The U.S. regulatory environment strongly impacts innovation and the development of new drugs and biologics. With this in mind, the Achieving Regulatory Approval and Compliance educational track at the 2012 BIO International Convention will tackle the most pressing regulatory issues facing the industry, specifically the reauthorization of the Prescription Drug User Fee Act (PDUFA V), implementation of the new biosimilars pathway, and efforts to modernize and expedite drug development. Hosted by the Biotechnology Industry Organization (BIO), this year’s global event for biotechnology will take place June 18-21, 2012 at the Boston Convention and Exhibition Center in Boston, MA.
“Attendees can expect to hear from a distinguished group of speakers from the Food and Drug Administration (FDA), as well as major biotechnology and pharmaceutical companies,” said BIO CEO and President Jim Greenwood. “Sessions will address the steps involved in research and development of healthcare products and how to successfully bring these products to market, all while maintaining rigorous standards for safety, effectiveness, and compliance.”