Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

DESIGN INPUTS ● INTERNALLY IMPOSED GSP REQUIREMENTS – Based on market research – Clinical trials – Competitor products – Contractual requirements ● EXTERNALLY IMPOSED GSP REQUIREMENTS – CUSTOMER NEEDS – STATED AND IMPLIED – REGULATORY / STATUTORY – ENVIRONMENTAL requirements

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

21

GOOD DESIGN PRACTICE

DESIGN INPUTS ● HUMAN FACTORS STUDIES – Nowadays more important than ever

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

22

11