Senior Leadership Agenda
2026 ISPE Europe Annual Conference
Designed for executives shaping enterprise-wide transformation and industry-wide innovation strategies.
Your time is valuable and your decisions have enterprise-wide impact. This agenda cuts straight to sessions featuring strategic perspectives on AI governance, global regulatory harmonization, and first-of-kind implementations that are reshaping competitive advantage in pharma.
Every recommendation addresses the questions you're asking in boardrooms and strategy sessions: How do we position for regulatory changes? Where should we place our digital transformation bets? What are industry leaders doing that we should know about?
This agenda includes decision-making guidance for every time slot, so you'll know exactly why each session matters to your role and goals.
Monday Schedule
| Time | Session | Type |
|---|---|---|
| 0730 – 1745 | Registration Open | Registration |
| 0830 – 1200 | Opening General Sessions
C-suite perspectives on industry direction and regulatory evolution - essential strategic context | General Session |
| 0945 – 1900 | Exhibition Area Open | Networking |
| 1000 – 1045 | Networking Break in the Exhibition Area | Networking |
| 1200 – 1330 | Networking Lunch in the Exhibition Area | Meal/Networking |
| 1330 – 1500 | Choose Your Focus: Option A: Quality Risk Management in the Light of New European Pharma Regulations Choose this if driving enterprise QRM transformation or preparing for new EU regulations Option B: Building a Sustainability Culture in Life Sciences Companies Choose this if setting organizational sustainability strategy and culture Option C: GEP & GMP Compliant Project Delivery Choose this if overseeing major capital programs or facility expansions Option D: Pharma Open Data Space: Turning Vision into Reality Choose this if exploring industry-wide data collaboration opportunities Option E: Drug Shortages Prevention Choose this if responsible for enterprise supply chain strategy | Interactive Forums |
| 1500 – 1545 | Networking Break in the Exhibition Area | Networking |
| 1545 – 1615 | KEY SESSION: Architecting Compliance: GxP for the AI Era Deep dive into Compliance-by-Design frameworks for AI systems - essential for digital transformation governance | Digital Compliance |
| 1615 – 1645 | KEY SESSION: The Dual Challenge: Data Security & AI Use for GxP Apps Advanced case study on dual risk mitigation - Expert-in-the-Loop approaches for enterprise AI deployment | Digital Compliance |
| 1645 – 1715 | KEY SESSION: ICH Guideline Interpretation and PACs Regulatory Strategy Expert analysis of divergent ICH interpretations across regions - strategic insights for global regulatory planning | Regulatory and Quality |
| 1715 – 1900 | Welcome Reception in the Exhibition Area | Networking |
Tuesday Schedule
| Time | Session | Type |
|---|---|---|
| 0730 – 1730 | Registration Open | Registration |
| 0830 – 0945 | Opening General Sessions
Strategic vision for biopharma industrialization and global access | General Session |
| 0945 – 1030 | Networking Break in the Exhibition Area | Networking |
| 0945 – 1600 | Exhibition Area Open | Networking |
| 1030 – 1100 | KEY SESSION: Advanced Digitalization in Personalized Medicine Strategic blueprint for patient-specific manufacturing operations - integration patterns without "rip-and-replace" | Pharma 4.0™ in Action |
| 1100 – 1130 | KEY SESSION: Managing the Nitrosamines Risk in Pharma Deep scientific and regulatory analysis - advanced risk assessment and long-term prevention strategies | Sustainability & Substances of Concern |
| 1130 – 1200 | KEY SESSION: First Commercial MTP-based Modular Plant in GMP Environment World-first implementation case study - advanced insights on integrated CSV and data-driven engineering for modular manufacturing | Pharma 4.0™ in Action |
| 1200 – 1330 | Networking Lunch in the Exhibition Area | Meal/Networking |
| 1330 – 1400 | RECOMMENDED: Implementing Data Integrity: Real-World Lessons Large-scale DI program preparing for FDA inspection - battle-tested governance and cultural change strategies | Digital Compliance |
| 1400 – 1430 | KEY SESSION: Audit Trails: Practical Approaches to Data Integrity Advanced audit trail management aligned with revised Annex 11 draft - expert guidance on configuration and retention | Digital Compliance |
| 1430 – 1500 | RECOMMENDED: Sustainability Through Optimization of CIP Processes Advanced CIP optimization case studies with quantified sustainability impact - substantial productivity improvements | Sustainability & Substances of Concern |
| 1500 – 1545 | Networking Break in the Exhibition Area | Networking |
| 1545 – 1700 | Closing General Sessions
| General Session |
| 1900 – 2300 | Networking Dinner Executive networking opportunity - connect with industry peers and potential partners | Networking |
Wednesday Schedule
| Time | Session | Type |
|---|---|---|
| 0730 – 1700 | Registration Open | Registration |
| 0830 – 1015 | Opening General Sessions
Industry benchmark data for strategic planning and organizational comparison | General Session |
| 0945 – 1400 | Exhibition Area Open | Networking |
| 1015 – 1100 | Networking Break in the Exhibition Area | Networking |
| 1100 – 1130 | KEY SESSION: Delivering Innovation via the Dossier of the Future Expert analysis of ICH M4(Q) revision and SPQS implications - generative AI for CMC submissions and new EU GPL Annex | Regulatory and Quality |
| 1130 – 1200 | KEY SESSION: CMC Structured Submissions in the Cloud with AI ISPE Project PRISM CMC use case - collaborative review platforms and AI-enabled structured submissions | Regulatory and Quality |
| 1200 – 1230 | KEY SESSION: The Continuing Challenge of LCM in a Global Landscape Expert industry and agency perspectives on lifecycle management - advanced strategies for global harmonization | Regulatory and Quality |
| 1230 – 1400 | Networking Lunch in the Exhibition Area | Meal/Networking |
| 1400 – 1630 | Closing General Sessions
Regulatory panel with agency perspectives - critical for strategic planning and compliance positioning | General Session |