April 26 - 29, 2020

GCSG 2020 US Conference

A Clear Vision for the Future

Register Now
Resources
Agenda

Prefer to view the agenda as a PDF?

DOWNLOAD NOW
  close filters  

Filter by

Type of activity

Day

Resources
Agenda

Prefer to view the agenda as a PDF?

DOWNLOAD NOW
Day 1: Sunday, April 26
7:30 am - 8:30 am
Conference Logistics

Registration & Breakfast for Seminar Attendees

Location
Lobby Level
8:30 am - 4:00 pm
Boot Camp

Expanded Access Platform Seminar (S4)

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.




8:30 am - 4:00 pm
Boot Camp

Exploring Direct to Patient (DtP) Clinical Trial Models Seminar (S3)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring Direct-to-Patient (DtP) clinical trial models. This bootcamp is designed to discuss best practices to engage your clinical teams, clinical sites, and couriers to ensure a successful partnership in a DtP supply chain model.




8:30 am - 4:00 pm
Boot Camp

Importing and Exporting Clinical Supplies Seminar (S5)

The class is designed for clinical supplies professional that want to learn more about shipping and distribution for global clinical trials. This seminar will cover regulations, temperature control, customs challenges, and logistics supply chain partnerships to ensure success with international distribution.




8:30 am - 4:00 pm
Boot Camp

Interactive Response Technology (IRT) in Clinical Supply Chain Seminar (S6)

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.




8:30 am - 4:00 pm
Boot Camp

Understanding the Essentials of the Clinical Supply Chain Seminar (S1)

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.



8:30 am - 4:00 pm
Boot Camp

Essentials of Cell and Gene Therapy Supply Chain Seminar (S2)

Cell & Gene therapies are increasing at an impressive rate. It is important to understand the manufacturing processes and supply chain requirements of these life-saving therapies. This boot camp will describe and contrast the different manufacturing and supply chain requirements of autologous and allogeneic cell and gene therapies.




3:00 pm - 5:30 pm
Conference Logistics

Speaker / Facilitator Registration Open

 

Location
Registration 2
4:30 pm - 5:00 pm
Conference Logistics

Speaker / Facilitator Meeting & Tour of Workshop Rooms

 

Location
Meet outside Grand Cypress Ballroom See Location map
5:00 pm - 5:30 pm
Conference Logistics

Conference Orientation (previously New Member Orientation)

 

Location
Grand Cypress Ballroom See Location map
5:45 pm - 7:00 pm
Conference Logistics

Registration Desk Open

Location
Upper Pool Deck
6:00 pm - 9:00 pm
Networking

GCSG Meet & Greet Networking Event – Cabana Nights

 



Location
Upper Pool Deck 1 & 2
Day 2: Monday, April 27
6:30 am - 7:15 am
Networking

Doggie Yoga

 



Location
Cypress Point
9:30 am - 10:45 am
Presentation

Keynote Address: Live Yes And….

Performance coach and professional improviser Travis Thomas will share the power of two words embraced by the world’s leading performers.


Social media: @LiveYesAnd


Location
Grand Cypress Ballroom See Location map
10:15 am - 11:15 am
Workshop

Packaging Temperature-Sensitive Products (WS32)

As our products become diverse, so do their handling requirements. Many innovative products now must maintain temperature at ultra-low conditions throughout the supply chain. This can present challenges when looking at the ‘traditional’ pack/label/ ship clinical supply chain. This workshop is designed to discuss challenges and potential solutions when handling, storing, labeling and shipping ultra cold / sensitive materials.

10:15 am - 11:15 am
Workshop

Impact of Falsified Medicines (MP5)

The Falsified Medicine’s Directive became effective in the EU February 2019.  The aim of the directive is to prevent counterfeit medicines from entering the supply chain although it has a wide range of impacts from manufacturing through distribution.  This min-presentation will present details of how this directive will impact the clinical supply chain and steps that should be taken to ensure compliance.

 

10:15 am - 11:15 am
Workshop

Approaches for Forecasting Clinical Trials with Limited Data (WS01)

When forecasting clinical trial supply needs we bring as much data to the table as possible in order to better understand inventory requirements, overages, campaigns and the overall supply chain.  What happens when our data is limited and it impacts the value or quality of the forecast? This workshop will discuss ways to get the best forecast when data is scarce.

10:15 am - 11:15 am
Workshop

Making the IRT More Site Friendly for ISTs (WS15)

Interactive response technologies (IRTs) are used consistently in standard Phase II and III clincial trials. The challenge for Investigator Sponsored Trials (ISTs) is that they typically occur at a single site. This workshop will focus on adapting and orienting your IRT to be more site friendly.

10:15 am - 11:15 am
Workshop

JIT Labeling and Release – A QP Perspective (WS18)

Just-in-Time (JIT)/ On Demand supply chains bring quality challenges to the forefront. Come to this workshop to discuss options for releasing IMP in a just-in-time/ on demand supply strategy.

10:15 am - 11:15 am
Workshop

Improving Patient Adherence (WS22)

Patient adherence has long been a concern for conducting successful clinical trials and getting drugs to market. This workshop will explain the difference between adherence, compliance and persistence and ways they can be improved.

10:15 am - 11:15 am
Workshop

Distribution Planning and the Role of Depots (WS08)

As the clinical supply chain expands into more and more countries, distribution planning has become exponentially more complex. This session will delve into the requirements for clinical supply chain distribution planning and where depots and and a knowledge of customs requirements are essential

10:15 am - 11:15 am
Workshop

Developing Strategies for Managing Combination Product (Basket/ Umbrella) Studies (WS04)

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.

10:15 am - 11:15 am
Workshop

Utilizing Operational Excellence to Improve the Clinical Supply Chain (WS25)

Operational Excellence is becoming a driver to improve the efficiency of 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.

10:15 am - 11:15 am
Workshop

Challenges of the Cell, Gene, CAR-T and Personalized Medicine Supply Chains (MP1)

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including cell, gene and immunotherapy treatments. Due in part to advancements in science and the availability of more sophisticated diagnostic tools, which give the medical community a better understanding of the human genome and make it easier to detect genetic mutations affecting individual patients, the outlook is positive. Come to this workshop to learn more about the challenges of cell, gene, CAR-T and personalized medicine supply chains.

10:15 am - 11:15 am
Workshop

Meaningful Metrics (KPIs) (WS11)

We all know metrics drive performance. The challenge with driving best outcomes for the clincial supply chain is directly linked to the quality of our metrics. This workshop will identify the most meaningful and impactful metrics to track to get the best supply chain performance.

10:15 am - 11:15 am
Workshop

Clinical Supply Connections with Clinical Operations and CROs (WS29)

As the clinical supply chain has become increasingly outsourced, understanding the value of creating better relationships with Clinical Operations and clinical research organizations (CROs) has become imperative. This workshop will describe ways to improve collaboration between clinical supplies and its key partners, Clinical Operations and CROs.

10:45 am - 11:00 am
Break

Room Transfer

 

11:30 am - 12:30 pm
Workshop

Cold Chain Distribution and Temperature Excursions (WS16)

This workshop will provide a forum for discussing the various ways the time out of label storage conditions can be minimized during distribution as well as strategies for managing the excursions when they occur.

11:30 am - 12:30 pm
Workshop

Pathways for Patient Access to Investigational Drugs (MP6)

This class provides a broad overview of the different mechanisms to support patients ability to access investigational drugs. Each mechanism has different requirements, which will be covered in this course, enabling you to successfully understand which is the best pathway based on the patient need. Topics covered will include Expanded Access, Right To Try (RTT), Continued Access, Clinical Trials and Patient Assistance.

11:30 am - 12:30 pm
Workshop

Linking Sponsor and Vendor Systems (WS02)

As the clinical supply industry continues to outsource more and more operational support, we find that systems integration between sponsor and vendor is essential. This workshop will identify the best ways to link Sponsor companies' internal systems with external vendor systems to create the most efficient clinical supply chain.

11:30 am - 12:30 pm
Workshop

Approaches for Forecasting Clinical Trials with Limited Data (WS01)

When forecasting clinical trial supply needs we bring as much data to the table as possible in order to better understand inventory requirements, overages, campaigns and the overall supply chain.  What happens when our data is limited and it impacts the value or quality of the forecast? This workshop will discuss ways to get the best forecast when data is scarce.

11:30 am - 12:30 pm
Workshop

Challenges of the Cell, Gene, CAR-T and Personalized Medicine Supply Chains (MP1)

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including cell, gene and immunotherapy treatments. Due in part to advancements in science and the availability of more sophisticated diagnostic tools, which give the medical community a better understanding of the human genome and make it easier to detect genetic mutations affecting individual patients, the outlook is positive. Come to this workshop to learn more about the challenges of cell, gene, CAR-T and personalized medicine supply chains.

11:30 am - 12:30 pm
Workshop

Direct to Patient Distribution (WS26)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct-to-patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct-to-patient supply chain model.

11:30 am - 12:30 pm
Workshop

Outsourcing Clinical Supply Management (WS09)

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.

11:30 am - 12:30 pm
Workshop

Inspection Readiness (WS05)

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!

11:30 am - 12:30 pm
Workshop

Program Management (WS23)

Holistic program management evaluates timing and supply for the entire asset lifecycle in order to synchronize demand and supply across all studies. This in turn drives feasible supply plans for all phases of the asset. This workshop will discuss the different aspects involved in program management rather than protocol-level project management.

11:30 am - 12:30 pm
Workshop

Clinical Supply Connections with Clinical Operations and CROs (WS29)

As the clinical supply chain has become increasingly outsourced, understanding the value of creating better relationships with Clinical Operations and clinical research organizations (CROs) has become imperative. This workshop will describe ways to improve collaboration between clinical supplies and its key partners, Clinical Operations and CROs.

11:30 am - 12:30 pm
Workshop

Cold Chain Capabilities and the Rise in Biologics (WS33)

Biologic development now comprises half of all clinical studies. Understanding temperature controls when developing biologics is essential. This workshop will do a deep dive into temperature control requirements of biologics.

1:00 pm - 1:15 pm
Break

Room Transfer

 

2:15 pm - 2:30 pm
Break

Return to Main Hall (Grand Cypress Ballroom)

 

5:30 pm - 5:45 pm
Conference Logistics

Bus Pick up

 

5:30 pm - 9:00 pm
Networking

GCSG Night Out at the Cabaret: A Clear Vision of the Past

Location
The Edison
9:00 pm - 12:00 am
Networking

After Party at the Speakeasy

Location
Enzo's Hideaway
Day 3: Tuesday, April 28
8:20 am - 8:30 am
Break

Room Transfer to Main Hall

 

9:45 am - 10:00 am
Break

Room Transfer

 

10:00 am - 11:00 am
Workshop

Cell Therapy Orchestration Platform (WS24)


We are all well aware of the extensive work that goes into supplying study drug to a clinical site.  However, there are many other activities that happen during a patient's visit to a clinical site in addition to dispensing study drug.  This workshop will discuss all of those other activities and the people who performs them as well as ways that CT Supplies organizations can help make the entire patient experience less stressful.


 


10:00 am - 11:00 am
Workshop

Returns and Reconciliation (WS20)

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. 

10:00 am - 11:00 am
Workshop

Clinical Supply Horror Stories (WS10)

Horror stories in clinical supplies…we've all had them! Share your stories and mitigations with your colleagues.

10:00 am - 11:00 am
Workshop

Maximizing Performance with Virtual Workers (WS34)

The paradigm shift to remote working scenarios can have an effect  on communication, productivity, job satisfaction and teamwork. Learn the warning signs of negative impact and ways to optimize performance in this workshop.

10:00 am - 11:00 am
Workshop

Pooled Supplies (WS27)

Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared.

10:00 am - 11:00 am
Workshop

Understanding Your Responsibilities as Importer of Record (IOR) (WS03)

Importation and movement of clinical supplies internationally will typically bring up questions about ownership of supplies, importation processes and Importer of Record (IOR) responsibilities. Knowing the specific obligations of the sponsor, clinical research organizations (CRO) and vendors will help to ensure maximum efficiencies when importing. This workshop will clarify the responsibilities surrounding IOR and ownership of clinical trial materials.

10:00 am - 11:00 am
Workshop

Ensuring Supply Chain Flexibility and Viability for Biologics (WS06)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

10:00 am - 11:00 am
Workshop

Defining the Patient Experience – A Site Nurse Perspective (WS34)

As clinical development focuses more on site and patient centricity, understanding the patient experience becomes essential for us to positively impact adherence and trial outcomes. This workshop will allow attendees to understand the patient's perspective on clinical supplies and how we can improve as an industry.

10:00 am - 11:00 am
Workshop

Protocol Interpretation for Clinical Supply Design: A Case Study (WS13)

Protocol interpretation has become increasingly challenging as protocols have become more complex. This workshop will utilize a case study to demonstrate key processes to utilize to ensure the best protocol interpretation.

10:00 am - 11:00 am
Workshop

Autologous vs. Allogeneic Supply Chains (WS17)

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

10:00 am - 11:00 am
Workshop

Clinical Supply Horror Stories (WS10)

Horror stories in clinical supplies…we've all had them! Share your stories and mitigations with your colleagues.

10:00 am - 11:00 am
Workshop

The Clinical Trial Regulation and its Evolving Regulatory Impact on Europe & ROW (MP3)

Clinical supply chains are adjusting to recent changes in regulations. This small group presentation will address proposed changes to EU regulation and provide an opportunity for discussion on how to mitigate risk during these changes.

10:00 am - 11:00 am
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (MP7)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging. Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region. This workshop will discuss best practices for storage, distribution, import/ export and reverse logistics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines. You will also get some hands on experience by working through a scenario for an Asia Pac study!

10:00 am - 11:00 am
Workshop

Project Management Skills (WS31)

Everyone in the clinical supply chain uses some sort of project management in their daily jobs. Come to this session to discuss some project management best practices or share some of yours! Whether you are new to clinical supplies or a seasoned professional, there is something for everyone in this workshop!

11:00 am - 11:20 am
Break

Room Transfer

 

11:15 am - 12:15 pm
Workshop

JIT Labeling and Release – A QP Perspective (WS18)

Just-in-Time (JIT)/ On Demand supply chains bring quality challenges to the forefront. Come to this workshop to discuss options for releasing IMP in a just-in-time/ on demand supply strategy.

11:15 am - 12:15 pm
Workshop

Sourcing and Labeling Biologics (WS21)

Are you working with biologic comparators/ co-meds? Sourcing and labeling biologic clinical trial material presents unique challenges. This workshop will discuss practices used to procure, maintain stock and label biologics.

11:15 am - 12:15 pm
Workshop

Brexit Update: Impact on the Clinical Supply Chain (MP4)

The session will give you an understanding of how the United Kingdom's exit from the European Union has affected the clinical trial supply chain. Experiences will be shared regarding challenges in the implementation of new processes post BREXIT.

11:15 am - 12:15 pm
Workshop

Strategies for Handling Ancillary Supplies (WS35)

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.

11:15 am - 12:15 pm
Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (MP2)

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 presentation will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implented into the Clinical Supply Chain. 

11:15 am - 12:15 pm
Workshop

Partnering with Clinical Operations Stakeholders and Influencing Country Selection (WS14)

In order to shorten clincial 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

11:15 am - 12:15 pm
Workshop

Utilizing Operational Excellence to Improve the Clinical Supply Chain (WS25)

Operational Excellence is becoming a driver to improve the efficiency of 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.

11:15 am - 12:15 pm
Workshop

Role of the Qualified Person (QP) Post Brexit (WS07)

The quality and regulatory units and Qualified Persons (QPs) in the EU are adjusting post-BREXIT. This workshop will provide an opportunity to discuss the QP role post-BREXIT as well as give you an opportunity to ask questions and discuss requirements with a QP from the EU.

11:15 am - 12:15 pm
Workshop

Change Management (WS28)

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.

11:15 am - 12:15 pm
Workshop

Licensed Pharmacist Networking (PNET1)

Get together with fellow pharmacists to discuss how pharmacists can share knowledge and expertise to help colleagues in the clinical supply industry.

11:15 am - 12:15 pm
Workshop

Meaningful Metrics (KPIs) (WS11)

We all know metrics drive performance. The challenge with driving best outcomes for the clincial supply chain is directly linked to the quality of our metrics. This workshop will identify the most meaningful and impactful metrics to track to get the best supply chain performance.

11:15 am - 12:15 pm
Workshop

Packaging Temperature-Sensitive Products (WS32)

As our products become diverse, so do their handling requirements. Many innovative products now must maintain temperature at ultra-low conditions throughout the supply chain. This can present challenges when looking at the ‘traditional’ pack/label/ ship clinical supply chain. This workshop is designed to discuss challenges and potential solutions when handling, storing, labeling and shipping ultra cold / sensitive materials.

11:15 am - 12:15 pm
Workshop

Developing Strategies for Managing Combination Product (Basket/ Umbrella) Studies (WS04)

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.

1:15 pm - 1:30 pm
Break

Room Transfer

 

1:45 pm - 2:45 pm
Workshop

Clinical Supply Connections with Clinical Operations and CROs (WS29)

As the clinical supply chain has become increasingly outsourced, understanding the value of creating better relationships with Clinical Operations and clinical research organizations (CROs) has become imperative. This workshop will describe ways to improve collaboration between clinical supplies and its key partners, Clinical Operations and CROs.

1:45 pm - 2:45 pm
Workshop

Direct to Patient Distribution (WS26)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct-to-patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct-to-patient supply chain model.

1:45 pm - 2:45 pm
Workshop

Making the IRT More Site Friendly for ISTs (WS15)

Interactive response technologies (IRTs) are used consistently in standard Phase II and III clincial trials. The challenge for Investigator Sponsored Trials (ISTs) is that they typically occur at a single site. This workshop will focus on adapting and orienting your IRT to be more site friendly.

1:45 pm - 2:45 pm
Workshop

Approaches for Forecasting Clinical Trials with Limited Data (WS01)

When forecasting clinical trial supply needs we bring as much data to the table as possible in order to better understand inventory requirements, overages, campaigns and the overall supply chain.  What happens when our data is limited and it impacts the value or quality of the forecast? This workshop will discuss ways to get the best forecast when data is scarce.

1:45 pm - 2:45 pm
Workshop

Cold Chain Capabilities and the Rise in Biologics (WS33)

Biologic development now comprises half of all clinical studies. Understanding temperature controls when developing biologics is essential. This workshop will do a deep dive into temperature control requirements of biologics.

1:45 pm - 2:45 pm
Workshop

Distribution Planning and the Role of Depots (WS08)

As the clinical supply chain expands into more and more countries, distribution planning has become exponentially more complex. This session will delve into the requirements for clinical supply chain distribution planning and where depots and and a knowledge of customs requirements are essential

1:45 pm - 2:45 pm
Workshop

Improving Patient Adherence (WS22)

Patient adherence has long been a concern for conducting successful clinical trials and getting drugs to market. This workshop will explain the difference between adherence, compliance and persistence and ways they can be improved.

1:45 pm - 2:45 pm
Workshop

Understanding Blockchain and AI in the Clinical Supply Chain (MP2)

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 presentation will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implented into the Clinical Supply Chain. 

1:45 pm - 2:45 pm
Workshop

Inspection Readiness (WS05)

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!

1:45 pm - 2:45 pm
Workshop

Impact of Falsified Medicines (MP5)

The Falsified Medicine’s Directive became effective in the EU February 2019.  The aim of the directive is to prevent counterfeit medicines from entering the supply chain although it has a wide range of impacts from manufacturing through distribution.  This min-presentation will present details of how this directive will impact the clinical supply chain and steps that should be taken to ensure compliance.

 

1:45 pm - 2:45 pm
Workshop

Outsourcing Clinical Supply Management (WS09)

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.

2:30 pm - 2:45 pm
Break

Return to Main Hall

 

6:30 pm - 10:00 pm
Break

Free Time / Dinner On Your Own

 

Day 4: Wednesday, April 29
8:15 am - 8:30 am
Break

Room Transfer

 

10:00 am - 10:15 am
Break

Room Transfer

 

10:30 am - 11:30 am
Workshop

Pathways for Patient Access to Investigational Drugs (MP6)

This class provides a broad overview of the different mechanisms to support patients ability to access investigational drugs. Each mechanism has different requirements, which will be covered in this course, enabling you to successfully understand which is the best pathway based on the patient need. Topics covered will include Expanded Access, Right To Try (RTT), Continued Access, Clinical Trials and Patient Assistance.

10:30 am - 11:30 am
Workshop

Outsourcing Clinical Supply Management (WS09)

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.

10:30 am - 11:30 am
Workshop

Program Management (WS23)

Holistic program management evaluates timing and supply for the entire asset lifecycle in order to synchronize demand and supply across all studies. This in turn drives feasible supply plans for all phases of the asset. This workshop will discuss the different aspects involved in program management rather than protocol-level project management.

10:30 am - 11:30 am
Workshop

Ensuring Supply Chain Flexibility and Viability for Biologics (WS06)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

10:30 am - 11:30 am
Workshop

Maximizing Performance with Virtual Workers (WS34)

The paradigm shift to remote working scenarios can have an effect  on communication, productivity, job satisfaction and teamwork. Learn the warning signs of negative impact and ways to optimize performance in this workshop.

10:30 am - 11:30 am
Workshop

Returns and Reconciliation (WS20)

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. 

10:30 am - 11:30 am
Workshop

Direct to Patient Distribution (WS26)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct-to-patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct-to-patient supply chain model.

10:30 am - 11:30 am
Workshop

Linking Sponsor and Vendor Systems (WS02)

As the clinical supply industry continues to outsource more and more operational support, we find that systems integration between sponsor and vendor is essential. This workshop will identify the best ways to link Sponsor companies' internal systems with external vendor systems to create the most efficient clinical supply chain.

10:30 am - 11:30 am
Workshop

Pooled Supplies (WS27)

Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will discuss those advantages as well as options for how pooled supplies can be prepared.

10:30 am - 11:30 am
Workshop

Protocol Interpretation for Clinical Supply Design: A Case Study (WS13)

Protocol interpretation has become increasingly challenging as protocols have become more complex. This workshop will utilize a case study to demonstrate key processes to utilize to ensure the best protocol interpretation.

10:30 am - 11:30 am
Workshop

Defining the Patient Experience – A Site Nurse Perspective (WS34)

As clinical development focuses more on site and patient centricity, understanding the patient experience becomes essential for us to positively impact adherence and trial outcomes. This workshop will allow attendees to understand the patient's perspective on clinical supplies and how we can improve as an industry.

10:30 am - 11:30 am
Workshop

Cold Chain Distribution and Temperature Excursions (WS16)

This workshop will provide a forum for discussing the various ways the time out of label storage conditions can be minimized during distribution as well as strategies for managing the excursions when they occur.

10:30 am - 11:30 am
Workshop

The Clinical Trial Regulation and its Evolving Regulatory Impact on Europe & ROW (MP3)

Clinical supply chains are adjusting to recent changes in regulations. This small group presentation will address proposed changes to EU regulation and provide an opportunity for discussion on how to mitigate risk during these changes.

11:15 am - 11:30 am
Break

Room Transfer

 

12:30 pm - 12:45 pm
Break

Room Transfer

 

1:00 pm - 2:00 pm
Workshop

Brexit Update: Impact on the Clinical Supply Chain (MP4)

The session will give you an understanding of how the United Kingdom's exit from the European Union has affected the clinical trial supply chain. Experiences will be shared regarding challenges in the implementation of new processes post BREXIT.

1:00 pm - 2:00 pm
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (MP7)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging. Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region. This workshop will discuss best practices for storage, distribution, import/ export and reverse logistics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines. You will also get some hands on experience by working through a scenario for an Asia Pac study!

1:00 pm - 2:00 pm
Workshop

Role of the Qualified Person (QP) Post Brexit (WS07)

The quality and regulatory units and Qualified Persons (QPs) in the EU are adjusting post-BREXIT. This workshop will provide an opportunity to discuss the QP role post-BREXIT as well as give you an opportunity to ask questions and discuss requirements with a QP from the EU.

1:00 pm - 2:00 pm
Workshop

Understanding Your Responsibilities as Importer of Record (IOR) (WS03)

Importation and movement of clinical supplies internationally will typically bring up questions about ownership of supplies, importation processes and Importer of Record (IOR) responsibilities. Knowing the specific obligations of the sponsor, clinical research organizations (CRO) and vendors will help to ensure maximum efficiencies when importing. This workshop will clarify the responsibilities surrounding IOR and ownership of clinical trial materials.

1:00 pm - 2:00 pm
Workshop

Partnering with Clinical Operations Stakeholders and Influencing Country Selection (WS14)

In order to shorten clincial 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

1:00 pm - 2:00 pm
Workshop

Clinical Supply Horror Stories (WS10)

Horror stories in clinical supplies…we've all had them! Share your stories and mitigations with your colleagues.

1:00 pm - 2:00 pm
Workshop

Project Management Skills (WS31)

Everyone in the clinical supply chain uses some sort of project management in their daily jobs. Come to this session to discuss some project management best practices or share some of yours! Whether you are new to clinical supplies or a seasoned professional, there is something for everyone in this workshop!

1:00 pm - 2:00 pm
Workshop

Sourcing and Labeling Biologics (WS21)

Are you working with biologic comparators/ co-meds? Sourcing and labeling biologic clinical trial material presents unique challenges. This workshop will discuss practices used to procure, maintain stock and label biologics.

1:00 pm - 2:00 pm
Workshop

Cell Therapy Orchestration Platform (WS24)


We are all well aware of the extensive work that goes into supplying study drug to a clinical site.  However, there are many other activities that happen during a patient's visit to a clinical site in addition to dispensing study drug.  This workshop will discuss all of those other activities and the people who performs them as well as ways that CT Supplies organizations can help make the entire patient experience less stressful.


 


1:00 pm - 2:00 pm
Workshop

Strategies for Handling Ancillary Supplies (WS35)

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.

1:00 pm - 2:00 pm
Workshop

Clinical Supply Horror Stories (WS10)

Horror stories in clinical supplies…we've all had them! Share your stories and mitigations with your colleagues.

1:00 pm - 2:00 pm
Workshop

Change Management (WS28)

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.

1:00 pm - 2:00 pm
Workshop

Autologous vs. Allogeneic Supply Chains (WS17)

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

1:45 pm - 2:00 pm
Break

Return to Main Hall

 

2:30 pm - 2:45 pm
Break

Room Transfer to Vendor Showcase

 



2:45 pm - 3:45 pm
Networking

Vendor Showcase – Forecasting Software – Invite Only

Plan to stay for these post-conference vendor showcases!  Learn more about cryogenic shipping and so much more!



Location

Access the Conference program and resources on your smartphone

Download app

Login

Please log in using your GCSG credentials.

Lost your password?