NIS Considerations – Russia (2017)

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:

• REGULATORY BODIES
• SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
  • Regulatory Roadmap for NIS
  • Regulatory Roadmap for NIS Involving the Collection and Export of Bio-samples
• REGULATORY SUBMISSIONS DOCUMENTS
  • EC Submissions Document Checklist(s)
  • Application for a Permit to Import (Export) Biological Materials Submission 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