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Guiding Principles

Events

25 - 27 June 2014

20th EGA Annual Conference 25 – 27 June 2014 - Madrid, Spain Click here for more information

21 January 2015

More details available in September 2014

22 - 23 January 2015

More details available in September 2014

23 - 24 April 2015

Coordinated by the European Biosimilars Group, a Sector Group of the EGA
More details available in November 2014

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Publications

  • KPMG Report - Advice on the implementation of EU-Directive 2011/62/EU

    Advice on the implementation of EU-Directive 2011/62/EU 

    KPMG Report Download PDF

                Folder Web 

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  • EGA Biosimilars Handbook

    EGA Biosimilars Handbook EGA_BIOSIMILARS_handbook_en.pdf



    EGA Biosimilars Handbook Italian version EGA_BIOSIMILARS_IT.pdf

     
  • EGA Q&A on the revised EMA Bioequivalence Guideline

    EGA Q&A on the revised EMA Bioequivalence Guideline, the EGA Contribution to the Promotion of Harmonised EU interpretation of the revised Bioequivalence Requirement dowload PDF 

     
  • Vision 2015

    EGA Vision 2015, the Way forward for more Efficient Regulatory Environment for Generic and Biosimilar Medicines
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