EMA Policy 0070: The Hidden Challenges

About the webinar

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.

To meet these timelines, proactive preparation is essential. Key early steps include:

• Estimating submission volume
• Developing a tentative project timeline
• Initiating project management tasks such as resource planning, vendor management, tracker setup, and tool selection
• Choosing an anonymization approach—either Qualitative or Quantitative

Thorough early planning can significantly ease the anonymization process and help ensure compliance with EMA Policy 0070.

What you'll learn

This session will highlight best practices for meeting EMA Policy 0070 requirements efficiently and effectively.

Attendees will gain practical insights into navigating challenges such as tight timelines and large volumes of documentation.

By understanding which proactive steps to take well in advance of the EMA’s invitation, participants will be better prepared to avoid last-minute stress, maintain submission quality, and ensure regulatory compliance.

Who Should Attend

• Sponsors
• Project Managers
• Clinical Data Analysts
• Regulatory Affairs Professionals
• External Researchers

Unable to join? Register and you will receive the recording after the live session.