Considerations for a Successful Biosimilars Program 2016

Topics

• Current regulatory guidelines and considerations for bringing biosimilars to market
• BPCI Act of 2009
• Integration of biosimilarity and comparability into developing biosimilars
• Strategies for developing and manufacturing biosimilars
• CMC regulatory challenges and considerations
• Identifying challenges encountered with extrapolations and Interchangeability
• Nonclinical and clinical challenges

Who should Attend

Attendees from:

• Functional Area Managers
• Senior Scientists and above
• Directors
• Vice Presidents
• Quality/Regulatory Managers
• Project Managers
• Investors
• Principle Investigators