Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars 2012

Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars is a webinar that covers topics such as:

• The process and requirements for demonstrating biosimilarity
• FDA`s regulation of biosimilars
• Quality Considerations for demonstrating biosimilarity
• The February 2012 FDA Guidance Documents on Biosimilars
• The process of obtaining biosimilar approval
• Safety Consideration for demonstrating biosimilarity

Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars brings together Managers, Regulatory Affairs Professionals, Scientists, Consultants, State Policy Officials, Research Analysts, Biologic and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Distributors, and Generic Firms, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists, Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries.