Module 9 2021

19/03/2021

Implications and Regulations of Changes During Process Development

Rhydian Howells, Diamond Pharma Services A Propharma Group Company

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i 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

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