EU Biosimilar Registration and Marketing Requirements

July 2, 2013 3:03 PM

Pharmaceutical Training International is organizing a new EU Biosimilar Registration and Marketing Requirements  training in London, UK on 3-4 September 2013.

Course Highlights

Practical solutions and regulatory considerations to successfully achieve EU submission compliance.

  • Clarify the latest regulatory requirements for the registration of Biosimilars
  • Examine EMA guidance on immunogenicity assessment of biotechnology derived therapeutic proteins
  • Learn how to Prepare Module 3 of the Common Technical Document: Special issues for Biosimilars
  • Identify risk benefit conclusions and relevancy to clinical practice

If you are interested, the website of the training is: www.pti-global.co.uk/event/biosim

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