NIS Considerations – Argentina (2017)

£200.00

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

  • Title: NIS Considerations – Argentina (2017)
  • Publication Date: 28 Nov 2017
  • No. of Pages: 26
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Argentina

 

This 26-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Argentina.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for Ciudad de Buenos Aires
    • Regulatory Roadmap for Buenos Aires Province
    • Regulatory Roadmap for Santa Fe Province
    • Regulatory Roadmap for Córdoba Province
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist
    • Data Protection Agency Submissions Document Checklist(s)
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
  • Considerations for Competent Authority and EC Approval, Contract Management, Consent, Safety Reporting, Study Amendments, Study Progress Management, End of Study Requirements and More
  • APPLICABLE LEGISLATION AND GUIDELINES
    • Regulatory Legislation and Guidelines for Ciudad De Buenos Aires
    • Regulatory Legislation and Guidelines for Buenos Aires Province
    • Regulatory Legislation and Guidelines for Santa Fe Province
    • Regulatory Legislation and Guidelines for Córdoba Province
  • USEFUL LINKS
    • Regulatory Requirements
    • Study Conduct Considerations

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