Conference: Artificial Intelligence in Laboratories

25/26 November 2025

Background & Objectives

This conference aims to address the impact of Artificial Intelligence (AI) on pharmaceutical laboratories and explore AI applications in analytical processes, regulatory compliance, and quality control.

Artificial Intelligence is transforming pharmaceutical laboratories by enhancing automation, data interpretation, and compliance monitoring. With the rise of machine learning, deep learning, and big data analytics, AI enables predictive analytics, anomaly detection, and process optimization, reducing human error and increasing efficiency. Regulatory authorities are increasingly focusing on these innovations to ensure AI implementation aligns with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines. This track will present case studies and discuss current trends, challenges, and opportunities for AI-driven laboratory operations.

This conference therefore deals with the following topics:

    • AI and GxPs
    • Case Studies

Target Audience

This conference will be of significant value to Laboratory managers, supervisors and analysts, Quality control managers, Heads of quality control, Qualified Persons (QPs), Analytical scientists, Senior laboratory staff and responsible authorities

This conference is also intended for employees in Quality Assurance and from contract laboratories. Furthermore, it is useful for service providers, such as contract research organisations and contract manufacturers.

Congress Registration

Moderation

Dr Karl-Heinz Bauer (Day 1)
Isabella Küfner (Day 2)

Programme

Tuesday, 25 November 2025

KEYNOTE on 25 November 2025: Artificial Intelligence in Pharmaceutical Industries
Dr Marcel Franke, Senior Scientist Predictive Formulation, Process Solutions/Upstream & Process Materials R&D Merck Life Science

AI-History in a Nutshell
Dr Karl-Heinz Bauer, Training - Beratung - Coaching
  • Milestones & History AI
  • Terms, Definition & Abbreviations
  • Commonly used AI-Tools & Plugins
  • AI-Hitlist and Press Review (2020–2025)
  • Opportunities and limitations of AI
  • Summary & Conclusion
AI needs Data Management and FAIR Data in the Lab
Christophe Girardey, wega
  • Data Management / Data Science as foundation for a successful AI implementation
  • The sad reality of Data within the lab: paper, proprietary data format, lack of system integration
  • How can digital system like LIMS/LES and standards in the lab (SiLA, AniML, Allotrope) set the right foundation for FAIR Data?
  • First use cases for AI within the Lab
Accelerating Analytical Method Development with Predictive Modelling and AI
Dr Raquel Figueiredo, BIAL
  • Accelerating data analysis
  • Predictive modeling
  • Automation of routine tasks
  • Enhancing method development
  • Accelerated drug discovery
Investigation and Root Cause Analysis using AI for Trending and Contamination Control
Susan Cleary, Novatek International
  • Critical data for investigation and root cause analysis using AI
  • How AI can be used for Investigation and Root Cause analysis
  • Insight into the level of validation required for use of AI technology
  • AI interaction with contamination control data
  • How AI is changing the way we interact with our data
Responsible AI Development of Alternative Microbiological Methods used for Environmental Monitoring – a Case Study with the APAS Independence
Dr Steven Giglio, Clever Culture Systems
  • AI governance model for the APAS Independence and the path to demonstrating robust performance
  • The ISPE AI Maturity model
  • How automated systems should be considered in terms of risk
  • Testing and regulatory considerations and methodology
  • What performance metrics would be considered important for validation
AI and GxPs: A Contradiction?
Dr Karl-Heinz Bauer, Training - Beratung - Coaching
  • Regulations for AI developers (The EU AI-Act)
  • Regulations for the AI-Users (e.g. GAMP 5, 21 CFR Part 11, EU GMP Annex 11)
  • Use Cases or QC & QA in Pharmaceutical Industry
    • (I) Annual Compilation of PQRs
    • (II) Handling of customer complaints regarding packaging materials
  • Live-Demo: Using AI-Power Prompts

Wednesday, 26 November 2025

KEYNOTE on 26 November 2025: From Bog to Bedside: Lessons from the First Dedicated Phage Therapy Center in North America
Prof Dr Steffanie Strathdee, University of California San Diego School of Medicine/Co-Director at the Center for Innovative Phage Applications and Therapeutics
>> Find out more

Case Study: Machine Learning for Mold vs Bacteria Identification
Lisa Mallam, bioMérieux
  • How trained AI model can recognize microbial type (training on labeled datasets of bacterial and mold images, learning patterns, adapt algorithm to adjust to image variability, materials and methods, results)
  • Examples on 3P®STATION
Case Study: AI-Based Automated Solution for Incubation and Colony Counting in Microbiological Quality Control
Camilla Giardini, Copan NewLab
  • Findings from a two-phase suitability assessment of an automated system that combines incubation, continuous plate reading, and AI-powered colony counting
  • Applications in environmental monitoring (EM) and Bioburden testing
  • Key performance indicators to benchmark the AI system’s results against those obtained from traditional methods
Utilizing ChatGPT to Establish Company-Wide Harmonized Equipment and System Validation Standards
Isabella Küfner, Boehringer Ingelheim
  • Cross-functional collaboration (QC, QIT, QEx) to develop and refine use case-specific prompts
  • Embraced the principle “standardize before you digitize” by leveraging chatGPT to streamline and simplify validation lifecycle deliverables
  • Integrated ChatGPT into a structured and iterative standardization framework
  • Consolidated validation requirements and test cases from over 10 sites across 7 languages
Large Language Models in the Service of Quality: Analyzing the Quality of Documentation
Dr Colin Lischik, Boehringer Ingelheim
  • Connecting a large language model to quality management system data
  • Quantitative evaluation of chat functionality
  • Utilizing the setup to determine the documentation quality for laboratory-specific events
AI-powered Pharma: Transforming Drug Discovery, Development and Production
Siobhan Fleming, SIEMENS
  • Real-world use cases and reference projects from SIEMENS
  • Understand how AI accelerates drug development, from discovery to operations, by enhancing decision-making, speeding up processes, and improving data accuracy
  • Siemens’ AI-powered tools, including FAIR data frameworks, digital twins, and generative AI copilots
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