The second (2nd) edition of our country-specific report on the regulatory and practical considerations for NIS in Bulgaria was
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:
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…
- Free sample of NIS Considerations – Bulgaria (V2 – Jan 2014)
- Purchase the report through our online shop