NIS Considerations – Germany (2018)

£200.00

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

  • Title: NIS Considerations – Germany (2018)
  • Publication Date: 17 April 2018
  • No. of Pages: 29
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Germany

This 29-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Germany.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for Non-interventional Studies in the Scope of the German Drug Act (§ 63f AMG; § 67 (6) AMG)
    • Regulatory Roadmap for Single-Country Mandated Post-Authorization Safety Studies (§ 63f AMG, § 63g AMG (PASS))
    • Regulatory Roadmap for Multi-Country Mandated Post-Authorization Safety Studies (§ 63g AMG (PASS))
    • Regulatory Roadmap for Parallel Submission Process to German Ethics Committees (New in 2018)
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for Ethics Committees, Competent Authority and Other Required Organisations
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees
    • 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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