CMC Regulatory Compliance for Biopharmaceuticals and Biologics

With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape of biopharmaceutical and biologic processes and products, it is most important for a company to have an effective CMC regulatory compliance strategy.  At each stage of drug development, from Phase 1 through market approval, the basic question needs to be addressed:  ‘What is absolutely necessary from a CMC regulatory compliance perspective to be successful in getting our biopharmaceutical/biologic through clinical trials and into the market?’  Deficiencies in CMC regulatory compliance have resulted in devastating clinical holds.  An ineffective CMC regulatory strategy can result in market approval delays as frequently as an ineffective Clinical regulatory strategy.

Much excitement in the United States has been generated since the passage of the Biologics Price Competition and Innovation Act (BPCI) of 2009 that opens the pathway for market approval of biosimilar biological products in the US.  Understanding the CMC regulatory compliance principles for biopharmaceuticals and biological is at the heart of understanding how to meet the CMC regulatory requirements for biosimilars (FDA, EMA and WHO).

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.