Module 3 Presentations
07/05/2024
PM Framework – the VUCA World
CMC Project Management
The Organisation for Professionals in Regulatory Affairs
3
(R)Evolution in the Era of Pharmaceuticals
2 nd wave of gold rush for (bio)therapeutics, but with three major differences …
Past
New Challenges and Opportunities to the Field are:
New manufacturing techniques used to produce products.
Technological advances to characterize products.
Today
Rapidly evolving scientific and regulatory landscape and related development strategies and procedures.
CMC Project Management
The Organisation for Professionals in Regulatory Affairs
4
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