Spring Intro 2023

23/03/2023

Summary

• Be aware of HTA requirements in development discussions • Include and work closely with Market Access colleagues as early as possible for mutual benefit. • Target Product Profile – define evidence needs. • Early Access Programmes • Include Market Access considerations in the development of regulatory strategy – Scientific advice strategy and input into development decisions/risk analysis planning – Clinical study design/strategy – Understand ‘trade offs’ and priorities • Consider post-approval studies • Consider RWE and how it can contribute to both regulatory strategy and HTA. • Keep an eye on the future – encourage further collaboration and contribute to policy development.

The Organisation for Professionals in Regulatory Affairs

35

Questions

The Organisation for Professionals in Regulatory Affairs

36

18