Module 9 2024

03/09/2024

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

Bioassays

Paula Urquhart, Senior Assay Development Scientist, Labcorp

10 September 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Topics to be Covered

• Bioassays – what are they and why are they needed? • Measurements in bioassays • Assay design and statistical analysis • Validation

The Organisation for Professionals in Regulatory Affairs

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