CMC Regulatory Compliance for Biopharmaceuticals and Biologics

At the end of the two-day course attendees will:

Gain a firm understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH) for biopharmaceuticals and biologics;
Appreciate the significant CMC regulatory differences between chemical-origin drugs and biopharmaceuticals and biologics;
Avoid major product delays or non-approvals due to an ineffective CMC regulatory strategy.