Day 1 : Tuesday, March 10
Boot Camp Registration Open
BC01-Understanding the Essentials of the Clinical Supply
This class, geared towards people new to the world of clinical trial supplies, focuses on drug development and what goes into planning for and delivering a study drug for a clinical trial. Topics include: reasons behind Good Manufacturing Practices (cGMPs), phases of new drug development and approval, randomizing and blinding clinical trial materials, quality assurance and documentation, protocol interpretation, patient compliance, labeling, standard operating procedures (SOPs), stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the European Union (EU) and rest of world (ROW). Attendees will hear a massive amount of information in a fun and interactive atmosphere.
Speakers:
BC02- Understanding VAT / IOR and International Shipment Workflows
Join our Clinical Supply Inspection Readiness Bootcamp, an intensive, full-day workshop designed to prepare you for regulatory success. Through interactive sessions, expert-led discussions, and hands-on activities, you’ll gain practical insights into inspection strategies, risk mitigation, and vendor collaboration. Perfect for professionals looking to enhance their readiness and confidence in navigating regulatory inspections.
Speakers:
Exhibitor Registration Open & Exhibitor Set Up
Presenters / Workshop Facilitators Orientation
If you are speaking or facilitating a workshop, please join us for a short orientation session and tour of the workshop rooms.
Start the Asia Pacific Conference Right! - Conference Orientation
Kick off the Asia Pacific Conference on the right foot! This orientation session will provide essential information and tips to help you make the most of your conference experience.
GCSG Meet & Greet Networking Event
GCSG is new to the Asia Pacific region! Join us for light refreshments and libations while you network with other clinical supply professionals and enjoy a jazz band.
Day 2 : Wednesday, March 11
Registration Open - Exhibitor Displays Open
Welcome & Opening Remarks
Keynote Presentation
Room Transfer
WS01.1-Global Release Strategies: Comparing QP Declarations, Release Inputs, and Timelines Across EU, North America, and APAC
Navigating clinical supply release processes across global regions can be complex and time-sensitive. This workshop will provide a comparative view of QP declarations in the EU, release requirements in North America, and evolving practices in APAC. Attendees will gain a clearer understanding of region-specific regulatory expectations, documentation inputs, and timelines — and how to build global strategies that reduce delays and ensure compliance across markets.
WS04.1-Managing Supply Constraints in Clinical Trials: Strategies for Comparator Sourcing and Inventory Planning
This workshop will take a practical look at managing supply constraints in clinical trials, with a focused lens on comparator sourcing. Through real-world scenarios, participants will explore how to proactively assess risk, plan for sourcing challenges, and implement strategies such as safety stock management and inventory optimization. The session will highlight key tools, techniques, and decision-making processes that enable teams to navigate complex supply environments and ensure continuity in trial execution.
WS05.1-Increasing Clinical Supplies Engagement in the Clinical Trial Protocol Design Process
This workshop focuses on the importance of early engagement and information gathering between the sponsor, CRO and clinical supplies stakeholders to strengthen study designs and optimize clinical supplies execution.
WS09.1-Global Clinical Trials for Biotechs: Outsourcing, Expansion & Partnerships
As emerging biotechs continue to drive innovation in drug development, navigating the complexities of global clinical trials has become increasingly critical—and challenging. This workshop will explore key strategies for successful trial expansion beyond domestic markets, with a focus on effective outsourcing models, vendor selection, and building strategic partnerships. Through real-world case studies and expert insights, participants will gain a deeper understanding of how to manage global logistics, ensure compliance, and scale clinical supply operations to meet the unique demands of biotech-driven trials.
WS11.1-Ensuring Trial Success: What You Need to Ask Your CRO
Choosing the right CRO partner is one of the most critical decisions a sponsor can make — and asking the right questions upfront can make or break your trial. This session will help you identify the must-have CRO capabilities based on the unique operational needs of your study, manage your budget effectively to avoid overspending, and streamline study startup to minimize costly delays.
Room Transfer
WS02.1-Latest Developments in Clinical Trials in China: Regulatory Trends, Opportunities, and Operational Insights
China continues to evolve as a critical player in global clinical research. This workshop will provide an up-to-date overview of regulatory changes, trial execution strategies, and key opportunities for sponsors operating in or entering the Chinese market. Learn how to navigate the latest policies, optimize trial setup, and leverage China’s growing innovation ecosystem to enhance your global development strategy.
WS03.1-From Forecast to First Patient In: Enhancing Clinical Trial Efficiency and Measuring Performance
In today’s fast-paced clinical development landscape, clinical supply teams must deliver with speed, precision, and agility. This workshop is designed for clinical supply professionals aiming to optimize forecasting, reduce drug waste, and support aggressive study timelines — while maintaining control through real-time performance tracking.
WS06.1-Programming IRT for Success: Streamlined Workflows, Real-Time Metrics, and Setup Best Practices
IRT plays a pivotal role in clinical trial execution — but its success starts long before first patient in. This workshop focuses on how thoughtful IRT programming and cross-functional collaboration can streamline setup, improve trial flexibility, and ensure robust real-time oversight.
WS10.1-Smart Packaging & Labeling Strategies: Enhancing Adherence, Blinding, and Drug-Specific Solutions
This interactive workshop will explore innovative packaging and labeling strategies designed to improve patient adherence, support effective blinding, and address drug-specific requirements in clinical trials. Through case studies and group discussions, participants will examine how smart technologies and tailored solutions can streamline clinical supply processes, reduce risk, and enhance trial integrity.
WS12.1-Temperature Excursion Management: Balancing Quality, Speed, and Real-World Challenges
This workshop explores how to manage temperature excursions while balancing the demands of quality, speed, and real-world complexity. Topics include handling excursions for take-home medications, approaches to adjudicating events without temperature data, and practical strategies to ensure compliance without compromising trial timelines.
Lunch & Exhibitor Displays Open
WS01.2-Global Release Strategies: Comparing QP Declarations, Release Inputs, and Timelines Across EU, North America, and APAC
Navigating clinical supply release processes across global regions can be complex and time-sensitive. This workshop will provide a comparative view of QP declarations in the EU, release requirements in North America, and evolving practices in APAC. Attendees will gain a clearer understanding of region-specific regulatory expectations, documentation inputs, and timelines — and how to build global strategies that reduce delays and ensure compliance across markets.
WS08.1-Essential Project Management Skills to Influence Stakeholders and Achieve Success
This workshop will focus on defining good project management for clinical supplies and the tools and techniques to ensure projects stay on time and on budget while collaborating with all key and diverse stakeholders.
WS09.2-Global Clinical Trials for Biotechs: Outsourcing, Expansion & Partnerships
As emerging biotechs continue to drive innovation in drug development, navigating the complexities of global clinical trials has become increasingly critical—and challenging. This workshop will explore key strategies for successful trial expansion beyond domestic markets, with a focus on effective outsourcing models, vendor selection, and building strategic partnerships. Through real-world case studies and expert insights, participants will gain a deeper understanding of how to manage global logistics, ensure compliance, and scale clinical supply operations to meet the unique demands of biotech-driven trials.
WS11.2-Ensuring Trial Success: What You Need to Ask Your CRO
Choosing the right CRO partner is one of the most critical decisions a sponsor can make — and asking the right questions upfront can make or break your trial. This session will help you identify the must-have CRO capabilities based on the unique operational needs of your study, manage your budget effectively to avoid overspending, and streamline study startup to minimize costly delays.
WS13.1-Cell & Gene Therapy Supply Chains: Nightmares and Solutions
This workshop is designed to share stories that people will remember. Cognitive research shows that our negativity bias allows us to remember bad things longer. Cell and gene horror stories will be shared from both the speakers as well as the attendees.
Room Transfer
Patient Testimonial
Closing Remarks
Vender Reception - Vendor Area
Explore the exhibitor area to learn more about what the leading players in the industry have to offer
Personal Time
GCSG Evening Event
Day 3 : Thursday, March 12
Registration Open - Exhibitor Displays Open
Opening Remarks
Plenary-Innovative Approaches to Clinical Trial Supply Chain using AI and Machine Learning
Buzzwords or real-life impact? Explore some of the most recent innovations that are already transforming clinical trial supply chains or are on the rise. This plenary session will highlight how these technologies improve demand forecasting, optimize inventory management, and enhance risk mitigation—helping teams run smarter, faster, and more agile trials.
Room Transfer
WS04.2-Managing Supply Constraints in Clinical Trials: Strategies for Comparator Sourcing and Inventory Planning
This workshop will take a practical look at managing supply constraints in clinical trials, with a focused lens on comparator sourcing. Through real-world scenarios, participants will explore how to proactively assess risk, plan for sourcing challenges, and implement strategies such as safety stock management and inventory optimization. The session will highlight key tools, techniques, and decision-making processes that enable teams to navigate complex supply environments and ensure continuity in trial execution.
WS05.2-Increasing Clinical Supplies Engagement in the Clinical Trial Protocol Design Process
This workshop focuses on the importance of early engagement and information gathering between the sponsor, CRO and clinical supplies stakeholders to strengthen study designs and optimize clinical supplies execution.
WS07.1-Enabling Patient-Centric Homecare: Practical Approaches to Monitoring, Packaging, and Site-Level Support
As clinical trials increasingly move closer to the patient, enabling effective homecare solutions is becoming a critical part of patient-centric strategies. This workshop will explore practical approaches to support home-based care, including innovative packaging for at-home administration, device integration to enhance compliance, and remote monitoring technologies. We’ll also discuss how to equip and engage clinical sites to support these models effectively. Join us to learn how pharma sponsors can balance innovation with operational feasibility to improve patient experience and trial outcomes.
WS13.2-Cell & Gene Therapy Supply Chains: Nightmares and Solutions
This workshop is designed to share stories that people will remember. Cognitive research shows that our negativity bias allows us to remember bad things longer. Cell and gene horror stories will be shared from both the speakers as well as the attendees.
Room Transfer
WS01.3-Global Release Strategies: Comparing QP Declarations, Release Inputs, and Timelines Across EU, North America, and APAC
Navigating clinical supply release processes across global regions can be complex and time-sensitive. This workshop will provide a comparative view of QP declarations in the EU, release requirements in North America, and evolving practices in APAC. Attendees will gain a clearer understanding of region-specific regulatory expectations, documentation inputs, and timelines — and how to build global strategies that reduce delays and ensure compliance across markets.
WS03.2-From Forecast to First Patient In: Enhancing Clinical Trial Efficiency and Measuring Performance
In today’s fast-paced clinical development landscape, clinical supply teams must deliver with speed, precision, and agility. This workshop is designed for clinical supply professionals aiming to optimize forecasting, reduce drug waste, and support aggressive study timelines — while maintaining control through real-time performance tracking.
WS06.2-Programming IRT for Success: Streamlined Workflows, Real-Time Metrics, and Setup Best Practices
IRT plays a pivotal role in clinical trial execution — but its success starts long before first patient in. This workshop focuses on how thoughtful IRT programming and cross-functional collaboration can streamline setup, improve trial flexibility, and ensure robust real-time oversight.
WS08.2-Essential Project Management Skills to Influence Stakeholders and Achieve Success
This workshop will focus on defining good project management for clinical supplies and the tools and techniques to ensure projects stay on time and on budget while collaborating with all key and diverse stakeholders.
Lunch - Exhibitor Displays Open
WS02.2-Latest Developments in Clinical Trials in China: Regulatory Trends, Opportunities, and Operational Insights
Join our Clinical Supply Inspection Readiness Bootcamp, an intensive, full-day workshop designed to prepare you for regulatory success. Through interactive sessions, expert-led discussions, and hands-on activities, you’ll gain practical insights into inspection strategies, risk mitigation, and vendor collaboration. Perfect for professionals looking to enhance their readiness and confidence in navigating regulatory inspections.
WS07.2-Enabling Patient-Centric Homecare: Practical Approaches to Monitoring, Packaging, and Site-Level Support
As clinical trials increasingly move closer to the patient, enabling effective homecare solutions is becoming a critical part of patient-centric strategies. This workshop will explore practical approaches to support home-based care, including innovative packaging for at-home administration, device integration to enhance compliance, and remote monitoring technologies. We’ll also discuss how to equip and engage clinical sites to support these models effectively. Join us to learn how pharma sponsors can balance innovation with operational feasibility to improve patient experience and trial outcomes.
WS10.2-Smart Packaging & Labeling Strategies: Enhancing Adherence, Blinding, and Drug-Specific Solutions
This interactive workshop will explore innovative packaging and labeling strategies designed to improve patient adherence, support effective blinding, and address drug-specific requirements in clinical trials. Through case studies and group discussions, participants will examine how smart technologies and tailored solutions can streamline clinical supply processes, reduce risk, and enhance trial integrity.
WS12.2-Temperature Excursion Management: Balancing Quality, Speed, and Real-World Challenges
This workshop explores how to manage temperature excursions while balancing the demands of quality, speed, and real-world complexity. Topics include handling excursions for take-home medications, approaches to adjudicating events without temperature data, and practical strategies to ensure compliance without compromising trial timelines.