April 23 - 26, 2023 - Orlando, FL

GCSG 2023 US Conference

We are “Blasting Through the Barriers of Clinical Supplies” at the 2023 US Conference!

Registration for tabletop exhibits and sponsorships is scheduled to open Tuesday, December 6th at 11:00am EST. Registration for all other registrant types will open on Tuesday, December 13th.

Check back often for more information!

We can’t wait to see you in Orlando!

Conference thumbnail

We are “Blasting Through the Barriers of Clinical Supplies” at the 2023 US Conference!

Registration for tabletop exhibits and sponsorships is scheduled to open Tuesday, December 6th at 11:00am EST. Registration for all other registrant types will open on Tuesday, December 13th.

Check back often for more information!

We can’t wait to see you in Orlando!

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Note: All times listed below reflect EDT
Virtual sessions only
Day 1: Sunday, April 23
7:00 am - 8:00 am
Conference Logistics

Boot Camp Registration Open

8:00 am - 4:30 pm
Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

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.

Location
Palm A-C
8:00 am - 4:30 pm
Boot Camp / Seminar

Using IRT to Maximize Control & Minimize Outages

This class is geared towards people that have some experience in the clinical trial supplies world. Attendees will be provided with a quick overview and then will take a deeper dive into Interactive Response Technology (IRT). This will include the development path for IRTs; the stages of build, from creating the User Requirement Specification (URS) to quoting, coding, validation, user acceptance testing and go-live; the reasons to use an IRT as well as when NOT to use an IRT; build requirements, including randomization codes and med code IDs; ensuring modules are built to manage individual regulatory country approvals, shipping requests and returns and reconciliation; as well as timelines from concept development to system go-live.

Location
Poinciana C-D
3:00 pm - 5:30 pm
Conference Logistics

Exhibitor Setup

Location
Windsong 1 - 6
3:00 pm - 6:00 pm
Conference Logistics

Registration/Information/Welcome Table Open

Location
Windsong Pre-Function
4:30 pm - 5:00 pm
Conference Logistics

Speaker/Facilitator Meeting & Tour of Workshop Rooms

Location
Windsong Pre-Function
6:00 pm - 8:00 pm
Networking

Meet & Greet – GCSG Networking Event

Location
Upper Pool Deck
8:00 pm - 12:00 am
Networking

GCSG After Hours…

Location
Windsong Fountain Lawn
Day 2: Monday, April 24
6:30 am - 7:15 am
Networking

Yoga

Location
Cypress Pointe
7:30 am - 8:15 am
Conference Logistics

Breakfast

Location
Portico
7:30 am - 8:15 am
Networking

Exhibitor Displays Open

Location
Windsong 1-6
7:30 am - 4:30 pm
Conference Logistics

Registration/Information/Welcome Table Open

Location
Windsong Pre-Function
8:15 am - 8:30 am
Conference Logistics

Transfer to Plenary Hall

8:50 am - 10:00 am
Presentation

Keynote Address – Anne Grady



Anne Grady is a best-selling author, entrepreneur, and an expert in building resilient teams, leaders, and organizations. She is also a two-time TEDx speaker, trainer, survivor, optimist, and inspirer.

Anne has a master’s degree in organizational communication and has spent the last twenty years working with some of the largest organizations around the globe, including: Microsoft, Dell, Lockheed Martin, Johnson & Johnson, ADP, and Google. Anne is featured in press and media and contributes to Harvard Business Review, Entrepreneur, Fast Company, Inc. Magazine, FOX Business and more.


Anne is known for her ability to intertwine storytelling, neuroscience, and psychology with wit, humor, and authenticity. She shares inspiring personal stories, cutting edge, research-based content, and implementation tools to transfer learning into real life. And she’ll make you laugh while she does it.


In her first two books, Anne provides practical strategies to improve relationships, increase productivity, and reduce stress. Her latest book, Mind Over Moment: Harness the Power of Resilience, outlines a science-based approach to build a resilient mindset, skill set, and the ability to reset.


Anne is a mental health advocate and donates a portion of all book proceeds to the National Alliance on Mental Illness and was recently named as one of SUCCESS Magazine’s Best Motivational Speakers to Know in 2022.

Location
Windsong 7-12
10:00 am - 10:15 am
Conference Logistics

Transfer to Workshop

10:15 am - 11:15 am
Workshop

New Concepts in Pooling Supplies Using Protocol Masters and Submission Strategy (WS08)

Pooling of supplies has been in use for a number of years. Recently, there has been a new strategy to use master protocols for pooling somewhat similar to program-level pooling but with a single protocol. The greatest challenge when using this strategy is to align the regulatory filing requirements for each of the sub-protocols. This workshop will explain how to achieve the greatest success when using this pooling strategy.

Location
Regency 6
10:15 am - 11:15 am
Workshop

Clinical Supplies Unblinding Risk Assessments (L01)

There are so many ways we can unblind our clinical trials. This workshop will discuss many of the different ways our clinical supply chain can contribute to unblinding. These can include differences in packaging configuration between arms in a trial, shipping to a clinical site with documents that could unblind the trial or IRT challenges that lead to unblinding.

Location
Regency 1
10:15 am - 11:15 am
Workshop

Cell and Gene Therapy – Transitioning from Standard Clinical Supply Chains to Cell & Gene Supply Chains (WS03)

How to transfer from Clinical Supply Chain in traditional Pharma to Cell Therapy Pharma. There are similarities, but many more differences such as extreme cold chain, label text differences, Chain of Custody/Chain of Identity Requirements, etc. This presentation will provide an overview of the similarities and differences as well as explain the exciting aspects of the cell therapy clinical supply chain.

Location
Regency 4
10:15 am - 11:15 am
Workshop

Cell and Gene Therapy – End-to-End Supply Chain Requirements and Systems to Use (WS02)

Chain of Custody/Chain of Identity is critical in cell therapy. This lecture will discuss the different systems that can be used to manage Chain of Custody/Chain of Identity. The discussion would include the risks and advantages of each different tracking system to use.

Location
Regency 3
10:15 am - 11:15 am
Workshop

Changes in Decentralized Trials Affecting New Strategies in Direct-to-Patient Distribution (L02)

New concepts and execution with decentralized trials have had a large impact on direct-to-patient distribution of clinical supplies. This workshop will discuss new concepts and different techniques being used to connect the best direct-to-patient strategy with new techniques in decentralized trials.

Location
Regency 2
10:15 am - 11:15 am
Workshop

What to Know & What to Avoid to Experience the Greatest Success when Sourcing Comparators (WS04)

Comparator sourcing is a complex and challenging requirement of the majority of clinical trials today. This workshop will discuss what some of the key challenges are and how to set yourself up for success when having to source for global clinical trials.

Location
Palm D-F
10:15 am - 11:15 am
Workshop

IRT Systems and How to Use Them for Forecasting & Data Analytics (WS06)

IRT systems have been in use for over 20 years yet there is still functionality that users may be unaware of that can improve their chances of clinical supply chain success. This workshop will focus on industry best practices to improve the forecast of study enrollment using data analytics to positively impact the clinical supply chain.

Location
Regency 5
10:15 am - 11:15 am
Workshop

Label Design Considerations for Clinical Supplies – What Goes on the Label & Where? (WS07)

Labeling clinical supplies is complex and varies depending upon what countries we are conducting studies in. This workshop will discuss what should go on the labels for all different clinical trial materials, where it should go and how to ensure the right language is being used at the site.

Location
Palm A-C
10:15 am - 11:15 am
Workshop

LATAM Region Import/Export/Distribution Challenges (WS10)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

Location
Regency 8
10:15 am - 11:15 am
Workshop

The Clinical Trial Regulation – QP Perspective & What to Consider for Success (WS05)

Now that the Clinical Trial Regulation is in place in Europe, what should we know, what should we be doing to comply with it and what are the timelines for compliance? This workshop will provide an opportunity to discuss requirements and ask questions from a QP perspective.

Location
Poinciana CD
10:15 am - 11:15 am
Workshop

Instilling an Inspection-Ready Culture in Your Clinical Supply Chain (WS01)

Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to bolster your knowledge on how to always be inspection ready!

Location
Poinciana AB
10:15 am - 11:15 am
Workshop

MENA Region (Middle East North Africa) / Import / Export / Distribution Challenges (WS09)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of Middle East/North Africa countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

Location
Regency 7
11:15 am - 11:30 am
Conference Logistics

Transfer to Workshop

11:30 am - 12:30 pm
Workshop

Temperature Excursions & Some of the Latest Technical Innovations to Mitigate Them (WS19)

The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the latest innovation and technical solutions to control, track, trend and avoid temperature excursions for the life of the product. This workshop will also provide examples of systems in use that can decrease investigations, route case analysis and CAPA timelines for temperature excursions.

Location
Regency 5
11:30 am - 12:30 pm
Workshop

How to Plan & Execute an Efficient Study Closeout (WS11)

One of the last things considered when executing the clinical supply strategy for clinical studies is the study closeout. This workshop will provide guidance for how to plan for and accomplish a study closeout that ensures the highest level of efficiency and cost-savings for the clinical supply chain. This could not be more important due to the focus on returns and reconciliation in the clinical trial regulation.

Location
Poinciana AB
11:30 am - 12:30 pm
Workshop

Creating Clinical Trial Supply Success for Small Start-ups in a Sea of Giant Companies (L04)

Leaders from small biopharma companies help you understand the challenges of working in a small organization and competing with mid-size to large companies for manufacturing and packaging slots while still delivering against tight timelines.

Location
Regency 2
11:30 am - 12:30 pm
Workshop

The Clinical Trial Regulation – Submission Strategies for Clinical Trial Supply (WS16)

With the advent of the Clinical Trial Regulation, a whole new filing process has been put in place. This workshop will review the updated process as well as the Clinical Trial Information System (CTIS) requirements. The facilitator will also explore challenges in filing in the CTIS based on the acceptability of new EMA stability guidance.

Location
Palm A-C
11:30 am - 12:30 pm
Workshop

Managing Import/Export Requirements for Your Products (WS18)

The global reach of today's clinical trials makes understanding your product and its specific transit & import/export requirements a must for any clinical supply chain.  This workshop will discuss ways to navigate the myriad of complex regulations involved in the import and export of clinical trial supplies, including valuation and harmonized system tariff codes.

Location
Palm D-F
11:30 am - 12:30 pm
Workshop

Diversity in the Clinical Supplies Industry…Let’s Discuss Microaggression (WS14)

An opportunity to talk about what our companies are doing (or what we'd like them to be doing) as it relates to increasing diversity, equity and inclusion (DEI) in hiring.

Location
Regency 4
11:30 am - 12:30 pm
Workshop

The Importance of Being Connected to and Engaged With our Analytical Group’s Stability Program to Improve Clinical Supply Outcomes (WS21)

As stability testing and re-test dates are so critical to clinical supplies, this workshop will explore ways to improve oversight and understanding of stability protocols. We will also discuss the importance of building relationships with analytical to get timely updates for CofA's to positively impact CTM planning and forecasting.

Location
Regency 7
11:30 am - 12:30 pm
Workshop

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS20)

In this workshop we will discuss ways to increase the influence of clinical supplies to achieve the best outcomes, the shortest timelines and the fewest number of changes to the clinical supply chain by working closely with our partners in clinical operations.

Location
Regency 6
11:30 am - 12:30 pm
Workshop

Cultural Evolution Within the Clinical Supplies Industry (Post-pandemic) (L05)

Post-pandemic our industry has experienced a tectonic shift in how we accomplish our mission and how we work together as teams. This workshop will provide a facilitated approach to produce tips and techniques to help leaders evolve and create high-performing teams, no matter where they are.

Location
Regency 1
11:30 am - 12:30 pm
Workshop

Breaking Silos to Drive Sustainability in the Clinical Trial Supply Chain (WS23)

We all know it's hard for employees or even individual departments to influence corporate policy. Let's discuss ways that clinical supply professionals can have a greater impact on corporate sustainability.

Location
Regency 8
11:30 am - 12:30 pm
Workshop

VAT Regulation & Rebate Options for Clinical Materials (WS12)

Value added tax (VAT) can significantly increase your clinical trial budget. This workshop will look at ways to maximize your ability to reclaim VAT as a clinical trial sponsor.

Location
Regency 3
11:30 am - 12:30 pm
Workshop

Supply Chain Best Practices – Open Forum (WS39)

This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.

Location
Poinciana CD
12:30 pm - 1:30 pm
Networking

Lunch & Ice Cream / Exhibitor Displays Open / Transfer to Workshop

Location
Portico / Windsong 1-6
1:30 pm - 2:30 pm
Workshop

The Clinical Supply Chain Professional Toolkit (WS32)

Sharing tools and techniques that help.

Location
Palm A-C
1:30 pm - 2:30 pm
Workshop

Mind The Gap: The Shortage of Clinical Supply Professionals (WS36)

In current times we are seeing a dramatic disconnect between the demand for clinical supplies staff and the available resource of talent. Consider the causative factors and explore winning solutions we can bring back to our organizations.

Location
Regency 4
1:30 pm - 2:30 pm
Workshop

MENA Region (Middle East North Africa) / Import / Export / Distribution Challenges (WS09)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of Middle East/North Africa countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

Location
Regency 7
1:30 pm - 2:30 pm
Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (WS22)

Blockchain is a type of distributed ledger, an expanding chronologically ordered list of cryptographically signed, irrevocable transactional records shared by all participants in a network. AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This workshop will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implemented into the Clinical Supply Chain.

Location
Regency 3
1:30 pm - 2:30 pm
Workshop

Preparing to Outsource & Selecting the Right Vendor (WS25)

Outsourcing has become the norm in our industry, yet we still see issues on both sides of the table. This workshop will provide insights into how to decrease risk and increase success when partnering.

Location
Poinciana CD
1:30 pm - 2:30 pm
Workshop

New Concepts in Pooling Supplies Using Protocol Masters and Submission Strategy (WS08)

Pooling of supplies has been in use for a number of years. Recently, there has been a new strategy to use master protocols for pooling somewhat similar to program-level pooling but with a single protocol. The greatest challenge when using this strategy is to align the regulatory filing requirements for each of the sub-protocols. This workshop will explain how to achieve the greatest success when using this pooling strategy.

Location
Regency 5
1:30 pm - 2:30 pm
Workshop

Ways of Working in the PM and CSC Relationship (WS33)

The PM and CSC overlap – How to leverage PM practices in day-to-day Clinical Supply Chain management

Location
Palm D-F
1:30 pm - 2:30 pm
Workshop

Direct to Patient: Latest Survey Results from the DTP Subteam (WS24)

In working to increase the use of DTP in clinical trials, the GCSG DTP subteam (under the Regulatory e-Team) sent out an industry survey. This workshop will review the findings, trends and possible directions forward to increase the adoption of DTP as a clinical supply distribution model.

Location
Poinciana AB
1:30 pm - 2:30 pm
Workshop

Compare & Contrast the Diverse Types of Access (Compassionate Use, Off-label Access, Continued Access, Special License sales & Right-to-Try) (WS15)

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will go over 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.

Location
Regency 1
1:30 pm - 2:30 pm
Workshop

How to Partner with Your Quality Assurance Organization (WS17)

As the world of clinical supplies becomes increasingly complex, it is essential that Clinical Supply partners with Quality to achieve the best outcomes. An essential step in this process is to build a quality culture within the clinical supply unit while developing excellent relationships between the two groups. This session will discuss ways to build that culture and partnership within your own organization.

Location
Regency 2
2:30 pm - 2:45 pm
Conference Logistics

Transfer to Plenary Hall

3:30 pm - 4:45 pm
Networking

Exhibitor Displays Open

Location
Windsong 1-6
4:45 pm - 5:15 pm
Break

Free Time

5:15 pm - 5:30 pm
Conference Logistics

Bus Loading / Departure

Location
Portico Patio
6:00 pm - 9:00 pm
Networking

GCSG Night Out Event

Buses departing back to hotel (once full) every hour starting at 8

Location
Universal Orlando City Walk
9:00 pm - 11:00 pm
Networking

GCSG After Hours Event

Location
Universal Orlando City Walk
Day 3: Tuesday, April 25
7:30 am - 8:15 am
Conference Logistics

Breakfast

Location
Portico
7:30 am - 4:30 pm
Conference Logistics

Registration/Information/Welcome Table Open

Location
Windsong Pre-Function
7:30 am - 8:15 am
Networking

Exhibitor Displays Open

Location
Windsong 1-6
8:15 am - 8:30 am
Conference Logistics

Transfer to Plenary Hall

8:45 am - 9:45 am
Presentation

Patient Testimonial: Katie Ortman Doble


Katie Ortman Doble is a patient advocate, writer and motivational speaker who inspires through her witty and optimistic outlook as a stage 4, ocular melanoma survivor. Doble credits a mix of integrative healing, positive attitude, and Western medicine for allowing her to survive cancer for nine years and counting. Her blog, Future Happy Self, is part self-exploration about her own journey to finding health and happiness and part advice column so that others may learn from her experiences. Doble works as a headhunter in the Colorado market in addition to doing patient advocacy and public speaking.


In 2017, Doble was given the Courage Award from the Melanoma Research Foundation. In 2018, a 5-part series on living wills written by Doble was featured on the Denver Hospice blog and picked up by Denver’s local Fox affiliate. Doble was the 2021 recipient of First Descents' Out Living It Award.


Doble lives in Denver with her husband, Nick, whom she met after first connecting on LinkedIn, and their dog Alice. Thanks to ocular melanoma, Doble and Alice have matching heterochromatic eyes. The Doble family loves to hike, bike, cook and travel.

Location
Windsong 7-12
9:45 am - 10:00 am
Conference Logistics

Transfer to Workshop

10:00 am - 11:00 am
Workshop

Changes in Decentralized Trials Affecting New Strategies in Direct-to-Patient Distribution (L02)

New concepts and execution with decentralized trials have had a large impact on direct-to-patient distribution of clinical supplies. This workshop will discuss new concepts and different techniques being used to connect the best direct-to-patient strategy with new techniques in decentralized trials.

Location
Regency 2
10:00 am - 11:00 am
Workshop

Instilling an Inspection-Ready Culture in Your Clinical Supply Chain (WS01)

Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to bolster your knowledge on how to always be inspection ready!

Location
Regency 5
10:00 am - 11:00 am
Workshop

Allogeneic Supply Chain –(Matched DONOR and Traditional) (WS37)

Things to consider and how to develop a robust allogeneic supply chain for your cell or gene therapy.

Location
Regency 3
10:00 am - 11:00 am
Workshop

Ways of Working in the PM and CSC Relationship (WS33)

The PM and CSC overlap – How to leverage PM practices in day-to-day Clinical Supply Chain management

Location
Poinciana CD
10:00 am - 11:00 am
Workshop

Diversity in the Clinical Supplies Industry…Let’s Discuss Microaggression (WS14)

An opportunity to talk about what our companies are doing (or what we'd like them to be doing) as it relates to increasing diversity, equity and inclusion (DEI) in hiring.

Location
Palm A-C
10:00 am - 11:00 am
Workshop

Clinical Supplies Unblinding Risk Assessments (L01)

There are so many ways we can unblind our clinical trials. This workshop will discuss many of the different ways our clinical supply chain can contribute to unblinding. These can include differences in packaging configuration between arms in a trial, shipping to a clinical site with documents that could unblind the trial or IRT challenges that lead to unblinding.

Location
Regency 1
10:00 am - 11:00 am
Workshop

Preparing to Outsource & Selecting the Right Vendor (WS25)

Outsourcing has become the norm in our industry, yet we still see issues on both sides of the table. This workshop will provide insights into how to decrease risk and increase success when partnering.

Location
Palm D-F
10:00 am - 11:00 am
Workshop

Mind The Gap: The Shortage of Clinical Supply Professionals (WS36)

In current times we are seeing a dramatic disconnect between the demand for clinical supplies staff and the available resource of talent. Consider the causative factors and explore winning solutions we can bring back to our organizations.

Location
Regency 7
10:00 am - 11:00 am
Workshop

The Clinical Supply Chain Professional Toolkit (WS32)

Sharing tools and techniques that help.

Location
Poinciana AB
10:00 am - 11:00 am
Workshop

Creating Clinical Trial Supply Success for Small Start-ups in a Sea of Giant Companies (L04)

Leaders from small biopharma companies help you understand the challenges of working in a small organization and competing with mid-size to large companies for manufacturing and packaging slots while still delivering against tight timelines.

Location
Regency 4
11:00 am - 11:15 am
Conference Logistics

Transfer to Workshop

11:15 am - 12:15 pm
Workshop

Cultural Evolution Within the Clinical Supplies Industry (Post-pandemic) (L05)

Post-pandemic our industry has experienced a tectonic shift in how we accomplish our mission and how we work together as teams. This workshop will provide a facilitated approach to produce tips and techniques to help leaders evolve and create high-performing teams, no matter where they are.

Location
Regency 3
11:15 am - 12:15 pm
Workshop

Supply Chain Best Practices – Open Forum (WS39)

This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.

Location
Palm D-F
11:15 am - 12:15 pm
Workshop

Cell and Gene Therapy – End-to-End Supply Chain Requirements and Systems to Use (WS02)

Chain of Custody/Chain of Identity is critical in cell therapy. This lecture will discuss the different systems that can be used to manage Chain of Custody/Chain of Identity. The discussion would include the risks and advantages of each different tracking system to use.

Location
Regency 7
11:15 am - 12:15 am
Workshop

VAT Regulation & Rebate Options for Clinical Materials (WS12)

Value added tax (VAT) can significantly increase your clinical trial budget. This workshop will look at ways to maximize your ability to reclaim VAT as a clinical trial sponsor.

Location
Palm A-C
11:15 am - 12:15 pm
Workshop

Label Design Considerations for Clinical Supplies – What Goes on the Label & Where? (WS07)

Labeling clinical supplies is complex and varies depending upon what countries we are conducting studies in. This workshop will discuss what should go on the labels for all different clinical trial materials, where it should go and how to ensure the right language is being used at the site.

Location
Regency 2
11:15 am - 12:15 pm
Workshop

What to Know & What to Avoid to Experience the Greatest Success when Sourcing Comparators (WS04)

Comparator sourcing is a complex and challenging requirement of the majority of clinical trials today. This workshop will discuss what some of the key challenges are and how to set yourself up for success when having to source for global clinical trials.

Location
Poinciana AB
11:15 am - 12:15 pm
Workshop

LATAM Region Import/Export/Distribution Challenges (WS10)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional. This workshop will discuss the regulatory requirements of Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

Location
Regency 5
11:15 am - 12:15 pm
Workshop

How to Plan & Execute an Efficient Study Closeout (WS11)

One of the last things considered when executing the clinical supply strategy for clinical studies is the study closeout. This workshop will provide guidance for how to plan for and accomplish a study closeout that ensures the highest level of efficiency and cost-savings for the clinical supply chain. This could not be more important due to the focus on returns and reconciliation in the clinical trial regulation.

Location
Regency 6
11:15 am - 12:15 pm
Workshop

IRT Systems and How to Use Them for Forecasting & Data Analytics (WS06)

IRT systems have been in use for over 20 years yet there is still functionality that users may be unaware of that can improve their chances of clinical supply chain success. This workshop will focus on industry best practices to improve the forecast of study enrollment using data analytics to positively impact the clinical supply chain.

Location
Poinciana CD
11:15 am - 12:15 pm
Workshop

The Clinical Trial Regulation – QP Perspective & What to Consider for Success (WS05)

Now that the Clinical Trial Regulation is in place in Europe, what should we know, what should we be doing to comply with it and what are the timelines for compliance? This workshop will provide an opportunity to discuss requirements and ask questions from a QP perspective.

Location
Regency 1
12:15 pm - 1:30 pm
Networking

Lunch & Oxygen Bar / Exhibitor Displays Open

Location
Portico / Windsong 1-6
1:30 pm - 2:30 pm
Showcase

Vendor Showcases

2:30 pm - 2:45 pm
Conference Logistics

Transfer to Plenary Hall

4:00 pm - 6:00 pm
Networking

Vendor Reception

Location
Windsong 1-6
9:00 pm - 12:00 am
Networking

GCSG After Hours

Location
Windsong Fountain Lawn
Day 4: Wednesday, April 26
7:30 am - 8:45 am
Conference Logistics

Breakfast

Location
Portico
7:30 am - 2:30 pm
Conference Logistics

Information/Help Desk Open

Location
Windsong Pre-Function
7:30 am - 9:00 am
Networking

Exhibitor Displays Open

Location
Windsong 1-6
10:30 am - 10:45 am
Conference Logistics

Transfer to Workshop

10:45 am - 11:45 am
Workshop

Temperature Excursions & Some of the Latest Technical Innovations to Mitigate Them (WS19)

The number of temperature excursions our industry experiences is still too high. This workshop will provide a forum for discussing the latest innovation and technical solutions to control, track, trend and avoid temperature excursions for the life of the product. This workshop will also provide examples of systems in use that can decrease investigations, route case analysis and CAPA timelines for temperature excursions.

Location
Palm A-C
10:45 am - 11:45 am
Workshop

How to Partner with Your Quality Assurance Organization (WS17)

As the world of clinical supplies becomes increasingly complex, it is essential that Clinical Supply partners with Quality to achieve the best outcomes. An essential step in this process is to build a quality culture within the clinical supply unit while developing excellent relationships between the two groups. This session will discuss ways to build that culture and partnership within your own organization.

Location
Regency 2
10:45 am - 11:45 am
Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (WS22)

Blockchain is a type of distributed ledger, an expanding chronologically ordered list of cryptographically signed, irrevocable transactional records shared by all participants in a network. AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This workshop will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implemented into the Clinical Supply Chain.

Location
Regency 7
10:45 am - 11:45 am
Workshop

Breaking Silos to Drive Sustainability in the Clinical Trial Supply Chain (WS23)

We all know it's hard for employees or even individual departments to influence corporate policy. Let's discuss ways that clinical supply professionals can have a greater impact on corporate sustainability.

Location
Regency 6
10:45 am - 11:45 am
Workshop

Compare & Contrast the Diverse Types of Access (Compassionate Use, Off-label Access, Continued Access, Special License sales & Right-to-Try) (WS15)

This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will go over 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.

Location
Regency 1
10:45 am - 11:45 am
Workshop

Direct to Patient: Latest Survey Results from the DTP Subteam (WS24)

In working to increase the use of DTP in clinical trials, the GCSG DTP subteam (under the Regulatory e-Team) sent out an industry survey. This workshop will review the findings, trends and possible directions forward to increase the adoption of DTP as a clinical supply distribution model.

Location
Regency 4
10:45 am - 11:45 am
Workshop

The Clinical Trial Regulation – Submission Strategies for Clinical Trial Supply (WS16)

With the advent of the Clinical Trial Regulation, a whole new filing process has been put in place. This workshop will review the updated process as well as the Clinical Trial Information System (CTIS) requirements. The facilitator will also explore challenges in filing in the CTIS based on the acceptability of new EMA stability guidance.

Location
Poinciana AB
10:45 am - 11:45 am
Workshop

The Importance of Being Connected to and Engaged With our Analytical Group’s Stability Program to Improve Clinical Supply Outcomes (WS21)

As stability testing and re-test dates are so critical to clinical supplies, this workshop will explore ways to improve oversight and understanding of stability protocols. We will also discuss the importance of building relationships with analytical to get timely updates for CofA's to positively impact CTM planning and forecasting.

Location
Regency 5
10:45 am - 11:45 am
Workshop

Managing Import/Export Requirements for Your Products (WS18)

The global reach of today's clinical trials makes understanding your product and its specific transit & import/export requirements a must for any clinical supply chain.  This workshop will discuss ways to navigate the myriad of complex regulations involved in the import and export of clinical trial supplies, including valuation and harmonized system tariff codes.

Location
Poinciana CD
10:45 am - 11:45 am
Workshop

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS20)

In this workshop we will discuss ways to increase the influence of clinical supplies to achieve the best outcomes, the shortest timelines and the fewest number of changes to the clinical supply chain by working closely with our partners in clinical operations.

Location
Palm D-F
10:45 am - 11:45 am
Workshop

Cell and Gene Therapy – Transitioning from Standard Clinical Supply Chains to Cell & Gene Supply Chains (WS03)

How to transfer from Clinical Supply Chain in traditional Pharma to Cell Therapy Pharma. There are similarities, but many more differences such as extreme cold chain, label text differences, Chain of Custody/Chain of Identity Requirements, etc. This presentation will provide an overview of the similarities and differences as well as explain the exciting aspects of the cell therapy clinical supply chain.

Location
Regency 3
11:45 am - 12:45 pm
Networking

Lunch & Puppy Party!

Location
Portico
12:45 pm - 1:00 pm
Conference Logistics

Transfer to Vendor Showcase

1:00 pm - 2:00 pm
Showcase

Vendor Showcases

2:00 pm - 2:15 pm
Conference Logistics

Transfer to Plenary Hall

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