Pharma Smart Manufacturing 2026

Scandic Spectrum Hotel Copenhagen, Denmark, October 13–14, 2026

The pharmaceutical manufacturing industry has spent 5 years running AI pilots. Most of them worked technically. Most of them never reached production.

Pharma Smart Manufacturing Conference 2026 brings together 100+ senior pharmaceutical and biotech manufacturing leaders for 2 days of practitioner-led case studies, interactive workshops and session with peer-to-peer exchange. The Pharma Manufacturing Conference is focused on one objective: turning digital roadmaps into validated, GMP-compliant manufacturing outcomes with measurable ROI.

European pharma manufacturers are navigating simultaneous pressures that no single organisation can solve alone. Unplanned downtime costs the sector an estimated €2.3 billion annually. The draft EU GMP Annex 22, the first regulatory framework governing artificial intelligence in GMP-critical processes, is expected to be adopted in 2026 with enforcement from 2027. And cybersecurity threats to operational technology environments in pharmaceutical production have increased by 300%, creating risks that extend beyond IT into batch integrity, data governance, and patient safety.

Pharma Smart Manufacturing Conference is structured around 2 conference days. Day 1 explores: strategy, AI & Digital Infrastructure, opening with a keynote from Inna Ben-Anat, AVP and Global Head of Smart Factories at Sanofi, on industrialising AI use cases beyond pilot stage. Sessions cover industrial AI governance under the EU AI Act, human-machine collaboration in next-generation facilities, intelligent automation for CAPA and deviation management, electronic batch records and real-time release by exception, and building an end-to-end digital thread from drug development through commercial manufacturing.

Day 2 shifts to Technology, Quality & Resilience. The keynote examines why manufacturing strategy is now a geopolitical decision, addressing API sourcing, nearshoring, and AI-powered supply chain digital twins for scenario planning and disruption prediction. Further sessions cover data-driven quality under Annex 11, 21 CFR Part 11, and ALCOA++ requirements, digital orchestration for scaling mRNA, viral vector, and personalised cell therapy manufacturing, building trusted IT/OT foundations for Pharma 5.0, the operational pathway to net zero pharmaceutical production, and AI governance frameworks that satisfy regulators without freezing innovation.

Two interactive workshops provide delegates with immediately applicable tools. "Building Your AI Validation Playbook" delivers a step-by-step GMP-compliant validation framework, covering risk-based approaches, AI-specific validation challenges, documentation packages, and model lifecycle management. "Data Integrity & ALCOA++ in Digital Manufacturing Systems" focuses on building audit-ready data practices for AI-enabled quality systems, including practical navigation of the revised Annex 11 requirements. Both workshops offer limited seats and require pre-registration.

The speaker faculty represents the organisations defining the future of smart pharmaceutical manufacturing. Confirmed presenters include senior leaders from Sanofi, Merck KGaA, Novo Nordisk, Takeda, Kyowa Kirin, Ferring Pharmaceuticals, BioNTech, Bayer, Polpharma, and Siemens. They will share real implementation experiences from their own manufacturing operations.

Registration is open HERE.