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
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