Module 9 2024

03/09/2024

Clinical Development

• A milestone step in translational science is to transform the scientific discoveries into therapeutic applications • The clinical development of biologicals and its regulation has a variety of product specific aspects which need to be carefully navigated • It is necessary to summarise clear quality and preclinical safety information for clinical trial regulators in order to address the critical benefit risk evaluation, particularly for FIH studies.

The Organisation for Professionals in Regulatory Affairs

55

Immunogenicity Issues

Day 1: Lecture 4

With

Dr Isabelle Cludts

The Organisation for Professionals in Regulatory Affairs

56

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