PDA Biosimilars Conference 2016

The 2016 PDA Biosimilars Conference will bring together all levels of industry professionals to network and benefit from a program that will provide an update on recent regulatory expectations for the approval of biosimilars. The Conference will bring together industry experts and regulators to review and discuss new development strategies for biosimilars. Successful case studies will be presented to illustrate how analytical similarity can be demonstrated and practical control strategies (process validation and specifications) can be developed. Attendees can expect to receive current updates from the regulatory agencies, about which CMC aspects have been most challenging for the CMC reviewer, and will have the opportunity to raise questions and concerns during the Conference.