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

• In: Poster Presentation
• At: Stockholm (Sweden) (2017)
• Type: Poster
• Poster code: P-D-013-Monday
• 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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