Navigating regulatory change in the US and Europe

Amid unpreceded regulatory disruption, and landmark legislative change, biopharma manufacturers are being subjected to an onslaught of new directions with which to contend. 

This session will focus on some of the key challenges facing biopharma manufacturers as they strive to remain responsive to regulatory changes, including:  

• Preparing for the next generation of FDA user fee agreements 

• Assessing European moves to increase the region’s competitiveness 

• Seeking certainty amid continuous change