April 26th - 29th, 2021

The GCSG 2021 US Virtual Conference

We’ve just released the agenda for our 2021 US Virtual Conference, taking place from April 26th to 29th!  Our theme this year is, “Converge, Converse, Connect!”  Download the agenda and mark your calendar to join us in April!

We’re working to bring you workshops on the topics you want to discuss.  We will be updating this list as topics and speakers/facilitators are confirmed.  If there is a workshop topic you’d like to see at a future conference, submit your suggestion here.

Workshop

Autologous vs. Allogeneic Supply Chains (WS04)

As the number of new Cell and Gene therapies grows in the clinical development space, it becomes increasingly important to understand the supply chain challenges of these unique therapies. This workshop will identify and differentiate the challenges of the autologous and allogeneic clinical supply chain requirements

Workshop

Brexit – Now We Know (WS18)

Welcome to 2021! The UK has officially exited the EU and now that we’ve got some experience with clinical trials post Brexit, let’s share those experiences! This workshop will discuss the implications of Brexit on Clinical Supplies – including EU27, the UK and NI.

Workshop

Case Study: Use & Benefits of IRT for Managing Complex Adaptive Studies (WS11)

Clinical study design is evolving as we work to accommodate flexibility in protocol deliverables and execution. This session will discuss how design has a critical role for adaptive multi-product trials.

Workshop

Overview of DtP models for Clinical Trials (MP1)

Direct-to-patient in clinical trial is not a buzzword anymore, it's a way to continue patient treatment and being patient centric.  This mini-presentation is designed to discuss DtP strategies, options to implement when planning a robust direct-to-patient supply chain model, risk management, resilient planning, reverse supply chain from the patient home, accountability and the future of decentralized clinical trials.

Workshop

Unique Features of Small Pharma and How Challenges Can be Overcome (WS14)

Clinical Supply Chains teams in start-up and small sponsor companies do not have the availability of advanced systems, funding and resources. This workshop will discuss some specific challenges and potential solutions, in addition the advantages and disadvantages of working in a less developed organizational environment.

Workshop

Utilizing Operational Excellence to Improve the Clinical Supply Chain (WS07)

Operational Excellence (OE) is becoming a driver to improve the efficiency when applied to the clinical supply chain.  Whether that comes in the form of lean clinical supply chains, better KPIs or automation, it is essential that we implement one, if not more, of these concepts to adapt to ever-changing clinical supply requirements.  This workshop will identify the different aspects of Operational Excellence and how they can be used in your clinical supply chain.

Workshop

AI – Applications for the Clinical Supply Chain (WS15)

AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This presentation will explain what AI is and discuss how it is being implemented into the Clinical Supply Chain.(1) Describe what AI is and how it can help the clinical supply chain (2) Explain what must be done with the clinical supply chain now in order for us to get the most out of AI (3) Give examples of how AI can be used to accelerate the clinical supply chain

Workshop

Change Management (WS08)

Change is the standard when working within the clinical supply chain. When change must be implemented and adopted, change management becomes essential. The key to change management is not the system being changed, it's the people that must buy into and accept the change to be successful. This workshop will identify ways to ensure people more quickly transistion to the new way of working.

Workshop

Innovation & Covid-19: How the Pandemic Has Catalyzed New Approaches and New Ways of Working (WS05)

Innovation in our space of Investigational Products has customarily occurred with a very structured and slow approach. At times taking years to establish even small step order changes. However, when crisis occurs innovation does not have this luxury. Many of the changes we’ve been forced to undertake this year have catalyzed huge paradigm shifts occurring at record speed. Furthermore, Investigational Products has been wedged in the middle of extreme innovations in scientific discovery, technology, development, manufacture, distribution and flexibility in regulations. Come join us for a lively discussion!

Workshop

Just in Time or Too Late? The Hurdles and Benefits of Introducing Make-to-Order Clinical Supply Chains (WS12)

Just-in-time is a key opportunity to resolve issues with clinical supply chains today. However, this strategy involves overcoming significant process and technology barriers in order to drive effective change. This workshop will explore these challenges, along with identifying digital solutions to maximize this opportunity.

Workshop

Vaccine Supply Chain (WS19)

The greatest outcome of the pandemic was the accelerated creation and approval of the CoVid-19 vaccines. This workshop will focus on what was learned from the development of the vaccines and how our normal Clinical Supply Chain had to evolve quickly.

Presentation

Welcome & Opening Remarks – Patient Testimonial

The Importance of the Patient Voice in Research

Learn how Sateria Venable, founder of the Fibroid Foundation, helped to design the largest fibroid research study to date.

Location
Auditorium
Workshop

Calculating Clinical Supply Valuation (WS20)

With global trials being the standard, it is incredibly important to understand the Customs value of clinical supplies that we have to account for in planning and budgeting for our Clinical Trials. This workshop will explore the different ways to value clinical supplies and how to choose the best way for the attendee.(1) List five (5) different ways to establish drug valuation (2) Identify two (2) common mistakes made when identifying the valuation of IMPs (3) Explain two (2) outcomes of incorrectly valuing our clinical supplies when shipping internationally

Workshop

Cell Therapy Orchestration Platform (WS06)

Cell Therapy clinical trials are becoming prevalent in the Pharmaceutical industry; identifying ways to orchestrate collection of starting material, cell therapy manufacture, logistics and patient delivery becomes essential to the success of these therapies. This workshop will provide an introduction to key aspects of supply chain management for cell therapies and how you can implement software to manage these complex supply chains.

Workshop

Inspection Readiness (WS02)

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

Workshop

Planning Clinical Supplies in a Whole New World: 2020 and Beyond (WS16)

The pandemic's impact for the Clinical Supply Chain was intense and educational. Many of our companies adapted quickly to a new way of planning, forecasting and distributing clinical supplies. This workshop will identify a number of new concepts and ideas that have positively affected the Clinical Supply Chain.

Workshop

QP Expectations & Responsibilities (WS13)

QP responsibilities are continuously evolving based on the updated regulations that came out in Europe in 2016 (?) as well as Brexit. This workshop will review the current requirements and responsibilities for QPs.

Workshop

Strategies for Handling Ancillary Supplies (WS09)

Ancillary supplies are often the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.

Workshop

DtP a Covid-19 Solution or a Long-Term Change to Clinical Trial Conduct? (WS21)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors shifted to direct-to-patient and decentralized clinical trials. This workshop will focus on the positive aspects and outcomes of the amazing pivot that the industry accomplished in adopting these new models.

Workshop

IoR, Import Licenses and VAT (WS17)

With global trials being the standard, it is incredibly important to understand the clinical supplies value and the value added tax we have to account for in budgeting for our Clinical Trials. This workshop will also discuss the importance of Import Licenses and the Importer of Record when shipping globally.

Workshop

Maximizing IP Supply Through Effective Use of the IRT (WS10)

With the rising costs of investigational supplies for clinical trials, it is becoming ever more important to maximize the use of IMP.  This session will explore different methods that can be employed through an IRT to best avoid waste and lower the overall cost of a clinical trial.  This will cover the study set-up, execution, and close-out phases of a clinical trial with an eye towards optimizing performance.

Workshop

Partnering with Clinical Operations Stakeholders (WS03)

In order to shorten clinical trial timelines and increase efficiency of the clinical supply chain, it is essential to develop an excellent rapport with our Clinical Operations stakeholders. This workshop will explore how to better partner and collaborate with Clinical Operations in order to get the best out of our clinical supply chain

Workshop

Unique Features of Small Pharma and How Challenges Can be Overcome (WS14)

Clinical Supply Chains teams in start-up and small sponsor companies do not have the availability of advanced systems, funding and resources. This workshop will discuss some specific challenges and potential solutions, in addition the advantages and disadvantages of working in a less developed organizational environment.

Workshop

Utilizing Operational Excellence to Improve the Clinical Supply Chain (WS07)

Operational Excellence (OE) is becoming a driver to improve the efficiency when applied to the clinical supply chain.  Whether that comes in the form of lean clinical supply chains, better KPIs or automation, it is essential that we implement one, if not more, of these concepts to adapt to ever-changing clinical supply requirements.  This workshop will identify the different aspects of Operational Excellence and how they can be used in your clinical supply chain.

Presentation

Welcome & Opening Remarks – Panel Discussion

Clinical Supply Chain Technology Driven Trends

With the advent of the pandemic and the adjusted vaccine supply chain, new technology has become the focus for all Pharma and Biotech companies. This Session will identify a number of new technological trends that can be implemented in the Clinical Supply Chain.

Location
Auditorium
Workshop

AI – Applications for the Clinical Supply Chain (WS15)

AI (Artificial Intelligence) or ML (Machine Learning) refers to software technologies that make a robot or computer act and think like a human. This presentation will explain what AI is and discuss how it is being implemented into the Clinical Supply Chain.

Workshop

Autologous vs. Allogeneic Supply Chains (WS04)

As the number of new Cell and Gene therapies grows in the clinical development space, it becomes increasingly important to understand the supply chain challenges of these unique therapies. This workshop will identify and differentiate the challenges of the autologous and allogeneic clinical supply chain requirements

Workshop

Brexit – Now We Know (WS18)

Welcome to 2021! The UK has officially exited the EU and now that we’ve got some experience with clinical trials post Brexit, let’s share those experiences! This workshop will discuss the implications of Brexit on Clinical Supplies – including EU27, the UK and NI.

Workshop

Case Study: Use & Benefits of IRT for Managing Complex Adaptive Studies (WS11)

Clinical study design is evolving as we work to accommodate flexibility in protocol deliverables and execution. This session will discuss how design has a critical role for adaptive multi-product trials.

Workshop

Change Management (WS08)

Change is the standard when working within the clinical supply chain. When change must be implemented and adopted, change management becomes essential. The key to change management is not the system being changed, it's the people that must buy into and accept the change to be successful. This workshop will identify ways to ensure people more quickly transistion to the new way of working.

Workshop

Innovation & Covid-19: How the Pandemic Has Catalyzed New Approaches and New Ways of Working (WS05)

Innovation in our space of Investigational Products has customarily occurred with a very structured and slow approach. At times taking years to establish even small step order changes. However, when crisis occurs innovation does not have this luxury. Many of the changes we’ve been forced to undertake this year have catalyzed huge paradigm shifts occurring at record speed. Furthermore, Investigational Products has been wedged in the middle of extreme innovations in scientific discovery, technology, development, manufacture, distribution and flexibility in regulations. Come join us for a lively discussion!

Workshop

Inspection Readiness (WS02)

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

Workshop

Just in Time or Too Late? The Hurdles and Benefits of Introducing Make-to-Order Clinical Supply Chains (WS12)

Just-in-time is a key opportunity to resolve issues with clinical supply chains today. However, this strategy involves overcoming significant process and technology barriers in order to drive effective change. This workshop will explore these challenges, along with identifying digital solutions to maximize this opportunity.

Workshop

Planning Clinical Supplies in a Whole New World: 2020 and Beyond (WS16)

The pandemic's impact for the Clinical Supply Chain was intense and educational. Many of our companies adapted quickly to a new way of planning, forecasting and distributing clinical supplies. This workshop will identify a number of new concepts and ideas that have positively affected the Clinical Supply Chain.

Workshop

Strategies for Handling Ancillary Supplies (WS09)

Ancillary supplies are often the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.

Workshop

Vaccine Supply Chain (WS19)

The greatest outcome of the pandemic was the accelerated creation and approval of the CoVid-19 vaccines. This workshop will focus on what was learned from the development of the vaccines and how our normal Clinical Supply Chain had to evolve quickly.

Presentation

Welcome & Opening Remarks – Keynote Address

Plant your Feet Firmly - in Mid-Air! How to stay focused and optimistic when everything is changing around you

People in our supply-chain world will thrive with three learnable skills, no matter how many unknowns they face. After this fast-paced, high-energy session, you’ll have these three skills in your backpack. * Stay focused, stay on track, and move to a higher place. * Take a quick self-assessment to see how much stress you have, and how to re-balance. * Inspired to move higher and further during this time; with change always comes opportunity if you know what to look for!

Location
Auditorium
Workshop

Calculating Clinical Supply Valuation (WS20)

With global trials being the standard, it is incredibly important to understand the Customs value of clinical supplies that we have to account for in planning and budgeting for our Clinical Trials. This workshop will explore the different ways to value clinical supplies and how to choose the best way for the attendee.

Workshop

DtP a Covid-19 Solution or a Long-Term Change to Clinical Trial Conduct? (WS21)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors shifted to direct-to-patient and decentralized clinical trials. This workshop will focus on the positive aspects and outcomes of the amazing pivot that the industry accomplished in adopting these new models.

Workshop

IoR, Import Licenses and VAT (WS17)

With global trials being the standard, it is incredibly important to understand the clinical supplies value and the value added tax we have to account for in budgeting for our Clinical Trials. This workshop will also discuss the importance of Import Licenses and the Importer of Record when shipping globally.

Workshop

Maximizing IP Supply Through Effective Use of the IRT (WS10)

With the rising costs of investigational supplies for clinical trials, it is becoming ever more important to maximize the use of IMP.  This session will explore different methods that can be employed through an IRT to best avoid waste and lower the overall cost of a clinical trial.  This will cover the study set-up, execution, and close-out phases of a clinical trial with an eye towards optimizing performance.

Workshop

Partnering with Clinical Operations Stakeholders (WS03)

In order to shorten clinical trial timelines and increase efficiency of the clinical supply chain, it is essential to develop an excellent rapport with our Clinical Operations stakeholders. This workshop will explore how to better partner and collaborate with Clinical Operations in order to get the best out of our clinical supply chain

Workshop

QP Expectations & Responsibilities (WS13)

QP responsibilities are continuously evolving based on the updated regulations that came out in Europe in 2016 (?) as well as Brexit. This workshop will review the current requirements and responsibilities for QPs.

Presentation

Closing Remarks & Vendor/GCSG Prize Draws

Don't miss your chance to win some great prizes!  Join us in the Auditorium!

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