The Global Harmonization Task Force
View Presentation *Larry Kessler, FDA Keywords: GHTF, safety, performance, clinical effectiveness For 15 years, the GHTF has developed a series of guidance documents in order to harmonize regulatory processes for medical devices for its five founding members (Australia, Canada, EU, Japan, and US). In addition, these documents provide a structure for countries developing a regulatory system to follow. Concepts of safety, effectiveness, and device performance will be discussed. We will also talk about Premarket review issues and clinical evidence as well as how GHTF handles emergin technologies.
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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