing a PSAP and the essential milestones for communication with the FDA are highlighted. The pre-market risk assessment forms the basis for good risk managemnt. Therefore, connections between the PSAP and other risk management activities will be clarified. Examples from real examples will be presented.


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