NIS Considerations – Romania (2017)

£200.00

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

  • Title: NIS Considerations – Romania (2017)
  • Publication Date: 17 Nov 2017
  • No. of Pages: 16
  • Format: PDF
  • Author/ Editor: Mirela Tudor

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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