Global Pharmaceutical Regulatory Affairs Summit

Karen Harry

Global eSubmissions:
DAY 2 – Thur, 7 Apr 16:00 – 16:45

CET/CEST (Cent Europe Summer, GMT+2)

Session: Recent Developments in eCTD 4.0

  • What are the significant changes from eCTD v3.2.2 to eCTD v4.0?
  • Objectives of this new format
  • Which countries have published implementation guidelines?




Join us in Berlin, Germany

April 6-8, 2022

Booth #17

April 6, 2022
April 7, 2022
April 8, 2022


Karen Harry image

Karen Harry

Director Regulatory Information, RIM Consulting, Calyx

Karen Harry has extensive industry experience in Regulatory Operations and Regulatory Information Management particularly in the implementation of regulatory processes and compliance with regulations. In her current role at Calyx, she leads a team of Regulatory Consultants who provide strategic regulatory input into the RIM software development lifecycle and supports clients with their subject matter expertise to effectively manage complex regulatory processes, in alignment with the changing regulatory landscape.

Karen is a member of the IDMP/SPOR Task Force within the PMS group in addition to participating in several working groups including SPOR PMS, IRISS and a Focus Group for Process looking at the TOM for step 1.

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