Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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- Maturity assessment techniques to evaluate organizational readiness for digital transformation.
- Risk assessment methodologies tailored to AI solutions, ensuring patient safety, data integrity, and product quality.
Participants will have the opportunity to discuss these aspects with their peers and industry experts and gain valuable insights into the validation aspects of AI/ML solutions and the associated challenges in digital transformation.
This workshop will explore:
- The benefits of proactive modeling in streamlining the integrated approach to combination products, focusing on safety, reliability, and effectiveness.
- The role of digital traceability in QbD, design controls, risk management, and lifecycle management.
- How to effectively leverage the large amounts of data generated during testing and manufacturing to identify and refine specifications and integrate them into risk management processes.
Additionally, model-based systems engineering (MBSE) will be introduced as a digital framework to systematically manage safety- and effectiveness-critical functions, ensuring a proactive and data-driven approach to combination product development. Attendees will explore key concepts through a combination of lectures, real-world case studies, and hands-on activities, equipping them with practical strategies to address the unique challenges of combination products, navigate evolving regulatory expectations, and foster innovation while ensuring compliance.
Executive Vice President Manufacturing and Supply
Sanofi
Key focus areas include:
Implementing a modern CMMS and data backbone to consolidate systems and provide enterprise-wide visibility.
Deploying smart building technologies to enable predictive maintenance and optimize energy usage.
Utilizing AI and machine learning to drive data-driven decision-making for asset management and capital planning.
Streamlining regulatory compliance and documentation through digital tools.
Implementing reliability-centered maintenance to capture asset condition, uncovering data-driven TCO strategies for asset management
Transforming vendor relationships and contracts from task-based agreements to outcome-focused partnership agreements.
Attendees will discover how biopharma organizations can kickstart a digital transformation journey, no matter an organization’s size. Attendees will gain insights on how to leverage Industry 4.0 technologies to modernize pharma facilities management and unlock new value.
1) To demonstrate the role of Software Quality Engineers in fostering a quality culture within the organization.
2) To highlight the integration of Pharma 4.0 principles in enhancing quality and compliance.
3) To share best practices and lessons learned from our journey in building a quality-focused team.
Costs are too high: Healthcare systems cannot afford the medicines
Speeds are too low: Patients deteriorate while waiting for the product to be delivered.
Capacity is too low: There is insufficient manufacturing capacity to meet demand.
The problem is how to release 200,000 batches in the same period and with the same human resources as it currently takes to release a single batch. Digitization plays a central role in solving this industrial problem. It will enable this paradigm shift as it has in other industries, such as the global airline industry, where passenger volumes have nearly doubled over the last 20 years, supported by air traffic control systems and other digital solutions.
NOTE: This session is 90 minutes
The landscape of clinical trials in cell and gene therapy (CGT) is evolving rapidly, driven by the need for more patient-centric, efficient, and scalable approaches. Decentralized clinical trials (DCTs) are emerging as a game-changer, leveraging cutting-edge technologies to streamline patient recruitment, enhance data collection, and ensure regulatory compliance. This panel brings together experts from quality and regulatory affairs, biotech leadership, scientific innovation, and digital compliance to explore the transformative impact of DCTs on CGT. Panelists will discuss the latest advancements in decentralized trial models, the role of AI and digital platforms in trial execution, and the regulatory considerations for ensuring quality and compliance. Attendees will gain insights into how technology-driven strategies are addressing key challenges in CGT trials, improving patient access, and accelerating drug development.
How reliance supports Post-Approval Change Management Protocols (PACMPs) and Established Conditions (ECs)
Case studies of successful reliance-based post-approval change approvals
Strategies for integrating reliance into non-ICH regulatory frameworksIndustry perspectives on using reliance for global lifecycle management
While reliance offers efficiency, challenges remain in harmonizing practices and aligning regulatory expectations. This session will discuss potential solutions, including regulatory cooperation, digital tools, and capacity-building efforts. Additionally, it will explore how emerging regulatory science initiatives can further enhance reliance-based decision-making. Attendees will gain actionable insights on optimizing regulatory pathways, improving supply chain continuity, and enhancing global collaboration in the evolving pharmaceutical landscape.
- Developed leaders with critical supply chain and operational expertise- Enhanced organization agility, strengthened resiliency, and fostered change readiness
- Aligned research and early-stage manufacturing strategy with operational realities post-acquisition
- Optimized provider partnerships to improve efficiency, quality, and compliance- Simplified requirements and reduced administrative burdens.
A Walk in Their Shoes: Legends, Leadership & the Ones Who Paved the Way.
This Event Requires Separate Registration and Fee – Space Is Limited!
We’re back—and this time, we’re walking in the footsteps of legends. After a year of anticipation, Women in Pharma’s signature Monday Night Networking Event returns with a bold new twist. Set against the moody backdrop of a swanky off-site jazz club, this immersive evening blends Old Hollywood elegance with purposeful storytelling to honor the pioneers—women and allies—who helped shape the pharmaceutical industry. This isn’t just a networking event. It’s a guided experience. Step into the shoes of the trailblazers who came before us. Through curated stories, conversation prompts, and collaborative table activities, you’ll connect more deeply—not just with other attendees, but with the history and future of women in pharma. Think vintage glamour, jazz in the air, and stories that stir your soul.
- Aligned research and early-stage manufacturing strategy with operational realities following multiple acquisitions.
- Created real-time visibility into third-party risks, supplier dependencies, and committed time horizons, improving forecasting and asset-level planning.
- Established a strategic provider pool, reduced supplier engagement from months to days, eliminated 380+ annual contracts, and delivered significant cost savings and working capital improvements.
- Strengthened governance and monitoring, enhancing coordination and resource allocation while improving compliance and agility.
Attendees will gain insights into how SOAR enables navigating a TUNA world and building supply chain resilience.
- A practical vision for a global dossier and what steps the industry can take now to progress this regionally and globally.
- A descriptive breakdown of the eCTD and relevant data standards (ICH, ISO, regional requirements). Exploring which content is prime for digitalization, which content will remain text-based, and the challenges for data-centric submissions.
- Current global initiatives/guidance supporting convergence of regulatory requirements and global collaboration (Reliance, Orbis, Access Consortium, African Medicines Agency, ICRMA, ICH M11, and others). What are the differences and overlaps?
-Impact to industry: what are the complexities required to support a core dossier approach and a successful regulatory strategy for an organization? Complexities include: strategic assessment of requirements, structured data and data quality, data ontologies, regulator agreements, language and translations, technical infrastructure, collaboration processes, technical security, etc.
- Case study example from industry leaders who are conducting pilots and studies focused on core dossier submissions and collaboration amongst regulatory authorities.
RABS and Isolators are described as appropriate technologies in Annex 1. By upgrading existing clean rooms to an automated H2O2 decontamination system, the advantages of both systems can be combined, resulting in superior sterility assurance. In this presentation, we will showcase the technical installation, qualification, and implementation of this technology in new and existing RABS clean rooms. This includes also the aspects of analytical methods to test for residual H2O2, both in the air and the filled product. Data from the last 8 successful years of operation will be shared. Attendees will get insights into the design, installation, qualification, and operation of automated decontamination of RABS clean rooms.
Abstract: In facility design, BMS is prioritized from the start, while EMS is often an afterthought—leading to costly retrofits, integration challenges, and compliance risks. This session will highlight the importance of early EMS planning to ensure seamless integration, regulatory alignment, and cost efficiency.
Key topics include: The Challenge of Late EMS Implementation: Retrofitting EMS increases costs, complicates system compatibility, and poses regulatory risks.
Benefits of Early EMS Integration: Ensuring seamless alignment with BMS supports compliance with FDA 21 CFR Part 11 and GMP requirements while optimizing data integrity.Collaboration in Design: Engaging architects, engineers, and vendors early streamlines facility layout, system interoperability, and long-term performance.
By embedding EMS into facility planning from the outset, companies can enhance regulatory readiness, reduce costs, and future-proof their operations for Pharma 4.0.
Key topics include:
Identifying and addressing technical hurdles—ensuring AI-generated outputs are reliable, explainable, and aligned with operational needs.
Developing a control strategy to manage AI decision-making, ensuring compliance, transparency, and trust.
Navigating workforce adoption—how process changes impact teams and what strategies drive engagement.
Building the AI adoption playbook—a structured approach to onboarding, training, and sustaining AI-powered workflows.
Scaling from pilot to enterprise in 90 days—what worked, what didn’t, and key lessons for future implementations.
Rather than another AI concept discussion, this session provides practical, actionable insights from a real deployment—offering attendees a proven framework to bridge the gap between technical success and organizational adoption.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.