Digital Transformation & Artificial Intelligence

Objectives

Reasons to attend this conference:

• You will get an overview of the current state of digital transformation and use of artificial intelligence in the pharmaceutical industry.
• You will learn how efficiency can be improved and quality can be supported through the implementation of digitalisation.
• In various case studies of pharmaceutical companies, projects from practice are presented.

Registration

Background

New forms of and approaches to digitalisation are increasingly finding their way into the pharmaceutical industry. The automation stage is already well advanced, but topics such as AI, IOT and Industry 4.0 are waiting in the wings. Artificial Intelligence has arrived in the general public with Chat GPT and Bard, and it has also found its way into the pharmaceutical industry.
Therefore, the track will also be dedicated to Artificial Intelligence and present and discuss initial experience from established projects. The focus will be on GxP-relevant aspects from the perspective of the pharmaceutical industry and regulatory authorities against the backdrop of the EU GMP Guideline Annex 22 ‘Artificial Intelligence’ published on 7 July 2025.

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with digitalisation and AI projects.
It particularly addresses the departments:

• IT
• Production
• Quality assurance
• Engineering / Technology

Moderators

Stefan Münch, Körber Pharma Consulting
Yves Samson, Kereon

Tuesday, 24 March 2026

Discipline beats Motivation: How to digitally Transform successfully
Stefan Münch, Körber Consulting
Yves Samson, Kereon

• Why should we become digital?
• Overcoming fears (from fear of loss to FOMO)
• You never walk alone - why collaboration matters
• AI as the 'supporting act'
  
  

Digital Transformation and AI from the Inspector’s Point of View
Dr Arno Terhechte, GMP Inspectorate, Bezirksregierung Münster

• Status quo Annex 11, 22 and chapter 4
• What is the task of regulation with regard to digital transformation
• „Stick to what you know“ Is Annex 11 the right place to address IT-security in that extend
• Lifecycle of regulation versus lifecycle of IT applications
• Annex 22 and future applications of AI in GMP regulated environments
• Level of transformation, experiences from inspections
  
  

Patient Information Leaflets (PIL) Footprint – How to move to EPI and its Advantages
Ana Cláudia Pinho, BIAL - Portela & C.ª

• From Static to Smart
• Quantifying the Impact
• Smart Tech, Smarter Communication
• Implementation & Impact
  
  

Digitalisation in the Pharmaceutical Industry
Kristina Keine, Bayer

• Advantages of digitalisation
• System landscape for digital readiness
• Use Cases
• Organisational framework to enable digital transformation  
  
  

From Excel to Excellence: How Digital Audits transform Quality and Efficiency
NN
Titus Krauss, Cluetec

• Over 75% of companies still audit manually or with basic tools like Excel
• Skills shortages and high expert costs demand smarter, more efficient audit methods
• Digital solutions including AI can transform system, process, and supplier audits alike
• Online checklists and digital CAPA tracking streamline audit execution
• Easy-to-implement tools enable more audits, in less time, with higher quality
  
  

Digital Process Optimization of Regulatory Intelligence
Dr Diane Spitznagel, Merck Life Science

• How to manage Regulatory Intelligence effectively in organizations with many users and multiple stakeholders?
• Transformation from a manual process to a digital process and data management, started from Outlook or Excel to SharePoint to a validated in-house built digital system
• Creation of a centralized digital hub as a single source of truth for regulatory intelligence records, systematically documented and auditable  
• Improved efficiency with search and communication function regarding standards/guidelines to reduce redundancies
• Integration with other systems such KPI systems and authority communication. Vision is to have a full digital end-to-end process  

Wednesday, 25 March 2026

How much can your AI (Artificial Intelligence) help you in your Investigations?
Dr Jean-Denis Mallet, ECA, former head of the French Inspection Department AFSSAPS

• What kind of investigation (nature and in depth) do the FDA and the EMA require?
• Some examples of Warning Letter on the topic
• Similar non-compliance statements from the EMA
• Some existing AI programmes (from Chat GPT, to Gemini, to Copilot to ... Mistral). How to choose?
• One example of a Production Deviation: can AI help and how much?
• One example of a Quality Control Deviation: can AI help too? And how?
• Repetition: did the AI learn from these examples (test)
  
  

Implementing AI Automation in GMP Manufacturing
Imge Yilmaz, QIAGEN

• Overview of a current trend where AI supports and automates decisions.
• Challenges in validation of AI-based automation systems under GxP
• Use case: Applying AI automation in packaging line
• Handling challenges: explainability, algorithm control, and change management
• Lessons learned and future roadmap
  
  

Beyond Hype and Shadow AI: Building trusted, compliant AI in GxP
Khaled Taj, WS Audiology
Jesper Madsen Wagner, Niras

• AI has great potential in Pharma and MedTech—when built on strong foundations. This session moves beyond the hype and uncontrolled “shadow AI” use, focusing on how to turn experimentation into governed, auditable AI copilots that genuinely create value in regulated settings
• Deep domain and process knowledge to correctly frame AI use cases
• Reliable data quality and availability as the bedrock of compliance
• Robust governance frameworks (e.g., the 4G model: Guard, Govern, Guide, Gate) to align with GxP, ISO, GDPR, and FDA expectations
• Practical use cases, such as applying AI to product risk management, showing how copilots can accelerate risk assessments while maintaining audit-readiness
  
  

AI in Maintenance – Between Expectation and Reality
Martin Kisselbach, CSL Behring
Dr Johannes Krämer, CSL Behring

• Critical Reflection on AI in Maintenance
• Expectations and roadblocks
• Limits of data driven Models  
• Pragmatic alternatives
• Practical experience at CSL
  
  

MIND the Gap: AI-driven Documentation Between Digitalisation and Regulation
Michael Sollfrank, Pharma Stulln
Dr Elke Oestreicher, Oestreicher

• Innovation leap in regulated processes: First real-world examples of how AI can digitalize batch records in a GMP-compliant and audit-proof way — a concrete implementation case rather than just strategy
• Technology meets regulation: Data capture, model architecture, validation, interfaces — and how Annex 11 & Annex 1 were considered and implemented right from the start
• Lessons from practice: What stumbling blocks actually occur? Which factors determine project success? First-hand learnings from day-to-day production
  
  

Security Aspects of AI in Manufacturing
Michael Wegmann, F. Hoffmann-La Roche

• Risks and challenges
• Mitigating controls and opportunities
• Compliance
• Outlook