NIS Considerations – Sweden (2018)

£200.00

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

  • Title: NIS Considerations – Sweden (2018)
  • Publication Date: 8 January 2018
  • No. of Pages: 20
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-SE-2015 Categories: , , Tags: , , ,

Description

NIS Considerations – Sweden

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

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. Summary of the Differences Between Different Types of Studies
    2. Regulatory Roadmap for Single-Country Mandated PASS
    3. Regulatory Roadmap for Multi-Country Mandated PASS with PRAC Endorsement
    4. Regulatory Roadmap for ‘Other’ NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. CEC Submissions Document Checklist
    2. Which Documents Need to Be Translated?
    3. Who Is Responsible for What?
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. Regulatory Requirements
    2. Data Privacy Considerations
    3. Best Practice Considerations
  7. DOCUMENT HISTORY

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