10 - 12 October 2023

See you next year!

Thank you to everyone who made the 2022 event possible. We were thrilled to be back together in person, and hope to see you in 2023!

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Thank you to everyone who made the 2022 event possible. We were thrilled to be back together in person, and hope to see you in 2023!

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Note: All times listed below reflect CEST (UTC/GMT+2)
Virtual sessions only
Day 1: Tuesday, October 4
7:45 am - 8:30 am
Conference Logistics

Boot Camp Registration Open

Registration for boot camp delegates & instructors only!

Location
Registration Area
8:00 am - 4:30 pm
Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

This class, geared towards people new to the world of clinical trial supplies, focuses on drug development and what goes into planning for and delivering a study drug for a clinical trial. Topics include: reasons behind Good Manufacturing Practices (cGMPs), phases of new drug development and approval, randomizing and blinding clinical trial materials, quality assurance and documentation, protocol interpretation, patient compliance, labeling, standard operating procedures (SOPs), stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the European Union (EU) and rest of world (ROW). Attendees will hear a massive amount of information in a fun and interactive atmosphere.

Objectives:

(1) Describe at least three (3) historical events that drove the development of GMPs
(2) Identify at least three (3) Quality rules to ensure IMP production meets global regulatory standards
(3) List three (3) regulatory requirements when shipping temperature-controlled IMPs

8:30 am - 4:00 pm
Boot Camp / Seminar

Import/Export

This class is designed for clinical supply professionals who want to learn more than just the basics about shipping and distribution for global clinical trials. This seminar will cover trade compliance, international shipment workflow and clearance, Value Added Tax (VAT) and logistics supply chain partnerships to ensure success with international distribution.

8:30 am - 4:00 pm
Boot Camp / Seminar

Using IRT to Maximize Control & Minimize Outages

This class is geared towards people that have some experience in the clinical trial supplies world. Attendees will be provided with a quick overview and then will take a deeper dive into Interactive Response Technology (IRT). This will include the development path for IRTs; the stages of build, from creating the User Requirement Specification (URS) to quoting, coding, validation, user acceptance testing and go-live; the reasons to use an IRT as well as when NOT to use an IRT; build requirements, including randomization codes and med code IDs; ensuring modules are built to manage individual regulatory country approvals, shipping requests and returns and reconciliation; as well as timelines from concept development to system go-live.

3:00 pm - 5:30 pm
Conference Logistics

Registration Open

Location
Registration Area
4:30 pm - 5:30 pm
Showcase

Vendor Showcase – Discussing and Addressing Your Challenges – Sponsored by Calyx

Join Calyx for an interactive session where you will have the opportunity to discuss with your peers the challenges you face in your role, and share some ideas on how to address them. You may have some concerns about the amount of medication you waste at site, or you could be unsure how to implement a direct-to-patient strategy for example. We expect this to be an engaging session where everyone has an opportunity to speak up and help each other!

4:30 pm - 5:30 pm
Showcase

Vendor Showcase – From Protocol Draft to LPO: How to Keep Your Clinical Supply Planning Under Control – Sponsored by N-Side

Challenges and limitations of clinical demand planning

Connecting the dots to get global visibility on your supply need - Understanding how robust and reliable forecasts avoid unnecessary wastage.

Collaborating with ClinOps, CMOs & IRT vendors to build a resilient supply chain strategy from protocol draft

Learning how to leverage patient actuals and realign your forecasts and the associated supply strategy

4:30 pm - 5:30 pm
Showcase

Vendor Showcase – Simplifying Supply Management to Achieve Efficient Operations – Sponsored by Medidata Solutions

In this session we will review complexity challenges in clinical studies and discuss methods that can be used to simplify clinical study operations as it relates to supply management. Scenarios covered will include Direct to Patient, Temperature Excursions, Adaptive Trials, and Supply Optimization.

6:30 pm - 8:30 pm
Networking

GCSG Meet & Greet Networking Event – Sponsored by PCI

Location
Terrace
Day 2: Wednesday, October 5
10:00 am - 10:15 am
Break

Room Transfer

10:15 am - 11:15 am
Workshop

Maintaining the Cohesion of a Virtual Clinical Supplies Team (WS09)

With the onset of the pandemic, the standard work paradigm shifted dramatically. Faced with team members being virtual, our leaders experienced increased levels of stress, difficulty managing teams and lower levels of team member engagement. This workshop will discuss strategies to improve virtual team leadership as well as team performance and engagement.

10:15 am - 11:15 am
Workshop

On Demand Site Centric Supply Chains (WS13)

On demand and JIT supply chain strategies have been around for years. Their adoption has been very slow based on numerous concerns. The pandemic allowed us to explore and experience success working with these supply chain models. This workshop will explore what on-demand and JIT supply chains are and how they can best be implemented, with little resistance, at your company.

10:15 am - 11:15 am
Workshop

Lessons Learned from Accelerated Covid Vaccine Development & Approval (WS01)

The development of the Covid vaccine was done at an incredibly accelerated pace in order to make the world a safer place by providing much needed immunity. The speed at which these vaccines were developed had never been seen before. This workshop will highlight the lessons learned from the accelerated development of this vaccine so you can use them to accelerate your clinical supply chain.

10:15 am - 11:15 am
Workshop

How Changes to Clinical Trial Regulations Continue to Affect Us (WS02)

The Clinical Trial Regulation (CTR) came into effect on 31-Jan-2022. With it there are many changes that must be taken into consideration and implemented in order to use the Clinical Trial Information System (CTIS) submission portal for the EU-27. This workshop will review all of the changes while providing recommendations on how to comply with them. It will also provide an update on any amendments that have been requested to change the CTR.

10:15 am - 11:15 am
Workshop

Developments in Patient Centric Clinical Trials (WS12)

Patient centricity has been a goal of our industry for a few years now. Some companies are doing better with it than others. This workshop will review some of the most successful patient centric approaches to clinical trials and their clincal supplies.

11:15 am - 11:30 am
Break

Room Transfer

11:30 am - 12:30 pm
Workshop

Metrics: What are the Key Metrics in Clinical Supplies? (WS05)

Metrics drive performance. For years all of us have been implementing different metrics to improve our clinical supply chains. This workshop will consolidate and discuss the best metrics to use to get the best results when packaging, labeling and distributing clinical supplies.

11:30 am - 12:30 pm
Workshop

Temperature Control & Packaging: Cryogenic to Room Temperature (WS08)

Temperature controlled packaging is a standard part of everything we do in clinical supplies. All of our products must be in a controlled environment to support stability and expiry dating. This workshop will discuss different packaging and shipping concepts to ensure there are appropriate controls for all temperatures from cryogenic to controlled room temperature.

11:30 am - 12:30 pm
Workshop

Risk Mitigation Strategies for Comparator Supply Procurement (WS11)

As comparator studies have grown exponentially over the past two decades, sourcing strategies for them have evolved and improved over time. This workshop will explore different strategies and risk mitigation for sourcing your comparators no matter how complex the study or where the study will be conducted globally.

11:30 am - 12:30 pm
Workshop

Regulatory, Labelling & Customs Requirements for CTM in Latin America (WS06)

Regulatory requirements for Latin America (LATAM) vary tremendously from country to country. As our clinical trials are being sent into Latin America in greater and greater numbers, it is essential to know the different requirements in order to avoid delays in entry. This workshop will define the important regulatory requirements for labeling and customs requirements to increase the chances of smoth entry into LATAM.

11:30 am - 12:30 pm
Workshop

IRT Systems & How They Are Evolving (WS10)

We've been working with interactive response technology (IRT) systems for over a decade. The advancements and improvements to these systems have become exponential. This workshop will discuss some of those improvements and how you can use them to improve your clinical supply and clinical trial outcomes.

11:30 am - 12:30 pm
Workshop

Expanded Access – Tips & Techniques for Success (WS14)

Expanded access programs (EAP) have tremendous challenges associated with them. Creating successful stakeholder teams and processes to ensure successful EAP outcomes is essential. This workshop will provide solutions to putting all of the necessary personnel and infrastructure in place to ensure EAP success at your company.

1:45 pm - 2:45 pm
Workshop

Developments in Patient Centric Clinical Trials (WS12)

Patient centricity has been a goal of our industry for a few years now. Some companies are doing better with it than others. This workshop will review some of the most successful patient centric approaches to clinical trials and their clincal supplies.

1:45 pm - 2:45 pm
Workshop

Clinical Trials: In what ways is the UK diverging from Europe? (WS03)

Since the UK left the European Union, they have been free to make their own laws. Whilst the EU Clinical Trial Regulation was adopted in Europe, the UK were free to take a different path. In this workshop we will examine the differences between EU and UK Laws and GMP requirements and assess any impact it may have on conducting clinical trials in those regions.

1:45 pm - 2:45 pm
Workshop

Cell & Gene Therapy (WS07)

Cell & gene (CGT) therapy is growing exponentially. The requirements for CGT vary from study to study and are tremendously different than standard biopharm supply chain requirements. This workshop will provide an overview of the differences as well as requirements and infrastructure that must be put in place to ensure CGT success.

1:45 pm - 2:45 pm
Workshop

Lessons Learned from Accelerated Covid Vaccine Development & Approval (WS01)

The development of the Covid vaccine was done at an incredibly accelerated pace in order to make the world a safer place by providing much needed immunity. The speed at which these vaccines were developed had never been seen before. This workshop will highlight the lessons learned from the accelerated development of this vaccine so you can use them to accelerate your clinical supply chain.

1:45 pm - 2:45 pm
Workshop

On Demand Site Centric Supply Chains (WS13)

Patient centricity has been a goal of our industry for a few years now. Some companies are doing better with it than others. This workshop will review some of the most successful patient centric approaches to clinical trials and their clincal supplies.

1:45 pm - 2:45 pm
Workshop

How Changes to Clinical Trial Regulations Continue to Affect Us (WS02)

The Clinical Trial Regulation (CTR) came into effect on 31-Jan-2022. With it there are many changes that must be taken into consideration and implemented in order to use the Clinical Trial Information System (CTIS) submission portal for the EU-27. This workshop will review all of the changes while providing recommendations on how to comply with them. It will also provide an update on any amendments that have been requested to change the CTR.

2:45 pm - 3:00 pm
Break

Room Transfer

3:00 pm - 4:00 pm
Presentation

Patient Testimonial – Carol Jarvis

In 2004, Carol Jarvis was diagnosed with Hodgkins Lymphoma. She endured countless treatments including several chemotherapy regimes, radiotherapy and a stem cell transplant, as her cancer proved extremely stubborn. Carol took part in her first clinical trial in 2006 and because her response was significant, it was deemed that her cure (if found) would need to be an experimental treatment. Finally, after three different clinical trials, Carol got to remission in 2011. After a donor bone marrow transplant to consolidate that remission, Carol has remained well since 2013.

Carol is one of the most in-demand session musicians in the UK. She's currently President of the International Trombone Festival Board and in 2023 will become the first female President of the International Trombone Association. Carol’s orchestrations and arrangements have featured on albums at the top of the UK and US billboard charts, been recorded at the famous Capitol Studios in Hollywood and also played during the Academy Awards ceremony.

During her fight, and since then, Carol has worked with many cancer charities throughout the world in many different ways. She continues to work closely with Lymphoma Action - the UK’s only charity dedicated to Lymphoma, where she has used her voiceover skills for their BBC Radio 4 appeal. She has also spoken to MPs at the Houses of Parliament about government policies, to help change industry practise and bring about improvements for those affected by cancer. Carol has earned a Beacon of Hope award for all her work for Lymphoma Action and a Champion award from the American Cancer Society for her charity work all over the globe.

Location
5:30 pm - 6:00 pm
Conference Logistics

Personal Time To Get Ready For Evening

6:00 pm - 6:15 pm
Conference Logistics

Departure For GCSG Night Out

Location
Hotel Reception
6:30 pm - 11:59 pm
Networking

GCSG Night Out – Sponsored By Alcura

Join us for an exciting evening celebrating Croatian culture and cuisine.  We will take a short journey by coach to the local port and sail on a replica galleon to Dubrovnik harbour, tasting some local delicacies and listening to Croatian folk music as the sun sets. After a short walk (about 5-10 minutes) through the old town we will have a buffet style dinner on a purpose built veranda on the beach with a view of one of the islands where Games of Thrones was filmed.  After dinner we’ll have music supplied by a DJ or you can indulge in your own music at the Karaoke microphone! Coaches will then take us the 20 minutes ride back to the hotel at the end of the evening. There are some steep steps leading down to the restaurant so if you have any access needs please let us know,  otherwise please allow a little time to negotiate them. Please wear shoes suitable for a short walk and no stilettos on the ship!  If you would prefer not to travel on the ship we will be able to ferry you directly to the restaurant by more conventional road transportation, just let us know at the registration desk by lunchtime on Wednesday

10:30 pm - 11:59 pm
Conference Logistics

Departure Back to the Hotel

Day 3: Thursday, October 6
10:00 am - 10:15 am
Break

Room transfer

10:15 am - 11:15 am
Workshop

Risk Mitigation Strategies for Comparator Supply Procurement (WS11)

As comparator studies have grown exponentially over the past two decades, sourcing strategies for them have evolved and improved over time. This workshop will explore different strategies and risk mitigation for sourcing your comparators no matter how complex the study or where the study will be conducted globally.

10:15 am - 11:15 am
Workshop

Temperature Control & Packaging: Cryogenic to Room Temperature (WS08)

Temperature controlled packaging is a standard part of everything we do in clinical supplies. All of our products must be in a controlled environment to support stability and expiry dating. This workshop will discuss different packaging and shipping concepts to ensure there are appropriate controls for all temperatures from cryogenic to controlled room temperature.

10:15 am - 11:15 am
Workshop

Regulatory, Labelling & Customs Requirements for CTM in Latin America (WS06)

Regulatory requirements for Latin America (LATAM) vary tremendously from country to country. As our clinical trials are being sent into Latin America in greater and greater numbers, it is essential to know the different requirements in order to avoid delays in entry. This workshop will define the important regulatory requirements for labeling and customs requirements to increase the chances of smoth entry into LATAM.

10:15 am - 11:15 am
Workshop

Expanded Access – Tips & Techniques for Success (WS14)

Expanded access programs (EAP) have tremendous challenges associated with them. Creating successful stakeholder teams and processes to ensure successful EAP outcomes is essential. This workshop will provide solutions to putting all of the necessary personnel and infrastructure in place to ensure EAP success at your company.

10:15 am - 11:15 am
Workshop

IRT Systems & How They Are Evolving (WS10)

We've been working with interactive response technology (IRT) systems for over a decade. The advancements and improvements to these systems have become exponential. This workshop will discuss some of those improvements and how you can use them to improve your clinical supply and clinical trial outcomes.

10:15 am - 11:15 am
Workshop

Metrics: What are the Key Metrics in Clinical Supplies? (WS05)

Metrics drive performance. For years all of us have been implementing different metrics to improve our clinical supply chains. This workshop will consolidate and discuss the best metrics to use to get the best results when packaging, labeling and distributing clinical supplies.

11:15 am - 11:30 am
Break

Room transfer

11:30 am - 12:30 pm
Workshop

Cell & Gene Therapy (WS07)

Cell & gene (CGT) therapy is growing exponentially. The requirements for CGT vary from study to study and are tremendously different than standard biopharm supply chain requirements. This workshop will provide an overview of the differences as well as requirements and infrastructure that must be put in place to ensure CGT success.

11:30 am - 12:30 pm
Workshop

Clinical Trials: In what ways is the UK diverging from Europe? (WS03)

Since the UK left the European Union, they have been free to make their own laws. Whilst the EU Clinical Trial Regulation was adopted in Europe, the UK were free to take a different path. In this workshop we will examine the differences between EU and UK Laws and GMP requirements and assess any impact it may have on conducting clinical trials in those regions.

11:30 am - 12:30 pm
Workshop

How Smart Devices Can Improve Clinical Trials (WS04)

Smart devices give us the ability to electronically track incredible amounts of data relating to clinical trials and clinical supplies. In this workshop we will explore a number of smart devices that have been developed to improve the clinical supply chain. We will also discuss ways to place smart devices into your clinical supply chain to improve outcomes.

11:30 am - 12:30 pm
Workshop

Maintaining the Cohesion of a Virtual Clinical Supplies Team (WS09)

With the onset of the pandemic, the standard work paradigm shifted dramatically. Faced with team members being virtual, our leaders experienced increased levels of stress, difficulty managing teams and lower levels of team member engagement. This workshop will discuss strategies to improve virtual team leadership as well as team performance and engagement.

1:45 pm - 2:45 pm
Presentation

Key Note Part 2: The Disney Strategy – How To Reach Your Own Everest

An approach using three different thinking styles, from the Dreamer, through the realist and the critic, that will help you also to reach your own goals, even if these are not climbing Everest.

Speakers
Location
3:15 pm - 4:15 pm
Showcase

Vendor Showcase – How to Sleep Well the Night Before (and After) Your Inspection, While Saving Resources in Temperature Control – Sponsored by TSS

We will be moderating an interactive session on digitalizing and automating temperature control and review, and share some examples of benefits that can be achieved. We will discuss and share best practices for:

Inspection readiness – taking the stress out, and impress your auditor!
Business case calculation – how to calculate the impact of digitalizing and automating temperature control, the business case everyone should do.

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