Spring Intro 2023

06/03/2023

TOPRA Introductory Course

An Introduction to Biotechnology Medicines

Paul Smith, MetisRA Consulting Limited, UK

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

1

Overview

• What is a biotechnology product

• Key regulatory aspects to consider

• Filing Biotechnology Products

• Advanced Therapy Medicinal Products (ATMPs)

• Hot Topics and Conclusions

2

Made with FlippingBook Annual report maker