Implications of Revised FDA CV Endpoint Definitions on Cardiovascular, Obseity, and Diabetes Drug Development

*** Please note - This session will be presented in English. ***

Time is Japanese Standard Time

The final FDA guidance document on cardiac safety assessment in anti-diabetic drug was published at the end of 2008 and the draft FDA document on standardized definitions for CV and bleeding endpoint definitions was published on November 22nd, 2010. This webinar will review the state of the art methods for cardiac safety assessment, and discuss what the implications are for sponsors for current and future trials that involve cardiovascular endpoints. 
   
   
This session will provide:
Explanations of the different definitions (CV death, myocardial infarction, unstable angina etc.) and provide an overview of what are the changes from what was previously used

Descriptions of the practical consequences in terms of study design, data collection and adjudication.

Expert Panelists: 
Dr. C. Michael Gibson, MD FACC
Dr. Didier Saur, MD 
 
To Register for this event please click here