Description
NIS Considerations – Romania
This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Romania. All sources of information are referenced and hyperlinked. Topics covered include:
- REGULATORY BODIES
- SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
- Regulatory Roadmaps for Non-Interventional Studies including Non-Interventional PASS
- REGULATORY SUBMISSIONS DOCUMENTS
- Regulatory Submissions Document Checklist
- EC Submissions Document Checklist(s)
- 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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