Philip Lange Møller
Danish Medicines Agency
In this workshop we will look at common documentation inspection trends and most common findings in contents review. Through sharing a series of examples we will look at common misconception of how to prepare a TMF for inspection and pitfalls to avoid.
Attend this session to:- Deep dive into best practices in TMF management
-Understand the tools available to optimise the best approaches in inspection preparedness
-Examine the different points of view and gain clarity on the role of the inspector