NIS Considerations – Hungary (2015)

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:

1. REGULATORY BODIES
2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
   1. Regulatory Roadmap for Mandated PASS
   2. Regulatory Roadmap for other NIS
3. REGULATORY SUBMISSIONS DOCUMENTS
   1. Regulatory/EC Submissions Document Checklist
   2. Which Documents Need to Be Translated?
   3. Who Is Responsible for What?
4. STUDY CONDUCT CONSIDERATIONS
5. APPLICABLE LEGISLATION AND GUIDELINES
6. USEFUL LINKS
   1. Regulatory Requirements
   2. Data Privacy Considerations
   3. Study Conduct Considerations
   4. Human Tissue Considerations
   5. Best Practice Considerations