GCSG 2026 European Knowledge Forum: Program

This beginner level class is geared toward people new to the clinical trial supplies world and focuses on drug development as well as planning for and delivering study drug for clinical trials. Topics will include: history of Good Manufacturing Practices (cGMPs), phases of drug development and approval, randomizing and blinding clinical supplies, quality assurance and documentation, protocol interpretation, labeling, SOPs, Good Distribution Practices (GDPs), drug accountability, and current regulations. Attendees will obtain a massive amount of information in a fun and interactive atmosphere.

Together, we’ll explore the unique challenges that arise, from site requirements and manufacturing hurdles to temperature control and shipping obstacles. We’ll also tackle the pressing issue of managing tight timelines. Expect dynamic discussions where participants share their stories and insights, showcasing valuable lessons learned that can help us all establish best practices in this evolving field.

This beginner level half-day boot camp will provide a comprehensive introduction to the world of AI, tracing its evolution from theory in the 1950s to the machine learning and generative models available today. Participants will explore the major classes of AI, their distinguishing features, and where each is most effectively applied — particularly within the context of Pharma R&D and the clinical trial supply chain.Through real-life examples, open discussions, and small exercises, the group will examine AI's current capabilities, its potential to optimize clinical operations, and the ethical and operational risks involved. A hands-on team project will challenge participants to design and defend an AI solution, emphasizing the importance of strategic framing, stakeholder alignment, and responsible implementation. The program will conclude with shared reflections and key takeaways to guide future AI initiatives.

This advanced level hands-on boot camp is designed for participants with intermediate IRT experience who want to deepen their understanding of advanced system capabilities in clinical trial management. Attendees will explore complex scenarios including adaptive trial designs, randomization algorithms, kit management, site resupply, and real-time data analytics. Through interactive exercises, case studies, and team discussions, participants will gain practical skills to highly optimize IRT setups, ensuring compliance, and improving operational efficiency in complex clinical trials.

This intensive boot camp focuses on the functional execution of Direct-to-Patient (DtP) and Direct-from-Patient (DfP) models. We move beyond theoretical benefits to address the "hard" problems of clinical supply: Site-to-Patient (S2P) vs. Depot-to-Patient (D2P) decision-making, the impact of DtP on secondary packaging and labeling, and the critical role of the Qualified Person (QP) in decentralized release. Through technical case studies and "war room" simulations, attendees will map out the end-to-end journey of an IMP (Investigational Medicinal Product) from the central depot to the patient’s doorstep, identifying failure points in the cold chain and data privacy gaps.

This intermediate level half-day boot camp introduces participants to essential AI concepts tailored for the clinical trial industry emphasizing data security and privacy. Attendees will gain hands-on experience with AI tools to enhance efficiency and learn strategies for ethical and secure AI use in clinical settings. Through interactive sessions and real-world examples, participants will leave equipped to implement AI responsibly in their work.

This lecture is designed to provide clinical trial staff with a high-level overview of shipping compliant requirements when dealing with dangerous goods (DG). The session is not full DG training; rather, its goal is to create awareness that materials you manage in a study, such as specific drugs or biologics, may require specialized shipping procedures. We will explore the various classifications—including de minimis, excepted quantities, limited quantities, and full DG—and the crucial role of the Safety Data Sheet (SDS). The lecture will provide staff with a general understanding so they know when to consult with vendor specialists and what specifics to look for in trial documentation.

This intermediate level session examines how AI and advanced analytics streamlined clinical supply planning and execution for a complex Phase 3 trial spanning multiple countries. By implementing predictive algorithms for demand forecasting, site resupply, and risk mitigation, the sponsor gained real-time insights to manage variable enrollment rates and sensitive cold-chain requirements. Attendees will learn how these technologies helped prevent overages, reduce wastage, and ensure on-time patient dosing across all geographies.

This advanced level lecture provides a foundational overview of Digital Supply Networks (DSNs) and their transformative potential for the clinical supply chain. Unlike traditional linear models, DSNs enable dynamic, real-time data flow across interconnected nodes—driving agility, transparency, and informed decision-making. Participants will explore the key technologies behind DSNs (such as IoT, AI, and cloud platforms), their application in clinical development, and how to begin transitioning from a traditional supply chain to a digitally connected platform.

This workshop will require active participation from attendees and will use a gamified approach to explore different comparator sourcing strategies used in clinical trials.

Participants will gain insights into selecting the most appropriate sourcing method based on trial complexity, geographic considerations, regulatory requirements, risk management and cost efficiency.

Together, we’ll explore the unique challenges that arise when managing the clinical supply chain for the different advanced therapies - from site requirements and manufacturing hurdles to temperature control and shipping obstacles. We’ll also tackle the pressing issue of managing tight timelines. Expect dynamic discussions where participants share their stories and insights, showcasing valuable lessons learned that can help us all establish best practices in this evolving field.

This beginner level workshop will provide attendees with a step-by-step interactive overview of what goes into shipping clinical supplies from shipping request to site/depot delivery. Key areas of focus will be on understanding regulatory requirements, developing risk management strategies and optimizing logistics and supply chain efficiency for international shipments.

This advanced level session explores actionable strategies to enhance the feasibility of Direct-to-Patient (DTP) distribution in clinical trials in Europe. Drawing on Tufts & GCSG Impact Summary insights, we’ll examine key challenges—technical support gaps, delivery logistics, and scheduling inefficiencies—and discuss solutions to improve site and patient experiences. Attendees will leave with a roadmap for maintaining DTP as a viable and patient-centric trial model.

Increasing global demand for comparator and standard-of-care products has created growing pressure on supply, raising important ethical and operational questions around allocation. This session will explore how sponsors and clinical supply partners can source comparators responsibly while balancing trial needs with broader patient access. The discussion will address ethical sourcing practices, supply constraints, market impact, and strategies to ensure fair and transparent allocation across global trials.

This workshop will concentrate on the importance of incorporating sustainable practices within clinical supply chain management. Participants will explore strategies to reduce environmental impact, manage waste efficiently and optimize resource use throughout the clinical trial lifecycle. Through the latest practical examples and interactive discussions, attendees will learn to align operational efficiency with sustainability goals, meeting both regulatory requirements and ethical responsibilities.

As clinical trials become increasingly global, sponsors often source comparator and standard-of-care products from third countries to address cost, availability, and supply constraints. This session will examine the regulatory, quality, and logistical challenges involved, including ensuring product authenticity, navigating import/export requirements, and maintaining GDP/GMP compliance. Experts will share practical strategies and case examples for managing risk and ensuring reliable supply across complex international clinical trial networks.

In this intermediate level lecture we will discuss some of the more common label regulatory hurdles and delays that may happen. The attendees will explore new and innovative ways to avoid or mitigate these regulatory delays.

As clinical trials become increasingly global, sponsors often source comparator and standard-of-care products from third countries to address cost, availability, and supply constraints. This session will examine the regulatory, quality, and logistical challenges involved, including ensuring product authenticity, navigating import/export requirements, and maintaining GDP/GMP compliance. Experts will share practical strategies and case examples for managing risk and ensuring reliable supply across complex international clinical trial networks.

The transition from clinical trial completion to a long-term post-trial access (PTA) program remains one of the most operationally sensitive phases in the drug development lifecycle. The ethical imperative to provide continued treatment to trial participants is meeting a "perfect storm" of new regulatory mandates, such as those under the EU Biotech Act, and updated CTR requirements. This session moves beyond theory to address the granular, "in-the-trenches" logistics of maintaining the supply chain for patients who no longer fit within a standard trial protocol but still require life-sustaining medication. Participants will examine the friction between global ethics and local feasibility. We will dissect the logistical shift from a centralized clinical supply model to a more fragmented, "commercial-lite" distribution network required for PTA. The lecture will also explore the role of AI-driven forecasting in managing the "long tail" of medication needs and the complexities of transitioning patients to Managed Access or Compassionate Use programs. Through real-world case studies, we will identify how to avoid the "access cliff" while managing the financial and legal risks inherent in delivering investigational products across international borders post-study.

This beginner level workshop will provide a comprehensive overview of best practices in Good Manufacturing Practice (GMP) Quality Assurance (QA) for clinical trials. Participants will learn about the essential principles of GMP, regulatory requirements, and the critical role of QA in ensuring the safety and efficacy of clinical trial materials. The session will cover strategies for implementing robust QA systems, conducting effective audits, managing quality risks and mitigation strategies.

In this workshop, the facilitators will provide strategies to turn stress into success in any situation. After taking a stress self-assessment, attendees will learn mental calming techniques that can interrupt intensely stressful mental escalations as well as ways to be an empathetic and calming leader in times of stress.

This workshop will focus on the transportation of temperature-sensitive clinical trial materials. Content includes an overview of temperature-controlled transport methods and their strengths and weaknesses. Participants in this workshop will form groups to evaluate and apply solutions to real-world clinical trial supply scenarios, then discuss the decisions as a wider group.

In the modern clinical supply chain, the most technologically advanced forecasting tool is only as good as the data coming from the field. As trials become more decentralized and complex, the disconnect between Clinical Supply Managers (CSMs), Clinical Research Associates (CRAs), and site staff remains a leading cause of drug waste, protocol deviations, and missed patient visits. This interactive workshop moves away from the "us vs. them" silos and provides a practical framework for building a transparent, high-functioning communication loop. Participants will engage in role-playing scenarios and hands-on exercises designed to troubleshoot common friction points—such as "just-in-case" over-ordering by sites and the lag in reporting damaged kits. We will explore how to empower CRAs to be "Supply Champions" during monitoring visits, ensuring they have the right checklists to verify inventory without adding to their administrative burden. The session also addresses the shift toward Site-Centric Supply Models, focusing on how to use digital dashboards to provide sites with the visibility they want while maintaining the control the sponsor requires.

This intermediate level interactive workshop explores the complexities of global distribution in clinical supply chains, focusing on real-world challenges and practical solutions. The attendees will bring examples of common pain points such as regulatory hurdles, customs clearance, temperature control, and coordination across multiple regions for the group to discuss and learn from.

As the number of temperature-sensitive therapies in clinical development continues to grow, maintaining a resilient cold chain has become critical to protecting product integrity and patient safety. This session will examine the real-world challenges of managing cold chain distribution across global clinical trial networks, including infrastructure variability, temperature excursions, and transport disruptions. Drawing on operational experience, speakers will share practical strategies to strengthen monitoring, contingency planning, and cross-partner coordination to ensure reliable temperature control throughout the clinical supply chain.

As the clinical supply chain landscape becomes increasingly global and complex, Latin America (LATAM) has emerged as a high-potential frontier for sponsors seeking diversity, cost-efficiency, and rapid recruitment. However, navigating the "LatAm Labyrinth" requires more than just a map; it requires a deep understanding of evolving regulatory frameworks, localized logistics, and the cultural nuances of patient engagement. This session provides a comprehensive look at the state of clinical trials in Latin America in 2026. We will dive into the recent regulatory harmonization efforts across major hubs like Brazil, Mexico, and Argentina, and discuss how decentralized clinical trial (DCT) technologies are bridging the gap between urban centers and remote populations. Participants will gain insights into the "hidden" hurdles of import/export compliance and temperature-controlled distribution in a region known for its diverse climates and infrastructure challenges. Whether you are considering your first trial in the region or looking to optimize an existing program, this lecture offers the strategic toolkit needed to succeed in the LATAM market.

This lecture explores the strategic and operational complexities of donating commercial drugs from clinical research. Donating unused or surplus clinical trial materials, including commercial comparator products, can provide meaningful patient and societal benefit while reducing waste. However, donation programs involve complex regulatory, ethical, and logistical considerations. This session will explore how sponsors can implement compliant and responsible donation strategies, addressing regulatory frameworks, product quality and traceability, supply chain logistics, and partnerships with charitable or healthcare organizations.

This session dives into the high-stakes, time-sensitive world of radiopharmaceutical (Radiopharma) logistics. Unlike traditional clinical supplies, radiopharmaceuticals are defined by their radioactive decay, meaning the "shelf life" is measured in hours or days rather than months. This lecture explores the unique intersection of just-In-time (JIT) manufacturing and stringent Dangerous Goods (DG) regulations. Attendees will learn how to navigate the "race against the clock" to ensure patient doses arrive at the clinical site with the required potency. We will cover the specialized infrastructure needed—from shielded packaging and GPS tracking to the critical coordination required between manufacturing, specialized couriers, and hospital nuclear medicine departments.

Clinical supply chain (CSC) has been viewed as a purely tactical "fulfillment" center—the last link in the chain rather than a seat at the head of the table. As we navigate the complex R&D landscape of 2026, characterized by high-cost biologics, accelerated timelines, and personalized medicine, this "reactive" model is no longer sustainable. This intensive workshop provides a blueprint for transforming CSC into a strategic engine that drives clinical program success and informs R&D decision-making from Phase I through to commercial launch. Through the tripartite lens of People, Process, and Product, we will dismantle the silos that separate supply teams from Clinical Operations and Regulatory Affairs. Participants will learn how to transition their teams from "kit-movers" to "program-architects" by leveraging advanced data analytics and fostering a culture of cross-functional leadership. We will examine how optimizing the "Process" (integrated demand forecasting) and the "Product" (early-stage CMC-Supply alignment) can drastically reduce R&D burn rates and increase speed-to-market.

This intermediate level workshop will provide a deeper understanding of the challenges of orphan indication and rare disease trials. Attendees will explore critical requirements for rare disease studies, such as smaller patient numbers and commensurate supplies, greater geographic representation and timelines.

In the geopolitical climate of 2026, the global clinical supply chain has moved from an era of "just-in-time" efficiency to one of "just-in-case" resilience. Supply chain leaders no longer have the luxury of assuming stable trade routes or consistent cross-border cooperation. This interactive workshop provides a strategic masterclass in de-risking your clinical programs against the backdrop of regional conflicts, trade protectionism, and climate-induced disruptions. We will move beyond simple contingency planning to explore the architectural shift toward localization—placing manufacturing and secondary packaging closer to patient hubs—and the rigorous implementation of dual-sourcing strategies. Participants will use real-world 2026 risk indices to simulate a "Black Swan" event, working in teams to pivot a supply chain mid-trial. We will dissect the cost-benefit analysis of maintaining redundant suppliers versus the "single-source" efficiency of the past, and learn how to quantify political risk in a way that resonates with C-suite stakeholders.

As clinical programs expand into increasingly diverse geographies, the "border" is no longer just a physical line on a map—it is a complex, shifting landscape of regulatory friction. By 2026, the global clinical supply chain must harmonize the stringent requirements of the EU Clinical Trials Regulation (CTR) with emerging frameworks in the APAC region, post-Brexit UK variations, and the evolving oversight of LATAM authorities. This hands-on workshop provides a masterclass in navigating the regulatory "checkpoints" that can make or break a global trial’s timeline. Moving beyond static checklists, this session utilizes live simulation exercises to address real-world compliance crises. We will dive into the nuances of Annex 16 certification in a decentralized world, the complexities of "Qualified Person" (QP) oversight for cross-border shipments, and the data integrity requirements of the ICH-GCP E6 (R3) updates. Participants will work in peer groups to map out a global distribution strategy that balances speed with "bulletproof" compliance, specifically focusing on the intersection of customs "red tape," fiscal representation, and local labeling mandates.

In a volatile clinical landscape, the traditional "transactional" model between sponsors and service providers is no longer a viable strategy for success. As trials become increasingly complex—incorporating cell and gene therapies, decentralized models, and hyper-local sourcing—the boundary between "client" and "vendor" must dissolve into a true strategic partnership. This interactive workshop moves beyond the standard RFP and SLA discussions to explore the psychology, data structures, and governance models required to build high-impact, resilient alliances. Participants will engage in a "Partnership Maturity" diagnostic to evaluate their current relationships and identify the "friction points" that lead to misalignment, such as opaque pricing, rigid change orders, and siloed communication. We will dissect the transition from KPI-driven oversight (Key Performance Indicators) to Vested Outsourcing and VPIs (Value Performance Indicators), where both parties share in the risks and rewards of clinical success. Through collaborative case studies, we will model how to integrate partner expertise into early-stage protocol planning, ensuring that the supply chain is an asset, not an afterthought.

This intermediate level workshop explores the unique complexities and common pitfalls in managing packaging and labeling for ISTs, including navigating country-specific regulations, GMP compliance, and timelines when sponsors are academic institutions or individual investigators. Participants will leave with practical tools, risk mitigation strategies, and collaboration models to better support ISTs without compromising quality or regulatory integrity.

This session dives into the high-stakes, time-sensitive world of radiopharmaceutical (Radiopharma) logistics. Unlike traditional clinical supplies, radiopharmaceuticals are defined by their radioactive decay, meaning the "shelf life" is measured in hours or days rather than months. This lecture explores the unique intersection of just-In-time (JIT) manufacturing and stringent Dangerous Goods (DG) regulations. Attendees will learn how to navigate the "race against the clock" to ensure patient doses arrive at the clinical site with the required potency. We will cover the specialized infrastructure needed—from shielded packaging and GPS tracking to the critical coordination required between manufacturing, specialized couriers, and hospital nuclear medicine departments.

This lecture explores the strategic and operational complexities of donating commercial drugs from clinical research. Donating unused or surplus clinical trial materials, including commercial comparator products, can provide meaningful patient and societal benefit while reducing waste. However, donation programs involve complex regulatory, ethical, and logistical considerations. This session will explore how sponsors can implement compliant and responsible donation strategies, addressing regulatory frameworks, product quality and traceability, supply chain logistics, and partnerships with charitable or healthcare organizations.

In the geopolitical climate of 2026, the global clinical supply chain has moved from an era of "just-in-time" efficiency to one of "just-in-case" resilience. Supply chain leaders no longer have the luxury of assuming stable trade routes or consistent cross-border cooperation. This interactive workshop provides a strategic masterclass in de-risking your clinical programs against the backdrop of regional conflicts, trade protectionism, and climate-induced disruptions. We will move beyond simple contingency planning to explore the architectural shift toward localization—placing manufacturing and secondary packaging closer to patient hubs—and the rigorous implementation of dual-sourcing strategies. Participants will use real-world 2026 risk indices to simulate a "Black Swan" event, working in teams to pivot a supply chain mid-trial. We will dissect the cost-benefit analysis of maintaining redundant suppliers versus the "single-source" efficiency of the past, and learn how to quantify political risk in a way that resonates with C-suite stakeholders.

This advanced level session explores actionable strategies to enhance the feasibility of Direct-to-Patient (DTP) distribution in clinical trials in Europe. Drawing on Tufts & GCSG Impact Summary insights, we’ll examine key challenges—technical support gaps, delivery logistics, and scheduling inefficiencies—and discuss solutions to improve site and patient experiences. Attendees will leave with a roadmap for maintaining DTP as a viable and patient-centric trial model.

Increasing global demand for comparator and standard-of-care products has created growing pressure on supply, raising important ethical and operational questions around allocation. This session will explore how sponsors and clinical supply partners can source comparators responsibly while balancing trial needs with broader patient access. The discussion will address ethical sourcing practices, supply constraints, market impact, and strategies to ensure fair and transparent allocation across global trials.

In this intermediate level lecture we will discuss some of the more common label regulatory hurdles and delays that may happen. The attendees will explore new and innovative ways to avoid or mitigate these regulatory delays.

The transition from clinical trial completion to a long-term post-trial access (PTA) program remains one of the most operationally sensitive phases in the drug development lifecycle. The ethical imperative to provide continued treatment to trial participants is meeting a "perfect storm" of new regulatory mandates, such as those under the EU Biotech Act, and updated CTR requirements. This session moves beyond theory to address the granular, "in-the-trenches" logistics of maintaining the supply chain for patients who no longer fit within a standard trial protocol but still require life-sustaining medication. Participants will examine the friction between global ethics and local feasibility. We will dissect the logistical shift from a centralized clinical supply model to a more fragmented, "commercial-lite" distribution network required for PTA. The lecture will also explore the role of AI-driven forecasting in managing the "long tail" of medication needs and the complexities of transitioning patients to Managed Access or Compassionate Use programs. Through real-world case studies, we will identify how to avoid the "access cliff" while managing the financial and legal risks inherent in delivering investigational products across international borders post-study.

This beginner level workshop will provide a comprehensive overview of best practices in Good Manufacturing Practice (GMP) Quality Assurance (QA) for clinical trials. Participants will learn about the essential principles of GMP, regulatory requirements, and the critical role of QA in ensuring the safety and efficacy of clinical trial materials. The session will cover strategies for implementing robust QA systems, conducting effective audits, managing quality risks and mitigation strategies.

In this workshop, the facilitators will provide strategies to turn stress into success in any situation. After taking a stress self-assessment, attendees will learn mental calming techniques that can interrupt intensely stressful mental escalations as well as ways to be an empathetic and calming leader in times of stress.

This workshop will focus on the transportation of temperature-sensitive clinical trial materials. Content includes an overview of temperature-controlled transport methods and their strengths and weaknesses. Participants in this workshop will form groups to evaluate and apply solutions to real-world clinical trial supply scenarios, then discuss the decisions as a wider group.

In the modern clinical supply chain, the most technologically advanced forecasting tool is only as good as the data coming from the field. As trials become more decentralized and complex, the disconnect between Clinical Supply Managers (CSMs), Clinical Research Associates (CRAs), and site staff remains a leading cause of drug waste, protocol deviations, and missed patient visits. This interactive workshop moves away from the "us vs. them" silos and provides a practical framework for building a transparent, high-functioning communication loop. Participants will engage in role-playing scenarios and hands-on exercises designed to troubleshoot common friction points—such as "just-in-case" over-ordering by sites and the lag in reporting damaged kits. We will explore how to empower CRAs to be "Supply Champions" during monitoring visits, ensuring they have the right checklists to verify inventory without adding to their administrative burden. The session also addresses the shift toward Site-Centric Supply Models, focusing on how to use digital dashboards to provide sites with the visibility they want while maintaining the control the sponsor requires.

This intermediate level interactive workshop explores the complexities of global distribution in clinical supply chains, focusing on real-world challenges and practical solutions. The attendees will bring examples of common pain points such as regulatory hurdles, customs clearance, temperature control, and coordination across multiple regions for the group to discuss and learn from.

As the number of temperature-sensitive therapies in clinical development continues to grow, maintaining a resilient cold chain has become critical to protecting product integrity and patient safety. This session will examine the real-world challenges of managing cold chain distribution across global clinical trial networks, including infrastructure variability, temperature excursions, and transport disruptions. Drawing on operational experience, speakers will share practical strategies to strengthen monitoring, contingency planning, and cross-partner coordination to ensure reliable temperature control throughout the clinical supply chain.

As the clinical supply chain landscape becomes increasingly global and complex, Latin America (LATAM) has emerged as a high-potential frontier for sponsors seeking diversity, cost-efficiency, and rapid recruitment. However, navigating the "LatAm Labyrinth" requires more than just a map; it requires a deep understanding of evolving regulatory frameworks, localized logistics, and the cultural nuances of patient engagement. This session provides a comprehensive look at the state of clinical trials in Latin America in 2026. We will dive into the recent regulatory harmonization efforts across major hubs like Brazil, Mexico, and Argentina, and discuss how decentralized clinical trial (DCT) technologies are bridging the gap between urban centers and remote populations. Participants will gain insights into the "hidden" hurdles of import/export compliance and temperature-controlled distribution in a region known for its diverse climates and infrastructure challenges. Whether you are considering your first trial in the region or looking to optimize an existing program, this lecture offers the strategic toolkit needed to succeed in the LATAM market.

Clinical supply chain (CSC) has been viewed as a purely tactical "fulfillment" center—the last link in the chain rather than a seat at the head of the table. As we navigate the complex R&D landscape of 2026, characterized by high-cost biologics, accelerated timelines, and personalized medicine, this "reactive" model is no longer sustainable. This intensive workshop provides a blueprint for transforming CSC into a strategic engine that drives clinical program success and informs R&D decision-making from Phase I through to commercial launch. Through the tripartite lens of People, Process, and Product, we will dismantle the silos that separate supply teams from Clinical Operations and Regulatory Affairs. Participants will learn how to transition their teams from "kit-movers" to "program-architects" by leveraging advanced data analytics and fostering a culture of cross-functional leadership. We will examine how optimizing the "Process" (integrated demand forecasting) and the "Product" (early-stage CMC-Supply alignment) can drastically reduce R&D burn rates and increase speed-to-market.

This intermediate level workshop will provide a deeper understanding of the challenges of orphan indication and rare disease trials. Attendees will explore critical requirements for rare disease studies, such as smaller patient numbers and commensurate supplies, greater geographic representation and timelines.

As clinical programs expand into increasingly diverse geographies, the "border" is no longer just a physical line on a map—it is a complex, shifting landscape of regulatory friction. By 2026, the global clinical supply chain must harmonize the stringent requirements of the EU Clinical Trials Regulation (CTR) with emerging frameworks in the APAC region, post-Brexit UK variations, and the evolving oversight of LATAM authorities. This hands-on workshop provides a masterclass in navigating the regulatory "checkpoints" that can make or break a global trial’s timeline. Moving beyond static checklists, this session utilizes live simulation exercises to address real-world compliance crises. We will dive into the nuances of Annex 16 certification in a decentralized world, the complexities of "Qualified Person" (QP) oversight for cross-border shipments, and the data integrity requirements of the ICH-GCP E6 (R3) updates. Participants will work in peer groups to map out a global distribution strategy that balances speed with "bulletproof" compliance, specifically focusing on the intersection of customs "red tape," fiscal representation, and local labeling mandates.

In a volatile clinical landscape, the traditional "transactional" model between sponsors and service providers is no longer a viable strategy for success. As trials become increasingly complex—incorporating cell and gene therapies, decentralized models, and hyper-local sourcing—the boundary between "client" and "vendor" must dissolve into a true strategic partnership. This interactive workshop moves beyond the standard RFP and SLA discussions to explore the psychology, data structures, and governance models required to build high-impact, resilient alliances. Participants will engage in a "Partnership Maturity" diagnostic to evaluate their current relationships and identify the "friction points" that lead to misalignment, such as opaque pricing, rigid change orders, and siloed communication. We will dissect the transition from KPI-driven oversight (Key Performance Indicators) to Vested Outsourcing and VPIs (Value Performance Indicators), where both parties share in the risks and rewards of clinical success. Through collaborative case studies, we will model how to integrate partner expertise into early-stage protocol planning, ensuring that the supply chain is an asset, not an afterthought.

This intermediate level workshop explores the unique complexities and common pitfalls in managing packaging and labeling for ISTs, including navigating country-specific regulations, GMP compliance, and timelines when sponsors are academic institutions or individual investigators. Participants will leave with practical tools, risk mitigation strategies, and collaboration models to better support ISTs without compromising quality or regulatory integrity.

This lecture is designed to provide clinical trial staff with a high-level overview of shipping compliant requirements when dealing with dangerous goods (DG). The session is not full DG training; rather, its goal is to create awareness that materials you manage in a study, such as specific drugs or biologics, may require specialized shipping procedures. We will explore the various classifications—including de minimis, excepted quantities, limited quantities, and full DG—and the crucial role of the Safety Data Sheet (SDS). The lecture will provide staff with a general understanding so they know when to consult with vendor specialists and what specifics to look for in trial documentation.

This intermediate level session examines how AI and advanced analytics streamlined clinical supply planning and execution for a complex Phase 3 trial spanning multiple countries. By implementing predictive algorithms for demand forecasting, site resupply, and risk mitigation, the sponsor gained real-time insights to manage variable enrollment rates and sensitive cold-chain requirements. Attendees will learn how these technologies helped prevent overages, reduce wastage, and ensure on-time patient dosing across all geographies.

This advanced level lecture provides a foundational overview of Digital Supply Networks (DSNs) and their transformative potential for the clinical supply chain. Unlike traditional linear models, DSNs enable dynamic, real-time data flow across interconnected nodes—driving agility, transparency, and informed decision-making. Participants will explore the key technologies behind DSNs (such as IoT, AI, and cloud platforms), their application in clinical development, and how to begin transitioning from a traditional supply chain to a digitally connected platform.

This workshop will require active participation from attendees and will use a gamified approach to explore different comparator sourcing strategies used in clinical trials.

Participants will gain insights into selecting the most appropriate sourcing method based on trial complexity, geographic considerations, regulatory requirements, risk management and cost efficiency.

Together, we’ll explore the unique challenges that arise when managing the clinical supply chain for the different advanced therapies - from site requirements and manufacturing hurdles to temperature control and shipping obstacles. We’ll also tackle the pressing issue of managing tight timelines. Expect dynamic discussions where participants share their stories and insights, showcasing valuable lessons learned that can help us all establish best practices in this evolving field.

This beginner level workshop will provide attendees with a step-by-step interactive overview of what goes into shipping clinical supplies from shipping request to site/depot delivery. Key areas of focus will be on understanding regulatory requirements, developing risk management strategies and optimizing logistics and supply chain efficiency for international shipments.

This workshop will concentrate on the importance of incorporating sustainable practices within clinical supply chain management. Participants will explore strategies to reduce environmental impact, manage waste efficiently and optimize resource use throughout the clinical trial lifecycle. Through the latest practical examples and interactive discussions, attendees will learn to align operational efficiency with sustainability goals, meeting both regulatory requirements and ethical responsibilities.