NIS Considerations – Greece (2019)

£200.00

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

 

  • Title: NIS Considerations – Greece (2019)
  • Publication Date: 16 Jan 2019
  • No. of Pages: 13
  • Format: PDF
  • Author/ Editor: Mirela Tudor

Description

NIS Considerations – Greece

 

This short 13-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Greece.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for Single-Country Mandated Post-Authorization Safety Studies (PASS) in Greece
    • Regulatory Roadmap for Multi-Country Mandated Post-Authorization Safety Studies in Greece
    • Regulatory Roadmap for Other Non-Interventional Studies in Greece
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for Ethics Committees
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees
    • Contracts, Consent, Safety Reporting, Study Progress and End of Study
    • SFEE Registration Process
  • APPLICABLE LEGISLATION AND GUIDELINES
  • USEFUL LINKS
    • Regulatory Requirements
    • Study Conduct Considerations
    • Data Privacy Considerations
    • Human Tissue and Genetic Research Considerations
    • Best Practice Considerations

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