NIS Considerations – Hungary (2015)

£200.00

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

  • Title: NIS Considerations – Hungary (2015)
  • Publication Date: 05 October 2015
  • No. of Pages: 16
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-HU-2015 Categories: , , Tags: , ,

Description

NIS Considerations – Hungary

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

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
  • Regulatory Roadmap for Mandated PASS
  • Regulatory Roadmap for other NIS
  • REGULATORY SUBMISSIONS DOCUMENTS
  • Regulatory/EC 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 Considerations
  • Best Practice Considerations

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