The purpose of this workshop is for interested parties from industry, academia, and other groups interested in the development of complex generic products to collaborate to discuss the concept, scope, and scientific/regulatory considerations of using modeling and AI for generic drug product development and assessment.
In the past ten years there have been unprecedented advancements and successes in AI and modeling across many fields, including deep learning, reinforcement learning, and groundbreaking achievements like AlphaGo, AlphaFold, and ChatGPT. These developments present tremendous opportunities for generic drug development, regulatory assessment, and decision-making.
The information exchange and discussions during the workshop will foster a shared understanding of the role modeling and AI play in advancing drug product development, enhancing regulatory consistency and efficiency, and streamlining drug product approval.
For more information about these events, as well as other FDA and CRCG collaborative activities, visit http://www.complexgenerics.org/.