The European Medicines Agency (EMA) has relaunched Policy 0070, and it’s transforming the regulatory landscape for drug development. Now, pharmaceutical companies are required to disclose anonymized clinical data supporting their products, fostering transparency and trust like never before. And that’s not all – Policy 0070 is driving innovation, preventing duplication of trials, and improving biomedical research. In this Clinical Research News article, Certara transparency and disclosure expert, Honz Slipka gives a deep dive into the EMA’s review process, timeline changes, and expert recommendations for a successful submission.
Read this article to learn:
- How to develop a redaction proposal document
- Tips for protecting your commercially confidential information (CCI)
- How to get the most out of your pre-submission meetings with the EMA
