NIS Considerations – India (2015)

£200.00

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

  • Title: NIS Considerations – India (2015)
  • Publication Date: 21 May 2015
  • No. of Pages: 20
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-IN-2015 Categories: , , Tags: , ,

Description

NIS Considerations – India

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

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Approval Requirements Comparison
    • Regulatory Roadmap for Post Marketing Studies of ‘New’ Drugs (Defined by DCGI)
    • Regulatory Roadmap for Post Marketing Studies of ‘New’ Drugs (Out of Definition by DCGI)
    • Regulatory Roadmap for Post Marketing Studies of ‘Old’ Drugs
    • Regulatory Roadmap for Studies Not Involving Drugs
  • 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

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