Spring Intro 2023

03/03/2023

TOPRA Introductory Course

New Product Development, the EU Regulatory Environment & the Role of Regulatory Affairs

Steve Brookes, Senior Director, Regulatory Sciences & RnD Project Lead, Biogen

Disclaimer: Content reflects my personal views

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

1

Learning outcomes

New Product Development ● Overview of the environment & process The EU Regulatory Environment ● The history & pharmaceutical legislation ● Evolution & decision makers The Role of Regulatory ● The perception ● Its importance & where it fits ● The various roles of a Regulatory Professional ● The rewards

2

1