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
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