NIS Considerations – Romania (2017)

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