Using Artificial Intelligence to Support Regulatory Processes and Decision-Making

Description: The EU Regulatory framework may be seen as rigid but is very rich in diversity and regulatory tools to ease innovation. In case of emergency, the regulatory framework can be flexible, creating new efficiencies and showing that other ways of working are possible.
With the revision of the General Pharmaceutical Legislation (GPL), some discussions are ongoing to refresh the EU regulation by including new concepts and tools taken advantage of the development of Artificial Intelligence (AI).

This session will describe the concept of Dynamic Regulatory assessment (DRA), which expands the concept of Phase review discussed in the draft GPL and anticipate how the new AI tools can help to gain efficiency in the EU regulatory decision making. EMA will present their current activities to adopt AI with actual use cases like the Scientific Explorer tool, explain their work plan 2023-2028, and a reflection paper on the use of AI in the medicinal product lifecycle.

This session will also present the scope of guidance documents from EMA and FDA to use AI models for evidence generation and how a risk-based approach of risk management using AI technology can help the Regulatory decision-making.

Panellist from EU Health Authorities and industry will therefore explore Regulatory stakeholders’ experience in using AI-enhanced digital technology with Regulatory tools to explain how this effective combination has the potential to drive better knowledge management and more efficient regulatory framework. Stakeholders will also discuss further opportunities to be considered ahead of the current vision, increasing efficiencies for either patients, regulators and industry.