Center for Professional Innovation & Education, Inc., King of Prussia, PA
Oct. 31 – Nov. 1, 2013
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.