October 5th - 7th, 2021

The GCSG 2021 European Virtual Knowledge Forum

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NOTE: All times listed below reflect British Summer Time
Day 1: Monday, October 4
5:00 pm - 6:00 pm
Networking

Knowledge Forum Orientation

Location
Auditorium
6:00 pm - 7:00 pm
Networking

Pre-Knowledge Forum GCSG Networking – Mesmerist

Come and join us for a truly magical experience with Nicolas Clement who is a professional French magician and mentalist and is a member of The Magic Circle. From Simon Cowell’s birthday party to the World Economic Forum in Davos, Nicolas has performed at some of the most prestigious events in UK and in the world. His magic is quick, modern, visual and entertaining. Come and take part in this interactive show and prepared to be confounded by his magical talents!

Location
Auditorium
Day 2: Tuesday, October 5
12:00 pm - 1:00 pm
Networking

Exhibit Hall Open

Let the games begin!! Visit & Play to Win BIG Prizes!!

Take a screen shot / selfie while chatting with a vendor at their booth. Post on GCSG Group LinkedIn feed, tagging BOTH GCSG & the Exhibitor. Comment about their services or how they've helped you in the past. One entry per post. Post as often as you like!
#gcsgtogetherwearestronger

Location
Exhibit Hall
12:30 pm - 1:00 pm
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
1:00 pm - 2:15 pm
Presentation

Welcome, Opening Remarks & Keynote Address

Dr Janet Lapp

Three Must-Have Change Habits


  • Do you know the top three must-have skills that supply chain professionals need to be successful (and stress-free) during turbulent change?

  • You’ll not just pick these up, but you will knock away outdated pillars, blow away perceptions of what’s possible, rewrite your story and move to a new level with renewed purpose and vision.

  • Learn what new studies are telling us about how to manage stress and change in our turbulent world and be focused, optimistic and moving forward together as a team …. no matter what


Location
Auditorium
2:15 pm - 2:30 pm
Conference Logistics

Virtual Room Transfer Challenge! Exhibit hall open!

Take a selfie as you watch the keynote, Dr Janet Lapp. Post it on GCSG Group LinkedIn feed with #gcsginittogether for a chance to win!

2:30 pm - 3:30 pm
Workshop

Leadership versus Management: When to Use One or the Other (WS04)

Management and leadership are two very distinct functions. Although, management and leadership do share many similar duties which consist of working with people and influencing others to achieve goals. They are not the same thing. But they are linked, and complementary. This workshop will explain the differences between the two, tools to use for each one and when to utilize them depending on your job and the required outcomes.

Location
Delta
2:30 pm - 3:30 pm
Workshop

The Clinical Trial Regulation: 2021 and Beyond (WS14)

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. On 21 April 2021, EMA’s Management Board confirmed that Clinical Trials Information System (CTIS) is fully functional, leading to the expectation that it will go live on 31 January 2022. This workshop will provide an opportunity for you to verify your preparations are on track and seek clarification from a QP.

Location
Bravo
2:30 pm - 3:30 pm
Workshop

Harmonising supply and demand throughout the trial life cycle (WS01)

As clinical supplies professionals maintaining continuity of supply is always a primary objective, likely residing behind patient safety in terms of prioritisation and notwithstanding the fact that patient outcomes are directly impacted by our success in meeting this objective. This workshop will discuss the key considerations to ensure supply is aligned with demand, throughout the project lifecycle.

Location
Charlie
2:30 pm - 3:30 pm
Workshop

Direct-to-Patient: The European Model (WS11)

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 workshop will discuss the various DtP models and how those models may vary, based on geographic location and local regulatory requirements.

Location
Alpha
2:30 pm - 3:30 pm
Workshop

Digital Parallels with Other Industries (WS06)

Whilst the pharmaceutical industry is often pioneering in the development of new medicines we often rely on the innovations of other industries to help develop our supply chain models. The same is true for new technologies and the perception remains that the pharmaceutical industry is risk averse in this context. This workshop will asses the use of technology in other industries and how those technologies could be adapted to benefit clinical trial supply.

Location
Echo
3:30 pm - 3:45 pm
Conference Logistics

Virtual Room Transfer Challenge! Exhibit hall open!

Which workshop did you attend first? Take a selfie giving all your GCSG friends a virtual high five & post to the GCSG Group LinkedIn feed!

3:45 pm - 4:45 pm
Workshop

GMP vs GCP and Who’s Responsible at the Clinical Site! (WS15)

As the GMP and GCP interface becomes increasingly blurred, this workshop will discuss the allocation of roles and responsibilities at the clinical site. We will learn from the experiences of a clinical trial site pharmacist and their interactions with other stakeholders - including physicians, CRAs, sponsor company representatives and patients.

Location
Alpha
3:45 pm - 4:45 pm
Workshop

Change Management: Working Successfully in Isolation/Remotely (WS12)

The paradigm shift to remote working scenarios can have a major impact on communication, productivity, job satisfaction and teamwork. In this workshop, you'll learn the warning signs of these negative impacts and how to optimize performance in these scenarios.

Location
Bravo
3:45 pm - 4:45 pm
Workshop

Identifying Causes of Clinical Trial Product Waste and Solutions to Minimise It (WS05)

Clinical supply strategies are evolving as we work to accommodate increasingly complex trial designs, personalised medicines and a post pandemic world. This session will help identify the causes of product waste in the clinical supply chain and a risk based approach to minimising it.

Location
Echo
3:45 pm - 4:45 pm
Workshop

DCT & Site/Patient-Centric Technologies (WS02)

Patient and site centricity are concepts with which many of us are now familiar, although as the concepts gain momentum so do the technologies utilised to facilitate them. This workshop will discuss the numerous technological advances in the space, their impact on the conduct of clinical trials and potential implications for clinical supplies.

Speakers
Location
Delta
3:45 pm - 4:45 pm
Workshop

Challenges and Benefits of Navigating the Clinical Supply Chain in Small and Start-up Companies (WS07)

This workshop provides a broad overview of the clinical supply chain from the context of a small or start-up company. In organisations of this nature the role of the clinical supplies professional is often extremely broad, the stakes are high and there is significant reliance on effective partnerships to achieve favourable outcomes. Whilst challenging, the role is smaller companies is also extremely rewarding, as individuals often have direct visibility to the implications of their actions.

Location
Echo
3:45 pm - 4:45 pm
Workshop

Cell and Gene Therapy Supply Chain (WS10)

Over the course of the last decade there has been an increased emphasis on research into and development of personalized medicines including cell, gene and immunotherapy treatments. Come to this workshop to learn more about how to overcome the unique supply chain challenges in this area and engage directly with a family member of someone who has benefitted from this new class of medicine.

Speakers
Location
Charlie
4:00 pm - 5:00 pm
Networking

Exhibit Hall Open!

Take a screen shot / selfie while chatting with a vendor at their booth. Post on GCSG Group LinkedIn feed, tagging BOTH GCSG & the Exhibitor. Comment about their services or how they've helped you in the past. One entry per post. Post as often as you like!
#gcsgtogetherwearestronger

Location
Exhibit Hall
5:00 pm - 5:15 pm
Conference Logistics

Virtual Room Transfer Challenge! Exhibit hall open!

5:45 pm - 6:45 pm
Showcase

Inceptua Vendor Showcase:Mitigating Risk in the Clinical Trial Supply Chain

The Clinical Trial supply chain has always presented challenges, but arguably never more so than now. In this session we will discuss the latest hurdles including Brexit and COVID and the knock on effects they have had on the supply chain. What are the risks associated and should the management of risk change in our new environment? Are there new considerations that require novel solutions in order to maintain robustness and ensure quality? We will be tackling these questions and more and look forward to you joining us.

Speakers
Location
Delta
5:45 pm - 6:45 pm
Showcase

N-Side Vendor Showcase: Enable ambitious clinical development timelines through an optimal supply chain

With the industry’s ambitions to reduce trial timelines, discover the challenges and solutions for the supply chain to meet these objectives. Learn how ClinOps, Supply and Manufacturing can collaborate towards a program-wide optimization, and do not miss our case study presentation: How end-to-end optimization enabled additional trials and faster recruitment on a program with 4 trials.

Location
Echo
6:15 pm - 7:00 pm
Networking

Exhibit Hall Open!

Which workshops did you attend today? Take a selfie giving all your GCSG friends a virtual high five & post to the GCSG Group LinkedIn feed!
#gcsgtogetherwearestronger

Location
Exhibit Hall
7:00 pm - 8:00 pm
Networking

GCSG Networking – Online interactive Escape Room

We need you to save the world! Your knowledge, skills and problem solving will be tested as part of a small team, as you collectively join up the logistical supply chain and get supplies to the right places, and save patients. Come and take part in a 45 minute interactive online escape room which has been written especially for the GCSG European Knowledge Forum, based on the logistics and challenges of Clinical Trials. No prior knowledge of escape rooms or clinical trials is needed. The game includes a short introduction to ensure you are all ready for the challenge, and everything else will be accessible inside the game. If you already know about how the supply chain works that might help you speed the way! Prizes for the best times, all you need is your computer, your headphones and pen and paper to take notes - and to work with the other people in your team!

Location
Auditorium
8:00 pm - 9:00 pm
Networking

Networking hang out – Wine Tasting

Location
Auditorium
Day 3: Wednesday, October 6
11:00 am - 12:00 pm
Networking

Exhibit Hall Open

Take a screen shot / selfie while chatting with a vendor at their booth. Post on GCSG Group LinkedIn feed, tagging BOTH GCSG & the Exhibitor. Comment about their services or how they've helped you in the past. One entry per post. Post as often as you like!
#gcsgtogetherwearestronger

Location
Exhibit Hall
12:00 pm - 1:00 pm
Showcase

Calyx Vendor Showcase: Leveraging IRT to Further Improve Trial Efficiencies

The usual medication stock management tools of patient prediction and ‘trigger and resupply’ are only the tip of the IRT iceberg when it comes to improving randomization and trial supply management. For example, IRT is commonly underused when it comes to reducing medication waste.
This session will review advanced IRT settings that can be applied to better control the supply chain.  The aim is to increase awareness of these standard IRT options, which can reduce site stock levels beyond those typically


Location
Delta
12:00 pm - 1:00 pm
Showcase

Thermo Fisher Vendor Showcase: Supply Chain Continuity

For over 30 years, we’ve supported the clinical trial supply, distribution & logistics requirements of pharmaceutical and biotech sponsors worldwide. With exposure to multi-national trials and thousands of protocols every year, Thermo Fisher Scientific has developed the industry’s best practices in clinical supply chain management.

Although decentralized clinical trials were on the rise for years before COVID-19, it was their success in keeping drug development programs on course during the pandemic that won these studies a new leading role in mainstream clinical research.

Find out more about how planned decentralized trails unleash benefits to the patient and how we support decentralized clinical trials with our unique Total Transportation Management best practices and Direct-To-Patient service offering. Learn more about the importance of QP release and regulatory compliance to enable supply chain continuity end-to-end. At Thermo Fisher our priority is to get the right drug to the right patient on-time.

Speakers
Location
Echo
1:00 pm - 2:15 pm
Presentation

Welcome, Opening Remarks & Panel Discussion

Decentralised Trials – Is it just a trend or the future state of Clinical Research?

Even though Decentralised trials have been conducted successfully pre-pandemic, the global spread, and impact, of COVID-19 accelerated the use of the model exponentially. Based on the data collected so far, there is clear evidence that this paradigm for conducting clinical trials has significant value.

This panel discussion will bring together experts from different sectors within Clinical Development and the Clinical Supply Chain, to share their experiences regarding the benefits and challenges of conducting decentralised trials and the corresponding use of Direct to Patient shipments.  The role of technology and the opportunities for future innovation will also be discussed.  Please join us for what promises to be a lively and informative discussion.

Location
Auditorium
2:15 pm - 3:00 pm
Workshop

Vaccine Supply Chain – Warp Speed and Beyond (WS03)

With many of us now benefitting from a new medicine for the first time, this workshop will discuss the learnings from developing and licensing a COVID vaccine in record time. We will also review the innovations and how those innovations will continue to impact clinical supplies beyond this first course of treatment in affluent countries.

Speakers
Location
Delta
2:30 pm - 3:30 pm
Workshop

Harmonising supply and demand throughout the trial life cycle (WS01)

As clinical supplies professionals maintaining continuity of supply is always a primary objective, likely residing behind patient safety in terms of prioritisation and notwithstanding the fact that patient outcomes are directly impacted by our success in meeting this objective. This workshop will discuss the key considerations to ensure supply is aligned with demand, throughout the project lifecycle.

Location
Charlie
2:30 pm - 3:30 pm
Workshop

Import and Export – Spotlight on Asia (WS13)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging. Planning up front for your 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 AsiaPac.

Speakers
Location
Alpha
2:30 pm - 3:30 pm
Workshop

Direct-to-Patient: The European Model (WS11)

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 workshop will discuss the various DtP models and how those models may vary, based on geographic location and local regulatory requirements.

Location
Bravo
2:30 pm - 3:30 pm
Workshop

Comparators: Reaching Out to Manufacturers for Direct Supply (WS08)

Sourcing comparator products has been a longstanding challenge for clinical supplies professionals, so much so that an entire industry sector has developed to facilitate it. This workshop will discuss the means by which a manufacturer could be approached directly and the benefits and pitfalls of doing so.

Location
Echo
2:30 pm - 3:30 pm
Workshop

Digital Parallels with Other Industries (WS06)

Whilst the pharmaceutical industry is often pioneering in the development of new medicines we often rely on the innovations of other industries to help develop our supply chain models. The same is true for new technologies and the perception remains that the pharmaceutical industry is risk averse in this context. This workshop will asses the use of technology in other industries and how those technologies could be adapted to benefit clinical trial supply.

Location
Echo
3:30 pm - 3:45 pm
Conference Logistics

Virtual Room Transfer Challenge! Exhibit hall open!

Share how working in clinical supplies & helping patients impacts you

3:45 pm - 4:45 pm
Workshop

Challenges and Benefits of Navigating the Clinical Supply Chain in Small and Start-up Companies (WS07)

This workshop provides a broad overview of the clinical supply chain from the context of a small or start-up company. In organisations of this nature the role of the clinical supplies professional is often extremely broad, the stakes are high and there is significant reliance on effective partnerships to achieve favourable outcomes. Whilst challenging, the role is smaller companies is also extremely rewarding, as individuals often have direct visibility to the implications of their actions.

Location
Bravo
3:45 pm - 4:45 pm
Workshop

DCT & Site/Patient-Centric Technologies (WS02)

Patient and site centricity are concepts with which many of us are now familiar, although as the concepts gain momentum so do the technologies utilised to facilitate them. This workshop will discuss the numerous technological advances in the space, their impact on the conduct of clinical trials and potential implications for clinical supplies.

Speakers
Location
Delta
3:45 pm - 4:45 pm
Workshop

Leadership versus Management: When to Use One or the Other (WS04)

Management and leadership are two very distinct functions. Although, management and leadership do share many similar duties which consist of working with people and influencing others to achieve goals. They are not the same thing. But they are linked, and complementary. This workshop will explain the differences between the two, tools to use for each one and when to utilize them depending on your job and the required outcomes.

Location
Echo
3:45 pm - 4:45 pm
Workshop

Post Brexit Updates: Impact or Not? (WS09)

This workshop will provide an opportunity to engage directly with an EU QP to discuss the impact of BREXIT on the clinical supply chain, including requirements for trials ongoing in the EU and United Kingdom.

Location
Charlie
3:45 pm - 4:45 pm
Workshop

The Clinical Trial Regulation: 2021 and Beyond (WS14)

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. On 21 April 2021, EMA’s Management Board confirmed that Clinical Trials Information System (CTIS) is fully functional, leading to the expectation that it will go live on 31 January 2022. This workshop will provide an opportunity for you to verify your preparations are on track and seek clarification from a QP.

Location
Alpha
4:45 pm - 5:00 pm
Conference Logistics

Virtual Room Transfer Challenge! Exhibit hall open!

Share something you learned in your last workshop on the GCSG Group LinkedIn feed. Tag your facilitators and #gcsginittogether.

5:00 pm - 5:30 pm
Networking

Exhibit Hall Open

Take a screen shot / selfie while chatting with a vendor at their booth. Post on GCSG Group LinkedIn feed, tagging BOTH GCSG & the Exhibitor. Comment about their services or how they've helped you in the past. One entry per post. Post as often as you like!
#gcsgtogetherwearestronger

Location
Exhibit Hall
5:30 pm - 6:30 pm
Showcase

Signant Health Vendor Showcase: Moving away from the spreadsheet; how to implement long term forecasting and planning process change within a sponsor organization

Signant Health will demonstrate how their SmartSignalsTM Forecasting and Planning applications have reduced the clinical drug supply budget by 20% annually for major Pharmaceutical clients. We have done this through a combination of accurate forecasting, real-time data integration, automated aggregation of demand at all BOM levels, standardised production planning, and allocation of supply to demand. Our Showcase will benefit from the presence of GSK, kindly providing an update on their Forecasting and Planning system implementations, giving real feedback on the process and how it has benefited their organisation, and taking your questions.

Speakers
Location
Delta
6:30 pm - 8:00 pm
Networking

GCSG Networking – Cocktail Making

Since we can't go to Europe we're bringing Europe to us. What a night we're planning, with Zest Mixology as we visit bars across Europe trying delicious drinks and playing games along the way. We will provide you with recipes and a shopping list for cocktails and mocktails, in advance, so that you can be ready for a highly interactive, vibrant hour, where we can shake our mock/cocktails simultaneously with the Mixology Hosts leading us to success!

 

Location
Auditorium
8:00 pm - 9:00 pm
Networking

Networking hang out – Chocolate/Cheese Tasting

Speakers
Location
Auditorium
Day 4: Thursday, October 7
10:30 am - 11:30 am
Networking

Exhibit Hall Open- Last Chance!

LAST CHANCE! Post a selfie holding a sign with one thing you liked about the knowledge forum! Don't forget
#gcsgtogetherwearestronger

Location
Exhibit Hall
11:30 am - 12:30 pm
Showcase

4G Clinical Vendor Showcase: Fully Integrated RTSM & Forecasting Solutions for Optimal Supply Management

The seamless workflow between 4G Clinical’s Prancer RTSMⓇ and 4C SupplyⓇ solutions will be showcased. Together, these solutions provide simplicity and control over supply chain decisions. Attendees will see first-hand a case study of the decision support provided by both solutions as they transition through early stage feasibility planning, RTSM setup, revisions to plans based on actual enrollment, and updates to resupply parameters based on the revised plans.

Location
Echo
12:30 pm - 1:00 pm
Conference Logistics

Lobby / Welcome Desk Open

Location
Lobby
1:00 pm - 2:00 pm
Presentation

Welcome, Opening Remarks & Patient Testimonial

Presented by Sebastian Terry


  • After the loss of a close friend in his early twenties, Sebastian had a moment of reflection which led him to asking himself a question that would go on to change his life- “Am I happy?”

  • The answer was NO, and so he wrote down a list of 100 things that he hoped would bring him closer to a sense of happiness.

  • Now 10 years on and counting, Seb has ticked off 74 items from his list, has raised almost half a million dollars for charities and has found a sense of purpose that he could never have dreamed of.

  • In this session we will consider the wider patient ecosystem, and the ways small things can have a profound impact on the community and world at large.

  • Seb’s decision many years ago has snowballed into books, TV shows and documentaries, has most impressively inspired a global community of individuals and organizations who have identified, pursued, and achieved their own goals, too


https://100things.com/about/

Location
Auditorium
2:00 pm - 2:15 pm
Conference Logistics

Virtual Room Transfer Challenge!

Take a selfie as you listen to the panel discussion. Extra points for showing you had your camera on during the session in your picture! Post on the GCSG Group LinkedIn feed to be entered to win!

2:15 pm - 3:15 pm
Workshop

Cell and Gene Therapy Supply Chain (WS10)

Over the course of the last decade there has been an increased emphasis on research into and development of personalized medicines including cell, gene and immunotherapy treatments. Come to this workshop to learn more about how to overcome the unique supply chain challenges in this area and engage directly with a family member of someone who has benefitted from this new class of medicine.

Speakers
Location
Charlie
2:15 pm - 3:15 pm
Workshop

Comparators: Reaching Out to Manufacturers for Direct Supply (WS08)

Sourcing comparator products has been a longstanding challenge for clinical supplies professionals, so much so that an entire industry sector has developed to facilitate it. This workshop will discuss the means by which a manufacturer could be approached directly and the benefits and pitfalls of doing so.

Location
Echo
2:15 pm - 3:15 pm
Workshop

GMP vs GCP and Who’s Responsible at the Clinical Site! (WS15)

As the GMP and GCP interface becomes increasingly blurred, this workshop will discuss the allocation of roles and responsibilities at the clinical site. We will learn from the experiences of a clinical trial site pharmacist and their interactions with other stakeholders - including physicians, CRAs, sponsor company representatives and patients.

Location
Alpha
2:15 pm - 3:15 pm
Workshop

Identifying Causes of Clinical Trial Product Waste and Solutions to Minimise It (WS05)

Clinical supply strategies are evolving as we work to accommodate increasingly complex trial designs, personalised medicines and a post pandemic world. This session will help identify the causes of product waste in the clinical supply chain and a risk based approach to minimising it.

Location
Echo
2:15 pm - 3:15 pm
Workshop

Import and Export – Spotlight on Asia (WS13)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging. Planning up front for your 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 AsiaPac.

Speakers
Location
Bravo
2:15 pm - 3:15 pm
Workshop

Vaccine Supply Chain – Warp Speed and Beyond (WS03)

With many of us now benefitting from a new medicine for the first time, this workshop will discuss the learnings from developing and licensing a COVID vaccine in record time. We will also review the innovations and how those innovations will continue to impact clinical supplies beyond this first course of treatment in affluent countries.

Speakers
Location
Delta
3:15 pm - 3:30 pm
Conference Logistics

Virtual Room Transfer Challenge!

LAST CHANCE! Post a selfie holding a sign with one thing you liked about the knowledge forum! Don't forget #gcsginittogether

3:30 pm - 4:15 pm
Presentation

Closing Remarks & GCSG/Vendor Prize Draws

Location
Auditorium

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