A VIRTUAL Success!

The GCSG 2020 Global Virtual Conference

COVID-19 kept us from meeting face-to-face, but it couldn’t keep us from coming together to network, learn and work together!  This year’s GLOBAL conference brought together the best of GCSG from around the world.  Thank you to all our registrants, exhibitors and sponsors for making this yet another successful GCSG event!

Resources
Agenda

View the Agenda as a PDF

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Virtual Conference Networking Schedule

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CE Approved Courses

CE Approved Courses

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Virtual Conference Vendor Showcase Schedule

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Resources
Agenda

View the Agenda as a PDF

Download Now
Virtual Conference Networking Schedule

View the Networking Schedule as a PDF

Download Now
CE Approved Courses

CE Approved Courses

Download Now
Virtual Conference Vendor Showcase Schedule

View the Vendor Showcase Schedule as a PDF

Download Now
NOTE: All times listed below reflect Eastern Daylight Time
Day 1: Monday, September 21
9:00 am - 9:45 am
Networking

Exhibitor Displays Open

Location
Exhibit Hall
9:00 am - 10:00 am
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
10:00 am - 10:15 am
Conference Logistics

Welcome & Opening Remarks

Location
Auditorium
10:15 am - 11:00 am
Presentation

Keynote Address: Leading in a Peak Performance Culture

This powerful program focuses on the leadership characteristics that are the foundation of the most successful organizations worldwide.  Attendees will discover the behaviors embodied by leaders that instill a desire in others to perform at a high level while avoiding environmental stress and burnout.  Notable in the content is that these are behaviors, processes and approaches that are easy to replicate, not nebulous values that can be subjective and hard to manifest.  They are designed to help all leaders drive corporate ideology throughout the organization and reconcile the challenge facing leadership of being the fulcrum between authority (ownership/C-Suite leadership) and impact (line level execution).  The content is a preview of Dave’s next book, Peak Performance Culture: The Five Metrics of Peak Performance Culture and represents data collected from over 1000 organizations over the last 25 years.

Location
Auditorium
11:00 am - 11:10 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

Take a picture of yourself watching Dave Mitchell and post it on LinkedIn with #GCSGinittogether & #theleadershipdifference

You could win!!

11:10 am - 11:50 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.

Location
BionicalEMAS Breakout Room
11:10 am - 11:50 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.

Location
BionicalEMAS Breakout Room
11:10 am - 11:50 am
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.

Location
PCI Breakout Room
11:10 am - 11:50 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!

Location
Suvoda Breakout Room
11:10 am - 11:50 am
Workshop

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

The session will share an understanding of the current state of the impact of the United Kingdom’s exit from the European Union as it relates to clinical trials. Information from the EU and UK regulatory agencies will be discussed and experiences of how clinical trial supply chains have reacted.

Location
Brizzey Breakout Room
11:10 am - 11:50 am
Workshop

Benefits of Utilizing a Demand-Led Approach to Manage Clinical Supplies, Reduce Supply Chain Risk and Improve Flexibility (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.

Location
PCI Breakout Room
11:10 am - 11:50 am
Workshop

Developing CTS Strategies for Adaptive Clinical (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.

Location
ISS Breakout Room
11:10 am - 11:50 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.

Location
Suvoda Breakout Room
11:50 am - 12:00 pm
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

Grab a beverage and be back in 10!  Post a photo on LinkedIn with #GCSGinittogether

You could win!!

12:00 pm - 12:40 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.

Location
Brizzey Breakout Room
12:00 pm - 12:40 pm
Workshop

Cold Chain Distribution and Temperature Excursions (WS16)

This workshop will define time out of environment (ToE) and  provide a forum for discussing both challenges and solutions for managing labeled storage conditions and ToE.  The workshop will address multiple ways the time out of label storage conditions can be minimized during distribution as well as ways to set up a successful temperature management program.  Attendees will  be able to identify successful strategies for managing temperature excursions when they occur.

Location
PCI Breakout Room
12:00 pm - 12:40 pm
Workshop

Distribution Planning and the Role of Depots post COVID-19 (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

Speakers
Location
Suvoda Breakout Room
12:00 pm - 12:40 pm
Workshop

How has COVID-19 changed eClinical technology and what changes do we think will be needed in the future? (WS15)


  • Direct to patient shipping, remote acceptance of shipments

  • Remote access to IRT system over mobile web

  • Need for rapid system implementation

  • eConsent to allow patients to remotely provide consent

  • New patient engagement tools for medication compliance, eCOA, etc.

  • Temperature excursion tracking

  • Drug accountability systems – in IRT and outside of IRT

Location
Suvoda Breakout Room
12:00 pm - 12:40 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.

Location
PCI Breakout Room
12:00 pm - 12:40 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.

Location
BionicalEMAS Breakout Room
12:00 pm - 12:40 pm
Workshop

Supply Chain Integrity and the Impact of Falsified Medicines (MP5)

The EU Falsified Medicines Directive became effective in February 2019.  The aim of the directive is to prevent falsified medicines entering the supply chain to ensure that medicines are safe and that trade is rigorously controlled.  This presentation will explain how this directive impacts Sponsors, the clinical supply chain and steps that should be taken to ensure compliance.

Location
ISS Breakout Room
12:00 pm - 12:40 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.

Location
ISS Breakout Room
12:45 pm - 2:00 pm
Networking

Exhibitor Displays Open

Location
Exhibit Hall
1:15 pm - 2:15 pm
Networking

Global Networking Event – Sponsored by ThermoFisher Scientific

Join Thermo Fisher Scientific for the first networking session of the GSCG Global Virtual Conference! Although the format of the 2020 GCSG conference has changed, our commitments have not. We understand that this year has been full of challenges – both in our professional and personal lives. Our relationships with our business partners, colleagues, family and friends have never been more important.  This session will be led by our Pharma Services Group Commercial President Leon Wyszkowski and Clinical Trial Division President Chris Armstrong.  For each person that attends the networking session, Thermo Fisher Scientific will make a donation to a charity supporting mental health and well-being. We look forward to connecting with you!

Location
Brizzey Breakout Room
2:15 pm - 3:00 pm
Showcase

Vendor Showcase – Go Beyond Clinical Supply Forecasting sponsored by N-SIDE

Join us for an exclusive demo on how to optimize your end-to-end clinical supply chain. Discover our Suite of integrated applications to answer your clinical supply chain planning and forecasting needs. During our showcase, you will learn:


  • How to reduce waste and costs with risk-based optimization while ensuring perfect patient service level.

  • How interactive dashboards can help you monitor and communicate your supply decisions easily.

  • How to increase control and clarity on what is going to happen in your trial thanks to real-time monitoring and reliable forecasts.

Location
PCI Breakout Room
2:15 pm - 3:00 pm
Showcase

Vendor Showcase – Innovation & Investment by the Pharma Services Group sponsored by Thermo Fisher Scientific

An opportunity to learn more about the Pharma Services Group at Thermo Fisher Scientific with particular insight into innovation and investment in infrastructure, digital enablement, packaging solutions,  temperature monitoring and our new state-of-the-art facility in Rheinfelden, Germany.

Location
Brizzey Breakout Room
Day 2: Tuesday, September 22
9:00 am - 9:45 am
Networking

Exhibitor Displays Open

Location
Exhibit Hall
9:00 am - 9:45 am
Showcase

Vendor Showcase – Standardizing the Regenerative Medicine Supply Chain in a Dynamic World sponsored by Cryoport

Wondering what new standards should be met for now and the future? Interested in innovative solutions that meet your company’s needs? Our Cryoport experts will share their thoughts and potential solutions that can support your unique supply chain strategy.

Location
BionicalEMAS Breakout Room
9:00 am - 10:00 am
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
9:00 am - 9:45 am
Showcase

Vendor Showcase – Defining the Role of End to End IRT in Clinical Supply Management sponsored by YPrime

YPrime’s IRT can help optimize your clinical supply strategy for all study types and virtually all levels of complexity. End-to-end drug accountability is part of our core functionality, regardless of whether the scope of work involves a small Phase I study or a complex global trial. Full self-service functionality means that you control resupply strategies, material release, depot management and more – without waiting on helpdesk or project management staff.

Join us for an interactive discussion about YPrime’s IRT!

Location
Suvoda Breakout Room
10:00 am - 10:05 am
Conference Logistics

Welcome & Opening Remarks

Location
Auditorium
10:05 am - 10:50 am
Presentation

Patient Testimonial: Amanda & Dylan Ross

Dylan Ross, an active GCSG member, is familiar with clinical trials due to the 15 years he’s spent working in pharmaceutical packaging and logistics.  He and his wife, Amanda, are also the proud parents of Charlie and Layla.  These two facts rather suddenly intersected in November of 2017 when Charlie, a fit and healthy 15-year old, was diagnosed with Stage 3 Nasopharyngeal Carcinoma (NPC).  This would be the start of a journey that no parent ever wants to see their child take.

Location
Auditorium
10:50 am - 11:00 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

How does working in clinical supplies & helping patients impact you?  Post the answer on LinkedIn with #GCSGinittogether

You could win!!

11:00 am - 11:40 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.

Location
BionicalEMAS Breakout Room
11:00 am - 11:40 am
Workshop

Pharmacy Manuals – A Critical Link in the Clinical Supply Chain (WS19)

As the dispensing requirements for novel therapies become increasingly complex and clinical sites are faced with limited resources and frequent staff rotation, the pharmacy manual has become a critical document in providing clear instruction on the proper way to prepare and handle investigational product.  This workshop will assess the site pharmacist’s challenges and relevance of the pharmacy manual, as well as discussing key components of the development of a pharmacy manual.

Location
Brizzey Breakout Room
11:00 am - 11:40 am
Workshop

Challenges of Returns and Reconciliation – Including COVID-19 (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.

Location
ISS Breakout Room
11:00 am - 11:40 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.

Location
Brizzey Breakout Room
11:00 am - 11:40 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.

Location
ISS Breakout Room
11:00 am - 11:40 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.

Location
PCI Breakout Room
11:00 am - 11:40 am
Workshop

Direct to Patient Distribution – The New Normal? (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.

Location
Suvoda Breakout Room
11:00 am - 11:40 am
Workshop

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

Clinical supply chains are adjusting to recent changes in the regulations. This workshop will provide an opportunity to discuss the recent changes and ask questions of a QP from the EU.

Location
PCI Breakout Room
11:40 am - 11:50 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

"The one word that best describes the GCSG Conference is: _____"  Post your answer on LinkedIn with #GCSGinittogether

You could win!!

11:50 am - 12:30 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.

Location
BionicalEMAS Breakout Rom
11:50 am - 12:30 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!

Location
Suvoda Breakout Room
11:50 am - 12:30 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.

Location
BionicalEMAS Breakout Room
11:50 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.

Speakers
Location
Brizzey Breakout Rooms
11:50 am - 12:30 pm
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.

Location
PCI Breakout Room
11:50 am - 12:30 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!

Speakers
Location
ISS Breakout Room
11:50 am - 12:30 pm
Workshop

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

The session will share an understanding of the current state of the impact of the United Kingdom’s exit from the European Union as it relates to clinical trials. Information from the EU and UK regulatory agencies will be discussed and experiences of how clinical trial supply chains have reacted.

Location
Brizzey Breakout Room
11:50 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.

Location
Suvoda Breakout Room
12:30 pm - 1:30 pm
Networking

Vendor Scavenger Hunt

Location
Exhibit Hall
1:30 pm - 2:30 pm
Networking

Direct to Patient Virtual Networking Roundtable – Sponsored by CPL Australia

Join CPL AUSTRALIA, experts in Direct to Patient clinical trials solutions for a virtual networking event!

You are invited to this round table discussion about direct to patient regulations, patient privacy, and services in Australia and New Zealand (be sure to bring all of your questions – and even your project management team to the event - to talk about the possible applicability for their studies). We’re not stopping there! We’ll also be talking about direct to patient in APAC, an emerging market for clinical trials, and how the challenges and patient confidentiality are being managed in the region. Come for the shoptalk – stay for the laughs with a special film/feature about the Australian way of life!  We can also do “share time” with our treasured Aussie/Kiwi souvenir! We will be bringing “Skippy the bush Kangaroo”.  To add an extra touch - Aussie snacks can be found on the following link:

Snacks https://www.amazon.com/slp/australian-food-and-snacks/ztthvtf4z4gubcu

Location
Suvoda Breakout Room
1:30 pm - 2:30 pm
Networking

Global Networking Event – Travel with TrialCard!

Join us on a fun-filled journey around the world with travel trivia, tips and prizes while we discover interesting stories and shenanigans from our friends at GCSG.

Location
ISS Breakout Room
5:00 pm - 6:00 pm
Networking

Whisk(e)y Tasting – Global Networking Event hosted by Richard Lambie

Join European Knowledge Forum Vice-Chair, Richard Lambie, for a virtual whiskey tasting experience!  Grab your favorite whiskey(s) from the cabinet and pull up a chair to discuss the many nuances of whiskeys from around the world.  Share your favorite brands with other whiskey connoisseurs and perhaps discover something new to try.

Location
PCI Breakout Room
Day 3: Wednesday, September 23
8:00 am - 8:45 am
Networking

Online Live Yoga Class

Start your day off right by joining us for a 45-minute yoga session led by our very own Hannah Pripps, a certified yoga instructor.  All levels welcome!

9:00 am - 10:00 am
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
9:00 am - 9:45 am
Networking

Exhibitor Displays Open

Location
Exhibit Hall
10:00 am - 10:05 am
Conference Logistics

Welcome & Opening Remarks

Location
Auditorium
10:05 am - 10:50 am
Presentation

Keynote Address: Live Yes And….

 “It’s not the note you play that’s the wrong note — it’s the note you play afterwards that makes it right or wrong.” —Miles Davis

Great teams that are sustained in the long run are built on the successful foundation of great cultures. It is the culture that reinforces the purpose and values as the team grows and expands. By focusing on individual and shared purpose, and fostering an environment of trust which leads to authenticity, you can build a culture that promotes life-transforming collaboration. Performance coach and professional improviser, Travis Thomas is also the author of "3 Words for Getting Unstuck: Live, Yes And!"
Social media: @LiveYesAnd

Get Unstuck with 3 Words. Buy Travis’ book!

Listen to Travis on The Weekly Yes, And Podcast on iTunes!

 

Location
Auditorium
10:50 am - 11:00 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

Take a selfie holding a sign with a message to Travis. Post it on LinkedIn with #GCSGinittogether and tag Travis Thomas!

You could win!!

11:00 am - 11:40 am
Workshop

Direct to Patient Distribution – The New Normal? (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.

Location
PCI Breakout Room
11:00 am - 11:40 am
Workshop

Benefits of Utilizing a Demand-Led Approach to Manage Clinical Supplies, Reduce Supply Chain Risk and Improve Flexibility (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.

Location
ISS Breakout Room
11:00 am - 11:40 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.

Location
BionicalEMAS Breakout Room
11:00 am - 11:40 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.

Location
PCI Breakout Room
11:00 am - 11:40 am
Workshop

Developing CTS Strategies for Adaptive Clinical (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.

Location
PCI Breakout Room
11:00 am - 11:40 am
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.

Location
Suvoda Breakout Room
11:00 am - 11:40 am
Workshop

Supply Chain Integrity and the Impact of Falsified Medicines (MP5)

The EU Falsified Medicines Directive became effective in February 2019.  The aim of the directive is to prevent falsified medicines entering the supply chain to ensure that medicines are safe and that trade is rigorously controlled.  This presentation will explain how this directive impacts Sponsors, the clinical supply chain and steps that should be taken to ensure compliance.

Location
ISS Breakout Room
11:00 am - 11:40 am
Workshop

Distribution Planning and the Role of Depots post COVID-19 (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

Speakers
Location
BionicalEMAS Breakout Room
11:00 am - 11:40 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.

Location
Brizzey Breakout Room
11:40 am - 11:50 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

Share a 'nugget' from your last workshop.  Post it on LinkedIn with #GCSGinittogether

You could win!!

11:50 am - 1:30 pm
Networking

Exhibitor Displays Open

Location
Exhibit Hall
12:00 pm - 12:45 pm
Showcase

Vendor Showcase – Dynamic Clinical Supply Optimization Software Powered by Natural Language Processing sponsored by 4G

A newly launched, award-winning supply forecasting optimization software will be showcased. Attendees will see firsthand how natural language processing (NLP) can be utilized to turn study parameters into detailed forecasts, as well as how easy the tool is to modify, perform scenario modeling and make informed decisions from powerful visualizations.

Location
Brizzey Breakout Room
12:45 pm - 1:45 pm
Networking

Live Yes, And… – Networking with Keynote Travis Thomas

Did you enjoy our keynote, Live Yes, And... by Travis Thomas?  If so, join us for an online networking event where you can meet Travis, talk about his book and dive deeper into the concept of living your best life by embracing the concept of "Yes, and...".  This foundation of improvisation holds the power to transform teams and cultures!

Prepare for the session by reading Travis' book or Listen to Travis on The Weekly Yes, And Podcast on iTunes!

Location
BionicalEMAS Breakout Room
5:00 pm - 6:00 pm
Networking

Global Networking Event – Cheese Tasting sponsored by Catalent

Join Catalent Pharma Solutions for a virtual Happy Hour! Since we can’t see all your smiling faces this year in person, we’re taking this time to sit back and relax in the comfort of our own homes after a long day of work – in this virtual environment of course!

Chat Cheese With Di Bruno bros Certified Cheese Professionals. Learn how to build a cheese plate, how to store cheese, the right way to taste cheese… Afterwards there will be a special gift for each attendee!

We look forward in seeing you there.

Location
Suvoda Breakout Room
Day 4: Thursday, September 24
9:00 am - 9:45 am
Networking

Exhibitor Displays Open

Location
Exhibit Hall
9:00 am - 9:45 am
Showcase

Vendor Showcase – Evolving Technology in Clinical Trials sponsored by Endpoint

What you’ll learn about:

• How the evolution of trial design has helped to evolve technology

• How the total eco-system will continue to evolve

• Where endpoint is helping to change IRT

Location
ISS Breakout Room
9:00 am - 10:00 am
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
10:00 am - 10:05 am
Conference Logistics

Welcome & Opening Remarks

Location
Auditorium
10:50 am - 11:00 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

What has COVID kept you from doing?  Post on LinkedIn with #LifepostCOVID and #GCSGinittogether

You could win!!

11:00 am - 11:40 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.

Location
ISS Breakout Room
11:00 am - 11:40 am
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.

Location
Brizzey Breakout Room
11:00 am - 11:40 am
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.

Location
BionicalEMAS Breakout Room
11:00 am - 11:40 am
Workshop

How has COVID-19 changed eClinical technology and what changes do we think will be needed in the future? (WS15)


  • Direct to patient shipping, remote acceptance of shipments

  • Remote access to IRT system over mobile web

  • Need for rapid system implementation

  • eConsent to allow patients to remotely provide consent

  • New patient engagement tools for medication compliance, eCOA, etc.

  • Temperature excursion tracking

  • Drug accountability systems – in IRT and outside of IRT

Location
Suvoda Breakout Room
11:00 am - 11:40 am
Workshop

Pharmacy Manuals – A Critical Link in the Clinical Supply Chain (WS19)

As the dispensing requirements for novel therapies become increasingly complex and clinical sites are faced with limited resources and frequent staff rotation, the pharmacy manual has become a critical document in providing clear instruction on the proper way to prepare and handle investigational product.  This workshop will assess the site pharmacist’s challenges and relevance of the pharmacy manual, as well as discussing key components of the development of a pharmacy manual.

Location
Brizzey Breakout Room
11:00 am - 11:40 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.

Location
BionicalEMAS Breakout Room
11:00 am - 11:40 am
Workshop

Cold Chain Distribution and Temperature Excursions (WS16)

This workshop will define time out of environment (ToE) and  provide a forum for discussing both challenges and solutions for managing labeled storage conditions and ToE.  The workshop will address multiple ways the time out of label storage conditions can be minimized during distribution as well as ways to set up a successful temperature management program.  Attendees will  be able to identify successful strategies for managing temperature excursions when they occur.

Location
PCI Breakout Room
11:00 am - 11:40 am
Workshop

Challenges of Returns and Reconciliation – Including COVID-19 (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.

Location
Suvoda Breakout Room
11:40 am - 11:50 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

What's for lunch / tea / dinner today?  Post a picture on LinkedIn with #GCSGinittogether

You could win!!

11:50 am - 12:35 pm
Showcase

Vendor Showcase – Come Meet the New Myoderm!

Join for a chance to WIN $100 AMAZON GIFT CARD!

30+ years of partnership

30+ years of customer focus

30+ years of flexible solutions

At Myoderm, our core values will never change. But something big IS about to change for us.

Join us to learn more about the new Myoderm!

Location
PCI Breakout Room
11:50 am - 12:35 pm
Showcase

Vendor Showcase – Deploying a Virtual Clinical Inventory sponsored by TrialCard

TrialCard will demonstrate how a VIRTUAL supply inventory reduces steps, requires less employee time, eliminates supply waste, minimizes risks, and has significant time and cost savings.  New case studies will be presented and giveaways provided during our VIRTUAL presentation.

Location
ISS Breakout Room
12:45 pm - 1:45 pm
Networking

Exhibitor Displays Open

Location
Exhibit Hall
5:00 pm - 6:00 pm
Networking

Wine Tasting – Global Networking Event hosted by Bev Nicol

Join European Knowledge Forum Chair, Bev Nicol, for a virtual wine tasting experience - no sommelier experience necessary!  Grab a bottle of your favorite wine - red or white, sweet or dry, domestic or imported - it doesn't matter.  This session is all about sharing your favorites and networking with friends and colleagues!

Speakers
Location
Suvoda Breakout Room
Day 5: Friday, September 25
9:00 am - 9:45 am
Networking

Exhibitor Displays Open

Location
Exhibit Hall
9:00 am - 10:00 am
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
10:00 am - 10:05 am
Conference Logistics

Welcome & Opening Remarks

Location
Auditorium
10:05 am - 10:50 am
Presentation

Patient Testimonial: The Emily Whitehead Foundation

Tom and Kari Whitehead founded The Emily Whitehead Foundation in honor of their daughter Emily. A leukemia survivor, Emily was the first child in the world to receive CAR T-cell therapy. They have seen first hand how cancer research is saving lives! Come hear about the Whitehead Family's journey over the past 10 years.

Location
Auditorium
10:50 am - 11:00 am
Break

Virtual Room Transfer

Virtual Room Transfer Challenge!

Leave a single word about The Emily Whitehead Foundation on GCSG's LinkedIn page with #GCSGinittogether.  Follow them here.

You could win!!

11:00 am - 11:40 am
Workshop

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

Clinical supply chains are adjusting to recent changes in the regulations. This workshop will provide an opportunity to discuss the recent changes and ask questions of a QP from the EU.

Location
PCI Breakout Room
11:00 am - 11:40 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.

Location
Brizzey Breakout Room
11:00 am - 11:40 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.

Location
Brizzey Breakout Room
11:00 am - 11:40 am
Workshop

Direct to Patient Distribution – The New Normal? (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.

Location
BionicalEMAS Breakout Room
11:00 am - 11:40 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.

Location
ISS Breakout Room
Topic
Maximizing Performance with Virtual Workers
11:00 am - 11:40 am
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.

Speakers
Location
Suvoda Breakout Room
11:00 am - 11:40 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.

Location
ISS Breakout Room
11:00 am - 11:40 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!

Speakers
Location
Suvoda Breakout Room
11:40 am - 11:50 am
Break

Virtual Room Transfer

LAST CHANCE Virtual Room Transfer Challenge!

Post a selfie holding a sign with one thing you liked about the conference!  Post it on LinkedIn with #GCSGinittogether

You could win!!

11:50 am - 12:40 pm
Networking

Exhibitor Displays Open

Location
Exhibit Hall
12:45 pm - 1:00 pm
Conference Logistics

Closing Remarks & Final Prize Draw

Location
Auditorium
1:00 pm - 1:30 pm
Workshop

Speaker Wrap Up & Feedback

Please take this time to complete the survey below on your experience as a speaker/facilitator at the 2020 Virtual Conference.

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