NIS Considerations – Slovenia (2018)

£200.00

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

  • Title: NIS Considerations – Slovenia (2018)
  • Publication Date: 24 January 2018
  • No. of Pages: 20
  • Format: PDF
  • Author/ Editor: Mirela Tudor

Description

NIS Considerations – Slovenia

 

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Slovenia.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • DISCLAIMER
  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
  • REGULATORY SUBMISSION ROADMAPS
    • ‘Other’ NIS
    • Single-Country Mandated PASS
    • Multi-Country Mandated PASS
  • REGULATORY SUBMISSIONS DOCUMENTS
    • NMEC Submissions Document Checklist
    • JAZMP Submissions 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
  • DOCUMENT HISTORY

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