May 1st - 4th, 2022

GCSG 2022 US Conference

We are “Back in the Saddle” for the 2022 US Conference!

Registration is scheduled to open on Wednesday, December 8th at 11 AM EST.

Check back often for more information!

We can’t wait to see you in San Antonio!

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Workshop Summary

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NOTE: All times listed below reflect Central Daylight Time (CDT)
Day 1: Sunday, May 1
8:30 am - 4:00 pm
Boot Camp / Seminar

An In-Depth Look at the Many Faces of Direct-to-Patient

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring Direct-to-Patient (DtP) clinical trial models. This bootcamp is designed to discuss best practices to engage your clinical teams, clinical sites, and couriers to ensure a successful partnership in a DtP supply chain model.

8:30 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.

8:30 am - 4:00 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

Location
Independence Ballroom (5 - 8)
3:00 pm - 6:00 pm
Conference Logistics

Registration / Information / Welcome Table Open

Location
Independence Ballroom Foyer
4:30 pm - 5:00 pm
Conference Logistics

Speaker / Facilitator Meeting / Tour of Workshop Rooms

Location
Independence Ballroom Foyer
5:00 pm - 5:30 pm
Conference Logistics

Conference Orientation

Location
Independence Ballroom (1 - 4)
5:30 pm - 8:30 pm
Networking

Meet & Greet – GCSG Networking Event

Location
Luckenbach Pavillon
9:00 pm - 12:00 am
Networking

After Hours

Location
Windmill Plaza
Day 2: Monday, May 2
6:30 am - 7:15 am
Networking

Yoga

Location
Luckenbach Pavillon
7:30 am - 8:15 am
Conference Logistics

Breakfast

Location
RW Pavillion
7:30 am - 8:15 am
Networking

Exhibitor Displays Open

Location
Independence Ballroom (5 - 8)
7:30 am - 4:30 pm
Conference Logistics

Registration / Information / Welcome Table Open

Location
Independence Ballroom Foyer
8:15 am - 8:30 am
Conference Logistics

Room Transfer

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.

Location
Independence Ballroom (1 - 4)
10:00 am - 10:15 am
Conference Logistics

Room Transfer

10:15 am - 11:15 am
Workshop

Taking the Fear Out of Regulatory Audits (WS23)

The majority of clinical trials are now on large molecules that are not typical oral solid dosage forms and blinding is an integral part of most of these clinical trials. This workshop will focus on new approaches to blinding these types of clinical materials.

Location
Fredericksburg ABC
10:15 am - 11:15 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.

10:15 am - 11:15 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.

10:15 am - 11:15 am
Workshop

Adjusting Operations & Timelines for Critical Projects (WS10)

One thing the pandemic has shown us is how well we can handle an increased operational tempo. This workshop will identify the need for timeline and operational flexibility when critical projects are introduced.

10:15 am - 11:15 am
Workshop

Blinding Considerations When Utilizing an IRT Configured for Resupply Operations (WS24)

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 operations.

10:15 am - 11:15 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.

10:15 am - 11:15 am
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.

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

Lessons Learned From Accelerated Covid Vaccine Development & Approval (WS28)

Thanks to the development of the Covid vaccines, it became clear that development times could be compressed while maintaining high quality, rapid scale-up and expedited regulatory approvals. This workshop will identify how standard techniques and processes for vaccines were accelerated and what can be utilized to help with other products in the clinical supply chain.

10:15 am - 11:15 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.

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.

Location
Hill Country D
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.

11:15 am - 11:30 am
Conference Logistics

Room Transfer

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.

11:30 am - 12:30 pm
Workshop

EU Clinical Trial Regulation (Annex 6) Update (L02)

The Clinical Trial Regulation is scheduled to become effective on 31 Jan 2022. This workshop will discuss the timing of implementation to comply with the regulation and the challenges and opportunities to the clinical supply chain so as to avoid delays and decrease waste.

11:30 am - 12:30 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.

11:30 am - 12:30 pm
Workshop

Medical Devices From a Supplier & QP perspective (WS01)

This workshop will discuss the ins and outs of medical devices from classification to blinding and everything in between. Share your expertise or come find a mentor to help you navigate the complexity of medical devices.

11:30 am - 12:30 pm
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.

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.

11:30 am - 12:30 pm
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.

11:30 am - 12:30 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.

11:30 am - 12:30 pm
Workshop

EU Clinical Trial Regulation (Annex 6) Update (L02)

The Clinical Trial Regulation is scheduled to become effective on 31 Jan 2022. This workshop will discuss the timing of implementation to comply with the regulation and the challenges and opportunities to the clinical supply chain so as to avoid delays and decrease waste.

Location
Hill Country D
11:30 am - 12:30 pm
Workshop

Blinding Considerations for 2020 & Beyond (WS25)

The majority of clinical trials are now on large molecules that are not typical oral solid dosage forms and blinding is an integral part of most of these clinical trials. This workshop will focus on new approaches to blinding these types of clinical materials.

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

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.

12:30 pm - 1:30 pm
Conference Logistics

Lunch / Exhibitor Displays Open

Location
RW Pavillion/Independence Ballroom (1 - 4)
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.

Location
Independence Ballroom (1 - 4)
3:15 pm - 4:45 pm
Networking

Exhibitor Displays Open

Location
Independence Ballroom (5 - 8)
4:45 pm - 5:45 pm
Showcase

Vendor Showcase(s)

6:00 pm - 9:00 pm
Networking

GCSG Night Out – “Texas State Fair”

Location
Independence Lawn
9:00 pm - 12:00 am
Networking

After Hours

Location
Windmill Plaza
Day 3: Tuesday, May 3
7:30 am - 8:15 am
Conference Logistics

Breakfast

Location
RW Pavillion
7:30 am - 4:30 pm
Conference Logistics

Registration / Information / Welcome Table Open

Location
Independence Ballroom Foyer
7:30 am - 8:15 am
Networking

Exhibitor Displays Open

Location
Independence Ballroom (1 - 4)
8:15 am - 8:30 am
Conference Logistics

Room Transfer

9:45 am - 10:00 am
Conference Logistics

Room Transfer

10:00 am - 11:00 am
Workshop

Taking the Fear Out of Regulatory Audits (WS23)

The majority of clinical trials are now on large molecules that are not typical oral solid dosage forms and blinding is an integral part of most of these clinical trials. This workshop will focus on new approaches to blinding these types of clinical materials.

Location
Fredericksburg ABC
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.

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.

10:00 am - 11:00 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.

10:00 am - 11:00 am
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.

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

The COVID-19 Pandemic & the Innovation it Has Driven (L03)

The Covid pandemic created hurdles and challenges that were difficult to overcome. Thanks to a highly innovative clinical supply chain, we were able to quickly pivot and support clinical studies. This workshop will explain best practices for innovation and creativity and describe some of the solutions that worked well.

10:00 am - 11:00 am
Workshop

IMP/CTM Information Required for Regulatory Filings (WS30)

The CMC section of the IND 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

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.

10:00 am - 11:00 am
Workshop

The COVID-19 Pandemic & the Innovation it Has Driven (L03)

The Covid pandemic created hurdles and challenges that were difficult to overcome. Thanks to a highly innovative clinical supply chain, we were able to quickly pivot and support clinical studies. This workshop will explain best practices for innovation and creativity and describe some of the solutions that worked well.

Location
Hill Country D
10:00 am - 11:00 am
Workshop

Autologous & Allogeneic Supply Chains – A Case Study (WS02)

This session will cover the differences autologous & allogeneic cell and gene supply chains using a case study.

10:00 am - 11:00 am
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.

11:00 am - 11:15 am
Conference Logistics

Room Transfer

11:15 am - 12:15 pm
Workshop

Blinding Considerations When Utilizing an IRT Configured for Resupply Operations (WS24)

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 operations.

11:15 am - 12:15 pm
Workshop

Adjusting Operations & Timelines for Critical Projects (WS10)

One thing the pandemic has shown us is how well we can handle an increased operational tempo. This workshop will identify the need for timeline and operational flexibility when critical projects are introduced.

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

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.

11:15 am - 12:15 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.

11:15 am - 12:15 pm
Workshop

Understanding Site’s Challenges with Clinical Supplies (WS20)

As patient and site-centricity grow in acceptance and appreciation, understanding the challenges the sites have in working with our clinical supplies becomes critical. This workshop will help you better understand the site's perspective on clinical supplies.

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.

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.

Location
Hill Country D
11:15 am - 12:15 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.

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

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.

11:15 am - 12:15 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.

12:15 pm - 1:30 pm
Conference Logistics

Lunch / Exhibitor Displays Open

Location
RW Pavillion/Independence Ballroom (1 - 4)
1:30 pm - 1:45 pm
Conference Logistics

Room Transfer

1:45 pm - 2:45 pm
Workshop

Lessons Learned From Accelerated Covid Vaccine Development & Approval (WS28)

Thanks to the development of the Covid vaccines, it became clear that development times could be compressed while maintaining high quality, rapid scale-up and expedited regulatory approvals. This workshop will identify how standard techniques and processes for vaccines were accelerated and what can be utilized to help with other products in the clinical supply chain.

1:45 pm - 2:45 pm
Workshop

EU Clinical Trial Regulation (Annex 6) Update (L02)

The Clinical Trial Regulation is scheduled to become effective on 31 Jan 2022. This workshop will discuss the timing of implementation to comply with the regulation and the challenges and opportunities to the clinical supply chain so as to avoid delays and decrease waste.

1:45 pm - 2:45 pm
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.

1:45 pm - 2:45 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.

1:45 pm - 2:45 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.

1:45 pm - 2:45 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.

1:45 pm - 2:45 pm
Workshop

Blinding Considerations for 2020 & Beyond (WS25)

The majority of clinical trials are now on large molecules that are not typical oral solid dosage forms and blinding is an integral part of most of these clinical trials. This workshop will focus on new approaches to blinding these types of clinical materials.

1:45 pm - 2:45 pm
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.

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.

1:45 pm - 2:45 pm
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.

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.

Location
Hill Country D
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.

Location
Independence Ballroom (1 - 4)
4:15 pm - 6:30 pm
Networking

Vendor Reception / Exhibitor Displays Open

Location
Independence Ballroom (5 - 8) & Foyer
4:30 pm - 5:30 pm
Showcase

Vendor Showcase(s)

Day 4: Wednesday, May 4
7:30 am - 8:45 am
Conference Logistics

Breakfast

Location
RW Pavillion
7:30 am - 8:30 am
Networking

Exhibitor Displays Open

Location
Independence Ballroom (5 - 8)
7:30 am - 2:30 pm
Conference Logistics

Registration / Information / Welcome Table Open

Location
Independence Ballroom Foyer
7:45 am - 8:45 am
Showcase

Vendor Showcase(s)

8:30 am - 9:15 am
Conference Logistics

Exhibitor Display Breakdown

Location
Independence Ballroom (5 - 8)
8:45 am - 9:00 am
Conference Logistics

Room Transfer

9:15 am - 10:15 am
Presentation

Early CTIS Experience from a Clinical Supply Perspective & Annex VI Current Status

Location
Independence Ballroom (1 - 4)
10:15 am - 10:30 am
Conference Logistics

Room Transfer

10:30 am - 11:30 am
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.

10:30 am - 11:30 am
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.

10:30 am - 11:30 am
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.

10:30 am - 11:30 am
Workshop

Medical Devices From a Supplier & QP perspective (WS01)

This workshop will discuss the ins and outs of medical devices from classification to blinding and everything in between. Share your expertise or come find a mentor to help you navigate the complexity of medical devices.

10:30 am - 11:30 am
Workshop

The COVID-19 Pandemic & the Innovation it Has Driven (L03)

The Covid pandemic created hurdles and challenges that were difficult to overcome. Thanks to a highly innovative clinical supply chain, we were able to quickly pivot and support clinical studies. This workshop will explain best practices for innovation and creativity and describe some of the solutions that worked well.

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.

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.

10:30 am - 11:30 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.

10:30 am - 11:30 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.

10:30 am - 11:30 am
Workshop

EU Clinical Trial Regulation (Annex 6) Update (L02)

The Clinical Trial Regulation is scheduled to become effective on 31 Jan 2022. This workshop will discuss the timing of implementation to comply with the regulation and the challenges and opportunities to the clinical supply chain so as to avoid delays and decrease waste.

Location
Hill Country D
10:30 am - 11:30 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.

11:30 am - 12:45 pm
Conference Logistics

Lunch

Location
RW Pavillion
12:45 pm - 1:00 pm
Conference Logistics

Room Transfer

1:00 pm - 2:00 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.

1:00 pm - 2:00 pm
Workshop

Autologous & Allogeneic Supply Chains – A Case Study (WS02)

This session will cover the differences autologous & allogeneic cell and gene supply chains using a case study.

1:00 pm - 2:00 pm
Workshop

Understanding Site’s Challenges with Clinical Supplies (WS20)

As patient and site-centricity grow in acceptance and appreciation, understanding the challenges the sites have in working with our clinical supplies becomes critical. This workshop will help you better understand the site's perspective on clinical supplies.

1:00 pm - 2:00 pm
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.

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.

1:00 pm - 2:00 pm
Workshop

IMP/CTM Information Required for Regulatory Filings (WS30)

The CMC section of the IND 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.

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

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.

1:00 pm - 2:00 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.

1:00 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.

1:00 pm - 2:00 pm
Workshop

The COVID-19 Pandemic & the Innovation it Has Driven (L03)

The Covid pandemic created hurdles and challenges that were difficult to overcome. Thanks to a highly innovative clinical supply chain, we were able to quickly pivot and support clinical studies. This workshop will explain best practices for innovation and creativity and describe some of the solutions that worked well.

Location
Hill Country D
2:00 pm - 2:15 pm
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