Post by Körber Pharma

The European Medicines Agency held a workshop with major EU pharma associations on Annex 22, focusing on guardrail architecture to enable generative models and dynamic systems.   Körber contributed to the associations’ response to EMA’s questions – thanks to Shaun Tyler and team for their engagement. The discussion highlighted an end‑to‑end approach based on Quality Risk Management as the industry’s preferred path.   With our PharmaGuardrails, we follow this approach: considering context of use, identifying key GenAI risks, and addressing them with targeted guardrails. As emphasized in the workshop, effectiveness must also be measured – hence our robust performance benchmarks to support controlled GenAI use in GMP operations.   We look forward to the workshop’s impact and the final Annex 22.