NIS Considerations – Brazil (2019)

£200.00

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

  • Title: NIS Considerations – Brazil (2019)
  • Publication Date: 17 Jan 2019
  • No. of Pages: 23
  • Format: PDF
  • Author/ Editor: Patricia Garcia

Description

NIS Considerations – Brazil

 

This 23 page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Brazil.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • Regulatory Roadmap for setting up Non-Interventional Studies in Brazil
    • Regulatory Requirements for Non-Interventional Studies
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist New in 2019: CEP and CONEP Requirements
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • Requirements Related to Competent Authority and Ethics Committees
    • Contracts, Consent, Safety Reporting, Study Progress, End of Study Requirements and More
    • Transfer of Value and Financial Disclosure
  • APPLICABLE LEGISLATION AND GUIDELINES
    • Links to Applicable Legislation for NIS in Brazil
  • USEFUL LINKS
    • Regulatory Requirements
    • Study Conduct Considerations
    • Data Privacy Considerations
    • Human Tissue and Genetic Research Considerations
    • Best Practice Considerations

Reviews

There are no reviews yet.

Be the first to review “NIS Considerations – Brazil (2019)”