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

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.

You 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.

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Meet Our Speaker

Naila Ali

Associate Director, Clinical Trial Disclosures

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Naila Ali

Naila is an experienced client manager with 10 years of clinical trials disclosures experience, which spans the continuum of authoring, review, and management of clinical trials disclosure activities (including registry authoring, redaction, and PLS) for global studies across multiple therapeutic areas, all study phases, and registries (including country-specific registries). She is embedded in the disclosures community and brings the most recent updates and information to clients as they work toward meeting commercial and ethical obligations. Naila’s strength lies in being a subject matter expert in clinical trials disclosure and leveraging that expertise to guide clients on interpreting and applying the most recent guidance and legislation.