Module 3 2019

Changes and Adaptions in CMC CMC is an Iterative Process of Changes and Improvements During Product Development

preclinical

Phase I

Phase II

Phase III

Phase IV/ post approval

Specifications

Analytics/ Controls

Storage

Labelling

Manufacturer

Shipping

Manufacturing process and strategy

Formulation/Containers/Closure

How to address this continuous level of changes in project management?

CMC Project Management

The Organisation for Professionals in Regulatory Affairs