I think that the proposal identifies some interesting potential areas of work. A couple of unsolicited thoughts:
In addition to developing generalized plans and associated SOPs, it may be important in phase I to develop assessment tools to identify gaps, and map the existing industry and FDA minimum standards and practices (I think this is referred to within the theory of change)
Globally-relevant partner stakeholders that immediately come to mind are IFPMA and PhRMA
Finding opportunities to improve FDA regulatory avenues is another downstream piece of work
Is the scope of work, at least initially, focused on US and European pharmaceutical infrastructure?
I think that the proposal identifies some interesting potential areas of work. A couple of unsolicited thoughts:
In addition to developing generalized plans and associated SOPs, it may be important in phase I to develop assessment tools to identify gaps, and map the existing industry and FDA minimum standards and practices (I think this is referred to within the theory of change)
Globally-relevant partner stakeholders that immediately come to mind are IFPMA and PhRMA
Finding opportunities to improve FDA regulatory avenues is another downstream piece of work
Is the scope of work, at least initially, focused on US and European pharmaceutical infrastructure?