NIS Considerations – Norway (2018)

£200.00

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies (NIS) in Norway.

  • Title: NIS Considerations – Norway (2018)
  • Publication Date: 09 Jan 2018
  • No. of Pages: 18
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Norway

 

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Norway.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for All NIS
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist
    • Which Documents Need to Be Translated?
    • Who Is Responsible for What?
  • STUDY CONDUCT CONSIDERATIONS
  • APPLICABLE LEGISLATION AND GUIDELINES
  • USEFUL LINKS
    • Regulatory Requirements
    • Data Privacy Considerations
    • Study Conduct Considerations
    • Best Practice Considerations

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