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• Karsten Krüger

Personal information

• Wants

  Projects in the Pharma industry in Regulatory Affairs / Regulatory Operation in the areas of regulatory document management, submission management, PIM/SPL/labeling, tool evaluation and assessment, post merger integration.

• Haves

  Topics: Regulatory Affairs IT, Regulatory Operations, eCTD, XML, labeling, PIM, PIM migration, SPL/PLR, CDISC, computer system validation, e-regulations from health authorities, project management, SDLC management, submissions management, submission planning, document management, SOP management, translation management. Systems: CoreDossier, Documentum, CSC FirstDoc, NextDocs, Insight Manager, Insight Publisher, ALiCE (labeling), SDL Trados, docuBridge, OPX2/Planisware

• Interests

  my family, traveling, networking

• Organizations

  Former member of EFPIA PRIMAG (Product and Regulatory Information Management Ad Hoc Group), EFPIA SWG (Security Working Group), EFPIA PIM Implementation Group

• Groups

  

• Employment status

  Executive

Educational background

• Languages

  German (First language), English (Fluent), French (Basic knowledge), Turkish (Basic knowledge)