Risk Management Strategies: US vs. EU

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commericalization.

In this audio conference, our speakers will compare and contrast the FDA and European Medicines Agency approaches to risk management. Dr. Stemhagen will focus on the US approache, while Dr. Blesse will provide an overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use. We will also explore the epidemiological methods for post-authorization safety studies, and ways to reduce risk.

This event is co-presented by Annette Stemhagen of United BioSource Corporation and Stefan Blesse of Granzer Regulatory Consulting. To learn more, please visit www.fxconferences.com.