NIS Considerations – Bulgaria (2015)

£200.00

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

  • Title: NIS Considerations – Bulgaria (2015)
  • Publication Date: 14 April 2015
  • No. of Pages: 13
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-BG-2015 Categories: , , Tag:

Description

NIS Considerations – Bulgaria

 

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

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Post Marketing Drug Studies Regulatory Requirements
      • Post-Marketing Drug Studies Roadmap
      • Submissions Documents
    • Medical Scientific Studies on Humans
      • Medical Scientific Studies on Humans Roadmap
      • Medical Scientific Studies on Humans 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

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