Module232025

(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.

Digitalization and Technological advances .

Today

Rapidly evolving scientific and regulatory landscape, complexity in supply chains and related strategies and procedures.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs