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:

• 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