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

The 6th International Seminar Establishing the swiftest pathway for registration of Biosimilars in USA 2014 covers topics such as:

• 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