Benefit Risk from a Regulatory Perspective
*Joyce Korvick, FDA Keywords: The use of frameworks in semi-quantitative, structured analyses during the regulatory decision making process may be useful throughout the therapeutic product life-cycle. A unified evaluation of benefits and risks during the product life-cycle presents challenges. In order to increase transparency during consideration of the benefits and risks of a biomedical therapy, a more systematic presentation of clinical trial and postmarket data is necessary. Elements and structure of such a framework will be discussed, as well as the potential usefulness in regulatory decision making.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC