Senior pharmaceutical manufacturing leaders will meet in Copenhagen on 13–14 October 2026 to discuss the practical challenges of scaling AI, automation and digital manufacturing while maintaining GMP compliance and operational resilience.
As pharmaceutical manufacturers accelerate investment in artificial intelligence, automation, connected production and data-driven operations, a critical question is emerging across the industry: how can these technologies move beyond promising pilots and deliver measurable value in regulated manufacturing?
This question will be at the centre of the Pharma Smart Manufacturing Conference 2026, taking place on 13–14 October 2026 at Scandic Spectrum in Copenhagen, Denmark.
From Digital Ambition to Manufacturing Reality
For pharmaceutical manufacturers, digital transformation is no longer simply about adopting new technology.
AI systems need to operate within GMP requirements. Manufacturing data needs to remain reliable and contextualised. Legacy equipment must coexist with new digital infrastructure. IT and OT environments need to become more connected without introducing unacceptable operational or cybersecurity risks.
At the same time, manufacturers are under pressure to improve productivity, increase flexibility, reduce downtime and accelerate time-to-market.
Pharma Smart Manufacturing 2026 has been designed around these execution challenges. The programme will explore Industrial AI and AI validation, MES, IT/OT integration, digital twins, ALCOA++ and data integrity, OT cybersecurity, predictive maintenance, modular manufacturing, robotics, advanced automation and Pharma 5.0.
Rather than focusing only on what emerging technologies could achieve, discussions will examine what it takes to make them work within the realities of pharmaceutical manufacturing.
Human-Machine Collaboration in Next-Generation Pharma Facilities
Michelangelo Canzoneri, Global Head of Group Smart Manufacturing at Merck KGaA, will contribute his perspective on the future of human-machine collaboration in next-generation manufacturing facilities.
The discussion will examine how pharmaceutical companies can design environments where people and intelligent technologies work effectively together, including AR/VR applications for training and standard work, collaborative robotics in aseptic manufacturing, and AI-augmented decision support for operators.
The session will also address one of the less visible challenges of smart manufacturing: workforce readiness and change management. As manufacturers introduce increasingly sophisticated technologies, building the skills and confidence required to use them effectively will be just as important as deploying the technology itself.
Scaling mRNA, Viral Vectors and Cell Therapy
Advanced therapies create manufacturing challenges that conventional production models were not designed to solve.
Tour Ala, IT Lead for Cell & Gene Therapy Industrialisation for Manufacturing and Supply Chain at Roche, and Kees Mensch, Head of IT at NecstGen, will address these challenges in “Scaling the Unscalable: Digital Orchestration for mRNA, Viral Vectors & Cell Therapy.”
Their session will show the digital and physical complexities involved in scaling mRNA, viral vectors and personalised cell therapies, including digital management of chain of identity and chain of custody across patients, sites and partners.
The discussion will also explore modular manufacturing for decentralised production and how digital orchestration can be aligned with evolving GMP guidance and EU Biotech Act initiatives to support global market readiness.
AI Meets GMP Compliance
One of the major themes will be the transition of AI from experimentation to regulated industrial applications.
Michael Mollmann, CEO of MugAIn Group, will address Industrial AI & GMP Compliance, examining best practices for AI validation and governance in regulated settings, the implications of the EU AI Act and AI risk classification for pharmaceutical applications, and the importance of maintaining data integrity and quality across AI and machine learning models.
As AI becomes more embedded in manufacturing processes and decision-making, the challenge for pharmaceutical organisations is increasingly shifting from whether AI can be used to how it can be implemented in a controlled, trustworthy and compliant way.
Building the Infrastructure for Pharma 5.0
Technology implementation will also be examined from an IT/OT perspective.
Pauline Christensen, Head of IT/OT & Infrastructure at ProjectBinder, together with Emil Iversen, IT/OT Advisor, will explore how manufacturers can build a trusted IT/OT foundation for Pharma 5.0.
Their session will address how organisations can de-risk the adoption of AI, IoT and robotics, strengthen operational resilience and sustainability, and better connect people, processes and technology to support faster decision-making.
Learning Beyond the Conference Stage
Pharma Smart Manufacturing 2026 will also provide opportunities for attendees to move beyond traditional presentations.
The programme includes two hands-on workshops:
Building Your AI Validation Playbook – focused on helping participants approach AI validation within regulated pharmaceutical environments.
Data Integrity & ALCOA++ in Digital Manufacturing Systems – examining how data integrity principles translate into increasingly digital and connected manufacturing operations.
An interactive session on emerging topics in pharmaceutical manufacturing will create additional space for participants to discuss developing challenges, compare approaches and exchange perspectives with peers. The format is designed to encourage practical discussion between professionals dealing with similar implementation, compliance and operational challenges.
Connecting the People Behind Pharma’s Manufacturing Transformation
Pharma Smart Manufacturing 2026 will provide a focused environment for senior industry professionals to benchmark approaches, discuss implementation challenges and build relationships with peers working through similar transformations.
For manufacturers currently evaluating AI, modernising manufacturing systems, strengthening IT/OT infrastructure or scaling digital initiatives, the conference offers an opportunity to examine not only what is possible, but what is already being put into practice.
