Module 9 2024

03/09/2024

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?

How do we determine what attributes are critical and could have an impact on Product Safety and Efficacy

What are the regulatory concerns?

How can we be proactive about change?

The Organisation for Professionals in Regulatory Affairs

61

Module 3 Guideline Requirements

Day 2: Lecture 6

With

Richard Keane

The Organisation for Professionals in Regulatory Affairs

62

31