On october 2 , the EMA published its multi-stakeholder workshop report on Annex 22 (“Artificial Intelligence” )
EMA aims to achieve the following objectives via this workshop:
- Collect expert insights on responsible AI requirements, risk identification and mitigation approaches, and practical safeguards
- Identify key principles such as data governance, model evaluation, transparency, accountability, and human oversight
- Identify specific considerations, challenges, and real-world constraints of the pharmaceutical industry
- Identify specific approaches to responsible use of AI in GMP applications
https://www.ema.europa.eu/en/events/good-manufacturing-practice-multistakeholder-workshop-expert-contributions-artificial-intelligence-guidance-development-annex-22