Day 1 : Sunday, April 26
6:30 am - 8:00 am
Conference Logistics
Boot Camp Registration
If you signed up for a boot camp, come sign in and grab your name badge before your class gets started.
7:00 am - 8:00 am
Conference Logistics
Breakfast for Boot Camp Registrants
If you signed up for a boot camp, come join us for breakfast.
8:00 am - 4:30 pm
Boot Camp / Seminar
Boot Camp 1 - Essentials of Clinical Supply (B)
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 a study drug for clinical trial. Topics will include: history of Good Manufacturing Practices (cGMPs), phases of drug development and approval, randomizing and blinding clinical materials, 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.
Speakers:
8:00 am - 4:30 pm
Boot Camp / Seminar
Boot Camp 2 - Clinical Supplies Shipping and Distribution: Far Beyond the Fundamentals (I)
This intermediate level interactive bootcamp provides a comprehensive introduction to the key concepts and practical considerations of international trade, focusing on import/export regulations, trade compliance and Value-Added Tax (VAT) implications. Participants will explore customs requirements, documentation, compliance obligations, and strategies to manage costs and mitigate risks. Through real-world examples, discussions, and hands-on exercises, attendees will gain the knowledge needed to navigate global supply operations effectively and ensure regulatory compliance across multiple markets.
Speakers:
8:00 am - 4:30 pm
Boot Camp / Seminar
Boot Camp 3 - Understanding the Deeper Capabilities of IRT Systems (A)
This advanced level hands-on bootcamp 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.
Speakers:
8:00 am - 12:00 pm
Boot Camp / Seminar
Boot Camp 4 - Artificial Intelligence (AI) Foundations (B)
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.
Attendees should bring a laptop and be prepared for an interactive session using light weight AI tools.
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.
Attendees should bring a laptop and be prepared for an interactive session using light weight AI tools.
Speakers:
12:00 pm - 4:30 pm
Boot Camp / Seminar
Boot Camp 5 - Artificial Intelligence (AI) A Hands-On Session for Experienced Users (I)
This intermediate level half-day Bootcamp 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.
Attendees should bring a laptop and be prepared for an interactive session using light weight AI tools.
Attendees should bring a laptop and be prepared for an interactive session using light weight AI tools.
Speakers:
3:00 pm - 5:30 pm
Conference Logistics
Exhibitor Setup
Calling all exhibitors! Stop by the registration table to grab your name badge, then head to the exhibit hall to set up your tabletop exhibit.
3:00 pm - 6:00 pm
Conference Logistics
Registration / Information / Welcome Table Open
Welcome to the GCSG 2026 US Conference! Stop by the registration table to grab your name tag.
5:00 pm - 5:30 pm
Conference Logistics
Speaker / Facilitator Meeting & Tour of the Workshop Rooms
Calling all Speakers & Facilitators! Join us for some last-minute pointers and a tour of the workshop rooms.
5:30 pm - 6:00 pm
Plenary
Welcome to the 2026 US Conference!
Whether this is your first GCSG Conference or you are an old-timer, we invite you to join us for a conference orientation. Join us to learn how you can get the most out of your conference experience.
6:00 pm - 8:00 pm
Networking
Meet & Greet Networking Event
Start making connections right away! Join us for our meet & greet event to network with colleagues from throughout the clinical supply arena.
Day 2 : Monday, April 27
8:50 am - 10:00 am
Plenary
Keynote Address - Lex Gillette - Sponsored by RxSource
Lex Gillette is an elite Paralympic athlete and internationally recognized keynote speaker whose message redefines what it means to have a vision. A five-time Paralympic medalist and four-time world champion, he is the most decorated totally blind long jumper in U.S. history and the most decorated totally blind long jumper in Paralympic history. Lex inspires leaders and teams to turn uncertainty into opportunity and vision into action.Robbed of his sight during childhood, Lex was determined not to fall victim to a world of darkness. His mother exposed him to many resources and tools essential to his independence and ability to achieve great things. "Elexis, it does not matter what anyone says. You decide what you can do, and no one else." Those are the exact words spoken by Lex's mother and were echoed in a 2016 Procter and Gamble commercial featuring them both. Those same words have helped her son succeed in transforming what was once a tragedy into a triumph. His athletic talents have been featured in the media including ESPN, Sports Illustrated, USA Today Sports, and People Magazine. He is a 2015 inductee in the AON Hall of Fame.
Off the field of play, Lex is devoted enhance the lives of children within the United States and abroad. He is an athlete-mentor for Classroom Champions, an organization that pairs Olympians, Paralympians, and professional athletes to K-8 students in underserved schools to concentrate on the importance of goal-setting, diversity, perseverance, teamwork, and healthy living. In 2022, he was elected by the Board of Directors to focus on strategic plans and partnerships to empower more athletes, especially those with disabilities, to be mentors and bring a vision of Classroom Champions to life for schools serving students with physical challenges like visual impairment. Positive role models and strong guidance shaped the trajectory of Lex's life. His mission is to provide the same support.
Lex is also a part of the LA28 Athletes' Commission. A collection of elite athletes comprised of nine Paralympians and nine Olympians who bring essential insights and perspectives to create an inclusive, innovative and seamless experience for athletes participating in the LA28 Games.
Lex is a sought-after inspirational keynote speaker who empowers his audiences to gaze beyond the horizon and see more than what is in front of their eyes. There is no need for sight when you have a vision®. That is the very phrase that has propelled Lex into a world of infinite opportunity. It is not our eyes that ultimately determine success in life. It is our ability to see a vision and do everything in our power to turn it into reality. During Lex's presentation, you will laugh, cry, be inspired, and you will learn how to become a better version of yourself. With every stage he graces, Lex is determined to do for his audience what was done for him - to Teach ... People ... To ... See.
10:15 am - 11:15 am
Workshop
L01 - How Quality and Regulations Shape Clinical Trial Ancillary Supply (B)
The Clinical Trial Ancillary Supply Chain (CTASC) is diverse and complex, with performance that can directly impact trial timelines, budgets and patient outcomes. This beginner level lecture explores how proactive collaboration with Quality and Regulatory partners strengthens ancillary supply chain performance, mitigates risks, and supports successful trial execution.
Speakers:
10:15 am - 11:15 am
Workshop
L02 - Emerging Markets: Setting Up Cell & Gene Therapy Trials & Launch Strategies (A)
This advanced level lecture will explore the unique challenges encountered during trial setup and product launch for Cell and Gene Therapies in emerging markets. Participants will gain insights into key lessons learned, effective planning considerations, and proven collaboration strategies. High-level case studies will highlight impactful best practices, tactics, and tools to ensure successful execution in these complex and evolving environments.
Speakers:
10:15 am - 11:15 am
Workshop
L05 - Designing the IRT to Prevent Accidental Unblinding (I)
Protecting study integrity starts with safeguarding the blind. This intermediate level interactive lecture will examine how IRT configuration can inadvertently lead to unblinding. Through real-world examples, attendees will learn to identify potential vulnerabilities and implement practical strategies to prevent accidental unblinding—ensuring your study remains robust from start to finish.
Speakers:
10:15 am - 11:15 am
Workshop
L07 - Introduction to Digital Supply Networks (A)
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.
Speakers:
10:15 am - 11:15 am
Workshop
WS06 - Elements of a Biotech Mindset: Driving Agility, Innovation, and Ownership in Clinical Supplies (I)
This workshop will explore how to build a highly functioning partnership that empowers individuals across both organizations to operate with speed, adaptability, cross-functional collaboration, and entrepreneurial ownership—regardless of company size.
Speakers:
10:15 am - 11:15 am
Workshop
WS07 - Navigating the Complexities of Packaging and Labeling for Investigator-Sponsored Trials (ISTs) (I)
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.
Speakers:
10:15 am - 11:15 am
Workshop
WS12 - Optimizing Direct-to-Patient Distribution: Addressing Barriers for Sustainable Trial Integration (A)
This advanced level session explores actionable strategies to enhance the feasibility of Direct-to-Patient (DTP) distribution in clinical trials. Drawing on Tufts & GCSG Impact Summary insights, we’ll examine key challenges—technical support gaps, delivery logistics, and scheduling inefficiencies—and discussion solutions to improve site and patient experiences. Attendees will leave with a roadmap for maintaining DTP as a viable and patient-centric trial model.
Speakers:
10:15 am - 11:15 am
Workshop
WS15 - Comparators: Sponsor and Vendor Collaboration (B)
This beginner level workshop will address the critical aspects of sourcing comparators for clinical trials. Participants will learn about common mistakes in comparator sourcing and strategies to mitigate risks associated with these choices. The session will explore the impact of comparator selection on the entire clinical supply chain, including labelling operations. Additionally, attendees will gain insights into effective communication practices between sponsors and vendors to ensure smooth operations.
Speakers:
10:15 am - 11:15 am
Workshop
WS17 - Latin America (LATAM) Importation Challenges and Considerations (B)
This beginner level session will provide an awareness of the regulatory requirements across different agencies to enable successful clinical supply planning. Discussion will include an overview of the regulatory requirements for Latin American countries for labeling and distribution.
Speakers:
10:15 am - 11:15 am
Workshop
WS21 - Introduction to Good Clinical Practices (GCP) (B)
Good Clinical Practices (GCP) are what our key stakeholders in Clinical Operations/Clinical Development are required to follow. It's important that clinical supply chain professionals understand GCPs as patient requirements should always be a consideration when packaging and labeling clinical supplies. This beginner level workshop will review GCPs and how the differ from GMPs, as well as how they are involved in drug development and the site.
Speakers:
10:15 am - 11:15 am
Workshop
WS25 - Clarifying Roles and Responsibilities through RACIs (B)
Knowing everyone's role & responsibilities is an essential requirement for successful teams. This beginner level workshop will provide an overview and process methods for deploying a RACI (Responsible, Accountable, Consulted, Informed) chart in support of those outcomes.
Speakers:
11:30 am - 12:30 pm
Workshop
L03 - Forecasting or Simulation? Choosing the Right Approach (A)
This advanced level lecture will explore forecasting and simulation techniques for clinical trials and supply chain management. Participants will learn the basics of different analytical approaches, and will learn the strengths and limitations of different methods. Participants will also learn how to use forecasts/simulations in combination with operational strategies to build a strong plan for their clinical trial(s).
Speakers:
11:30 am - 12:30 pm
Workshop
L04 - Foundations of IRT UAT Script Writing (I)
This intermediate level workshop provides a practical, regulatory-aligned approach to writing UAT test scripts for IRT grounded in CSA, ICH Q9, and ISPE GAMP 5 principles.
The session will guide attendees with steps for creating, organizing, and executing right-sized UAT test scripts that support the full UAT lifecycle from planning through documentation.
The session will guide attendees with steps for creating, organizing, and executing right-sized UAT test scripts that support the full UAT lifecycle from planning through documentation.
Speakers:
11:30 am - 12:30 pm
Workshop
L08 - Implementing a Control Tower for Real-Time Executive Dashboards and Actionable Insights (A)
This advanced level session explores how a Control Tower aggregates data across multiple source systems to provide real-time dashboards and actionable insights. In clinical operations, it serves as a centralized, data-driven command center, enhancing visibility, streamlining trial supply planning, and enabling proactive decision-making. Attendees will gain a strategic perspective on how adopting a Control Tower model can drive innovation and deliver tangible operational benefits in clinical supply chain management.
Speakers:
11:30 am - 12:30 pm
Workshop
L09 - Case Study: Using AI and Advanced Analytics to Optimize a Large Phase 3 Global Trial (I)
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.
Speakers:
11:30 am - 12:30 pm
Workshop
WS05 - Temperature Excursion Considerations for Comparator Product Sourcing (I)
This intermediate level workshop will help clinical supply professionals proactively identify and mitigate temperature excursions for comparator products used in clinical trials.
Speakers:
11:30 am - 12:30 pm
Workshop
WS09 - Universal Ancillary Procurement vs Local Sourcing (I)
Join us for an insightful intermediate level workshop that explores the strategic decision-making process between universal ancillary procurement and local sourcing. This intermediate level session will delve into the benefits and challenges of each approach, examining factors such as cost efficiency, supply chain reliability, sustainability, and community impact.
Speakers:
11:30 am - 12:30 pm
Workshop
WS10 - Middle East & North Africa (MENA) - Strategy and Requirements
This beginner level session will cover the unique aspects of conducting clinical trials in MENA countries, including regulatory landscapes, cultural considerations, patient recruitment strategies, and logistical challenges.
Speakers:
11:30 am - 12:30 pm
Workshop
WS11 - Managing Controlled Substances in Global Clinical Trials (B)
This beginner level workshop will provide an overview of ways a controlled substance can enter into a clinical trial and management of controlled substances across multiple countries.
Speakers:
11:30 am - 12:30 pm
Workshop
WS14 - Drug Accountability and Destruction at Study Closeout (I)
This intermediate level workshop will provide a comprehensive overview of the critical processes involved in drug accountability and destruction at the closeout of clinical studies. Participants will learn about regulatory requirements, best practices for tracking and documenting drug usage, and methods for the safe and compliant destruction of unused investigational products. The session will also cover common challenges and solutions to ensure a smooth and efficient study closeout.
Speakers:
11:30 am - 12:30 pm
Workshop
WS18 - Import/Export Essentials (B)
This beginner level workshop will provide the 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.
Speakers:
11:30 am - 12:30 pm
Workshop
WS22 - Innovative Label Strategies to Overcome Regulatory Hurdles (I)
In this intermediate level workshop 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.
Speakers:
1:30 pm - 2:30 pm
Workshop
L06 - Regulatory Submissions Best Practices for Clinical Trials (A)
This advanced level lecture provides a practical guide to regulatory submission strategies that drive clinical trial success worldwide. Participants will learn how to prepare high-quality regulatory packages, navigate region-specific requirements, and avoid common pitfalls that cause delays or rejections. The session covers best practices in dossier planning, document management, cross-functional coordination, and effective use of electronic submission platforms such as the eCTD.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS01 - Clinical Supplies: Trials and Tribulations (I)
This intermediate level workshop will provide a forum to share challenging situations that the attendees have experienced with the clinical supply chain. The attendees will bring stories that everyone can learn from and then the group will address them by providing possible solutions that everyone can use.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS08 - Real-World Strategies for successful Clinical Supply Vendor Transitions (I)
Vendor transitions in the clinical supply space—whether due to performance, scalability, or strategic alignment—are highly complex and high-risk if not managed carefully. This intermediate level workshop provides real-world strategies for planning and executing successful transitions between clinical supply vendors, including depots, packaging providers, IRT vendors, and logistics partners. Participants will explore change management tactics, risk mitigation plans, stakeholder communication, and regulatory considerations through practical examples and peer discussion.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS16 - Comparator Sourcing and Supply: Discussion around Industry Trends, Changes and Challenges when Using Comparator drugs (I)
In this intermediate level session attendees will discuss the nuances of supplying commercial materials in clinical trials conducted in Europe. Topics to include the requirements for using non-EU sourced drugs, the impact of changing the source country and the timelines involved.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS19 - Temperature Monitoring & Managing Excursions Throughout the Drug Lifecycle (B)
This beginner level workshop will identify best practices for monitoring temperatures and manage excursions throughout the entire drug lifecycle, from manufacturing to distribution and storage. New tools and techniques will be discussed which will enable excursion data to be tracked against stability data to allow rapid adjudication. Open discussions will provide a forum to explore the latest innovations and ways to manage cumulative data to assess total time out of temperature to avoid replacing supplies at the site.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS20 - Introduction to Expanded Access Program (B)
This beginner level workshop will explore the primary challenges in expanded access (EA): Ethics, Supply Planning and Regulatory. Real-life scenarios (failures and successes) will be shared , highlighting how these experts navigated the obstacles.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS23 - Blinding in Clinical Trials (B)
This beginner level workshop provides a comprehensive overview of blinding in clinical trials, focusing on its critical role in minimizing bias and ensuring data integrity. Participants will learn about various blinding methods (single, double, and triple blinding), practical implementation challenges, and strategies to maintain blinding throughout the study. The session also covers regulatory expectations and real-world scenarios where blinding may be compromised. Designed for clinical operations, study managers, and quality assurance professionals, this workshop equips attendees with the knowledge to design and manage effective blinding processes.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS24 - Best Ways to Handle Stress in Leadership (B)
In this beginner level 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.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS26 - Best Practices in Clinical GMP QA (B)
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.
Speakers:
1:30 pm - 2:30 pm
Workshop
WS28 - Pharmacy Manual in Clinical Trials: Purpose and Scope (B)
The Pharmacy Manual is an integral document for conducting a clinical trial that provides critical study information and guidance to positively influence site GxP compliance. This beginner level session will discuss best industry practice for pharmacy manuals, components and aspects that allow sites to comply with ICH E6(r3).
Speakers:
1:30 pm - 2:30 pm
Workshop
WS29 - Clinical Trial Start-Up Best Practices: Avoiding Delays and Ensuring Readiness (B)
This beginner level workshop explores best practices for clinical supplies to support studies before and during clinical trial start-up. Participants will learn how to create a comprehensive clinical supply start-up plan, collaborate effectively with CMC teams, and identify key timeline deliverables to ensure sites are adequately stocked.
Through real-world examples and actionable tools, attendees will gain strategies to identify and mitigate risks, coordinate efficiently with clinical stakeholders, and ensure clinical supplies arrive on time and are stored and managed correctly throughout the study.
Through real-world examples and actionable tools, attendees will gain strategies to identify and mitigate risks, coordinate efficiently with clinical stakeholders, and ensure clinical supplies arrive on time and are stored and managed correctly throughout the study.
Speakers:
Day 3 : Tuesday, April 28
8:45 am - 9:45 am
Plenary
Patient Testimonial; Michelle Stump-Kerry - Sponsored by Clinigen
Michelle Stump-Kerry has spent 25 years on the inside of clinical research—managing strategies, building systems, and driving innovation across the biopharmaceutical industry. Then one day, she found herself on the other side: sitting in a doctor's office, facing her own diagnosis, navigating the very healthcare system she'd spent decades helping to build.That shift in perspective changed everything.
Today, as Vice President of Strategy, Organizational Readiness & Enablement in life science technology, Michelle brings both voices to the table—the industry leader who understands operational complexity and the patient who knows what it feels like when the system fails to see you as human. It's this rare dual lens that drives her life's work: building trust between an industry that wants to heal and the patients who desperately need to believe in it.
Michelle's philosophy is simple but powerful: innovation moves at the speed of trust. She's dedicated to transforming how clinical research engages with patients—not waiting until they're desperate for options, but building relationships from the moment of diagnosis. Through speaking engagements, practical frameworks, and relentless advocacy, she's proving that operational excellence and genuine human connection aren't opposing forces—they're the same goal, seen through different eyes.
10:00 am - 11:00 am
Workshop
L01.2 - How Quality and Regulations Shape Clinical Trial Ancillary Supply (B)
The Clinical Trial Ancillary Supply Chain (CTASC) is diverse and complex, with performance that can directly impact trial timelines, budgets and patient outcomes. This beginner level lecture explores how proactive collaboration with Quality and Regulatory partners strengthens ancillary supply chain performance, mitigates risks, and supports successful trial execution.
Speakers:
10:00 am - 11:00 am
Workshop
L02.2 - Emerging Markets: Setting Up Cell & Gene Therapy Trials & Launch Strategies (A)
This advanced level lecture will explore the unique challenges encountered during trial setup and product launch for Cell and Gene Therapies in emerging markets. Participants will gain insights into key lessons learned, effective planning considerations, and proven collaboration strategies. High-level case studies will highlight impactful best practices, tactics, and tools to ensure successful execution in these complex and evolving environments.
Speakers:
10:00 am - 11:00 am
Workshop
WS02 - Global Distribution: Real-World Challenges & Solutions (I)
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 that the group can learn from.
Speakers:
10:00 am - 11:00 am
Workshop
WS04 - VAT and IOR Considerations in Clinical Supply Chains (I)
This intermediate level workshop will focus on the critical aspects of Value Added Tax (VAT) and Importer of Record (IOR) considerations in clinical supply chains. Participants will learn about the regulatory requirements and best practices for managing VAT and IOR in the context of clinical trials. The session will cover strategies to ensure compliance, optimize cost management, and streamline logistics. Attendees will gain insights into the complexities of international clinical supply chains and how to navigate these challenges effectively.
Speakers:
10:00 am - 11:00 am
Workshop
WS06.2 - Elements of a Biotech Mindset: Driving Agility, Innovation, and Ownership in Clinical Supplies (I)
This workshop will explore how to build a highly functioning partnership that empowers individuals across both organizations to operate with speed, adaptability, cross-functional collaboration, and entrepreneurial ownership—regardless of company size.
Speakers:
10:00 am - 11:00 am
Workshop
WS13 - Clinical Trial Supplies for Orphan Indications & Rare Disease Trials (I)
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.
Speakers:
10:00 am - 11:00 am
Workshop
WS14.2 - Drug Accountability and Destruction at Study Closeout (I)
This intermediate level workshop will provide a comprehensive overview of the critical processes involved in drug accountability and destruction at the closeout of clinical studies. Participants will learn about regulatory requirements, best practices for tracking and documenting drug usage, and methods for the safe and compliant destruction of unused investigational products. The session will also cover common challenges and solutions to ensure a smooth and efficient study closeout.
Speakers:
10:00 am - 11:00 am
Workshop
WS17.2 - Latin America (LATAM) Importation Challenges and Considerations (B)
This beginner level session will provide an awareness of the regulatory requirements across different agencies to enable successful clinical supply planning. Discussion will include an overview of the regulatory requirements for Latin American countries for labeling and distribution.
Speakers:
10:00 am - 11:00 am
Workshop
WS18.2 - Import/Export Essentials (B)
This beginner level workshop will provide the 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.
Speakers:
10:00 am - 11:00 am
Workshop
WS27 - European Qualified Person (QP) Declarations & QP Certification – Overview (B)
QP Declarations and Certification and release requirements can be complex. This complexity can affect timelines and stakeholder expectations. This beginner level workshop will discuss what is the minimum requirements as inputs to progress QP certifications and declarations within expected timelines.
Speakers:
10:00 am - 11:00 am
Workshop
WS30 - Navigating Child-Resistant and Repackaging Strategies in the EU (I)
This intermediate level workshop delves into the regulatory requirements and practical considerations for implementing child-resistant packaging and repackaging of clinical supplies within the European Union. Participants will explore EU-specific regulations and labeling requirement. The session will also cover challenges and best practices for repackaging clinical materials while ensuring compliance and maintaining product integrity.
Speakers:
11:15 am - 12:15 pm
Workshop
L03.2 - Forecasting or Simulation? Choosing the Right Approach (A)
This advanced level lecture will explore forecasting and simulation techniques for clinical trials and supply chain management. Participants will learn the basics of different analytical approaches, and will learn the strengths and limitations of different methods. Participants will also learn how to use forecasts/simulations in combination with operational strategies to build a strong plan for their clinical trial(s).
Speakers:
11:15 am - 12:15 pm
Workshop
L05.2 - Designing the IRT to Prevent Accidental Unblinding (I)
Protecting study integrity starts with safeguarding the blind. This intermediate level interactive lecture will examine how IRT configuration can inadvertently lead to unblinding. Through real-world examples, attendees will learn to identify potential vulnerabilities and implement practical strategies to prevent accidental unblinding—ensuring your study remains robust from start to finish.
Speakers:
11:15 am - 12:15 pm
Workshop
L07.2 - Introduction to Digital Supply Networks (A)
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.
Speakers:
11:15 am - 12:15 pm
Workshop
WS01.2 - Clinical Supplies: Trials and Tribulations (I)
This intermediate level workshop will provide a forum to share challenging situations that the attendees have experienced with the clinical supply chain. The attendees will bring stories that everyone can learn from and then the group will address them by providing possible solutions that everyone can use.
Speakers:
11:15 am - 12:15 pm
Workshop
WS03 - Import/Export and Distribution Challenges in Emerging Markets (I)
This intermediate level workshop provides an in-depth look at the unique import/export and distribution challenges faced in emerging markets. Participants will explore regulatory complexities, customs requirements, infrastructure limitations, and logistical hurdles specific to these regions. Through case studies and interactive discussions, attendees will learn practical strategies to navigate these obstacles, ensuring efficient and compliant clinical supply delivery. This session is designed for supply chain managers, logistics professionals, and clinical operations teams working or planning to work in emerging markets.
Speakers:
11:15 am - 12:15 pm
Workshop
WS07.2 - Navigating the Complexities of Packaging and Labeling for Investigator-Sponsored Trials (ISTs) (I)
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.
Speakers:
11:15 am - 12:15 pm
Workshop
WS09.2 - Universal Ancillary Procurement vs Local Sourcing (I)
Join us for an insightful intermediate level workshop that explores the strategic decision-making process between universal ancillary procurement and local sourcing. This intermediate level session will delve into the benefits and challenges of each approach, examining factors such as cost efficiency, supply chain reliability, sustainability, and community impact.
Speakers:
11:15 am - 12:15 pm
Workshop
WS12.2 - Optimizing Direct-to-Patient Distribution: Addressing Barriers for Sustainable Trial Integration (A)
This advanced level session explores actionable strategies to enhance the feasibility of Direct-to-Patient (DTP) distribution in clinical trials. Drawing on Tufts & GCSG Impact Summary insights, we’ll examine key challenges—technical support gaps, delivery logistics, and scheduling inefficiencies—and discussion solutions to improve site and patient experiences. Attendees will leave with a roadmap for maintaining DTP as a viable and patient-centric trial model.
Speakers:
11:15 am - 12:15 pm
Workshop
WS15.2 - Comparators: Sponsor and Vendor Collaboration (B)
This beginner level workshop will address the critical aspects of sourcing comparators for clinical trials. Participants will learn about common mistakes in comparator sourcing and strategies to mitigate risks associated with these choices. The session will explore the impact of comparator selection on the entire clinical supply chain, including labelling operations. Additionally, attendees will gain insights into effective communication practices between sponsors and vendors to ensure smooth operations.
Speakers:
11:15 am - 12:15 pm
Workshop
WS19.2 - Temperature Monitoring & Managing Excursions Throughout the Drug Lifecycle (B)
This beginner level workshop will identify best practices for monitoring temperatures and manage excursions throughout the entire drug lifecycle, from manufacturing to distribution and storage. New tools and techniques will be discussed which will enable excursion data to be tracked against stability data to allow rapid adjudication. Open discussions will provide a forum to explore the latest innovations and ways to manage cumulative data to assess total time out of temperature to avoid replacing supplies at the site.
Speakers:
11:15 am - 12:15 pm
Workshop
WS21.2 - Introduction to Good Clinical Practices (GCP) (B)
Good Clinical Practices (GCP) are what our key stakeholders in Clinical Operations/Clinical Development are required to follow. It's important that clinical supply chain professionals understand GCPs as patient requirements should always be a consideration when packaging and labeling clinical supplies. This beginner level workshop will review GCPs and how the differ from GMPs, as well as how they are involved in drug development and the site.
Speakers:
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Hosted by Bluefin Clinical
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Hosted by Loftware
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Hosted by Marken
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Hosted by N-SIDE
1:30 pm - 2:30 pm
Showcase
Vendor Showcase - Real-Time Visibility. Real-World Impact. - Hosted by Clinigen
Discover how Clinigen’s eCEMS portal transforms clinical trial supply oversight through real-time data access and intuitive dashboards—enabling proactive planning, rapid issue resolution, and seamless collaboration across global trial operations.
2:45 pm - 3:45 pm
Presentation
Plenary Session - Key Challenges in Transitioning from Clinical to Commercial: Bridging the Gap to Launch Readiness (I)
This intermediate level plenary will guide you through the critical transition from clinical phase to commercial launch. Participants will leave with a deeper understanding of the activities & requirements of moving from clinical development to commercialization, including timeline, quality, production, stakeholder, logistical and artwork and serialization differences.
Speakers:
Day 4 : Wednesday, April 29
9:30 am - 10:30 am
Presentation
Plenary Session - Company Strategies for Patient Centricity (I)
This intermediate level plenary examines how companies are embedding patient-centric principles into their clinical development strategy. Participants will explore approaches to engage patients meaningfully throughout the trial lifecycle, including communication, trial design, support programs, and feedback integration. The session highlights successful case studies and practical tools companies use to prioritize patient needs, improve experience, and foster trust with current and future trial participants.
Speakers:
10:45 am - 11:45 am
Workshop
L04.2 - Foundations of IRT UAT Script Writing (I)
This intermediate level workshop provides a practical, regulatory-aligned approach to writing UAT test scripts for IRT grounded in CSA, ICH Q9, and ISPE GAMP 5 principles.
The session will guide attendees with steps for creating, organizing, and executing right-sized UAT test scripts that support the full UAT lifecycle from planning through documentation.
The session will guide attendees with steps for creating, organizing, and executing right-sized UAT test scripts that support the full UAT lifecycle from planning through documentation.
Speakers:
10:45 am - 11:45 am
Workshop
L06.2 - Regulatory Submissions Best Practices for Clinical Trials (A)
This advanced level lecture provides a practical guide to regulatory submission strategies that drive clinical trial success worldwide. Participants will learn how to prepare high-quality regulatory packages, navigate region-specific requirements, and avoid common pitfalls that cause delays or rejections. The session covers best practices in dossier planning, document management, cross-functional coordination, and effective use of electronic submission platforms such as the eCTD.
Speakers:
10:45 am - 11:45 am
Workshop
WS02.2 - Global Distribution: Real-World Challenges & Solutions (I)
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 that the group can learn from.
Speakers:
10:45 am - 11:45 am
Workshop
WS04.2 - VAT and IOR Considerations in Clinical Supply Chains (I)
This intermediate level workshop will focus on the critical aspects of Value Added Tax (VAT) and Importer of Record (IOR) considerations in clinical supply chains. Participants will learn about the regulatory requirements and best practices for managing VAT and IOR in the context of clinical trials. The session will cover strategies to ensure compliance, optimize cost management, and streamline logistics. Attendees will gain insights into the complexities of international clinical supply chains and how to navigate these challenges effectively.
Speakers:
10:45 am - 11:45 am
Workshop
WS05.2 - Temperature Excursion Considerations for Comparator Product Sourcing (I)
This intermediate level workshop will help clinical supply professionals proactively identify and mitigate temperature excursions for comparator products used in clinical trials.
Speakers:
10:45 am - 11:45 am
Workshop
WS20.2 - Introduction to Expanded Access Program (B)
This beginner level workshop will explore the primary challenges in expanded access (EA): Ethics, Supply Planning and Regulatory. Real-life scenarios (failures and successes) will be shared , highlighting how these experts navigated the obstacles.
Speakers:
10:45 am - 11:45 am
Workshop
WS22.2 - Innovative Label Strategies to Overcome Regulatory Hurdles (I)
In this intermediate level workshop 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.
Speakers:
10:45 am - 11:45 am
Workshop
WS23.2 - Blinding in Clinical Trials (B)
This beginner level workshop provides a comprehensive overview of blinding in clinical trials, focusing on its critical role in minimizing bias and ensuring data integrity. Participants will learn about various blinding methods (single, double, and triple blinding), practical implementation challenges, and strategies to maintain blinding throughout the study. The session also covers regulatory expectations and real-world scenarios where blinding may be compromised. Designed for clinical operations, study managers, and quality assurance professionals, this workshop equips attendees with the knowledge to design and manage effective blinding processes.
Speakers:
10:45 am - 11:45 am
Workshop
WS24.2 - Best Ways to Handle Stress in Leadership (B)
In this beginner level 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.
Speakers:
10:45 am - 11:45 am
Workshop
WS25.2 - Clarifying Roles and Responsibilities through RACIs (B)
Knowing everyone's role & responsibilities is an essential requirement for successful teams. This beginner level workshop will provide an overview and process methods for deploying a RACI (Responsible, Accountable, Consulted, Informed) chart in support of those outcomes.
Speakers:
10:45 am - 11:45 am
Workshop
WS26.2 - Best Practices in Clinical GMP QA (B)
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.
Speakers:
1:00 pm - 2:00 pm
Workshop
L08.2 - Implementing a Control Tower for Real-Time Executive Dashboards and Actionable Insights (A)
This advanced level session explores how a Control Tower aggregates data across multiple source systems to provide real-time dashboards and actionable insights. In clinical operations, it serves as a centralized, data-driven command center, enhancing visibility, streamlining trial supply planning, and enabling proactive decision-making. Attendees will gain a strategic perspective on how adopting a Control Tower model can drive innovation and deliver tangible operational benefits in clinical supply chain management.
Speakers:
1:00 pm - 2:00 pm
Workshop
L09.2 - Case Study: Using AI and Advanced Analytics to Optimize a Large Phase 3 Global Trial (I)
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.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS03.2 - Import/Export and Distribution Challenges in Emerging Markets (I)
This intermediate level workshop provides an in-depth look at the unique import/export and distribution challenges faced in emerging markets. Participants will explore regulatory complexities, customs requirements, infrastructure limitations, and logistical hurdles specific to these regions. Through case studies and interactive discussions, attendees will learn practical strategies to navigate these obstacles, ensuring efficient and compliant clinical supply delivery. This session is designed for supply chain managers, logistics professionals, and clinical operations teams working or planning to work in emerging markets.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS08.2 - Real-World Strategies for successful Clinical Supply Vendor Transitions (I)
Vendor transitions in the clinical supply space—whether due to performance, scalability, or strategic alignment—are highly complex and high-risk if not managed carefully. This intermediate level workshop provides real-world strategies for planning and executing successful transitions between clinical supply vendors, including depots, packaging providers, IRT vendors, and logistics partners. Participants will explore change management tactics, risk mitigation plans, stakeholder communication, and regulatory considerations through practical examples and peer discussion.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS10.2 - Middle East & North Africa (MENA) - Strategy and Requirements
This beginner level session will cover the unique aspects of conducting clinical trials in MENA countries, including regulatory landscapes, cultural considerations, patient recruitment strategies, and logistical challenges.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS11.2 - Managing Controlled Substances in Global Clinical Trials (B)
This beginner level workshop will provide an overview of ways a controlled substance can enter into a clinical trial and management of controlled substances across multiple countries.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS16.2 - Comparator Sourcing and Supply: Discussion around Industry Trends, Changes and Challenges when Using Comparator drugs (I)
In this intermediate level session attendees will discuss the nuances of supplying commercial materials in clinical trials conducted in Europe. Topics to include the requirements for using non-EU sourced drugs, the impact of changing the source country and the timelines involved.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS27.2 - European Qualified Person (QP) Declarations & QP Certification – Overview (B)
QP Declarations and Certification and release requirements can be complex. This complexity can affect timelines and stakeholder expectations. This beginner level workshop will discuss what is the minimum requirements as inputs to progress QP certifications and declarations within expected timelines.
Speakers:
1:00 pm - 2:00 pm
Workshop
WS28.2 - Pharmacy Manual in Clinical Trials: Purpose and Scope (B)
The Pharmacy Manual is an integral document for conducting a clinical trial that provides critical study information and guidance to positively influence site GxP compliance. This beginner level session will discuss best industry practice for pharmacy manuals, components and aspects that allow sites to comply with ICH E6(r3).
Speakers:
1:00 pm - 2:00 pm
Workshop
WS29.2 - Clinical Trial Start-Up Best Practices: Avoiding Delays and Ensuring Readiness (B)
This beginner level workshop explores best practices for clinical supplies to support studies before and during clinical trial start-up. Participants will learn how to create a comprehensive clinical supply start-up plan, collaborate effectively with CMC teams, and identify key timeline deliverables to ensure sites are adequately stocked.
Through real-world examples and actionable tools, attendees will gain strategies to identify and mitigate risks, coordinate efficiently with clinical stakeholders, and ensure clinical supplies arrive on time and are stored and managed correctly throughout the study.
Through real-world examples and actionable tools, attendees will gain strategies to identify and mitigate risks, coordinate efficiently with clinical stakeholders, and ensure clinical supplies arrive on time and are stored and managed correctly throughout the study.
Speakers:
2:15 pm - 3:15 pm
Presentation
Plenary Session - The Evolution of AI and Its Impact on the Clinical Supply Chain (I)
This intermediate level plenary explores how artificial intelligence (AI) is transforming the clinical supply chain—from forecasting and planning to real-time monitoring and risk mitigation. Participants will examine the evolution of AI tools, machine learning algorithms, and predictive analytics, and how they are being applied to optimize supply chain efficiency, reduce waste, and improve patient service levels. Real-world use cases will highlight AI's current capabilities and future potential in reshaping supply operations across the clinical trial lifecycle.
Speakers:
