ERA at TOPRA 2025: Session 3 – Human – Applying Artificial Intelligence in Real-Life

Artificial Intelligence has already been a hot topic in numerous workshops, conferences, symposia and more in the past years. This session focused on questions such as:

How is it actually being applied in pharmaceutical development and regulation?

Where has it made the most impact in the field?

The session put aside the high-level discussions on what is possible with AI and discussed the real-life examples of where AI is already making a difference.

Points to note:

• Auto dossier was presented and Demo shown of how it can automate CTD building
• Collaborare: Unleashing the power of
  patient voices using AI.  This was presented and showed how patient voices can be added to decision making with AI tools
• The Paul-Ehrlich Institut presented their ICSR processing tool and its benefits
• The EMA presented its Signal detection tool and it benefits
• Large Language models are routinely used today by industry and regulators to aid decision making and streamline their processes leaving more time for analysis and less time spent on admin, data collection and sorting
• The AI workplan to 2028 is published – ‘Data and AI in medicines regulation
• Fears of error introduced by AI was tempered by asking why we expect 100% accuracy from AI when humans do not output 100% accuracy all the time either
• AI guidance from EMA will be principles based to future proof it as much as possible. Reflection papers will be followed by guidance in time

Written by

Alice D’Alton