NIS Considerations – Netherlands (2018)

£200.00

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

  • Title: NIS Considerations – The Netherlands (2018)
  • Publication Date: 07 Oct 2018
  • No. of Pages: 24
  • Format: PDF
  • Author/ Editor: Mark Heinemann

Description

NIS Considerations – Netherlands

 

This 24-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in the Netherlands.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmaps for non-WMO Research
    • Differentiation between non-WMO and WMO Research (Medisch-wetenschappelijk Onderzoek met Mensen)
    • Regulatory Roadmaps for Prospective Non-Interventional Studies and Voluntary Post-Authorization Safety Studies (PASS)
    • Regulatory Roadmaps for Mandated PASS (Netherlands Only) and Multi-Country Mandated PASS (International)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees (DCRF)
    • Considerations for Ethics Approval, Contract Management, Consent, Safety Reporting, Study Progress Management, End of Study Requirements and More
    • Transfer of Value and Financial Disclosure Requirements
  • 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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