NIS Considerations – Poland (2017)

£200.00

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

  • Title: NIS Considerations – Poland (2017)
  • Publication Date: 07 Jul 2017
  • No. of Pages: 18
  • Format: PDF
  • Author/ Editor: Mirela Tudor

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

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