The second (2nd) edition of our country-specific report on the regulatory and practical considerations for NIS in Bulgaria wasNIS-Considerations-Bulgaria_Title-page published today (11th Jan 2014).
NIS Considerations ‘Bulgaria’ provides a comprehensive overview of the country-specific regulatory and practical considerations when conducting non-interventional studies (NIS) in Bulgaria.
The report explore the Country-specific requirements when conducting non-interventional studies in Bulgaria and looks specifically at:

  • Regulatory classification
  • Applicable legislation and guidelines
  • Regulatory maps for
    • Multi-country mandated post-authorisation safety studies (PASS)
    • Bulgaria-only mandated post-authorisation safety studies (PASS)
    • Other NIS
  • Approval requirements
  • Submission documents
  • Approval timeframes
  • Responsibilities
  • Practical considerations
  • Industry best practice
  • Data privacy considerations
  • Human tissue research considerations

Learn more…