NIS Considerations – Turkey (2016)

£200.00

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

  • Title: NIS Considerations – Turkey (2016)
  • Publication Date: 28 January 2016
  • No. of Pages: 26
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-TR-2015 Categories: , , Tags: ,

Description

NIS Considerations – Turkey

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Turkey.  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. Substantial Amendment Checklist
    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. Best Practice Considerations
  7. DOCUMENT HISTORY

Reviews

There are no reviews yet.

Be the first to review “NIS Considerations – Turkey (2016)”