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:

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. Regulatory Roadmap forAll NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. Regulatory Submissions Document Checklist
    2. Which Documents Need to Be Translated?
    3. Who Is Responsible for What?
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. Regulatory Requirements
    2. Study Conduct Considerations
    3. Data Privacy Considerations
    4. Human Tissue and Genetic Research Considerations
    5. Best Practice Considerations

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