International Society for Pharmacoeconomics &Outcomes Research
ISPOR Comments to the FDA Concept Paper: RISK MANAGEMENT PROGRAMS Presented by Marilyn Dix Smith RPh, PhD ISPOR Executive Director On behalf of the ISPOR Risk Management Special Interest Group
PPT Slide
The mission of the International Society for Pharmacoeconomics and Outcomes Research is to translate….. outcomes research into practice to ensure that society allocates scarce health care resources safely, fairly, and efficiently.
ISPOR Health Science Strategic Initiatives
FDA Concept Paper: RISK MANAGEMENT PROGRAMS ISSUES TO CONSIDER
Risk Management = Minimizing (?) Risk AND Maximizing (?) Benefits= Outcomes Management
? Outcomes Measures = ? Outcomes Management = ? Risk Management
Pharmacoeconomic Modeling = Define Risk Management Plans ‘learn from today to predict for tomorrow’
Outcomes Assessment = Key in Risk Management Plan Development and Evaluation
OUTCOMES ASSESSMENT
Outcomes Assessment TOOLS are key
Outcomes Assessment = Quantitative Measurements (as well as Qualitative Measurements)
Developing a strong rationale for each tool or combination of tools will require developing a much stronger research base
FDA’s four-level risk management system may send false-signals to prescribers and patients
Risk Management Program Assessment must be specific to be successful
For more information on Outcomes Assessment, see: www.ispor.org
Home Page: http://www.fda.gov/cder/meeting/riskManagement.htm
Download presentation source