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How to Evaluate Your RiskMAP

Dr. Annette Stemhagen
VP Epidemiology & Risk Management
United BioSource Corporation

Purchase recording - US$199

Purchase a recording of this audio conference 

A key element of any Risk Minimization Action Plan (RiskMAP) is the description of ways in which the Sponsor will determine if the risk minimization efforts are working. In this audio conference, Dr. Stemhagen will discuss strategies and approaches for evaluating RiskMAPs, in conjunction with the types of risk minimization "tools" that can be implemented. She will also describe the range of evaluation methods that can be used to evaluate risk management interventions, such as use of existing databases, market research data, and ad hoc data collection through registries and large simple studies. Dr. Stemhagen will provide attendees with examples of metrics developed from ongoing programs, and outline strategies for selecting the most appropriate evaluation tools for the circumstances.

This audio conference will address:

  • Why you need a RiskMAP
  • Available resources for evaluating your RiskMAP
  • How to select the most appropriate resources
  • Methods for evaluating risk management interventions
  • Examples of RiskMAP evaluation metrics

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?

  • 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.

Purchase recording US$199

 

   

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