Webinar—EMA Policy 0070: Unlocking the Secrets to a Successful Submission

Under EMA Policy 0070, sponsors are mandated to submit anonymized clinical reports for publication on the Clinical Data Publication (CDP) portal, where they can be accessed by external researchers. Before public release, all personal data and Commercially Confidential Information (CCI) must be properly anonymized by the sponsor.

Policy 0070 submissions often span thousands of pages, all of which must be anonymized within a relatively short timeframe. For initial marketing authorization applications, the process begins with an invitation letter from the EMA on Day 121 of the procedure. Sponsors are then expected to submit the anonymization proposal package between Day 181 and up to 30 days after the CHMP opinion. Thorough early planning can significantly ease the anonymization process and help ensure compliance with EMA Policy 0070.

What you'll learn

This webinar will provide practical guidance on how to efficiently and effectively meet EMA Policy 0070 requirements. You'll learn best practices for managing tight timelines and handling large volumes of documentation, while maintaining submission quality and ensuring regulatory compliance. The session will also highlight proactive steps you can take well in advance of the EMA’s invitation to help you avoid last-minute stress and be better prepared for a smooth, successful submission process.