NIS Considerations – Russia (2015)

£200.00

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

  • Title: NIS Considerations – Russia (2015)
  • Publication Date: 08 July 2015
  • No. of Pages: 14
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-RU-2015 Categories: , , Tags: ,

Description

NIS Considerations – Russia

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Russia.  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 for NIS
    2. Regulatory Roadmap for NIS Involving the Collection and Export of Biosamples
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. EC Submissions Document Checklist(s)
    2. Application for a Permit to Import (Export) Biological Materials Submission Document Checklist
    3. Which Documents Need to Be Translated?
    4. Who Is Responsible for What?
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. Regulatory Requirements
    2. Data Privacy Considerations
    3. Study Conduct Considerations
    4. Best Practice Considerations

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