News
What Annex 22 spells for AI in GMP manufacturing
6+ hour, 57+ min ago (970+ words) Europe's first dedicated framework for artificial intelligence in GMP manufacturing is close to finalisation and it is more demanding and more consequential than many manufacturers may currently appreciate. Pharmaceutical manufacturers in Europe have great ambitions for AI: in a survey…...
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EMA and FDA issue joint AI guidance for medicine development
5+ mon, 3+ hour ago (333+ words) The regulators" 10 principles aim to support pharma companies with evidence generation and monitoring for new medicines. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly proposed ten principles for good artificial intelligence (AI) practice,…...
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