NIS Considerations – Poland (2017)

Description

NIS Considerations – Poland

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

• SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
• Non-Interventional Studies in the Context of Regulations in Poland

• Regulatory Roadmaps for National and International Post-Authorization Safety Studies
• Regulatory Roadmaps for All Other Non-Interventional Studies

• REGULATORY SUBMISSIONS DOCUMENTS
  • Regulatory/ EC Submissions Document Checklist
  • Translation Requirements
  • Submission  Responsibilities (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