Module 3 2019

(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