Day 1 : Tuesday, October 10
7:30 am - 8:30 am
Conference Logistics
Boot Camp Registration Open
8:00 am - 4:30 pm
Boot Camp / Seminar
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. Atttendees 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:
8:00 am - 4:30 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.
Speakers:
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.
Speakers:
3:00 pm - 5:30 pm
Conference Logistics
Exhibitor Set Up
3:00 pm - 5:30 pm
Conference Logistics
Registration Open
Registration Welcome sponsored by:
4:00 pm - 4:30 pm
Conference Logistics
Presenters / WS Facilitators Orientation
Are you speaking at a plenary session or facilitating one of our many workshops? If so, plan to join this session to learn all the last-minute tips and tricks you'll need to be a success!
4:30 pm - 5:30 pm
Showcase
Vendor Showcase: A Toolkit for Sourcing Commercial Medicines for your Clinical Trials - Hosted by Abacus Medicine Pharma Services
- Introduction to Abacus Medicine Pharma Services
- Expect the unexpected
- When to take action
- Tools to minimize the risk of disruption
Speakers:
4:30 pm - 5:30 pm
Showcase
Vendor Showcase: Cold Chain Logistics Assuring Product Integrity – Crucial Factors To Consider - Hosted by Clinigen
This session will discuss the most common challenges in ensuring the integrity of your product and which cold-chain supplies management methods to consider to mitigate the risk of temperature excursions.
Speakers:
4:30 pm - 5:30 pm
Showcase
Vendor Showcase: The Route to Sustainability - Hosted by Inceptua
The pandemic has impacted traditional ways of conducting business but now, 2 years later, industry has greatly diverted back to practices pre-pandemic. Evolution of research, macro economics and global sustainability are challenging the healthcare industry to innovate. In this session you will learn about the latest industry trends and a use-case on improving environmental sustainability.
Speakers:
5:45 pm - 6:15 pm
Presentation
Start The Knowledge Forum Right! - Conference Orientation
Whether this is your first time attending or you are an 'old pro', plan to join us at the conference orientation to learn how you can make the most of your time at the GCSG 2023 European Knowledge Forum!
6:30 pm - 8:30 pm
Networking
GCSG Meet & Greet Networking Event
Sponsored by:
Day 2 : Wednesday, October 11
7:30 am - 8:30 am
Networking
Registration Open - Exhibitor Displays Open
8:30 am - 9:00 am
Presentation
Welcome & Opening Remarks European GCSG Scholarship Announcement
9:00 am - 10:00 am
Presentation
Keynote Presentation: Shola Kaye - Sponsored by Calyx
Shola Kaye is the author of two books and an award-winning international speaker on Communication, Inclusive Leadership and Empathy at Work. She’s passionate about helping organisations create an atmosphere of belonging for their people. When a workplace is fully inclusive and welcoming, amazing things happen. People are transformed into leaders. Teams and groups perform better. Everyone gains. Shola’s work has appeared in a variety of industry journals, she’s a LinkedIn Learning instructor, and her clients include The United Nations and Deloitte.
Sponsored by:
Sponsored by:
10:00 am - 10:15 am
Break
Room transfer
10:15 am - 11:15 am
Workshop
WS01- Cell and Gene Therapy - Transitioning from Standard Clinical Supply Chains to Cell & Gene Supply Chains
How to transfer from Clinical Supply Chain in traditional Pharma to Cell Therapy Pharma. There are similarities, but many more differences such as extreme cold chain, label text differences, Chain of Custody/Chain of Identity Requirements, etc. This presentation will provide an overview of the similarities and differences as well as explain the exciting aspects of the cell therapy clinical supply chain.
Speakers:
10:15 am - 11:15 am
Workshop
WS02- Spotlight on China - More than tea and temples, What to know when planning your Clinical Supply Strategy for a population above 1.4 billion!
Awareness of the regulatory requirements across different agencies is critical for being a successful Clinical Trial Supplies professional. This workshop will discuss the regulatory requirements of China for Importation, Labeling and Distribution as well as how the rules impact CT supplies timelines and planning.
Speakers:
10:15 am - 11:15 am
Workshop
WS09- New Concepts in Pooling Supplies, Using Protocol Masters and Submission Strategy
Pooling of supplies has been in use for a number of years. Recently, there has been a new strategy to use master protocols for pooling somewhat similar to program-level pooling but with a single protocol. The greatest challenge when using this strategy is to align the regulatory filing requirements for each of the sub-protocols. This workshop will explain how to achieve the greatest success when using this pooling strategy.
Speakers:
10:15 am - 11:15 am
Workshop
WS10- Sharing Experiences of a Clinical Site Pharmacy and How to Improve
Hear first hand from a Clinical Trial Pharmacist, who will describe the clinical sites' challenges when using clinical supplies in support of a clinical trial. There will be explanations of ways a clinical trial can experience a deviation at the site due to clinical supply issues, inclduing daily challenges and ways to overcome and address from the sites perspective.
Speakers:
10:15 am - 11:15 am
Workshop
WS11- DTP in Action; Exchange on DTS experiences and Lessons Learned
During this workshop you will hear from industry experts on their experiences in DTP, and exchange valuable insights for all attending. This workshop will review some of the most successful patient centric approaches to clinical trials and their clincal supplies.
Speakers:
10:15 am - 11:15 am
Workshop
WS17- VAT Regulation & Rebate Options for Clinical Materials
Value added tax (VAT) can significantly increase your clinical trial budget. This workshop will look at ways to maximize your ability to reclaim VAT as a clinical trial sponsor.
Speakers:
11:15 am - 11:30 am
Break
Room transfer
11:30 am - 12:30 pm
Workshop
WS03- Industry Evolution - A vision of the clinical supply chain in the next decade
Our industry has experienced a tectonic shift in how we accomplish our mission and how we work together as teams. This WS will aim to provide valuable discussion on insights into where we are heading and what we could expect in the realm of clinical supplies.
Speakers:
11:30 am - 12:30 pm
Workshop
WS04- What to Know & What to Avoid to Experience the Greatest Success when Sourcing Comparators
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:
11:30 am - 12:30 pm
Workshop
WS06- Understanding Blockchain and Artificial Intelligence (AI) in the Clinical Supply Chain
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 workshop will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implemented into the Clinical Supply Chain.
Speakers:
11:30 am - 12:30 pm
Workshop
WS12- QP Certification- Your Questions Answered
Bring your experiences and Q&As to this interactive session to hear the insights of our QP colleagues, based on current regulations.
Speakers:
11:30 am - 12:30 pm
Workshop
WS14- Improving Communication: Getting Clinical Trial Supplies a Seat at the Table
In this workshop we will discuss ways to increase the influence of clinical supply colleagues, to achieve the best outcomes, the shortest timelines and the fewest number of changes to the clinical supply chain by working closely with our partners in clinical operations.
Speakers:
11:30 am - 12:30 pm
Workshop
WS16- Logistical challenges to Clinical Trial Management
The global reach of today's clinical trials makes understanding your product and its specific transit & import/export requirements a must for any clinical supply chain. This workshop will discuss ways to navigate the myriad of complex regulations involved in the import and export of clinical trial supplies, including valuation and harmonized system tariff codes.
Speakers:
12:30 pm - 1:45 pm
Networking
Lunch - Exhibitor Displays Open
1:45 pm - 2:45 pm
Workshop
WS01- Cell and Gene Therapy - Transitioning from Standard Clinical Supply Chains to Cell & Gene Supply Chains
How to transfer from Clinical Supply Chain in traditional Pharma to Cell Therapy Pharma. There are similarities, but many more differences such as extreme cold chain, label text differences, Chain of Custody/Chain of Identity Requirements, etc. This presentation will provide an overview of the similarities and differences as well as explain the exciting aspects of the cell therapy clinical supply chain.
Speakers:
1:45 pm - 2:45 pm
Workshop
WS02- Spotlight on China - More than tea and temples, What to know when planning your Clinical Supply Strategy for a population above 1.4 billion!
Awareness of the regulatory requirements across different agencies is critical for being a successful Clinical Trial Supplies professional. This workshop will discuss the regulatory requirements of China for Importation, Labeling and Distribution as well as how the rules impact CT supplies timelines and planning.
Speakers:
1:45 pm - 2:45 pm
Workshop
WS05- Optimising the Clinical Supply Chain with Digital Tracking Technologies
A vision of the digital supply chain includes GPS technology and smart packaging. The utilisation of GPS tracking and such technologies is common for Autologous Cell Therapy products and it's use in clinical trial setting was accelerated to mitigate risk during COVID times. This intereactive discussion will cover how the Digital Supply Chain is evolving and becoming common place as we enter 2024.
Speakers:
1:45 pm - 2:45 pm
Workshop
WS10- Sharing Experiences of a Clinical Site Pharmacy and How to Improve
Hear first hand from a Clinical Trial Pharmacist, who will describe the clinical sites' challenges when using clinical supplies in support of a clinical trial. There will be explanations of ways a clinical trial can experience a deviation at the site due to clinical supply issues, inclduing daily challenges and ways to overcome and address from the sites perspective.
Speakers:
1:45 pm - 2:45 pm
Workshop
WS11- DTP in Action; Exchange on DTS experiences and Lessons Learned
During this workshop you will hear from industry experts on their experiences in DTP, and exchange valuable insights for all attending. This workshop will review some of the most successful patient centric approaches to clinical trials and their clincal supplies.
Speakers:
1:45 pm - 2:45 pm
Workshop
WS13- Understanding the EU requirements for Auxiliary Medicinal Products (AMPs)
Under the Clinical Trial Regulation, Auxiliary Medicines have been categorized as Authorised and Unauthorised, and there are requirements that go along with each. What does the Regulation have to say about Auxiliary Medicines and how does that impact sponsors and how these are sourced and labelled? We also invite attendees to share different strategies they have used under the CTR for auxiliary medicines.
Speakers:
2:45 pm - 3:00 pm
Break
Room transfer
3:00 pm - 4:00 pm
Presentation
Patient Testimonial: Cathy Molohan
Cathy is co-founder and former CFO/CHRO of EnglishBusiness AG (management training, facilitation and translations) but gave up this role in 2020 to dedicate herself to Parkinson’s advocacy and consultancy. She is responsible for International Relations at Yuvedo, a foundation committed to accelerating the search for a cure for Parkinson’s and helping those affected to live better lives until a cure is found. Cathy has spoken at the World Parkinson Congress, Kyoto, 2019; is a member of the Roche Parkinson’s patient council and serves as a consultant on digital biomarkers and patient centricity for various companies.
Cathy was born in Ireland and has lived in Germany for 25 years. She is married with 2 children (Keira, 18 and Conor, 14).
Cathy was diagnosed with Parkinson’s in 2011, aged 38. She is an eternal optimist and believer in the power of communication!
Cathy was born in Ireland and has lived in Germany for 25 years. She is married with 2 children (Keira, 18 and Conor, 14).
Cathy was diagnosed with Parkinson’s in 2011, aged 38. She is an eternal optimist and believer in the power of communication!
4:00 pm - 4:15 pm
Presentation
Closing Remarks
4:15 pm - 5:30 pm
Networking
Vendor Reception & PRIZE DRAWS!
5:30 pm - 6:00 pm
Break
Personal Time
6:00 pm - 6:15 pm
Conference Logistics
Departure for GCSG Night Out at Hotel Reception
6:30 pm - 12:00 am
Networking
GCSG Night Out - Sponsored by PCI
Sponsored by:
10:30 pm - 12:00 am
Networking
Departures to Hotel
11:59 pm - 3:00 am
Networking
After hour event
Day 3 : Thursday, October 12
8:00 am - 8:30 am
Networking
Registration Open - Exhibitor Displays Open
8:45 am - 9:00 am
Presentation
Opening Remarks
9:00 am - 10:00 am
Presentation
Panel Discussion: DTP Implications for Europe
Speakers:
10:00 am - 10:15 am
Break
Room transfer
10:15 am - 11:15 am
Workshop
WS03- Industry Evolution - A vision of the clinical supply chain in the next decade
Our industry has experienced a tectonic shift in how we accomplish our mission and how we work together as teams. This WS will aim to provide valuable discussion on insights into where we are heading and what we could expect in the realm of clinical supplies.
Speakers:
10:15 am - 11:15 am
Workshop
WS04- What to Know & What to Avoid to Experience the Greatest Success when Sourcing Comparators
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:
10:15 am - 11:15 am
Workshop
WS07- Expanded 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:
10:15 am - 11:15 am
Workshop
WS08- How to Conduct Efficient IRT UAT
IRT systems have been in use for more than 20 years, but there is still functionality that users may not be aware of that could improve their chances of success in the clinical supply chain. This workshop focuses on industry best practices to improve IRT UAT preparation and execution, all the way from URS creation to Go-Live, while meeting the required functionality for the trial and the regulatory requirements regarding UAT.
Speakers:
10:15 am - 11:15 am
Workshop
WS15- The Clinical Supply Chain Professional Toolkit
This workshop will focus on innovative tools and techniques to address legacy and present day challenges within Clinical Supply Chain.
Speakers:
10:15 am - 11:15 am
Workshop
WS17- VAT Regulation & Rebate Options for Clinical Materials
Value added tax (VAT) can significantly increase your clinical trial budget. This workshop will look at ways to maximize your ability to reclaim VAT as a clinical trial sponsor.
Speakers:
11:15 am - 11:30 am
Break
Room transfer
11:30 am - 12:30 pm
Workshop
WS05- Optimising the Clinical Supply Chain with Digital Tracking Technologies
A vision of the digital supply chain includes GPS technology and smart packaging. The utilisation of GPS tracking and such technologies is common for Autologous Cell Therapy products and it's use in clinical trial setting was accelerated to mitigate risk during COVID times. This intereactive discussion will cover how the Digital Supply Chain is evolving and becoming common place as we enter 2024.
Speakers:
11:30 am - 12:30 pm
Workshop
WS06- Understanding Blockchain and Artificial Intelligence (AI) in the Clinical Supply Chain
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 workshop will explain what Blockchain and AI are and discuss how they are transitioning from theoretical concepts to how they are being implemented into the Clinical Supply Chain.
Speakers:
11:30 am - 12:30 pm
Workshop
WS09- New Concepts in Pooling Supplies, Using Protocol Masters and Submission Strategy
Pooling of supplies has been in use for a number of years. Recently, there has been a new strategy to use master protocols for pooling somewhat similar to program-level pooling but with a single protocol. The greatest challenge when using this strategy is to align the regulatory filing requirements for each of the sub-protocols. This workshop will explain how to achieve the greatest success when using this pooling strategy.
Speakers:
11:30 am - 12:30 pm
Workshop
WS13- Understanding the EU requirements for Auxiliary Medicinal Products (AMPs)
Under the Clinical Trial Regulation, Auxiliary Medicines have been categorized as Authorised and Unauthorised, and there are requirements that go along with each. What does the Regulation have to say about Auxiliary Medicines and how does that impact sponsors and how these are sourced and labelled? We also invite attendees to share different strategies they have used under the CTR for auxiliary medicines.
Speakers:
11:30 am - 12:30 pm
Workshop
WS14- Improving Communication: Getting Clinical Trial Supplies a Seat at the Table
In this workshop we will discuss ways to increase the influence of clinical supply colleagues, to achieve the best outcomes, the shortest timelines and the fewest number of changes to the clinical supply chain by working closely with our partners in clinical operations.
Speakers:
11:30 am - 12:30 pm
Workshop
WS18- Preparing to Outsource & Selecting the Right Vendor
Outsourcing has become the norm in our industry, yet we still see issues on both sides of the table. This workshop will provide insights into how to decrease risk and increase success when partnering.
Speakers:
12:30 pm - 1:15 pm
Networking
Lunch - Exhibitor Displays Open
1:00 pm - 2:00 pm
Showcase
Vendor Showcase: Comparator Sourcing Strategies, What’s New? - Hosted by Inceptua
Attendees may be very familiar with central sourcing, local sourcing and site sourcing strategies when it comes to comparator sourcing. All have meaningful use-cases, benefits but also risks. This educational session will give you insights on traditional comparator sourcing strategies in a practical way that you can take back to your company situation and will also introduce some new tools and solutions developed in response to the evolving needs in our industry.
Speakers:
1:00 pm - 2:00 pm
Showcase
Vendor Showcase: Evolution of RTSM Forecasting Technology in the Face of Increasing Trial Protocol Complexity - Hosted by 4G
Clinical trials are increasingly complex and expensive, meaning that RTSM forecasting technology has to evolve to keep up. Instead of the single forecasting algorithm which was previously used in all trials, modern RTSM platforms support a portfolio of forecasting algorithms to choose from. To leverage this technology, RTSM vendors are collaborating with sponsors to identify and implement the optimal forecasting setup for each trial
Speakers:
1:00 pm - 2:00 pm
Showcase
Vendor Showcase: Temperature Monitoring Strategies in Decentralized Trials - Hosted by TSS
In light of the recent EMA and FDA guidelines, this session will discuss what role temperature monitoring may play in decentralized (DCT) and direct-to-patient (DTP) studies.
Speakers:
2:00 pm - 2:15 pm
Break
Room transfer
2:15 pm - 3:15 pm
Workshop
WS07- Expanded 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:
2:15 pm - 3:15 pm
Workshop
WS08- How to Conduct Efficient IRT UAT
IRT systems have been in use for more than 20 years, but there is still functionality that users may not be aware of that could improve their chances of success in the clinical supply chain. This workshop focuses on industry best practices to improve IRT UAT preparation and execution, all the way from URS creation to Go-Live, while meeting the required functionality for the trial and the regulatory requirements regarding UAT.
Speakers:
2:15 pm - 3:15 pm
Workshop
WS12- QP Certification- Your Questions Answered
Bring your experiences and Q&As to this interactive session to hear the insights of our QP colleagues, based on current regulations.
Speakers:
2:15 pm - 3:15 pm
Workshop
WS15- The Clinical Supply Chain Professional Toolkit
This workshop will focus on innovative tools and techniques to address legacy and present day challenges within Clinical Supply Chain.
Speakers:
2:15 pm - 3:15 pm
Workshop
WS16- Logistical challenges to Clinical Trial Management
The global reach of today's clinical trials makes understanding your product and its specific transit & import/export requirements a must for any clinical supply chain. This workshop will discuss ways to navigate the myriad of complex regulations involved in the import and export of clinical trial supplies, including valuation and harmonized system tariff codes.
Speakers:
2:15 pm - 3:15 pm
Workshop
WS18- Preparing to Outsource & Selecting the Right Vendor
Outsourcing has become the norm in our industry, yet we still see issues on both sides of the table. This workshop will provide insights into how to decrease risk and increase success when partnering.
Speakers:
3:15 pm - 3:30 pm
Break
Room transfer
3:30 pm - 4:15 pm
Presentation
Closing Remarks, Survey Completion, Prize Draws
4:15 pm - 4:45 pm
Presentation
