Module 14 2022

22/03/2022

How existing documents fit in the STED

Adapted from GHTF, 2011

The Organisation for Professionals in Regulatory Affairs

7

Documentation

Consider the Reviewer • Who is the expert on the product?… YOU

• Reviewer/Assessor is not necessarily an expert in YOUR product • Documents will need to clearly explain the key information and the rationale • Lead the reviewer through the data so they can follow the story of design • Lots of detailed data without clear explanation will likely raise more questions

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

8

4