Optimizing Sponsor-FDA Interaction During Development
*Duane Snavely, Merck Keywords: We will discuss various opportunities that exist for interaction between statistics/clinical personnel from FDA and industry (e.g., Type A, B or C meetings) and topics that have been important for optimizing drug development and review. Topics include interaction on clinical program and protocol design and analysis issues, impact of emerging external information on ongoing studies, and statistical review aids
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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