NIS Considerations – Belgium (2018)

£200.00

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

 

  • Title: NIS Considerations – Belgium (2018)
  • Publication Date: 10 Aug 2018
  • No. of Pages: 28
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-BE-2018 Categories: , , Tags: , , , ,

Description

NIS Considerations – Belgium

 

This 28-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Belgium.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for Studies Within the Scope of the ‘LEHP’ (loi relative aux expérimentations sur la personne humaine)
    • Regulatory Roadmap for Single-Country Mandated Post-Authorization Safety Studies (PASS)
    • Regulatory Roadmap for Multi-Country Mandated Post-Authorization Safety Studies
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for Ethics Committees (Central and Local)
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees
    • (New in 2018):
      • Choosing the Right EC
      • Difference between EC Accreditations
      • CHRAU and Single Opinion
      • “Single Entry Point for Applications”
      • Insurance Considerations
      • Contracts, Consent, Safety Reporting, Study Progress and End of Study
      • Transfer of Value and Financial Disclosure
  • 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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