NIS Considerations – Italy (2015)

£200.00

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

  • Title: NIS Considerations – Italy (2015)
  • Publication Date: 13 November 2015
  • No. of Pages: 21
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-IT-2015 Categories: , , Tags: , ,

Description

NIS Considerations – Italy

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

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. Regulatory Roadmap for Multi-Country Mandated Prospective PASS
    2. Regulatory Roadmap for Single-Country Mandated Prospective PASS
    3. Regulatory Roadmap for Prospective Voluntary PASS and Other NIS
    4. Regulatory Roadmap for Multi-Country Mandated Retrospective PASS
    5. Regulatory Roadmap for Single-Country Mandated Retrospective PASS
    6. Regulatory Roadmap for Retrospective Voluntary PASS and Other NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. Regulatory 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. Study Conduct Considerations
    3. Best Practice Considerations

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