Module 14 2022

22/03/2022

TARGET PRODUCT PROFILE (TPP)

● ORIGINATES FROM PHARMACEUTICALS – Strategic development tool – Template described by US FDA (2007)

● Links the statements in the Instructions for Use…. …. with the supporting data

…. and identifies minimally acceptable data

● Used in parallel with the GSPR CHECKLIST

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

25

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

26

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