Clinical Trial Data Sharing Under EMA Policy 0070

The landscape for clinical trial data sharing is evolving rapidly. European Medicines Agency’s (EMA) Policy 0070 requires sponsors to publicly disclose clinical data for medicinal products in the European Union. It was suspended after Brexit and the COVID-19 pandemic. With the 2023 Policy 0070 relaunch, pharmaceutical companies face new challenges and opportunities in data transparency and disclosure.

Submit the form to download your copy and streamline your approach to clinical trial disclosure.

What you’ll learn

The new Anonymization Report Template and its impact on protecting patient privacy

Industry trends in data treatment for sensitive information

Certara’s innovative solutions for efficient Policy 0070 compliance

About the authors

Honz Slipka

Senior Transparency Specialist

With a research background in neuroscience, and experience in health information technology, Honz Slipka has a thorough understanding of data analysis, regulatory standards, and best practices in the field of clinical data privacy. Drawing from his experiences, Honz is a champion of innovation, helping to lead the field of science, healthcare, and research into the modern age of technological efficiency, clinical transparency, and data utility.

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.