Day 1 : Tuesday, October 15
Boot Camp Registration Open
BC01 - How to Plan and Implement an Expanded Access Program
Expanded Access, Named Patient, Compassionate Use… the names for the process are as varied as the options for supporting them. This interactive course will give an overview of expanded access as well as discuss relevant regulations and their impact on operational and strategic planning. Attendees will be able to hear from subject matter experts with many years experience on best practices and important questions to ask when supporting these types of studies. Come to this boot camp to discuss the regulations for expanded access and how they impact your operational and strategic supply planning.
Speakers:
BC02 - 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.
Speakers:
BC03 - Mastering Clinical Supply Planning
Planning the clinical supply chain is a formidable task, full of challenges and complexities. With the variety of information to consider, external influences, and the inherent uncertainties of clinical trials, supply managers often find themselves under pressure to deliver a supply plan that is not only accurate but also highly efficient. This advanced one-day boot camp is tailored for supply chain managers and planners familiar with the basics who would like to elevate their skills and knowledge. Together, we will address the main drivers of inefficiencies in clinical supply planning and navigate good practices to avoid them.
Speakers:
BC04 - 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.
Speakers:
Exhibitor Set Up
Registration Open
Presenters / WS Facilitators Orientation
Vendor Showcase - Exploring Comparator Sourcing Strategies and Opportunities for Use within China - Hosted by Bionical Emas
- Central Sourcing vs. Local Sourcing; the benefits and challenges of each model
- How accessible are commercial products for use in clinical trials in China
- What’s the process for accessing products locally; POA, trial disclosure, pricing differentiators, lead times, documents provided with products
- When to decide which sourcing strategy to use and the timelines associated
- Any other factors that come into play when deciding the best sourcing strategy
Presented by: James Rowley, Strategic Account Director, Clinical Trial Supply, Bionical Emas
Vendor Showcase - Implementing Sustainable Sourcing Practices for Commercial Medicines in Your Clinical Trials - Hosted by Abacus Medicine
- Understanding the commercial medicine supply chain inside out
- Predicting the future - data analytics, AI and market intelligence
- Review regularly
- Back-up & risk mitigation
- Learn from experience - case studies
Presented by Ian Hoban & Lucy Fox, Business Development Directors, Abacus Medicine
Vendor Showcase - Navigating Regulatory Changes for Packaging & Labeling: Lessons Learned From the Transition to the EU Clinical Trial Regulation - Hosted by Clinigen
This session will discuss Clinigen's proactive approach to managing the regulatory change for packaging and labelling to ensure seamless compliance.
This included a comprehensive impact analysis, client education initiatives and tailored solutions to reduce complexity and avoid delays.
You will learn best practices for navigating change and gain insight into how you can mitigate risk and maintain operational excellence.
Presented by: Mélany Pierard, Project Manager, Team Lead, Clinical Supply Management & Mathieu Denis, Project Manager Solutions, Clinical Supply Management
Start The Knowledge Forum Right!
GCSG Meet & Greet Networking Event
Day 2 : Wednesday, October 16
Registration Open - Exhibitor Displays Open
Welcome & Opening Remarks (& European GCSG Scholarship Announcement)
Patient Testimonial; Dalia Ismail - Sponsored by Almac Group
Dalia began her career in clinical research in 2010, after studying biomedical science and pharmacology at King’s College London. She has since worked in trial management at Parexel, Quintiles, The Institute of Cancer Research London, Amgen and Allergan. Dalia joined Janssen in 2016 and is a Senior Clinical Trial Manager in haematology oncology. She recently completed her masters degree in Clinical Trials at The University of Edinburgh.Dalia was diagnosed with breast cancer in 2022. After completing a full spectrum of active treatment, including surgery, chemotherapy and radiotherapy, she remains on preventative treatments and entered a clinical trial in 2023, at Mount Vernon Cancer Centre.
Dalia realised that despite good outcomes for breast cancer patients generally, that young age of diagnosis (under 35) is associated with less favourable outcomes and more aggressive treatment strategies. Outcome data and clinical trial data is also limited due to under 35’s representing only around 2% of breast cancer patients.
Dalia is passionate about furthering research, patient advocacy, informed consent and increasing awareness of breast cancer in younger people. She has worked with various charities and brands over the last two years on breast cancer campaigns, including Breast Cancer Now, Coppafeel! and Penny Brohn UK, and has been featured in media outlets, including the BBC, The Mail Online and HELLO magazine, for her advocacy work.
Sponsored by:
Room Transfer
WS01.1 - What to Consider When Getting into Cell & Gene Therapy
This workshop will be a discussion focused on the challenges of cell and gene therapy. Key topics to be discussed will include CGT's patient orientation, temperature controlled logistics, site requirements, manufacturing challenges and aggressive timing.
Speakers:
WS03.1 - Lessons Learned After 30 Years In Clinical Supplies
In 30 years, a lot could be learned in the clinical supply industry. This workshop will leverage SME's and participant's knowledge to provide solution to the attendee's biggest issues and questions.
Speakers:
WS06.1 - Using AI to predict enrollment & forecasting
Clinical supply's greatest challenge is patient enrolment. It is the greatest cause of supply chain turmoil. This workshop will discuss how AI is being used to not only accelerate enrolment but to predict it and how those trends can be used by the clinical supply chain.
Speakers:
WS15.1 - Building Career Success (as YOU define it) and a Great Work-Life Balance
Participants will be guided through self-reflection, share and develop insights and leave with an action they can take immediately, to progress their careers and positively impact their work-life balance.
The exercise is designed to benefit the individuals, the companies they work for, the customers they serve, and the family and friends they care about.
In addition to enabling important self-reflection and action planning, the participants can take this approach back to the work-place to support conversations with their teams.
Speakers:
WS16.1 - Understanding the Requirements & Challenges for Importer of Record (IoR)
Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.
Speakers:
WS18.1 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process
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 while utilizing internal stakeholder inputs to update your metrics.
Speakers:
Room Transfer
WS02.1 - Clinical Supply Chain Open Forum
This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.
Speakers:
WS08.1 - Compare & Contrast the Diverse Types of Access
This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will go over all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to-try.
Speakers:
WS09.1 - How to Accomplish Drug Pooling in Europe
Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will focus on the challenges of doing pooling of supplies in Europe as well as provide some solutions to accomplish the most pooling possible.
Speakers:
WS10.1 - QP Certification, your questions answered
Speakers:
WS13.1 - Resources to Assist Patients in Identifying and Navigating Clinical Trials
This workshop will identify one of the largest challenges we have in the clinical trial industry, which is finding and enrolling patients. It will provide a different perspective to help understand how we can support patients in finding appropriate clinical trials to treat or cure many of the diseases from which they suffer today.
Speakers:
WS17.1 - Clinical Supplies Stakeholder Management
Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how cross-functional teams can collaborate effectively to develop a robust clinical supply strategy with accurate forecasting, strong vendor partnerships and smooth operational execution.
Speakers:
Lunch - Exhibitor Displays Open
WS04.1 - Creating Clinical Trial Supply Success for Small Start-ups in a Sea of Giant Companies
Speakers:
WS05.1 - Comparator Sourcing Challenges & Supply Chains
Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success. Comparator sourcing, a complex and challenging activity, is required to conduct the majority of clinical trials today. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.
Speakers:
WS11.1 - Inspection Readiness Across the Pipeline
Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to discuss how to apply 80-20 rule, prepare for inspections & get ready for the inspection room as well as learn about some key tools to help you stay calm, succeed and always be inspection ready!
Speakers:
WS12.1 - Understanding EU Labeling Regulations
Awareness of labelling regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the labelling requirements in the EU that when correctly implemented allow you to avoid delays and supply chain disruptions.
Speakers:
WS14.1 - Navigating DTP - Stakeholder Perspectives & Challenges
DTP is a complex process with multiple stake holders with patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees and couriers to name a few. GCSG DTP Team will lead discussion about varied stakeholder perspectives, experiences and lessons learned (sponsors, vendors, etc.).
Speakers:
WS16.2 - Understanding the Requirements & Challenges for Importer of Record (IoR)
Ever have an international shipment get delayed due to documentation issues? This workshop will discuss what the importer of record (IoR) does, along with various other document requirements that enable shipments between countries to occur smoothly.
Speakers:
Room Transfer
Keynote Presentation
Exclusively represented by Leading Authorities speakers bureau, Dr. Boschi takes audiences on a fascinating journey deep inside the brain to help them understand why we do the things we do and how this knowledge can be applied to becoming our best selves in the workplace and beyond. She’s a warm presence who gets meeting-goers enthusiastically engaged with amusing anecdotes and interactive elements to her presentation, and translates complex neuroscience and psychology concepts in clear and concise ways. As she breaks down what’s really going on inside our brains, she examines the business case for optimising the physical and psychological aspects of teams, and shares tangible takeaways for channelling wellbeing into collective innovation, peak performance, and growth.
Throughout her career, Dr. Boschi has held senior talent management and organisation development roles at international companies across a range of disciplines, including sales, marketing, international relations, organisation design, and leadership development. She is particularly passionate about developing person-centric approaches to corporate spaces in a world that is placing increased demand on our biological and cognitive resources. Her extensive research in the field includes the impact of chronic, work-induced stress on brain function, which she detailed in her acclaimed book Why We Do What We Do: Understanding Our Brain to Get the Best Out of Ourselves and Others.
A member of the British Psychological Society, Dr. Boschi delivers compelling messages that are backed by science, grounded in the real world, and communicated in a style that engages all of her audiences.
Speakers:
Closing Remarks
Vendor Reception & Prize Draws!
Personal Time
Departure for GCSG Night Out at Hotel Reception
GCSG Night Out
Departures to Hotel
Day 3 : Thursday, October 17
Registration Open - Exhibitor Displays Open
Opening Remarks
Clinical Trial Trends
Speakers:
Room Transfer
Vendor Showcase - Acceleration to Market Through Innovation and Integration - Hosted by Thermo Fisher Scientific
Hear from industry experts on how we've successfully executed in these two areas and how the combination of our innovation and integration efforts uniquely enables Thermo Fisher to support acceleration of your molecule to market.
Presented by: Sarah Englert, Sr. Director R&D Projects, Eric Deschamps, Sr. Director Pharma Services Integration and Luke Wilson, Senior Director, Sales
Vendor Showcase - Clinical Trial Logistics – Planning is Key! - Hosted by Marken
- Types of Logistics, dependent on supply chain, study design - Depot to Depot; site to Depot, Direct to Patient
- Depot Strategy - how to select depots for optimising patient reach and cost control
- Cold chain Packaging what to consider
- Sustainability in logistics
Presented by: Manishaa O'Brien, Senior Director, Business Development & Zarina Abdoel-Piroe, Director, Business Development
Vendor Showcase - Innovating in Forecasting & Planning – Deep Dive into a Freshly Released Planning Platform - Hosted by N-Side
- Choosing a forecasting & planning tool – criteria, challenges & opportunities in our industry
- Discover N-SIDE Lighthouse, a forecasting & planning solution for all trials and users
- Navigate a live demo – build a trial in N-SIDE Lighthouse, create a supply and distribution plan and monitor an ongoing trial
- Learn about the long-term vision of N-SIDE for its clinical supply chain solutions
Presented by: Yoni Van den Branden, Associate Director - Business Development EU and Laurent Verdickt, Solution Engineer Life Sciences
Room Transfer
WS04.2 - Creating Clinical Trial Supply Success for Small Start-ups in a Sea of Giant Companies
Speakers:
WS05.2 - Comparator Sourcing Challenges & Supply Chains
Comparator sourcing is a complex and challenging activity required to conduct the majority of clinical trials today. During this workshop we will discuss some of the key challenges of sourcing and procuring comparators and how to set yourself up for success. Comparator sourcing, a complex and challenging activity, is required to conduct the majority of clinical trials today. This workshop will prompt discussion around some of the key challenges and how to set yourself up for success when sourcing for global clinical trials.
Speakers:
WS07.1 - SMART Packaging for Adherence Measurement: Understanding the Impact on Supply Planning
Drug administration and compliance have always been a challenge. With the advent of SMART devices, this has become easier. This workshop will discuss how and why to integrate SMART technology into your supply chain to improve adherence.
Speakers:
WS12.2 - Understanding EU Labeling Regulations
Awareness of labelling regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the labelling requirements in the EU that when correctly implemented allow you to avoid delays and supply chain disruptions.
Speakers:
WS13.2 - Resources to Assist Patients in Identifying and Navigating Clinical Trials
This workshop will identify one of the largest challenges we have in the clinical trial industry, which is finding and enrolling patients. It will provide a different perspective to help understand how we can support patients in finding appropriate clinical trials to treat or cure many of the diseases from which they suffer today.
Speakers:
WS14.2 - Navigating DTP - Stakeholder Perspectives & Challenges
DTP is a complex process with multiple stake holders with patients, investigators, site staff, pharmacies, depots, Health Authorities, Ethics Committees and couriers to name a few. GCSG DTP Team will lead discussion about varied stakeholder perspectives, experiences and lessons learned (sponsors, vendors, etc.).
Speakers:
Lunch - Exhibitor Displays Open
WS02.2 - Clinical Supply Chain Open Forum
This forum will give attendees the opportunity to ask questions and get solutions to some of their current challenges with their clinical supply chains.
Speakers:
WS06.2 - Using AI to predict enrollment & forecasting
Clinical supply's greatest challenge is patient enrolment. It is the greatest cause of supply chain turmoil. This workshop will discuss how AI is being used to not only accelerate enrolment but to predict it and how those trends can be used by the clinical supply chain.
Speakers:
WS09.2 - How to Accomplish Drug Pooling in Europe
Supplying multiple clinical trials from a pooled inventory of material provides a number of advantages. This workshop will focus on the challenges of doing pooling of supplies in Europe as well as provide some solutions to accomplish the most pooling possible.
Speakers:
WS11.2 - Inspection Readiness Across the Pipeline
Instilling an inspection ready culture in your operations groups is vital to success. Come to this session to discuss how to apply 80-20 rule, prepare for inspections & get ready for the inspection room as well as learn about some key tools to help you stay calm, succeed and always be inspection ready!
Speakers:
WS17.2 - Clinical Supplies Stakeholder Management
Clinical Supplies bridges the gap between many stakeholders (both internal and external stakeholders). Clinical Supplies are always being asked to expedite and be the most flexible amongst all the teams. This session will explore how cross-functional teams can collaborate effectively to develop a robust clinical supply strategy with accurate forecasting, strong vendor partnerships and smooth operational execution.
Speakers:
WS18.2 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process
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 while utilizing internal stakeholder inputs to update your metrics.
Speakers:
Room Transfer
WS01.2 - What to Consider When Getting into Cell & Gene Therapy
This workshop will be a discussion focused on the challenges of cell and gene therapy. Key topics to be discussed will include CGT's patient orientation, temperature controlled logistics, site requirements, manufacturing challenges and aggressive timing.
Speakers:
WS03.2 - Lessons Learned After 30 Years In Clinical Supplies
In 30 years, a lot could be learned in the clinical supply industry. This workshop will leverage SME's and participant's knowledge to provide solution to the attendee's biggest issues and questions.
Speakers:
WS07.2 - SMART Packaging for Adherence Measurement: Understanding the Impact on Supply Planning
Drug administration and compliance have always been a challenge. With the advent of SMART devices, this has become easier. This workshop will discuss how and why to integrate SMART technology into your supply chain to improve adherence.
Speakers:
WS08.2 - Compare & Contrast the Diverse Types of Access
This session provides a broad overview of the diverse mechanisms to support patients ability to access investigational drugs. In this workshop we will go over all these mechanisms which will enable you to successfully understand which is the best pathway based on the patient need. Topics covered will include compassionate use, off-label access, continued access, special license sales and right-to-try.
Speakers:
WS10.2 - QP Certification, your questions answered
Speakers:
WS15.2 - Building career success (in the way that you define it) and a great work-life balance
Interactive workshop, in which participants are guided through self-reflection, share and develop insights and leave with an action they can take immediately, to progress their careers and positively impact their work-life balance.
The exercise is designed to benefit the individuals, the companies they work for, the customers they serve, and the family and friends they care about.
In addition to enabling important self-reflection and action planning, the participants can take this approach back to the work-place to support conversations with their teams.
Speakers:
Room Transfer
Environmental Sustainability and the Supply of Medicines for use in Clinical Trials
Speakers:
