Module 3 Presentations

07/05/2024

Reactive

 

Proactive/ in-control of … Leader and “active creator”

 

“Servant of many masters”

Definition and Challenges of CMC Project Management

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

9

Confucius (Chinese philosopher) said …

The route/way becomes the destination … this is especially true for the development of new compounds and/or therapeutic approaches

Quality and Price/COG

QTPP in mind!?

… or your business case? … or your stakeholders? … or your scientific career? … others

 CMC  Regulations  Competitors  Market pull or push?  …

It starts with innovations and ideas …

QTPP: Quality Target Product Profile

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

10