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Streamline Your Approach to EMA Policy 0070

Policy 0070― published by the European Medical Agency (EMA) in October 2014― has made the world of regulatory writing a more complicated place. The policy requires specified submission documents to be made public for all marketing authorization applications (MAA’s) submitted as of January 1, 2015 and for all indication extensions and line extensions submitted as … Continued

https://www.certara.com/blog/streamline-your-approach-to-ema-policy-0070/

Navigating EMA Policy 0070—How Do We Ensure Compliance?

Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.

https://www.certara.com/on-demand-webinar/navigating-ema-policy-0070-how-do-we-ensure-compliance/

EMA Policy 0070 Compliance Tips from James Bond

In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In … Continued

https://www.certara.com/blog/ema-policy-0070-compliance-tips-from-james-bond/

How AI Tech Is Changing Regulatory Writing

Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with … Continued

https://www.certara.com/blog/how-ai-tech-is-changing-regulatory-writing/
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