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

Description

The International Seminar Establishing the swiftest pathway for registration of Biosimilars in USA 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

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Important

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