NIS Considerations – Belarus (2015)

£200.00

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

  • Title: NIS Considerations – Belarus (2015)
  • Publication Date: 13 April 2015
  • No. of Pages: 12
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Belarus

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

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap forAll 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
    • Study Conduct Considerations
    • Data Privacy Considerations
    • Human Tissue and Genetic Research Considerations
    • Best Practice Considerations

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