Module 9 2021

19/03/2021

Masterclass

Clinical Development of Biopharmaceuticals

22 March 2021

Tara Hutton, Director, Biogen Idec Ltd

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

 Understand aspects of clinical development for biopharmaceuticals;  Identify key considerations when designing a first-in- human study;  Be aware of the clinical pharmacology of biopharmaceuticals;  Appreciate the continuum of clinical development post first-in-human studies;  Recognise the continuation of clinical development post-approval;

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The Organisation for Professionals in Regulatory Affairs

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