Global Harmonization – Global Regulatory and Clinical Affairs for Drug Development
View Presentation *Mark Bach, Merck Keywords: The goal of industry to support global registration of new drugs and vaccines is challenging because of medical, regulatory and operational issues. Disease prevalence, genetic and environmental factors and concomitant therapy may vary by region. Regulatory issues include study approval timelines ranging from one to eight months, sometimes conflicting requirements for study design, requirements for country-specific sub-analyses, and increasing scrutiny of studies performed in emerging markets. Operational challenges include variable local infrastructure, the need to execute a trial across multiple languages and time zones, and in some cases, lack of well-trained investigators. The presentation will review these issues and potential solutions.
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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