Wednesday FoREMS: Evolving Towards More Systematic Benefit-Risk Assessments of Medications
Wednesday August 10, 2011
Evolving Towards More Systematic Benefit-Risk Assessments of Medications
FDA and industry each evaluate the benefits and risks of medications to determine whether the benefits outweigh the risks. With the increasing complexity of healthcare information, there is a growing need for better knowledge management and enhanced decision making when evaluating the benefits and risks of medications. This presentation and panel will provide an overview of the evolving external environment and systematic approaches to benefit-risk assessments.
Highlights and Takeaways
- Evolution of risk management towards a broader consideration of benefit-risk management
- Review of benefit-risk assessment methods and frameworks
- Discussion of ways to integrate systematic approaches to benefit-risk assessment into broader clinical development
Guest Speakers
- Nayan Acharya, Senior Director, Office of Risk Management & Pharmacoepidemiology (ORMP) - Eli Lilly and Company
- Rebecca Noel, Research Scientist - Eli Lilly and Company
- Bennett Levitan, Director, Quantitative Safety Research, Department of Epidemiology - Johnson & Johnson Pharmaceutical R&D
Webinar Slide Set:
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Session Recording:
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