NIS Considerations – Austria (2018)

£200.00

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

  • Title: NIS Considerations – Austria (2018)
  • Publication Date: 13 March 2018
  • No. of Pages: 21
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Austria

This 21 page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Austria.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for Non-interventional Studies in the Scope of the Austrian Drug Act (AMG) and NIS Ordinance
    • Regulatory Roadmap for Single-Country Mandated Post-Authorization Safety Studies (PASS)
    • Regulatory Roadmap for Multi-Country Mandated Post-Authorization Safety Studies
  3. REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for Ethics Committees and BASG
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  4. STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees
    • Contracts, Consent, Insurance, Safety Reporting, Study Progress, End of Study Requirements and More
    • Transfer of Value and Financial Disclosure
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    • Regulatory Requirements
    • Study Conduct Considerations
    • Data Privacy Considerations
    • Human Tissue and Genetic Research Considerations
    • Best Practice Considerations

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