Module 9 2024

03/09/2024

Comparability

The Organisation for Professionals in Regulatory Affairs

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Problem Statement

Biotechnology and Biological products and processes are complex, subject to variability and inevitably will be changed pre- and post- approval.

• How do we assess the impact of these changes?

• What are the regulatory concerns?

• How can we be proactive about change?

The Organisation for Professionals in Regulatory Affairs

22

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