GCSG 2025 Asia Pacific Conference: Program

This class is designed for clinical supply professionals who want to  learn more than just the basics about shipping and distribution for  global clinical trials. This seminar will cover trade compliance,  international shipment workflow and clearance, Value Added Tax (VAT) and  logistics supply chain partnerships to ensure success with  international distribution.

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.

This workshop will focus on the challenges associated with cell and gene therapy supply chains and the solutions to address them. Key topics will include patient orientation for CGT, temperature-control, site requirements, manufacturing challenges, and managing aggressive timelines.

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will review all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to -try.

As our industry continues to evolve with innovative medicines in development and patients recruited from diverse populations, traditional packaging and labelling strategies are also being challenged.  This interactive workshop will review the packaging and labelling solutions to meet the needs of this evolution.

Outsourcing has become the norm in our industry, but challenges persist on both sides. This workshop will focus on the importance of managing clinical supplies by viewing your vendor as a key partner. We will discuss strategies for seamlessly integrating your vendor into your supply chain, using internal stakeholder input to refine metrics, and minimizing risks to enhance overall success.

Awareness of regulatory requirements from various agencies is crucial for success in clinical trial supplies. This workshop will explore China's regulations on importation, labeling, and distribution, and discuss how these rules affect timelines and planning for clinical trial supplies.

Learning by the shared experiences of industry veterans, this workshop will focus on innovative tools and techniques to address legacy and present day challenges within the clinical supply chain.

In recent years, there has been a growing emphasis on self-service tools to swiftly address trial execution challenges. This workshop will focus on managing clinical supply chain settings within IRT systems, including forecasting activities, and will discuss the ideal level of control needed to optimize both forecasting and overall supply chain management.

Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.

This workshop will focus on the challenges associated with cell and gene therapy supply chains and the solutions to address them. Key topics will include patient orientation for CGT, temperature-control, site requirements, manufacturing challenges, and managing aggressive timelines.

On average, 55-75% of drugs are wasted in clinical trials. Although overproduction has long been an accepted practice in clinical supply and manufacturing, it is increasingly unsustainable. This workshop will examine how technology can drive the transition to a more sustainable clinical supply chain and will discuss effective strategies and best practices for achieving this shift.

This workshop will explore successful patient-centric approaches for clinical trials and their clinical supplies. The GCSG Direct-To-Patient (DTP) Team will facilitate a discussion on the complexities of the DTP process, sharing insights, experiences, and lessons learned from a wide range of stakeholders, including patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees, couriers, sponsors, and vendors.

Outsourcing has become the norm in our industry, but challenges persist on both sides. This workshop will focus on the importance of managing clinical supplies by viewing your vendor as a key partner. We will discuss strategies for seamlessly integrating your vendor into your supply chain, using internal stakeholder input to refine metrics, and minimizing risks to enhance overall success.

Awareness of regulatory requirements from various agencies is crucial for success in clinical trial supplies. This workshop will explore China's regulations on importation, labeling, and distribution, and discuss how these rules affect timelines and planning for clinical trial supplies.

Learning by the shared experiences of industry veterans, this workshop will focus on innovative tools and techniques to address legacy and present day challenges within the clinical supply chain.

As our industry continues to evolve with innovative medicines in development and patients recruited from diverse populations, traditional packaging and labelling strategies are also being challenged.  This interactive workshop will review the packaging and labelling solutions to meet the needs of this evolution.

In recent years, there has been a growing emphasis on self-service tools to swiftly address trial execution challenges. This workshop will focus on managing clinical supply chain settings within IRT systems, including forecasting activities, and will discuss the ideal level of control needed to optimize both forecasting and overall supply chain management.

On average, 55-75% of drugs are wasted in clinical trials. Although overproduction has long been an accepted practice in clinical supply and manufacturing, it is increasingly unsustainable. This workshop will examine how technology can drive the transition to a more sustainable clinical supply chain and will discuss effective strategies and best practices for achieving this shift.

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will review all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to -try.

This workshop will explore successful patient-centric approaches for clinical trials and their clinical supplies. The GCSG Direct-To-Patient (DTP) Team will facilitate a discussion on the complexities of the DTP process, sharing insights, experiences, and lessons learned from a wide range of stakeholders, including patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees, couriers, sponsors, and vendors.

Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.