A Milestone in Pharmacovigilance: W?rwag Pharma Submits its First AI-Generated ICSR

W?rwag Pharma and the field of pharmacovigilance have reached a groundbreaking milestone: we have successfully submitted to EMA our first Individual Case Safety Report (ICSR) generated by TheraLyze , an advanced AI-powered case intake platform.

This achievement reflects W?rwag Pharma’s commitment to innovation and patient safety while highlighting the transformative potential of automation. The platform processed raw safety data, performed accurate medical coding, and generated ICH-compliant E2B R3 files, which were seamlessly imported into our pharmacovigilance database.

While TheraLyze.ai handled the case processing with exceptional accuracy and quality, our skilled pharmacovigilance team ensured compliance with the highest industry standards through rigorous quality control (QC) before submission. This collaboration of cutting-edge technology and human expertise ensures reliable and compliant safety reporting.

The introduction of AI into pharmacovigilance heralds a new era of possibilities. By automating labor-intensive tasks such as case processing, automation allows us to redirect resources toward high-value activities like risk assessment and proactive safety measures. This milestone is not just about efficiency—it’s about accelerating insights that enhance patient safety.

We recognize that technologies are continuously evolving, and QC remains critical in maintaining accuracy and reliability. However, this milestone demonstrates that AI can streamline processes, improve data analysis, and play a transformative role in the future of pharmacovigilance.

At W?rwag Pharma, we are proud to lead the industry into this new era of AI-powered pharmacovigilance. Partnering with TheraLyze.ai, we are shaping the future of smart safety systems, empowering organizations to achieve better outcomes faster and more efficiently.

This achievement is only the beginning, and we are excited about the opportunities ahead. Together with TheraLyze.ai, we look forward to advancing pharmacovigilance practices worldwide.

Let’s shape the future of pharmacovigilance together!

"AI won’t replace us – but it will challenge those who refuse to adapt and take advantage of its potential." Reinhold Schilling (Head of Global Pharmacovigilance)

?