6th International Seminar Establishing the swiftest pathway for registration of Biosimilars in USA 2014

Topics

• Developing a Biosimilars Program with US focus
  • Lessons learned from past EU and US experience
  • What to consider
  • Advisory 1st FDA meeting
  • Quality testing and essential supportive in vitro testing
• Biosimilars US and EU regulations and guidances
  • Deep insights and practical solutions
  • Compare and contrast
• Clinical program- consulting FDA (and advantages of Scientific Advice from EMA?)
• Nonclinical development: too much, too little? Planning for clinical work