This training covers the key requirements in the relevant parts of 21 CFR: Parts 11, 50, 54, 56 and 312. We look at the forms required by FDA: 1572, Financial Disclosure etc.
We can also cover the history and structure of FDA and the specifics of FDA inspections.
We can also consider the implications of conducting IND trials outside the US – the key differences between EU and US regulation and what that means in practice.
Please contact me for more information and to organise your course.