What is required of biopharmaceutical sponsors by the FDA when it comes to managing risk? What are the best strategies for implementation?
The first part of this presentation focuses on the status of the FDA Guidance Documents on Risk Management back in 2005, including a description of what the FDA has termed the "toolbox" for Risk Minimization Action Plans (RiskMAP). The second part discusses the conduct of these unique programs through large simple trials, registries, and other approaches.
This event is presented by Annette Stemhagen of Covance. To learn more, please visit www.fxconferences.com.
