Module232025

The CMC Challenge – Innovations vs Legislations vs Operations vs Efficiency

Are we opening Pandora´s Box by applying new processes (“the product is the process” - true?) and technologies?

New business opportunities, cheaper and faster, but … new CMC (and RA) and SC challenges and related risks …

How to mitigate risks, how to gain control of these changes & opportunities, and how to keep the desired quality?

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs