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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