Module 9 2024

03/09/2024

Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products

Clinical Development of Biopharmaceuticals

Tara Hutton, Director, Biogen

09 September 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i 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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