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Digitalisation and artificial intelligence (AI) are transforming pharmaceutical development and manufacturing at an unprecedented pace.
Advances in data analytics, automation, machine learning, digital twins, and other AI-enabled technologies are creating new opportunities. These include enhancing product quality, manufacturing efficiency, supply chain resilience. These changes can also improve decision-making across the pharmaceutical product lifecycle.
EMA's Quality Innovation Group (QIG) is organising a roundtable meeting with representatives from industry, academia and regulators to support dialogue on these rapid developments. Broad topics for discussion include:
The meeting aims to provide a forum for the exchange of knowledge and practical experience on the development, implementation, and use of digital and AI-enabled technologies in the fields mentioned.
It also aims to explore scientific and regulatory challenges associated with these technologies and consider potential approaches to address them.
In addition, it looks to support continued collaboration on the opportunities, challenges, and future perspectives associated with digitalisation and AI in pharmaceutical manufacturing.
Moreover, meeting discussions are meant to help QIG gain insight into emerging scientific and technological developments. This enables the timely provision of regulatory support as well as fostering a shared understanding of innovation in AI.
The meeting is intended for stakeholders in industry and academia involved in the development, implementation, application, or regulation of digital and AI-enabled technologies in the mentioned fields.
Participants are invited to present recent related case studies that illustrate how digitalisation and AI applies in manufacturing and quality control.
The meeting builds on previous QIG listen-and-learn focus group (LLFG) meetings from 2023 and 2024 focused on digitalisation and pharmaceutical process models in manufacturing. The experience gained through numerous one-on-one QIG meetings with stakeholders also contributed towards this meeting.
For more information, see: