Description
NIS Considerations – Poland
This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in Poland. All sources of information are referenced and hyperlinked. Topics covered include:
- SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
- Non-Interventional Studies in the Context of Regulations in Poland
- Regulatory Roadmaps for National and International Post-Authorization Safety Studies
- Regulatory Roadmaps for All Other Non-Interventional Studies
- REGULATORY SUBMISSIONS DOCUMENTS
- Regulatory/ EC Submissions Document Checklist
- Translation Requirements
- Submission Responsibilities (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
Reviews
There are no reviews yet.