Safety Analysis Planning for Treatments Used in Multiple Indications
View Presentation *Achim Guettner, Novartis Pharma AG Keywords: In this presentation I will give an overview of the planning activities for safety analyses for a compound that is currently in phases II and III in clinical development. The compound is used in multiple indications and therapeutic areas. Doses, regimens and route of administrations differ for the individual populations. For prospectively planning of safety analyses it is important to understand where a common approach across indication can be applied and to understand that the risks might be different across indications. It will be outlined how standard approaches improve the understanding of the safety profile of the drug throughout the development program.
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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