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Mapping and optimizing the procedure for managing a change in CEP for TSE at a global pharmaceutical company

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Poster
  • By: INADSSON, Karin (Student, Stockholm, Sweden)
  • Co-author(s): Karin Inadsson: Student in Master of Science in Pharmacy at Uppsala University , Stockholm, Sweden
  • Abstract:

    Backgrounds

    A “Certificate of Suitability” (CEP) for Transmissible Spongiform Encephalopathy (TSE) is a part of the dossier. The CEP is a way to demonstrate TSE compliance for gelatin of animal origin. A change in the CEP has to be managed as a regulatory change. The authorities have different requirements to manage the change, which can complicate

    ..

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Last update 4 October 2019

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