NIS Considerations – Italy (2019)

£200.00

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

  • Title: NIS Considerations – Italy (2019)
  • Publication Date: 18 Jan 2019
  • No. of Pages: 22
  • Format: PDF
  • Author/ Editor: Mirela Tudor

Description

NIS Considerations – Italy

 

This 22-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Italy.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Submission Roadmaps for Observational Studies:
      • Non-Interventional Studies
      • Non-Interventional PASS (voluntary and mandated)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for Ethics Committees
    • AIFA Involvement in Post-Authorization Safety Studies
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Considerations: Competent Authority, Ethics Approval, Contract Management, Consent, Safety Reporting, Study Amendments, Study Progress Management, End of Study Requirements and More
  • 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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