NIS Considerations – South Korea (2015)

£200.00

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

  • Title: NIS Considerations – South Korea (2015)
  • Publication Date: 27 July 2015
  • No. of Pages: 11
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – South Korea

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in South Korea.  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 Mandated NIS
    2. Regulatory Roadmap for ‘Other’ NIS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. EC 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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