Module 3 Presentations

07/05/2024

Why Project Management in CMC?

Faster Time + High Quality = More Expensive

Faster Time + Less Expensive = Lower Quality

High Quality + Less Expensive = Slower Time

Take-home message:  Every project is different, but they all have scope and constraints  The 4 golden triangle components are “linked” together  Changing one will affect at least one of the other …  This is not negotiable!  You can not have it all! - It´s a balance!

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

13

CMC Project Management

 CMC project management is essential to the delivery of all drug development programs.  CMC project management requires a high level of technical knowledge to balance project acceleration and quality .  The effective CMC project manager aims to fully integrate the deliverables of the CMC development plan within the objectives of the drug development team.  This is achieved by keeping CMC development off the critical path (where possible) and by delivering nonclinical- and clinical trial materials on time and within budget.

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

14