Audio Conference

The Evolution of Risk Management: A Guide for Pharma & Biotech Dr. Annette Stemhagen VP Epidemiology & Risk Management United BioSource Corporation Purchase recording US$199

Purchase recording of this audio conference 

Since the FDA released three Concept Papers on Risk Management in 2003, there has been increasing attention on the requirements for risk management programs for both new and old products. This presentation will review the evolution of risk management strategies, with discussion of the FDA risk management guidances. It will also look at strategies for developing risk minimization action plans (RiskMAPS), designing interventions, and evaluating risk management programs in order to minimize patient risks and maintain benefits.

This audio conference will address:

• Regulatory guidance on pre- and post-marketing risk management
• Risk management activities to consider during drug development in order to establish a background of product risks in relation to the patient population
• Program designs for creating risk management interventions after marketing
• Defining successful interventions through program evaluation
  

About the speaker:

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 Dr. Stemhagen was appointed as the Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee. Dr. Stemhagen is a Fellow and past Vice President of the International Society of Pharmacoepidemiology, as well as a former member of the DIA Board of Directors. She holds an adjunct faculty appointment at the University of Pennsylvania School of Medicine.

Dr. Stemhagen earned a Bachelor of Arts degree in Biology from the University of Pennsylvania and both a Masters and a Doctoral degree in Public Health (Epidemiology) from the University of Pittsburgh Graduate School of Public Health.

Who should attend?

• Senior Management
• Risk Managers
• Clinical Directors and VPs
• Medical Affairs Directors and VPs
• Safety Managers
• Regulatory Affairs Directors and VPs
• Marketing
  

This audio conference is classified as General Interest.

Purchase recording US$199