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Wednesday, November 15 • 14:30 - 15:15
Case Study: The EU CTR and Its Impact on the TMF

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  • Review the EU CTR and examine the effect on the TMF content and processes
  • Learn how Ascendis Pharma implemented the new documentation requirements brought upon by the new regulation and integrated them into its budding TMF processes
  • Discuss the process that require updating due to redactions, new documents, and the Clinical Trials Application System (CTIS)

avatar for Karla Navera-Andersen

Karla Navera-Andersen

eTMF Manager, Global Trial Support, Ascendis Pharma
Karla Navera-Andersen is an eTMF Manager at Ascendis Pharma. Karla holds a Master of Arts in English and a Pharma Consultant Diploma.She has spent over 14 years working with TMFs, starting her TMF career as a student in the paper TMF archive in a large pharmaceutical company in Denmark.Since... Read More →

Wednesday November 15, 2023 14:30 - 15:15 GMT