GCSG – Global Clinical Supplies Group

Boot Camp Registration Open

Boot Camps sponsored by:

How to Plan and Implement an Expanded Access Program

Expanded Access, Named Patient, Compassionate Use… the names for the process are as varied as the options for supporting them. This interactive course will give an overview of expanded access as well as discuss relevant regulations and their impact on operational and strategic planning. Atttendees will be able to hear from subject matter experts with many years experience on best practices and important questions to ask when supporting these types of studies. Come to this boot camp to discuss the regulations for Expanded Access and how they impact your operational and strategic supply planning.

Import/Export and VAT Boot Camp

The class is designed for clinical supplies professional that want to learn more about the fundamentals of international logistics as well as build more specific knowledge on trade compliance, Value Added Tax (VAT) and best practices when planning and executing global clinical trials. This class will cover international shipping regulations, temperature control during extended transit, customs clearance, VAT strategies and how to maximize logistics supply chain partnerships to ensure success with international distribution.

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.

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.

Exhibitor Setup

Registration/Information/Welcome Table Open

Registration Welcome sponsored by:

Speaker/Facilitator Meeting & Tour of Workshop Rooms

Start the Conference Right! – Conference Orientation – Sponsored by Medidata Solutions

Whether this is your first time attending or you are an 'old pro', plan to join us at the conference orientation to learn how you can make the most of your time at the GCSG 2023 Conference!

Sponsorsored by:

Meet & Greet – “Cabana Nights”

Be transported to the islands with the sound of Caribbean steel drums and waterfalls as you mingle and network around the upper pool deck and play games on the beach.

Sponsored by:

GCSG After Hours…

Yoga

Breakfast

Monday's meals sponsored by:

Exhibitor Displays Open

Registration/Information/Welcome Table Open

Transfer to Plenary Hall

Welcome & Opening Remarks

Transfer to Workshop

Overcoming sub-Saharan Africa Region (West, Central and East 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 West, Central and East Africa countries for labelling and distribution as well as how they impact CT supplies timelines and planning.

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

Comparator sourcing, a complex and challenging activity, is required to conduct the majority of clinical trials today. 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.

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.

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.

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.

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.

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!

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.

Transfer to 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.

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.

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

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.

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.

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.

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.

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.

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

Monday's meals sponsored by:


Enjoy a little treat after lunch with Liquid Nitrogen Ice Cream! Flash freezing ice cream reduces the size of ice crystals resulting in creamier tasting ice cream. Don’t miss out on a frozen treat!

Ice cream sponsored by:

The Clinical Supply Chain Professional Toolkit (WS32)

This workshop will focus on innovative tools and techniques to address legacy and present day challenges within Clinical Supply Chain.

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.

Planning Studies Using Auxiliary Supplies with the EU Regulation Changes (WS30)

Under the Clinical Trial Regulation, Auxiliary Medicines have been categorized as Authorised and Unauthorised, and there are requirements that go along with each. What does the Regulation have to say about Auxiliary Medicines and how does that impact sponsors and how these are sourced and labelled? We also invite attendees to share different strategies they have used under the CTR for auxiliary medicines.

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.

Overcoming sub-Saharan Africa Region (West, Central and East 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 West, Central and East Africa countries for labelling and distribution as well as how they impact CT supplies timelines and planning.

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

DTP in Action: Exchange on Direct to Patient Experiences & Lessons Learned (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.

Transfer to Plenary Hall

Closing Remarks & Raffle Draw

Exhibitor Displays Open

Free Time

Bus Loading / Departure

GCSG Night Out Event at Universal CityWalk – Sponsored by Marken

Get ready for one of the most incredible parties GCSG has ever thrown—a huge bash that fills three different clubs in Universal CityWalk at Universal Orlando Resort. Take a trip to New Orleans at Pat O’Brien’s®, explore the home of the king of reggae at Bob Marley—A Tribute to FreedomSM, and take the stage at CityWalk’s Rising Star nightclub. It’s an entire evening of excitement!

Sponsored by:

GCSG After Glow Party at the Red Coconut Club – Sponsored by Xerimis

Get ready to celebrate with a huge party at Universal CityWalk. GCSG has reserved the Red Coconut Club just for you! Enjoy the trendy, tropical cool of Orlando’s hottest ultra-lounge where you can take in the view on the balcony, mellow out at intimate tables inside, or mix with lively crowds around the bars.

Sponsored by:

Breakfast

Tuesday's meals sponsored by:

Exhibitor Displays Open

Registration/Information/Welcome Table Open

Transfer to Plenary Hall

Welcome & Opening Remarks

Transfer to 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.

The Clinical Supply Chain Professional Toolkit (WS32)

This workshop will focus on innovative tools and techniques to address legacy and present day challenges within Clinical Supply Chain.

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.

Planning Studies Using Auxiliary Supplies with the EU Regulation Changes (WS30)

Under the Clinical Trial Regulation, Auxiliary Medicines have been categorized as Authorised and Unauthorised, and there are requirements that go along with each. What does the Regulation have to say about Auxiliary Medicines and how does that impact sponsors and how these are sourced and labelled? We also invite attendees to share different strategies they have used under the CTR for auxiliary medicines.

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

Let’s Discuss Unconscious Bias: How to Recognize and Address Behaviors that Disrupt Equity & Belonging in the Workplace (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.

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!

Transfer to 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.

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.

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.

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.

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.

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

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

Comparator sourcing, a complex and challenging activity, is required to conduct the majority of clinical trials today. 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.

Lunch & Oxygen Bar / Exhibitor Displays Open

Tuesday's meals sponsored by:


Need a pick-me-up after GCSG’s Night Out? Come by the Oxygen Bar for an energy boost to increase concentration (or relieve a headache!)

Oxygen bar sponsored by:

Vendor Showcase – Leveraging 4C Supply® for Improved Drug Supply Forecasting – Hosted by 4G Clinical

In the pharmaceutical industry, efficient and accurate supply forecasting is crucial for ensuring timely and cost-effective production and distribution of IMP. This session will explore several use cases for 4C Supply®, a powerful tool for modeling study demand and forecasting drug supply, and how it can help stakeholders make better, more informed decisions.

This vendor showcase will discuss how 4C Supply® puts data visibility and scenario planning in the hands of clinical supply professionals, allowing them to have greater control over the production and distribution processes. By providing sponsors with the data they need to make informed decisions, 4C Supply® can help organizations streamline their supply chains and reduce costs while ensuring sufficient supplies for patient treatment.

Attendees will leave the presentation with a deeper understanding of the benefits of 4C Supply® and how it can help them improve their drug supply forecasting processes. They will also gain valuable insights into how to use data effectively to plan production and make better decisions in the face of challenging scenarios.

Vendor Showcase – Reimagine Clinical Supply Chain Operations Through Automation – Hosted by SAP

Learn how to harmonize your clinical and commercial supply chain to achieve quality assurance, development, and operational excellence. The head of clinical supply chain planning at Roche will share how they have reinvented and standardized their clinical processes to support new types of clinical trials and medicines giving them full visibility of their global supply chain status to proactively avoid shortages and waste.

Transfer to Plenary Hall

Closing Remarks & Raffle Draw

Vendor Reception

GCSG After Hours – Sponsored by Sharp Clinical Services

Breakfast

Exhibitor Displays Open

Information/Help Desk Open

Welcome & Opening Remarks

Transfer to 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.

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.

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.

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

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.

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.

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.

Lunch & Puppy Party!

Come enjoy a little puppy love to decrease your stress levels! We’ll have an animal shelter mobile unit on site with puppies of all shapes and sizes just waiting to be loved on.

Puppy party sponsored by:

Transfer to Vendor Showcase

Vendor Showcase – Optimizing Your Clinical Drug Forecast and Supplies Using IRT – Hosted by Endpoint Clinical

An interactive workshop where we will go into details and best practices on how you can utilize your IRT functionality to improve your clinical trials supply management.  This session will include an overview of how to utilized IRT to make better informed decisions about your demand & supply plan.  We will also review important IRT settings for creating the user specifications, how they impact your demand & supply plan, and common pitfalls and ways to solve them in supply forecasting.

Transfer to Plenary Hall

Closing Remarks & Raffle Draw – Bingo Card Raffles