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How
to Evaluate Your RiskMAP
Dr.
Annette Stemhagen
VP Epidemiology & Risk Management
United BioSource Corporation
Purchase
recording - US$199
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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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