Day 1 : Sunday, May 1
8:00 am - 4:00 pm
Boot Camp / Seminar
Import / Export, Trade Compliance & Value Added Tax: Beyond the Fundamentals
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.
3:00 pm - 5:30 pm
Conference Logistics
Exhibitor Setup
3:00 pm - 6:00 pm
Conference Logistics
Registration / Information / Welcome Table Open
4:30 pm - 5:00 pm
Conference Logistics
Speaker / Facilitator Meeting / Tour of Workshop Rooms
5:00 pm - 5:30 pm
Conference Logistics
Conference Orientation
6:00 pm - 8:00 pm
Networking
Meet & Greet - GCSG Networking Event
8:00 pm - 12:00 am
Networking
After Hours
Day 2 : Monday, May 2
6:30 am - 7:15 am
Networking
Yoga
7:30 am - 8:15 am
Conference Logistics
Breakfast
7:30 am - 8:15 am
Networking
Exhibitor Displays Open
7:30 am - 4:30 pm
Conference Logistics
Registration / Information / Welcome Table Open
8:15 am - 8:30 am
Conference Logistics
Room Transfer
8:30 am - 8:50 am
Presentation
Welcome & Opening Remarks
8:50 am - 10:00 am
Presentation
Keynote Address: Courtney Clark
Keynote Speaker, Courtney Clark, is the luckiest unlucky person in the world. After a series of major struggles beginning in her mid-20s, she has built two successful businesses and is the author of two books. She works with people who want to adapt faster and achieve more, and has spoken worldwide to organizations like Procter & Gamble, Dell, S&P, Humana, Cisco, and Cardinal Health.
Courtney’s resilience work has been called “practical,” “powerful,” and “empowering” by industry leaders, and she’s been featured in Forbes, Psychology Today, USA Today, and The Chicago Tribune.
Speakers:
10:00 am - 10:10 am
Presentation
Hybrid Conference Welcome!
We are so happy that even though you weren't able to join us in San Antonio, you will be joining us virtually for the GCSG 2022 US Conference! We are excited to be offering this option and hope that you get a lot out of it.
10:00 am - 10:15 am
Conference Logistics
Room Transfer
10:15 am - 11:15 am
Workshop
Brexit: Lessons Learned & Main Takeaways for the World (WS19)
Brexit was finally implemented at the end of 2020. This workshop will discuss the ongoing impacts that it has introduced to the clinical supply chain and how to overcome the challenges of packaging and distributing clinical supplies in the EU-27 and the UK.
10:15 am - 11:15 am
Workshop
Comparator Sourcing: Best Practices & Innovation in Procurement & Supply Chain (WS12)
This workshop will discuss the options for establishing a successful comparator program including acquisition, pedigree, distribution and reconciliation.
10:15 am - 11:15 am
Workshop
Direct-to-Patient: The Benefits & Why it Should Continue (L01)
This workshop will discuss what we've learned about the value of direct-to-patient (DtP) distribution during the pandemic & why we need to keep it as an option for clinical trials and clinical supplies.
10:15 am - 11:15 am
Workshop
Emotional Intelligence & Leadership in Clinical Supplies (WS21)
As Millenials & Gen Z's become the majority in our workplaces, it is essential for today's leaders to understand the value of emotional intelligence and new styles of leadership in order to attract, engage and retain this incredible workforce.
10:15 am - 11:15 am
Workshop
Harmonizing IP Supply & Demand Plans Throughout the Trial (WS05)
The importance of maintaining the harmony across investigational product supply and demand is essential. This workshop will discuss practical and tactical ways to do that.
Speakers:
10:15 am - 11:15 am
Workshop
IMP/CTM Information Required for Regulatory Filings (WS30)
The CMC section of the IND/IMPD contains information that has a direct impact on clinical trial supplies. Failure to prepare IMP that follows the requirements listed in this section can have a significant impact on a clinical trial. This session will discuss the CMC information contained in a clinical trial regulatory filing and how it should be monitored to avoid issues with clinical supplies.
10:15 am - 11:15 am
Workshop
Maintaining Cohesion in a Remotely-Managed Clinical Supply Team (WS04)
The pandemic showed us the importance of being able to work remotely. This workshop will discuss ways to increase the cohesiveness of a remote clinical supplies team.
10:15 am - 11:15 am
Workshop
Risk-Based Management: Tools for the Clinical Supply Chain (WS32)
ICH Q9 has been in effect for over a decade, yet most of us don't have an effective risk evalution and mitigation strategy process. This workshop will explore ways to better document and control risk-based management using real life stories and experiences.
10:15 am - 11:15 am
Workshop
Taking the Fear Out of Regulatory Audits (WS23)
Nothing creates a greater level of gut-wrenching anxiety than being audited by a regulatory agency. This workshop will discuss tips, techniques and best practices to being inspection ready, properly prepared to handle a regulatory audit and able to appropriately interact with inspectors/investigators.
11:15 am - 11:30 am
Conference Logistics
Room Transfer
11:30 am - 12:30 pm
Workshop
Autologous and Allogenic Supply Chains – Best Practices (WS02)
This session will cover the differences autologous & allogeneic cell and gene supply chains using a case study.
Speakers:
11:30 am - 12:30 pm
Workshop
Decentralized Clinical Trial Supply Chains (WS11)
This workshop will identify how some companies are using centralized locations to ship medications. The focus will be on how to establish a network of sites & depots that ship within their own network in support of decentralized trials and the pros and cons of doing so.
Speakers:
11:30 am - 12:30 pm
Workshop
EU Clinical Trial Regulation (Annex 6) Update (L02)
The Clinical Trial Regulation went into effect on 31 January 2022. Perhaps the most positive aspect of the regulation will be the ability to file a clinical trial application (CTA) part 1 submission in multiple EU countries all at one time. This filing will be submitted through the clinical trial information system (CTIS). While there is a great deal of information and guidance on how to populate data into the CTIS available, this workshop will discuss the upside and challenges of the CTIS and identify key experiences and necessary clinical supply information to help the attendee better navigate the portal to help your company have the greatest possible success in all future CTA filings.
Speakers:
11:30 am - 12:30 pm
Workshop
How SMART Devices Can Improve Drug Administration (WS06)
Drug administration and compliance have always been a challenge. With the advent of SMART device technology, this has become easier. This workshop will discuss how and why to integrate SMART devices into your supply chain.
11:30 am - 12:30 pm
Workshop
JIT Labeling Success By Collaborating Early With QA (WS13)
This workshop will discuss just-in-time (JIT) labeling and how the regulatory landscape has changed to increase QA's support. The focus will be on partnering early with QA to understand and mitigate their concerns in order to get buy-in from the very beginning.
11:30 am - 12:30 pm
Workshop
Metrics - What Are Valuable Metrics to Use for Clinical Supplies? (WS31)
As we all know, metrics drive performance. Having the right metrics in place makes all the difference between focusing on the right things or the wrong things. This workshop will identify the best metrics to use to drive the best clinical supply outcomes.
Speakers:
11:30 am - 12:30 pm
Workshop
Operational Excellence in Different Working Structures (WS15)
In the chaotic world of clinical supplies, establishing Operational Excellence is invaluable to decreasing the waste of time, manpower and materials while also minimizing errors and rework. This workshop will explain how to implement Operational Excellence as part of the clinical supply chain.
11:30 am - 12:30 pm
Workshop
Outsourced Clinical Supply Management Models (WS03)
During this session we will share various tips and tricks to getting the best outcomes when managing an outsourced clinical supply chain.
11:30 am - 12:30 pm
Workshop
Regulatory, Labeling & Customs Requirements for CTM in Latin America (LATAM) (WS22)
Awareness of the regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the regulatory requirements of Latin American countries and how they impact clinical trial supply timelines and planning.
12:30 pm - 1:30 pm
Conference Logistics
Lunch / Exhibitor Displays Open
12:30 pm - 1:30 pm
Showcase
Vendor Showcase - DTP Phases of Maturity - How to Advance Maturity Using Technology to Create Sustainable & Patient-centric Supply Chains - Co-hosted by Signant Health & Marken
Many sponsors are running their Direct to Patient (DtP) supply chains manually, without proper technology to enable efficient and patient-centric processes. Learn how a technology-driven model, bundled with logistics expertise, can shift your DtP capabilities from a “one-off” situation into a standard operating procedure.
12:30 pm - 1:30 pm
Showcase
Vendor Showcase - New Opportunities to Automate Temperature Management in Clinical Studies - Reduce Quarantines in Your Clinical Studies by over 90% - Hosted by TSS & endpoint Clinical
Advances in automation, Cloud, and IoT technologies are enabling sponsors to achieve striking advances in handling temperature management in clinical trials. This session will cover the following:
- Understand how automating the review process can decrease your excursions by over 90%
- How next-gen data collection technology can ease the burden for sites while ensuring compliance
- The importance of integration with the broader eClinical ecosystem
12:30 pm - 1:30 pm
Showcase
Vendor Showcase - Overcoming supply chain risks to ensure clinical trial continuity - Case Study: How to manage a stockout crisis without impacting patients and recruitment? - Hosted by N-Side
N-SIDE will share its experience and introduce the main drivers of risk and stockout in the clinical trial supply chain. Join us to learn how to mitigate these risks while ensuring absolutely no impact on your clinical trial timelines or patients.
- Learn how to identify, locate and quantify risks
- Discover the main causes of risk in the clinical supply chain
- Mitigate risk without going too far - learn how to find innovative solutions to eliminate stockout without slowing down recruitment
Case Study: Avoiding 500 missed dispensing visits without halting recruitment. Follow N-SIDE in the process of saving a trial in 5 days.
- Learn how to identify, locate and quantify risks
- Discover the main causes of risk in the clinical supply chain
- Mitigate risk without going too far - learn how to find innovative solutions to eliminate stockout without slowing down recruitment
Case Study: Avoiding 500 missed dispensing visits without halting recruitment. Follow N-SIDE in the process of saving a trial in 5 days.
1:30 pm - 1:45 pm
Conference Logistics
Room Transfer
1:45 pm - 2:45 pm
Presentation
Covid-19 Supply Chain: Managing Risk & Disruption - Panel Discussion
COVID-19 impacted the world in ways no one could have imagined at the start of the pandemic. It has transformed our workforce, our brick & mortar sites and our supply chain. The gaps created in the supply chain exposed companies to the vulnerabilities of their supply chains in a very real way. From making API in China, to getting disenfectant (and toilet paper) for sites to remain operational to the avialability of flights for international shipments - our supply chain and the way we plan it will never be the same. Hear from some industry colleagues about how their companies were able to mitigate the risk and turn the disruption into something positive for the clinical supply chain.
Speakers:
2:45 pm - 3:15 pm
Presentation
Closing Remarks & Raffle Drawings
3:15 pm - 4:45 pm
Networking
Exhibitor Displays Open
4:45 pm - 5:45 pm
Showcase
Vendor Showcase - Flexible Supply Management to Achieve Efficient Operations - Hosted by Medidata
We continue to make study execution more complex in order to achieve scientific results. However, taking a simplified approach to study design can result in a successful trial that is easier to run and support. Matching the level of complexity to the needs of the study is key to achieving efficient operations. We will review the application of clinical supply management technologies for this objective.
4:45 pm - 5:45 pm
Showcase
Vendor Showcase - Re-envisioning the Commercial Supply Chain with SaaS-based Solutions to Deliver Transparent, Virtual, Game-Changing Value - Hosted by SupplyRx
From concept-to-cloud, SupplyRx introduces their next-generation SaaS-based solution for virtual clinical supply through pharmacies (specialty, LDD, retail & mail-order) in North America. Please join us to learn the many benefits of a virtual cloud-based system for patients, sites, sponsors and CROs. A perfect solution for studies requiring approved medicines (standard of care, rescue, cold-chain, specialty or LDD) and ancillary supplies. Benefits include increased transparency, lower costs, no inventory to manage or store, no traditional supply chain costs and you only pay for what is dispensed. Accountability is seamless with on-line reporting and all claims are linked by site and subject.
Supply simplified. Savings optimized. Trials maximized.
Supply simplified. Savings optimized. Trials maximized.
- Case Study 1 – Benefits in Oncology
- Case Study 2 – Large Pharma – Cost savings with decreased site burden while rescuing study mid-stream
4:45 pm - 5:45 pm
Showcase
Vendor Showcase - What Comparator Sourcing Issues Caused You to Lose Sleep in 2021? - Hosted by Abacus Medicine
An interactive session where Ian Hoban, Business Development Director and Clinical Trial Solutions lead, will introduce the rebranded Abacus Medicine Pharma Services (formerly Aposave) and then present An Overview of the 2021 Annual Survey of Clinical Trials Supplies Professionals and interim 2022 results, followed by:
- Discussion of key issues uncovered
- Our interpretation of survey
- What killer questions do you want answered next year?
6:00 pm - 9:00 pm
Networking
GCSG Night Out - "Texas State Fair"
9:00 pm - 12:00 am
Networking
After Hours
Day 3 : Tuesday, May 3
7:30 am - 8:15 am
Conference Logistics
Breakfast
7:30 am - 8:15 am
Networking
Exhibitor Displays Open
7:30 am - 4:30 pm
Conference Logistics
Registration / Information / Welcome Table Open
8:15 am - 8:30 am
Conference Logistics
Room Transfer
8:30 am - 8:45 am
Presentation
Welcome & Opening Remarks
8:45 am - 9:45 am
Presentation
Keynote Address: Sarita Maybin
Sarita Maybin provides her audiences with the skills to transform uncomfortable conversations into constructive communication. With real stories, real solutions, and a relatable presence, she breaks down barriers to reveal how to work together better.
In her 20+ years as an international speaker and communication expert, Sarita has spoken in all 50 states, 10 countries—including Iceland—and on the prestigious TEDx stage. Her extensive client list includes Hewlett-Packard, Los Angeles County, Kaiser Permanente, Department of the Navy, University of California and many others.
Sarita has made it her mission to inspire others to embrace positivity, even amid the challenges of our ever-changing high-tech times. Raised as a "military brat" moving from country to country, Sarita quickly learned how to make fast friends and finesse stressful situations.
She is a former university dean of students and literally wrote the book on how to answer the perpetually perplexing question: If You Can't Say Something Nice, What DO You Say? She continues the conversation on what to say in her new book Say What You Mean in a Nice Way.
In her 20+ years as an international speaker and communication expert, Sarita has spoken in all 50 states, 10 countries—including Iceland—and on the prestigious TEDx stage. Her extensive client list includes Hewlett-Packard, Los Angeles County, Kaiser Permanente, Department of the Navy, University of California and many others.
Sarita has made it her mission to inspire others to embrace positivity, even amid the challenges of our ever-changing high-tech times. Raised as a "military brat" moving from country to country, Sarita quickly learned how to make fast friends and finesse stressful situations.
She is a former university dean of students and literally wrote the book on how to answer the perpetually perplexing question: If You Can't Say Something Nice, What DO You Say? She continues the conversation on what to say in her new book Say What You Mean in a Nice Way.
Speakers:
9:45 am - 10:00 am
Conference Logistics
Room Transfer
10:00 am - 11:00 am
Workshop
Comparator Sourcing: Best Practices & Innovation in Procurement & Supply Chain (WS12)
This workshop will discuss the options for establishing a successful comparator program including acquisition, pedigree, distribution and reconciliation.
10:00 am - 11:00 am
Workshop
Decentralized Clinical Trial Supply Chains (WS11)
This workshop will identify how some companies are using centralized locations to ship medications. The focus will be on how to establish a network of sites & depots that ship within their own network in support of decentralized trials and the pros and cons of doing so.
Speakers:
10:00 am - 11:00 am
Workshop
Early CTIS Experience from a Clinical Supply Perspective & Annex VI Current Status (L03)
Discussion regarding the current experiences with CTA submissions now that the Clinical Trial Regulation has become applicable as of 31 Jan 2022. What are the hot industry topics and how has the CTR impacted supply planning for studies conducted in the EU.
Speakers:
10:00 am - 11:00 am
Workshop
Emotional Intelligence & Leadership in Clinical Supplies (WS21)
As Millenials & Gen Z's become the majority in our workplaces, it is essential for today's leaders to understand the value of emotional intelligence and new styles of leadership in order to attract, engage and retain this incredible workforce.
10:00 am - 11:00 am
Workshop
Harmonizing IP Supply & Demand Plans Throughout the Trial (WS05)
The importance of maintaining the harmony across investigational product supply and demand is essential. This workshop will discuss practical and tactical ways to do that.
Speakers:
10:00 am - 11:00 am
Workshop
IMP/CTM Information Required for Regulatory Filings (WS30)
The CMC section of the IND/IMPD contains information that has a direct impact on clinical trial supplies. Failure to prepare IMP that follows the requirements listed in this section can have a significant impact on a clinical trial. This session will discuss the CMC information contained in a clinical trial regulatory filing and how it should be monitored to avoid issues with clinical supplies.
10:00 am - 11:00 am
Workshop
Maintaining Cohesion in a Remotely-Managed Clinical Supply Team (WS04)
The pandemic showed us the importance of being able to work remotely. This workshop will discuss ways to increase the cohesiveness of a remote clinical supplies team.
10:00 am - 11:00 am
Workshop
Outsourced Clinical Supply Management Models (WS03)
During this session we will share various tips and tricks to getting the best outcomes when managing an outsourced clinical supply chain.
10:00 am - 11:00 am
Workshop
Risk-Based Management: Tools for the Clinical Supply Chain (WS32)
ICH Q9 has been in effect for over a decade, yet most of us don't have an effective risk evalution and mitigation strategy process. This workshop will explore ways to better document and control risk-based management using real life stories and experiences.
10:00 am - 11:00 am
Workshop
Taking the Fear Out of Regulatory Audits (WS23)
Nothing creates a greater level of gut-wrenching anxiety than being audited by a regulatory agency. This workshop will discuss tips, techniques and best practices to being inspection ready, properly prepared to handle a regulatory audit and able to appropriately interact with inspectors/investigators.
11:00 am - 11:15 am
Conference Logistics
Room Transfer
11:15 am - 12:15 pm
Workshop
Challenges of Importing/Exporting CTM Into & Out of the U.S. (WS08)
Many people don't realize how challenging it is to bring clinical supply materials into the U.S. This workshop will discuss the use of the Automated Commercial Environment (ACE) system for import and how to export clinical supplies more smoothly and efficiently.
Speakers:
11:15 am - 12:15 pm
Workshop
Clinical Supply Chain Challenges When Working With Emerging Markets in Asia-Pac (WS17)
Asia-Pac is a large and diverse array of countries, people, markets and clinical sites. This workshop will identify some of the more common issues and pitfalls with the clinical supply chain and how to overcome them.
11:15 am - 12:15 pm
Workshop
How SMART Devices Can Improve Drug Administration (WS06)
Drug administration and compliance have always been a challenge. With the advent of SMART device technology, this has become easier. This workshop will discuss how and why to integrate SMART devices into your supply chain.
11:15 am - 12:15 pm
Workshop
IoR: The Ins & Outs of Global Distribution (WS26)
Ever have a shipment going to another country 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.
11:15 am - 12:15 pm
Workshop
Metrics - What Are Valuable Metrics to Use for Clinical Supplies? (WS31)
As we all know, metrics drive performance. Having the right metrics in place makes all the difference between focusing on the right things or the wrong things. This workshop will identify the best metrics to use to drive the best clinical supply outcomes.
Speakers:
11:15 am - 12:15 pm
Workshop
Operational Excellence in Different Working Structures (WS15)
In the chaotic world of clinical supplies, establishing Operational Excellence is invaluable to decreasing the waste of time, manpower and materials while also minimizing errors and rework. This workshop will explain how to implement Operational Excellence as part of the clinical supply chain.
11:15 am - 12:15 pm
Workshop
Packaging Technology for Clinical Supplies (WS29)
Knowing the best materials and their specifications is invaluable to ensuring stability and compliance. This workshop will explain packaging technology information and requirements to help small companies choose the best clinical supply packaging solutions.
Speakers:
11:15 am - 12:15 pm
Workshop
Project Management Best Practices for Clinical Supplies (WS14)
This workshop will focus on defining good project management for clinical supplies and the tools and techniques to ensure projects stay on time and on budget while collaborating with all key stakeholders.
11:15 am - 12:15 pm
Workshop
The Covid-19 Pandemic and How Our Industry Has Evolved (L04)
The Covid pandemic created hurdles and challenges that were difficult to overcome. This workshop will provide an overview as to where our industry was pre-pandemic and the systems and practices we have implemented to overcome the pandemic. The discussion will include insights into how much we have evolved, adapted and flexed to be successful.
Speakers:
11:15 am - 12:15 pm
Workshop
Using Expanded Access: Understanding Supply Chain Requirements, Planning and Forecasting (WS18)
This interactive presentation will give an overview of expanded access/compassionate use programs and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.
Speakers:
12:15 pm - 1:30 pm
Conference Logistics
Lunch / Exhibitor Displays Open
12:30 pm - 1:30 pm
Showcase
Vendor Showcase - Advancing IRT into the Future - Hosted by YPrime
This session will benefit advanced clinical supply IRT users and technology innovation-minded professionals alike. We will examine the age-old statement, "IRT should only do two things - randomize patients and manage clinical supply." Is it time for this statement to evolve? If so, what will the future hold for IRT in the clinical supply manager's toolkit?
- How IRT supports DCT today and the impact of IRT’s evolution
- Advanced IRT functionalities for today's clinical supply chain
- The next evolution of integrated IRT and clinical supply systems
12:30 pm - 1:30 pm
Showcase
Vendor Showcase - Integrated Forecasting and RTSM Solution to Help Address Complex Trial Supply Networks - Hosted by 4G
The seamless workflow between 4G Clinical’s Prancer RTSMⓇ and 4C SupplyⓇ solutions will be showcased. Together, these solutions provide increased control and visibility over supply chain decisions within complex networks. 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.
12:30 pm - 1:30 pm
Showcase
Vendor Showcase - Navigating Supply Chain Complexities for Cell and Gene Treatments - Hosted by Marken
With the growing complexities of Cell and Gene treatment journeys in a post-pandemic world, the supply chain continues to have many unique challenges. This session will discuss the key obstacles of delivering personalized medicine, explore strategic solutions for an integrated value chain and cover valuable lessons learned and best practices to accelerate the scale and availability of advanced therapies.
1:30 pm - 1:45 pm
Conference Logistics
Room Transfer
1:45 pm - 2:45 pm
Workshop
Ancillary Supply Management & IRT Integration (WS07)
As the use of ancillary supplies grows in clinical trials, using an IRT to manage them has become invaluable. This workshop will discuss how to integrate ancillary supplies into your IRT design implementation.
Speakers:
1:45 pm - 2:45 pm
Workshop
Blinding Considerations When Utilizing an IRT Configured for Resupply Operations (WS25)
If an IRT is improperly configured, you can unblind the site and/or the entire study. This workshop will discuss how to properly design and create specifications to ensure the right people are blinded throughout the study and especially during resupply operationsBlinding Considerations When Utilizing an IRT Configured for Resupply Operations
1:45 pm - 2:45 pm
Workshop
Brexit: Lessons Learned & Main Takeaways for the World (WS19)
Brexit was finally implemented at the end of 2020. This workshop will discuss the ongoing impacts that it has introduced to the clinical supply chain and how to overcome the challenges of packaging and distributing clinical supplies in the EU-27 and the UK.
1:45 pm - 2:45 pm
Workshop
Decentralized Clinical Trials in APAC - An Emerging Market (WS16)
As clinical supply chains expand into Asia-Pac, two areas of opportunity identified during the pandemic were the implementation of decentralized trials (DCTs) and direct-to-patient distribution (DtP). This workshop will identify ways to leverage DCTs while avoiding the pitfalls of working in these emerging markets.
1:45 pm - 2:45 pm
Workshop
Direct-to-Patient: The Benefits & Why it Should Continue (L01)
This workshop will discuss what we've learned about the value of direct-to-patient (DtP) distribution during the pandemic & why we need to keep it as an option for clinical trials and clinical supplies.
1:45 pm - 2:45 pm
Workshop
Diversity in the Clinical Supplies Industry – Let’s Talk! (WS33)
An opportunity to talk about what our companies are doing (or we would like to see them doing) as it relates to increasing diversity, equity and inclusion (DEI) in hiring. We will also talk more about a new e-Team in GCSG that will focus on DEI in our industry.
1:45 pm - 2:45 pm
Workshop
Regulatory, Labeling & Customs Requirements for CTM in Latin America (LATAM) (WS22)
Awareness of the regulatory requirements across different agencies is critical for being a successful clinical trial supply professional. This workshop will discuss the regulatory requirements of Latin American countries and how they impact clinical trial supply timelines and planning.
1:45 pm - 2:45 pm
Workshop
Strategies for Programming Resupply Strategies Into Your IRT/RTSM (WS09)
This workshop will discuss the factors to consider when determining resupply strategies while using an IRT. While many people think this is something that is programmed into the IRT, it requires well-defined specifications for it to work well.
1:45 pm - 2:45 pm
Workshop
Using Value Stream Mapping to Improve Clinical Supply Chain Efficiency (WS27)
Value stream mapping is a lean management method that allows you to visualize, analyze and improve all the steps in a product delivery process. This workshop will focus on how to utilize value stream mapping for the clinical supply chain.
Speakers:
2:45 pm - 3:00 pm
Conference Logistics
Room Transfer
3:00 pm - 4:00 pm
Presentation
Clinical Trial Supplies: Creating (& Keeping) the Workforce of the Future - Panel Discussion
Recruiting and holding on to that next generation of stars in your organization is critical for accomplishing current and future goals. In this panel, we will discuss the ways we currently recruit talent and what needs to change in order to hire & keep the talent that will sustain our industry into 2030 and beyond.
Speakers:
4:00 pm - 4:15 pm
Presentation
Closing Remarks & Raffle Drawings
4:15 pm - 6:15 pm
Networking
Vendor Reception / Exhibitor Displays Open
9:00 pm - 12:00 am
Networking
After Hours
Day 4 : Wednesday, May 4
7:30 am - 8:45 am
Conference Logistics
Breakfast
7:30 am - 8:30 am
Networking
Exhibitor Displays Open
7:30 am - 2:30 pm
Conference Logistics
Registration / Information / Welcome Table Open
8:30 am - 9:15 am
Conference Logistics
Exhibitor Display Breakdown
8:45 am - 9:00 am
Conference Logistics
Room Transfer
9:00 am - 9:15 am
Presentation
Welcome & Opening Remarks
9:15 am - 10:15 am
Presentation
Lessons Learned From Conducting Covid Clinical Trials And Building A Clinical Supplies Team During The Peak Of The Pandemic - Panel Discussion
10:15 am - 10:30 am
Conference Logistics
Room Transfer
10:30 am - 11:30 am
Workshop
Ancillary Supply Management & IRT Integration (WS07)
As the use of ancillary supplies grows in clinical trials, using an IRT to manage them has become invaluable. This workshop will discuss how to integrate ancillary supplies into your IRT design implementation.
Speakers:
10:30 am - 11:30 am
Workshop
Blinding Considerations When Utilizing an IRT Configured for Resupply Operations (WS25)
If an IRT is improperly configured, you can unblind the site and/or the entire study. This workshop will discuss how to properly design and create specifications to ensure the right people are blinded throughout the study and especially during resupply operationsBlinding Considerations When Utilizing an IRT Configured for Resupply Operations
Zoom Link
Zoom Link
10:30 am - 11:30 am
Workshop
Challenges of Importing/Exporting CTM Into & Out of the U.S. (WS08)
Many people don't realize how challenging it is to bring clinical supply materials into the U.S. This workshop will discuss the use of the Automated Commercial Environment (ACE) system for import and how to export clinical supplies more smoothly and efficiently.
Speakers:
10:30 am - 11:30 am
Workshop
Clinical Supply Chain Challenges When Working With Emerging Markets in Asia-Pac (WS17)
Asia-Pac is a large and diverse array of countries, people, markets and clinical sites. This workshop will identify some of the more common issues and pitfalls with the clinical supply chain and how to overcome them.
10:30 am - 11:30 am
Workshop
Decentralized Clinical Trials in APAC - An Emerging Market (WS16)
As clinical supply chains expand into Asia-Pac, two areas of opportunity identified during the pandemic were the implementation of decentralized trials (DCTs) and direct-to-patient distribution (DtP). This workshop will identify ways to leverage DCTs while avoiding the pitfalls of working in these emerging markets.
10:30 am - 11:30 am
Workshop
EU Clinical Trial Regulation (Annex 6) Update (L02)
The Clinical Trial Regulation went into effect on 31 January 2022. Perhaps the most positive aspect of the regulation will be the ability to file a clinical trial application (CTA) part 1 submission in multiple EU countries all at one time. This filing will be submitted through the clinical trial information system (CTIS). While there is a great deal of information and guidance on how to populate data into the CTIS available, this workshop will discuss the upside and challenges of the CTIS and identify key experiences and necessary clinical supply information to help the attendee better navigate the portal to help your company have the greatest possible success in all future CTA filings.
Zoom Link
Zoom Link
Speakers:
10:30 am - 11:30 am
Workshop
JIT Labeling Success By Collaborating Early With QA (WS13)
This workshop will discuss just-in-time (JIT) labeling and how the regulatory landscape has changed to increase QA's support. The focus will be on partnering early with QA to understand and mitigate their concerns in order to get buy-in from the very beginning.
Zoom Link
Zoom Link
10:30 am - 11:30 am
Workshop
Packaging Technology for Clinical Supplies (WS29)
Knowing the best materials and their specifications is invaluable to ensuring stability and compliance. This workshop will explain packaging technology information and requirements to help small companies choose the best clinical supply packaging solutions.
Speakers:
10:30 am - 11:30 am
Workshop
Project Management Best Practices for Clinical Supplies (WS14)
This workshop will focus on defining good project management for clinical supplies and the tools and techniques to ensure projects stay on time and on budget while collaborating with all key stakeholders.
11:30 am - 12:45 pm
Conference Logistics
Lunch
12:45 pm - 1:00 pm
Conference Logistics
Room Transfer
1:00 pm - 2:00 pm
Workshop
Autologous and Allogenic Supply Chains – Best Practices (WS02)
This session will cover the differences between autologous & allogeneic cell and gene supply chains using a case study.
Speakers:
1:00 pm - 2:00 pm
Workshop
Early CTIS Experience from a Clinical Supply Perspective & Annex VI Current Status (L03)
Discussion regarding the current experiences with CTA submissions now that the Clinical Trial Regulation has become applicable as of 31 Jan 2022. What are the hot industry topics and how has the CTR impacted supply planning for studies conducted in the EU.
Zoom Link
Zoom Link
Speakers:
1:00 pm - 2:00 pm
Workshop
IoR: The Ins & Outs of Global Distribution (WS26)
Ever have a shipment going to another country 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.
1:00 pm - 2:00 pm
Workshop
Strategies for Programming Resupply Strategies Into Your IRT/RTSM (WS09)
This workshop will discuss the factors to consider when determining resupply strategies while using an IRT. While many people think this is something that is programmed into the IRT, it requires well-defined specifications for it to work well.
1:00 pm - 2:00 pm
Workshop
The Covid-19 Pandemic and How Our Industry Has Evolved (L04)
The Covid pandemic created hurdles and challenges that were difficult to overcome. This workshop will provide an overview as to where our industry was pre-pandemic and the systems and practices we have implemented to overcome the pandemic. The discussion will include insights into how much we have evolved, adapted and flexed to be successful.
Zoom Link
Zoom Link
Speakers:
1:00 pm - 2:00 pm
Workshop
Using Expanded Access: Understanding Supply Chain Requirements, Planning and Forecasting (WS18)
This interactive presentation will give an overview of expanded access/compassionate use programs and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.
Zoom Link
Zoom Link
Speakers:
1:00 pm - 2:00 pm
Workshop
Using Value Stream Mapping to Improve Clinical Supply Chain Efficiency (WS27)
Value stream mapping is a lean management method that allows you to visualize, analyze and improve all the steps in a product delivery process. This workshop will focus on how to utilize value stream mapping for the clinical supply chain.
Speakers:
2:00 pm - 2:15 pm
2:00 pm - 2:15 pm
Conference Logistics
Room Transfer
2:15 pm - 2:30 pm
Presentation
