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GAPP-PROGAPP-PRO
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    • WP1: Coordination and Sustainability
    • WP2: Dissemination and Communication
    • WP3: Evaluation
    • WP4: SOHO preparation processes
    • WP5: Pilot-test of GAPP methodology on SoHO
    • WP6: Pilot-test of GAPP methodology for cross-country and joint country assessments
    • WP7: Analysis of pilot tests results
    • WP8: Refine of GAPP Guideline
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GAPP-PRO Bulletin

GAPP PPDs

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Preparation Process Dossiers: Pilots and assessment methodology

The GAPP-PRO Consortium welcomes the formal adoption of the EU regulation on substances of human origin (SoHO), which will be published in the Official Journal in the following weeks. Among other, the new legal act aims to contribute to increase the resilience of SoHO supply, establish/improve quality and safety standards system, strengthen the principle of unpaid donations in order to guarantee equal and high protection of the health of donors and patients.

GAPP meeting

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Interim meeting outcomes, information on the testing of the SPA Module of the SoHO Platform and outcomes of the webinars held for the SCB SPA WG

The GAPP-PRO Consortium welcomes the formal adoption of the EU regulation on substances of human origin (SoHO), which will be published in the Official Journal in the following weeks. Among other, the new legal act aims to contribute to increase the resilience of SoHO supply, establish/improve quality and safety standards system, strengthen the principle of unpaid donations in order to guarantee equal and high protection of the health of donors and patients.

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GAPP-PRO, Piloting GAPP model approach for assessing and authorizing novel substances of human origin preparation PROcess, is a project co-funded by the Heath Programme of the European Union. Grant Agreement 101128035 – EU4H-2022-JA-07, February 2024 – June 2027. Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HADEA. Neither the European Union nor the granting authority can be held responsible for them.

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GAPPGAPP
  • About
  • Work Packages
    • WP1: Coordination and Sustainability
    • WP2: Dissemination and Communication
    • WP3: Evaluation
    • WP4: SOHO preparation processes
    • WP5: Pilot-test of GAPP methodology on SoHO
    • WP6: Pilot-test of GAPP methodology for cross-country and joint country assessments
    • WP7: Analysis of pilot tests results
    • WP8: Refine of GAPP Guideline
  • News
  • Download
  • Contact