Module 9 2024

03/09/2024

For biologicals in particular

• Regulatory authorities’ concerns are similar to those for “traditional” pharmaceuticals

Risk : benefit evaluation

•

Safety

•

• Quality (purity and potency)

Efficacy

•

Biopharmaceuticals

•

• Greater emphasis on assessment of manufacture and control of the product

The Organisation for Professionals in Regulatory Affairs

51

Preclinical Testing of Biologicals

Day 1: Lecture 2

With

Dr. Alison Wolfreys

The Organisation for Professionals in Regulatory Affairs

52

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