NIS Considerations – Malaysia (2018)

£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 (2018)
  • Publication Date: 06 June 2018
  • No. of Pages: 14
  • Format: PDF
  • Author/ Editor: Patricia Garcia

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:
  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for All NIS
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist
    • Which Documents Need to Be Translated?
    • Who Is Responsible for What?
  • STUDY CONDUCT CONSIDERATIONS
  • APPLICABLE LEGISLATION AND GUIDELINES
  • USEFUL LINKS
    • Regulatory Requirements
    • Data Privacy Considerations
    • Study Conduct Considerations
    • Human Tissue Research Considerations
    • Best Practice Considerations

Reviews

There are no reviews yet.

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