NIS Considerations – Spain (2018)

£200.00

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

  • Title: NIS Considerations – Spain (2018)
  • Publication Date: 16 Nov 2018
  • No. of Pages: 25
  • Format: PDF
  • Author/ Editor: Patricia Garcia
SKU: NIS-C-ES-2018 Categories: , , Tags: , , ,

Description

NIS Considerations – Spain

This 25-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Spain.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Submission Roadmaps:
      • Mandated Post-Authorization Safety Study (EPA-LA)
      • Prospective Post-authorisation Follow-Up Study (EPA-SP)
      • Other Post-Authorization Studies (OPA-OD)
      • Non-Post-Authorization Studies (Non-EPA)
      • Post-Authorisation Study promoted by Health Authorities or Publicly Funded Body (EPA-AS)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document for Ethics Committees and Autonomous Communitites
    • 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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