Development of Advanced Therapy Medicinal Products in Europe

March 1, 2018
image_pdfPDF

 

Advanced Therapy Medicinal Products are innovative and complex medicinal products for which successful development requires a good understanding of the applicable regulatory requirements.

 

This WhitePaper on Advanced Therapy Medicinal Products (ATMP) in Europe, adapted from the article published in the Gazette de l’AFAR N°94 in January 2017, provides:

  • A review of the regulatory background applicable to ATMP with a focus on the main measures laid down by the Regulation specifically applicable to ATMPs i.e. Regulation EC N° 1394/2007;
  • Points to consider for the development of these types of therapies;
  • An analysis of effectiveness and limitations of the measures laid down by the Regulation on ATMPs to foster the development of these medicinal products.

Download the
White Paper

    By sending this form, I agree that my personal data will be saved and processed according to data protection regulations and will be used only for commercial and marketing purposes only.

    Learn more


    BlueReg undertakes to comply with the regulations in force applicable to the processing of personal data and, in particular, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 applicable as from 25 May 2018 (hereinafter, "the General Data Protection Regulations" or GPDR) and the national laws resulting therefrom.
    Any inquiries, correction or declaration of event related to personal data processed should be sent to: GDPR data request

    GDPR data request

    Thank you for your interest in BlueReg.


    The file will be sent to you by email.

    Download your White paper


    Line - Organism