Day 1 : Sunday, April 21
8:00 am - 4:30 pm
Boot Camp / Seminar
Expanded Access
This interactive seminar will give an overview of expanded access and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.
8:00 am - 4:30 pm
Boot Camp / Seminar
Inspection Readiness
8:00 am - 4:30 pm
Boot Camp / Seminar
IRT Deep Dive
8:00 am - 4:30 pm
Boot Camp / Seminar
Mastering Clinical Supply Planning
Planning the clinical supply chain can be an extremely difficult task. Between the quantity of information to consider, the uncertainty of future trials, the  missing information, clinical supply managers can easily feel under pressure to deliver a safe, yet efficient, supply plan. This bootcamp aims at teaching  methods to streamline the planning process, from data collection, to planning  methods, and share good practices to easily improve the quality of your  planning. This one-day session will bring attendees through different steps  of forecasting and planning in clinical supply chain. Together, we will  address the basics and quickly move into sharing concrete, actionable good practices
- An introduction to planning & forecasting in clinical supply
- Collecting assumptions and working with limited data
- Good practices & pitfalls in planning
-  Impact of external events and decisions on your planning – How to turn this to your advantage?
- Interactive exercises to apply learnings
8:00 am - 4:30 pm
Boot Camp / Seminar
Understanding the Essentials of the Clinical Supply Chain
This class is geared toward people new to the clinical trial supplies world, and focuses on drug development and what goes into planning for and delivering a study drug for 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, stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the EU and ROW. Attendees will hear a massive amount of information in a fun and interactive atmosphere.
Day 2 : Monday, April 22
10:15 am - 11:15 am
Workshop
L1 - Cell and Gene Therapy Supply
Learn about the various supply chains of CGT and how they differ from traditional supply chains. Understand key considerations for both clinical and commercial and the support from digitization.
10:15 am - 11:15 am
Workshop
L2 - Data & Analytics to Drive the Clinical Supply Chain
The life blood of any AI or ML system is data. Our biggest challenge to date is collecting and scrubbing that data to get the most out of it for AI. This workshop will discuss ways to ensure the best data collection and integrity is built into all of our systems. Once data can be relied on, this workshop will then explore how data and analytics can drive operational excellence within the clinical supply chain.
10:15 am - 11:15 am
Workshop
L3 - Using AI to Predict Enrollment
Clinical supply's greatest challenge is patient enrollment. It is the greatest cause of supply chain turmoil. This workshop will discuss how AI is being used to not only accelerate enrollment but to predict it and how those trends can be used by the clinical supply chain.
10:15 am - 11:15 am
Workshop
WS01 - Precision Dispensing - Packaging Labeling And Dispensing From Central Pharmacy
This workshop will discuss the challenges of specialty pharmacies and central pharmacies in clinical supply support. It will also discuss the role and responsibilities that central and specialty pharmacies have vs. standard clinical supply chains.
10:15 am - 11:15 am
Workshop
WS03 - How to Use ChatGPT to Write UAT Scripts for IRT and Perform Clinical Planning
With the advent of AI and AI tools, the industry has evolved to better understand and use those tools to improve the clinical supply chain. This workshop will use one of those tools, ChatGPT, to demonstrate how this can be used to identify user requirement specifications and write user acceptance scripts to ensure an IRT has been built fit to purpose.
10:15 am - 11:15 am
Workshop
WS05 - Updates On New Regulations, Understanding Their Impact
We live in a highly regulated environment where new regulations are identified without much notice. This workshop will summarize a few of the latest regulations that have recently been released that will impact the clinical supply chain.
10:15 am - 11:15 am
Workshop
WS06 - Navigating Ancillary Management Challenges
This interactive discussion will cover topics such as:
- Identify important considerations for ensuring compatibility of IMP with  common infusion materials and how they impact delivery of drug to the patient
- Identify key stakeholders (e.g. CMC, Clinical, CROs, CMOs) that are  involved in the process and how they may be leveraged to support the process.
- Discuss how to develop a plan to ensure availability and continuity of compatible ancillaries across all regions the trials will be conducted in
- Poll group and review pros and cons of different organizational  approaches to management and delivery of ancillary supplies
10:15 am - 11:15 am
Workshop
WS15 - VAT Recovery
Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).
10:15 am - 11:15 am
Workshop
WS20 - SMART Packaging for Adherence Measurement: Understanding the Impact on Supply Planning
Drug administration and compliance have always been a challenge. With the advent of SMART devices, this has become easier. This workshop will discuss how and why to integrate SMART technology into your supply chain to improve adherence
10:15 am - 11:15 am
Workshop
WS21 - Inspection Readiness Across the Pipeline
Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to discuss how to apply 80-20 rule, prepare for inspections & get ready for the inspection room as well as learn about some key tools to help you stay calm, succeed and always be inspection ready!
10:15 am - 11:15 am
Workshop
WS27 - Remote Working and Returning to the Office
During the pandemic, remote work became the standard for our industry. Now that the pandemic is behind us, there is an industry drive to bring people back into the office. This workshop will focus on adapting your communication and collaboration style to achieve the same level of success that a non-hybrid style provided pre-pandemic.
11:30 am - 12:30 pm
Workshop
WS04 - Resources to Assist Patients in Identifying and Navigating Clinical Trials
This workshop will identify one of the largest challenges we have in the clinical trial industry, which is finding and enrolling patients. It will provide a different perspective to help understand how we can support patients in finding appropriate clinical trials to treat or cure many of the diseases from which they suffer today.
11:30 am - 12:30 pm
Workshop
WS08 - Understanding the Requirements & Challenges for Importer of Record (IoR)
Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.
11:30 am - 12:30 pm
Workshop
WS10 - Lessons Learned After 30 Years In Clinical Supplies
In 30 years, a lot could be learned in the clinical supply industry. This workshop will leverage SME's and participant's knowledge to provide solution to the attendee's biggest issues and questions.
11:30 am - 12:30 pm
Workshop
WS11 - Understanding EU Labeling Regulations
Awareness of labeling regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the labeling requirements in the EU that when correctly implemented allow you to avoid delays and supply chain disruptions.
11:30 am - 12:30 pm
Workshop
WS12 - Regulatory Label Requirements for Comparators
This workshop will discuss the options for establishing labeling requirements for your comparator program. This discussion will also include the challenges for ensuring comparators are labeled correctly for global trials including use of authorized auxiliary medicinal products (AAMPs) and unauthorized auxiliary medicinal products (UAMPs).
11:30 am - 12:30 pm
Workshop
WS17 - Clinical Supply Chain Open Forum
This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.
11:30 am - 12:30 pm
Workshop
WS23 - Latest ERP SYSTEMS / Solutions and What Challenges Are Faced
As our companies grow and evolve, clinical supply chain management can utilize better and better tools for success. This workshop will explore the options for enterprise resource planning (ERP) solutions and how they can be integrated into your clinical supply unit.
11:30 am - 12:30 pm
Workshop
WS24 - Comparator Sourcing Challenges & Supply Chains
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.
11:30 am - 12:30 pm
Workshop
WS26 - Essential Leadership Skills
With the ever-evolving clinical supply chain, leadership has become an essential aspect that all of us must demonstrate at any given time. This workshop will provide essential leadership tools and identify skills necessary for team success.
11:30 am - 12:30 pm
Workshop
WS28 - Building Accountability Within Your Team
In this session, we will discuss and define accountability with case studies provided to demonstrate techniques and concepts to instill a culture of accountability within your team.
11:30 am - 12:30 pm
Workshop
WS29 - DTP
1:30 pm - 2:30 pm
Workshop
L4 - Getting the Most Out of Your IRT User Experience
Over the past few years, the emphasis has been on more self-service tools to adapt more quickly to trial execution challenges. This workshop will focus on how to control clinical supply chain settings in IRT and discuss what the right level of control should look like.
1:30 pm - 2:30 pm
Workshop
WS02 - Strategies to Evaluate & Mitigate Clinical Supply Risk
This session focuses on strategies that build understanding of risk assessment within clinical supplies. The focus will be on planning, a study's protocol requirements, drug characteristics, packaging specifications, vendor partnerships and collaboration and patient compliance concerns which must be identified and addressed in order to mitigate risk for successful clinical supply outcomes.
1:30 pm - 2:30 pm
Workshop
WS07 - What to Consider When Getting into Cell & Gene Therapy
This workshop will be a discussion focused on the challenges of cell and gene therapy. Key topics to be discussed will include CGT's patient orientation, temperature controlled logistics, site requirements, manufacturing challenges and aggressive timing.
1:30 pm - 2:30 pm
Workshop
WS09 - Overcoming the Black Box Effect in Forecasting and RTSM
Randomization and Trial Supply Management (RTSM) users sometimes do not trust the results they receive. This results in additional verification of the output. These systems are often complicated and lack transparency and therefore can be hard to understand. In this workshop, we explore how products can evolve and what users can do to reduce or eliminate the confusion of what happens inside the system (black box effect) and let the users truly benefit from their added value.
1:30 pm - 2:30 pm
Workshop
WS13 - Japan: Direct to Patient and The Decentralized Landscape
As clinical supply chains evolve in Asia-Pac, two areas of opportunity identified during the pandemic were the implementation of decentralized trials (DCTs) and direct-to-patient distribution (DtP).This workshop will identify ways to leverage DtP while avoiding the pitfalls of working in these emerging markets.
1:30 pm - 2:30 pm
Workshop
WS14 - Understanding the Importance and Required Processes of Reconciliation & Destruction
Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
1:30 pm - 2:30 pm
Workshop
WS16 - Clinical Supplies Stakeholder Management
Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).
1:30 pm - 2:30 pm
Workshop
WS18 - How to Accomplish Drug Pooling in Europe
Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will focus on the challenges of doing pooling of supplies in Europe as well as provide some solutions to accomplish the most pooling possible.
1:30 pm - 2:30 pm
Workshop
WS19 - Using Data to Find Wasteful Processes and Cost Savings
Data is available in multiple locations and in order to ensure its successful use, it must be properly collected, shared, organized, cleaned and visualized. Each step of this process increases its value tremendously. When properly queried, this data can be used to identify and eliminate waste as well as alert clinical supplies when the supply chain is destabilizing.
1:30 pm - 2:30 pm
Workshop
WS22 - End-to-End Clinical Supply Management
Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.
1:30 pm - 2:30 pm
Workshop
WS25 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process
As the incidence of outsourcing the clinical supply chain has increased, understanding the value of clinical supply management using your vendor as a partner has become essential. This workshop will explore how to best utilize your vendor partner as a seamless part of your supply chain while utilizing internal stakeholder inputs to update your metrics.
Day 3 : Tuesday, April 23
10:00 am - 11:00 am
Workshop
L2 - Data & Analytics to Drive the Clinical Supply Chain
The life blood of any AI or ML system is data. Our biggest challenge to date is collecting and scrubbing that data to get the most out of it for AI. This workshop will discuss ways to ensure the best data collection and integrity is built into all of our systems. Once data can be relied on, this workshop will then explore how data and analytics can drive operational excellence within the clinical supply chain.
10:00 am - 11:00 am
Workshop
L1 - Cell and Gene Therapy Supply
Learn about the various supply chains of CGT and how they differ from traditional supply chains. Understand key considerations for both clinical and commercial and the support from digitization.
10:00 am - 11:00 am
Workshop
L3 - Using AI to Predict Enrollment
Clinical supply's greatest challenge is patient enrollment. It is the greatest cause of supply chain turmoil. This workshop will discuss how AI is being used to not only accelerate enrollment but to predict it and how those trends can be used by the clinical supply chain.
10:00 am - 11:00 am
Workshop
WS01 - Precision Dispensing - Packaging Labeling And Dispensing From Central Pharmacy
This workshop will discuss the challenges of specialty pharmacies and central pharmacies in clinical supply support. It will also discuss the role and responsibilities that central and specialty pharmacies have vs. standard clinical supply chains.
10:00 am - 11:00 am
Workshop
WS03 - How to Use ChatGPT to Write UAT Scripts for IRT and Perform Clinical Planning
With the advent of AI and AI tools, the industry has evolved to better understand and use those tools to improve the clinical supply chain. This workshop will use one of those tools, ChatGPT, to demonstrate how this can be used to identify user requirement specifications and write user acceptance scripts to ensure an IRT has been built fit to purpose.
10:00 am - 11:00 am
Workshop
WS05 - Updates On New Regulations, Understanding Their Impact
We live in a highly regulated environment where new regulations are identified without much notice. This workshop will summarize a few of the latest regulations that have recently been released that will impact the clinical supply chain.
10:00 am - 11:00 am
Workshop
WS06 - Navigating Ancillary Management Challenges
This interactive discussion will cover topics such as:
- Identify important considerations for ensuring compatibility of IMP with  common infusion materials and how they impact delivery of drug to the patient
- Identify key stakeholders (e.g. CMC, Clinical, CROs, CMOs) that are  involved in the process and how they may be leveraged to support the process.
- Discuss how to develop a plan to ensure availability and continuity of compatible ancillaries across all regions the trials will be conducted in
- Poll group and review pros and cons of different organizational  approaches to management and delivery of ancillary supplies
10:00 am - 11:00 am
Workshop
WS15 - VAT Recovery
Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).
10:00 am - 11:00 am
Workshop
WS20 - SMART Packaging for Adherence Measurement: Understanding the Impact on Supply Planning
Drug administration and compliance have always been a challenge. With the advent of SMART devices, this has become easier. This workshop will discuss how and why to integrate SMART technology into your supply chain to improve adherence
10:00 am - 11:00 am
Workshop
WS21 - Inspection Readiness Across the Pipeline
Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to discuss how to apply 80-20 rule, prepare for inspections & get ready for the inspection room as well as learn about some key tools to help you stay calm, succeed and always be inspection ready!
10:00 am - 11:00 am
Workshop
WS27 - Remote Working and Returning to the Office
During the pandemic, remote work became the standard for our industry. Now that the pandemic is behind us, there is an industry drive to bring people back into the office. This workshop will focus on adapting your communication and collaboration style to achieve the same level of success that a non-hybrid style provided pre-pandemic.
11:15 am - 12:15 pm
Workshop
L4 - Getting the Most Out of Your IRT User Experience
Over the past few years, the emphasis has been on more self-service tools to adapt more quickly to trial execution challenges. This workshop will focus on how to control clinical supply chain settings in IRT and discuss what the right level of control should look like.
11:15 am - 12:15 pm
Workshop
WS04 - Resources to Assist Patients in Identifying and Navigating Clinical Trials
This workshop will identify one of the largest challenges we have in the clinical trial industry, which is finding and enrolling patients. It will provide a different perspective to help understand how we can support patients in finding appropriate clinical trials to treat or cure many of the diseases from which they suffer today.
11:15 am - 12:15 pm
Workshop
WS08 - Understanding the Requirements & Challenges for Importer of Record (IoR)
Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.
11:15 am - 12:15 pm
Workshop
WS11 - Understanding EU Labeling Regulations
Awareness of labeling regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the labeling requirements in the EU that when correctly implemented allow you to avoid delays and supply chain disruptions.
11:15 am - 12:15 pm
Workshop
WS12 - Regulatory Label Requirements for Comparators
This workshop will discuss the options for establishing labeling requirements for your comparator program. This discussion will also include the challenges for ensuring comparators are labeled correctly for global trials including use of authorized auxiliary medicinal products (AAMPs) and unauthorized auxiliary medicinal products (UAMPs).
11:15 am - 12:15 pm
Workshop
WS17 - Clinical Supply Chain Open Forum
This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.
11:15 am - 12:15 pm
Workshop
WS23 - Latest ERP SYSTEMS / Solutions and What Challenges Are Faced
As our companies grow and evolve, clinical supply chain management can utilize better and better tools for success. This workshop will explore the options for enterprise resource planning (ERP) solutions and how they can be integrated into your clinical supply unit.
11:15 am - 12:15 pm
Workshop
WS24 - Comparator Sourcing Challenges & Supply Chains
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.
11:15 am - 12:15 pm
Workshop
WS26 - Essential Leadership Skills
With the ever-evolving clinical supply chain, leadership has become an essential aspect that all of us must demonstrate at any given time. This workshop will provide essential leadership tools and identify skills necessary for team success.
11:15 am - 12:15 pm
Workshop
WS28 - Building Accountability Within Your Team
In this session, we will discuss and define accountability with case studies provided to demonstrate techniques and concepts to instill a culture of accountability within your team.
11:15 am - 12:15 pm
Workshop
WS29 - DTP
Day 4 : Wednesday, April 24
10:45 am - 11:45 am
Workshop
WS18 - How to Accomplish Drug Pooling in Europe
Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will focus on the challenges of doing pooling of supplies in Europe as well as provide some solutions to accomplish the most pooling possible.
10:45 am - 11:45 am
Workshop
WS02 - Strategies to Evaluate & Mitigate Clinical Supply Risk
This session focuses on strategies that build understanding of risk assessment within clinical supplies. The focus will be on planning, a study's protocol requirements, drug characteristics, packaging specifications, vendor partnerships and collaboration and patient compliance concerns which must be identified and addressed in order to mitigate risk for successful clinical supply outcomes.
10:45 am - 11:45 am
Workshop
WS07 - What to Consider When Getting into Cell & Gene Therapy
This workshop will be a discussion focused on the challenges of cell and gene therapy. Key topics to be discussed will include CGT's patient orientation, temperature controlled logistics, site requirements, manufacturing challenges and aggressive timing.
10:45 am - 11:45 am
Workshop
WS09 - Overcoming the Black Box Effect in Forecasting and RTSM
Randomization and Trial Supply Management (RTSM) users sometimes do not trust the results they receive. This results in additional verification of the output. These systems are often complicated and lack transparency and therefore can be hard to understand. In this workshop, we explore how products can evolve and what users can do to reduce or eliminate the confusion of what happens inside the system (black box effect) and let the users truly benefit from their added value.
10:45 am - 11:45 am
Workshop
WS10 - Lessons Learned After 30 Years In Clinical Supplies
In 30 years, a lot could be learned in the clinical supply industry. This workshop will leverage SME's and participant's knowledge to provide solution to the attendee's biggest issues and questions.
10:45 am - 11:45 am
Workshop
WS13 - Japan: Direct to Patient and The Decentralized Landscape
As clinical supply chains evolve in Asia-Pac, two areas of opportunity identified during the pandemic were the implementation of decentralized trials (DCTs) and direct-to-patient distribution (DtP).This workshop will identify ways to leverage DtP while avoiding the pitfalls of working in these emerging markets.
10:45 am - 11:45 am
Workshop
WS14 - Understanding the Importance and Required Processes of Reconciliation & Destruction
Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries. Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
10:45 am - 11:45 am
Workshop
WS16 - Clinical Supplies Stakeholder Management
Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how clinical supplies can better partner and collaborate with Clinical Operations/Clinical Program teams (on strategy and operational execution), CMC/Manufacturing Teams (around forecast ) and Vendors (CMOs, CDMOs, IRT Vendors).
10:45 am - 11:45 am
Workshop
WS19 - Using Data to Find Wasteful Processes and Cost Savings
Data is available in multiple locations and in order to ensure its successful use, it must be properly collected, shared, organized, cleaned and visualized. Each step of this process increases its value tremendously. When properly queried, this data can be used to identify and eliminate waste as well as alert clinical supplies when the supply chain is destabilizing.
10:45 am - 11:45 am
Workshop
WS22 - End-to-End Clinical Supply Management
Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.
10:45 am - 11:45 am
Workshop
WS25 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process
As the incidence of outsourcing the clinical supply chain has increased, understanding the value of clinical supply management using your vendor as a partner has become essential. This workshop will explore how to best utilize your vendor partner as a seamless part of your supply chain while utilizing internal stakeholder inputs to update your metrics.
