Center for Professional Innovation & Education, Inc., Berlin, Germany
Oct. 7 & 8, 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.
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