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Avoiding Policy 0070 Pitfalls and Ensuring Compliance

Avoiding Policy 0070 Pitfalls case study

The European Medicines Agency (EMA) Policy 0070 guidance was initially issued in 2016 and since then has undergone several iterations. The evolving guidance adds complexities to the Marketing Authorisation Application submission process, challenging organizations to be agile with their teams and processes as they establish best practices and stay current with policy changes. Although Policy 0070 continues to be expanded for openness and greater data utility, many aspects of the disclosure process remain undefined, leaving sponsors to work through complex issues on their own. Further updates are expected as the EMA incorporates additional requirements such as advanced anonymization techniques and dataset de-identification. Avoiding Policy 0070 pitfalls, ensuring compliance, and keeping teams engaged within the changing paradigm is challenging but critical to success.

CASE STUDY: “The Bear, The Alligator, and the Sloth”

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By: Certara

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