CHCUK: NIS Considerations – Slovenia

• Title: NIS Considerations – Slovenia (2015)
• Publication Date: 21 November 2015
• No. of Pages: 21
• Format: PDF
• Price: £50
• Author/ Editor: Stuart McCully

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:

1. DISCLAIMER
2. REGULATORY BODIES
3. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
4. REGULATORY SUBMISSION ROADMAPS
   1. ‘Other’ NIS
   2. Single-Country Mandated PASS
   3. Multi-Country Mandated PASS
5. REGULATORY SUBMISSIONS DOCUMENTS
   1. NMEC Submissions Document Checklist
   2. JAZMP Submissions Document Checklist
   3. Which Documents Need to Be Translated?
6. WHO IS RESPONSOBLE FOR WHAT?
7. STUDY CONDUCT CONSIDERATIONS
8. APPLICABLE LEGISLATION AND GUIDELINES
9. USEFUL LINKS
   1. Regulatory Requirements
   2. Data Privacy Considerations
   3. Study Conduct Considerations
   4. Best Practice Considerations