NIS Considerations – Germany (2018)

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