A step-by-step readiness checklist to help sponsors plan, anonymize, redact CCI, and deliver a compliant EMA Policy 0070 submission efficiently and with confidence.
Learn how to manage EMA Policy 0070 requirements with confidence by balancing clinical trial data transparency, patient privacy, and protection of commercially confidential information (CCI) within strict EMA submission timelines. This EMA Policy 0070 Checklist helps you address common gaps in anonymization strategy, documentation, and governance that can lead to delays, rework, or regulatory non-compliance in line with current European Medicines Agency (EMA) clinical data publication requirements.
Designed for regulatory affairs, medical writing, disclosure, and transparency teams, the EMA Policy 0070 Submission Readiness Checklist helps align cross-functional stakeholders around roles, responsibilities, and milestones. By standardizing critical steps in the EMA Policy 0070 Checklist, it reduces reliance on manual workflows and minimizes submission risk.
What you’ll learn:
- How to plan and manage an EMA Policy 0070 submission, including governance, timelines, and cross-functional coordination.
- How to select and implement an appropriate anonymisation strategy while identifying and justifying commercially confidential information (CCI).
- How to prepare, quality-check, and submit compliant Policy 0070 documentation with confidence and efficiency.
- Turn regulatory complexity into submission confidence
Early, structured planning is essential to successful EMA Policy 0070 submissions. By applying the right framework from the outset, you can:
- Reduce delays and avoid last-minute remediation
- Improve submission quality and regulator confidence
- Minimize operational burden across teams
- Support transparency while protecting patient and company interests
Download the guide to learn how to align strategy, execution, and compliance for successful EMA Policy 0070 submissions.
