It's been a few months since the European Medicines Agency relaunched Policy 0070. Since then, our Transparency & Disclosure team at Certara has worked on quite a number of submissions for various pharmaceuticals, and we've observed a few things: 1. Although the policy is still in its first few months, the EMA is quite organized and very responsive. 📩 - From preparing structured Lists of Expected Documents, to replying to inquiries about out-of-scope documents, everything moves quickly and dynamically. 2. Publicly disclosed Anonymization Reports available through the EMA portal indicate various approaches to clinical data anonymization. ⚖ - Some sponsors use a qualitative assessment, some use quantitative risk measurement, some use both. Which one do you think is best? 3. Commercially confidential information (CCI) remains a vague and subjectively grey area. 💰 - While we've developed a process that work very well, the strategy for protection of sensitive company data is still one of the most common and first questions that we get asked by clients.
EMA Policy 0070 states the agency will share anonymized clinical drug trial documents for anyone to read and learn about the research. Senior Transparency Specialist Honz Slipka breaks down this regulation in this Clinical Research News article. Read it to learn how to ensure successful Policy 0070 submissions for your drug program. https://ow.ly/Yx9M50QXCa5 #EMA #Transparency #Policy0070 #HealthCanada #DrugApproval #Disclosure #RegulatoryAffairs #Compliance
