EMA Policy 0070: Advanced Strategies for Compliance,
Anonymization, and CCI Justification

About the Webinar

As European Medicines Agency Policy 0070 enters its expanded Step 2 phase, sponsors must prepare for a significant increase in scope, document volume, and regulatory scrutiny. Building on the foundations covered in Part 1, this webinar goes deeper into the operational realities of Policy 0070—focusing on practical challenges, high‑impact decisions, and lessons learned from early submissions.

Attendees will gain actionable guidance on advanced anonymization techniques, developing robust Confidential Commercial Information (CCI) justifications, and preparing internal systems for the expanded submission landscape under Step 2. Whether preparing a new Marketing Authorization Application (MAA), managing major variations, or optimizing cross-functional workflows, this webinar delivers the insights and tools needed to strengthen compliance and mitigate regulatory risk.

What You’ll Learn

• Advanced anonymization strategies: How to select and justify quantitative versus qualitative approaches, including managing rare events and small patient populations.
• Defensible CCI justifications: Common rejection themes from EMA, what is typically accepted, and how to build evidence-based rationales supported by public-domain references.
• Step 2 Policy 0070 readiness and scalability: How to scale processes, manage compressed timelines, and align cross-functional teams to handle increased submission volume and complexity.

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