NIS Considerations – Malaysia (2015)

£200.00

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

  • Title: NIS Considerations – Malaysia (2015)
  • Publication Date: 18 May 2015
  • No. of Pages: 15
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-MY-2015 Categories: , , Tags: , , ,

Description

NIS Considerations – Malaysia

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Malaysia.  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. 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. Study Conduct Considerations
    4. Human Tissue Research Considerations
    5. Best Practice Considerations

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