Mid-Career Leaders Agenda
2026 ISPE Europe Annual Conference
Built for managers implementing technologies, leading teams, and solving complex operational challenges daily.
You don't need more theory, you need solutions that work. This agenda prioritizes sessions featuring detailed case studies, implementation playbooks, and lessons learned from organizations tackling the exact challenges keeping you up at night. Every recommendation comes from peers who've been in your shoes.
Whether you're preparing your team for AI adoption, navigating regulatory complexity, or building the business case for your next initiative, these sessions deliver frameworks you can adapt and apply immediately.
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
Strategic industry perspectives from senior leaders - valuable context for your leadership role | 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 you're implementing ICH Q9(R1) or need to strengthen QRM maturity Option B: Building a Sustainability Culture in Life Sciences Companies Choose this if you're leading sustainability initiatives or building business cases Option C: GEP & GMP Compliant Project Delivery Choose this if you're managing capital projects or facility upgrades Option D: Pharma Open Data Space: Turning Vision into Reality Choose this if you're working on data strategy or cross-company collaboration Option E: Drug Shortages Prevention Choose this if you're responsible for supply chain resilience or manufacturing continuity | Interactive Forums |
| 1500 – 1545 | Networking Break in the Exhibition Area | Networking |
| 1545 – 1615 | KEY SESSION: Regulatory and Quality: A Case for QMS Implementation Strengthen your arguments for championing quality-first approaches - gain frameworks to influence stakeholders | Regulatory and Quality |
| 1615 – 1645 | RECOMMENDED: Bridging Regulatory and Continuous Improvement Mindsets Based on 60+ industry interviews - understand the real tensions between compliance and improvement and how to bridge them | Regulatory and Quality |
| 1645 – 1715 | KEY SESSION: Successful Business Cases for Sustainability Initiatives Master lifecycle cost analysis, risk mitigation, and stakeholder engagement - apply these frameworks Monday morning | Sustainability & Substances of Concern |
| 1715 – 1900 | Welcome Reception in the Exhibition Area | Networking |
Tuesday Schedule
| Time | Session | Type |
|---|---|---|
| 0730 – 1730 | Registration Open | Registration |
| 0830 – 0945 | Opening General Sessions
Industry leadership perspectives on manufacturing transformation | General Session |
| 0945 – 1030 | Networking Break in the Exhibition Area | Networking |
| 0945 – 1600 | Exhibition Area Open | Networking |
| 1030 – 1100 | KEY SESSION: Laying the Groundwork for AI-Enabled Validation Strategic and practical guidance on AI readiness in GxP environments - essential for preparing your organization | Digital Compliance |
| 1100 – 1130 | RECOMMENDED: Streamlining Innovation: Cloud-based Regulatory Collaboration Understand how cloud platforms enable real-time multi-agency reviews - efficiency gains for industry and regulators | Regulatory and Quality |
| 1130 – 1200 | KEY SESSION: Operational Excellence Through Connected Frontlines: A Case Study Detailed Eli Lilly case study - actionable insights on validation, data integrity, and change management | GEP & GMP Compliant Project Delivery |
| 1200 – 1330 | Networking Lunch in the Exhibition Area | Meal/Networking |
| 1330 – 1400 | RECOMMENDED: The PACMP: An Exercise in Risk Management and Communication Master post-approval change management protocols - essential as PACMPs become standard regulatory tools | Regulatory and Quality |
| 1400 – 1430 | RECOMMENDED: Virtual Engineering for Pharma: From Design to Validation See how simulation supports layout design to regulatory qualification - real case study with CFD and discrete event simulation | Pharma 4.0™ in Action |
| 1430 – 1500 | KEY SESSION: From Firefighting to Flow: How We Got Deviations in Control Practical deviation management transformation - specific techniques for shorter closure times and fewer repeat deviations | Regulatory and Quality |
| 1500 – 1545 | Networking Break in the Exhibition Area | Networking |
| 1545 – 1700 | Closing General Sessions
| General Session |
| 1900 – 2300 | Networking Dinner Build relationships with peers facing similar challenges - invaluable for knowledge sharing | Networking |
Wednesday Schedule
| Time | Session | Type |
|---|---|---|
| 0730 – 1700 | Registration Open | Registration |
| 0830 – 1015 | Opening General Sessions
Industry benchmark data to compare your organization's digital maturity | General Session |
| 0945 – 1400 | Exhibition Area Open | Networking |
| 1015 – 1100 | Networking Break in the Exhibition Area | Networking |
| 1100 – 1130 | KEY SESSION: Validating AI: From Data Integrity to Audit Readiness Practical guidance on embedding compliance in AI projects - learn what auditors actually ask | Digital Compliance |
| 1130 – 1200 | RECOMMENDED: Beyond SOPs: Compliance by Design Through Intelligent Agents Next-evolution thinking on GxP compliance - how intelligent agents can operationalize regulatory intent | Digital Compliance |
| 1200 – 1230 | RECOMMENDED: Explainable Compliance Challenge assumptions about GAMP 5 - real examples of what works and how to foster critical thinking in your team | Digital Compliance |
| 1230 – 1400 | Networking Lunch in the Exhibition Area | Meal/Networking |
| 1400 – 1630 | Closing General Sessions
Regulatory perspectives to inform your compliance strategy | General Session |