Hi all,
One of the projects I'm working on is a joint US-Australian collaboration, for which we hold the US IND and an Australian partner holds a filing with TGA. With our first IND annual report coming due in the next couple months, I need to compile study-wide safety data. My first thought was that we could generate the same data tables (such as demographics, SAE's, TEAE's by Organ Class, etc, etc, etc) for both submissions, however I'm being told that none of these tables are required by TGA.
I can't imagine nothing is required, but I'm hoping someone could shed some light for me. In a nutshell, what sort of annual reporting actually
is required by TGA, for a Phase III clinical trial involving a biologic (monoclonal)?
Thanks! Ken
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Kenneth Rockwell PharmD, MS
Director of Regulatory Affairs
Philadelphia PA
United States
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