Scope and Context for Lifecycle Safety Planning and Evaluation: Towards A Quantitative Safety Analysis Template
*George Rochester, FDA, CDER 


The Future of Drug Safety Evaluation depends on new thinking on a systematic approach to safety planning and evaluation throughout the product lifecycle. This talk will describe the key elements that form the framework for communication, tracking, feedback and regulatory review of accumulating safety data. A template for a Quantitative Safety Analysis Plan will be presented within the context of new processes, people and technologies that are required to support a modern safety evaluation program as we move toward challenges of Food Drug and Administration Amendment Act of 2007.