NIS Considerations – Peru (2018)

£200.00

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

  • Title: NIS Considerations – Peru (2018)
  • Publication Date: 30 Aug 2018
  • No. of Pages: 12
  • Format: PDF
  • Author/ Editor: Patricia Garcia

Description

NIS Considerations – Peru

 

This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Peru.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist
    • EC Submissions Document Checklist(s)
    • 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
    • Best Practice Considerations

Reviews

There are no reviews yet.

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