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Audio conference highlights

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 commercialization.

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

This audio conference covers:

• Understanding the EU risk management guideline
• When you need an EU risk management plan
• The process for compiling a risk management plan
• The differences between the EU guideline and FDA guidance documents

About the speakers:

Dr. Annette Stemhagen is a pharmacoepidemiologist and Vice President of Epidemiology and Risk Management with United BioSource Corporation. Her work focuses on strategies to support the commercialization of medical products, including meeting regulatory requirements for risk assessment and risk management. In 2004 she was appointed industry representative to the FDA Drug Safety and Risk Management Advisory Committee. She is a Fellow and past Vice President of the International Society of Pharmacoepidemiology, and a former member of the DIA Board of Directors. She holds an adjunct faculty appointment at the University of Pennsylvania School of Medicine.

Dr. Stefan Blesse is a veterinarian and principal consultant with Granzer Regulatory Consulting & Services, based in Germany. He has spent 15 years working in Regulatory Affairs, and has held various positions of global responsibility with both large and small pharmaceutical companies like Hoechst and Bayer. He has extensive experience with CTD submmission, and has been involved in submissions around the world, including The US, Europe and Asia-Pacific.

Who should attend?

• Regulatory Affairs Directors and VPs
• Directors and Managers in Risk Management
• Safety Directors and Managers
• Epidemiologists
• Outcomes Researchers

This audio conference is classified as General Interest.