NIS Considerations – Saudi Arabia (2018)

£200.00

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

  • Title: NIS Considerations – Saudi Arabia (2018)
  • Publication Date: 30 January 2018
  • No. of Pages: 11
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-SA-2015 Categories: , , Tags: ,

Description

NIS Considerations – Saudi Arabia

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Saudi Arabia.  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 All NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. Regulatory Submissions Document Checklist
    2. SFDA Notification Documentation
    3. Which Documents Need to Be Translated?
    4. 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. Study Conduct Considerations
    4. Human Tissue Research Considerations
    5. Best Practice Considerations

Reviews

There are no reviews yet.

Be the first to review “NIS Considerations – Saudi Arabia (2018)”