April 28 to May 1, 2019 - San Antonio, TX

GCSG 2019 US Conference

Global Clinical Supplies Group
2019 US Annual Conference

Hyatt Regency Hill Country Resort & Spa

 

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Day

Day 1: Sunday, April 28
8:30 am - 4:00 pm
Boot Camp

Clinical Trial Supply Boot Camp


This class is geared toward people new to the clinical trial supplies world.
Attendees will be provided with an overview of drug development and what goes into planning for and delivering the study drug for a clinical trial.
Included in the training will be the reason behind cGMPs, phases of new drug development and approval, randomizing and blinding clinical trial materials, Quality Assurance & documentation, protocol interpretation, patient CTM compliance, labeling, SOPs, stability, Good Distribution Practices, returned drug accountability, and changing regulations in the EU and ROW.
This is an informal workshop that will give attendees a massive amount of information in a fun and interactive atmosphere.

8:30 am - 4:00 pm
Boot Camp

Interactive Response Technology (IRT) Boot Camp

This class is geared towards people that have some experience in the clinical trial supplies world.  Attendees will be provided with an overview of and a deeper dive into Interactive Response Technology (IRT).  This will include the development path for IRTs, the stages of build, from creating the User Requirement Specification to quoting, to coding, validation, user acceptance testing through to go live.  Included in the training will be the reasons to use an IRT, when not to use one, the requirements that include: randomization codes, medcode IDs, ensuring that modules are built in to cover country approvals from Regulatory Affairs,  shipping requests, what to do when using warehouses versus depots, building in returns and reconciliation modules early on so they're ready when the trial is closing out, as well as timelines from concept development to switching it on.

8:30 am - 3:00 pm
Boot Camp

The Basics of Forecasting & Planning Boot Camp

This class is geared toward people new to the clinical trial supplies world.  Attendees will be provided with an overview of protocol interpretation, clinical supplies forecasting using spreadsheets and forecasting systems, collection of information required for creating a forecast and adapting and maintaining the supply plan as the study progresses.  Students will learn how to create individual and program level study plans as well as how to convert the forecast to manufacturing demand.

3:00 pm - 5:30 pm
Conference Logistics

Exhibitor Setup

Location
Independence 1-3
3:00 pm - 6:00 pm
Conference Logistics

Registration/ Information/Welcome Table Open

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

Speaker / Facilitator Meeting & Tour of Workshop Rooms

Location
Independence Foyer
5:30 pm - 8:30 pm
Networking

Meet & Greet – GCSG Networking Event

Location
Lukenbach/ Texas Pool
9:00 pm - 11:59 pm
Networking

Speakeasy

Location
Charlies Long Bar and Gallery
Day 2: Monday, April 29
6:30 am - 7:15 am
Networking

Free Yoga Class

Location
Lukenbach Pavilion
7:30 am - 8:15 am
Conference Logistics

Exhibitor Displays Open

Location
Independence 1-3
7:30 am - 4:30 pm
Conference Logistics

Registration/ Information/ Welcome Table Open

Location
Independence Foyer
7:30 am - 8:15 am
Conference Logistics

Breakfast

Location
RW Pavilion / Independence Foyer
8:15 am - 8:25 am
Break

Room Transfer to Main Hall

8:25 am - 8:50 am
Conference Logistics

Welcome & Opening Remarks

Location
Independence 4-5
8:50 am - 10:00 am
Presentation

Keynote Address:   Nick Webb





There are three “Future Shifts” that will impact the future of healthcare in a very big way. These shifts include Disruptive Innovation, Consumerization and Connection Architecture. The best hospitals and clinics are leveraging Innovation Best Practice, Patient Experience (PX) Design and a wide range of enabling technologies to drive efficiencies, operational excellence while concurrently delivering world-class Patient Experiences (PX). In this high-energy presentation, Nicholas will provide you actionable insights on how to leverage innovation best practices from years of research from of his upcoming book the Innovation Mandate.



Location
Independence 4-5
10:00 am - 10:15 am
Break

Room Transfer

10:15 am - 11:15 am
Workshop

Vendor Management (WS7)

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.

10:15 am - 11:15 am
Workshop

Bridging the Cultural & Regulatory Gaps in Japan (WS27)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of Japan for packaging, labeling and distribution as well as how they impact CT supplies timelines and planning. 

10:15 am - 11:15 am
Workshop

CMC Regulatory Workshop @ filings and how they relate to IP (WS10)

The CMC section of the IND contains information that has a direct influence on clinical trial supplies and failure to prepare IP that follows the requirements listed in that section can cause significant impact to 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 wth clinical supplies.

10:15 am - 11:15 am
Workshop

Speed, Quality & Cost – Why You Should Be Conducting Your Clinical Trials in Australia (WS22)

Over the last 20 years Australia has grown to become a destination of choice for the conduct of early phase clinical trials. Rapid ethics approval and a simple notification to the Therapeutic Goods Administrations (TGA) means that from submission to FPFD it will only take on average 6 weeks.  Coupled with the attractive R&D tax incentive program offered by the Australian Government this swift to study data can then be used to support an IND or IMPD application allowing companies to speed up their drug development process

10:15 am - 11:15 am
Workshop

Qualified Person (WS29)

The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations and the impact of Brexit.  This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU and UK.  

10:15 am - 11:15 am
Workshop

Import and Export of Controlled Substances (WS16)

International shipping of IP can be an intricate process under normal circumstances but becomes exceptionally  complex when dealing with controlled substances.  This workshop will discuss the requirements for shipping controlled substances that go beyond those required for other shipments.

10:15 am - 11:15 am
Workshop

Insource or Outsource cGMP Batch Documentation (WS18)

Reviewing manufacturing and packaging batch records for release of investigational product is a integral part of the clinical supply chain.   The decision on whether to retain the responsibility at the sponsor company or to fully/ partially outsource can be challenging.  This session will look at the benefits and risks of outsourcing this key quality activity and how to appropriately manage communication of delegated responsibilities. 

10:15 am - 11:15 am
Workshop

Artificial Intelligence in Clinical Supplies (WS4)

Artficial Intelligence (AI) is a term being bandied about the pharma dn biotech industry. So many companies say they use AI to help them perform an action or to identify trends and patterns in huge amounts of data.  Is it all that it's cracked up to be? This workshop will identify what it is, how it can be used to support clinical development and what are the myths of AI.

10:15 am - 11:15 am
Workshop

Flexible Solutions in a Changing Market (WS41)

In this session the delegate will learn:


(1) List three market drivers changing the Clinical Supplies Market


(2) List three challenges facing sponsors in changing Clinical Supplies Market


(3) List three ways the JIT Manufacturing Solution can help overcome these challenges

10:15 am - 11:15 am
Workshop

EU Regulation 536/2014 (Clinical Trial Regulation) and the Regulatory Impact on Clinical Supplies (WS3)

Clinical Supply Chains are adjusting to recent changes in the regulations.  This workshop will discuss as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.

10:15 am - 11:15 am
Workshop

Annex 13 and Annex VI Requirement Changes (WS38)

Although Regulation 536/2014 has not been fully implemented aspects have been incorporated into the Directive that is still in effect and with the publication of Guidelines 2017/1569 and 2017/1572. .  This workshop will discuss the changes that have been made in anticipation of the implementation of 536/2014 and how they are impacting clinical supplies.

10:15 am - 11:15 am
Workshop

Strategies When Using Pooled Supplies (WS31)

This workshop will discuss the situations where establishing a pooled supply strategy is advantageous as in the case of limited supplies.


10:15 am - 11:15 am
Workshop

How to Develop SOP’s to Meet Regulatory Expectations (WS19)

SOPs evolve as a company grows with the development of the drug being studied.  Processes that may work for a small company will not function reliably for a larger company with a more established pipeline.  This workshop will discuss the ways SOP details change as companies grow with the drug's development and how to maintain well controlled processes. 

10:15 am - 11:15 am
Workshop

Developments in Expanded Access (MP1)

This interactive presentation will give an overview of expanded access and discuss new regulations and their impact to planning and execution of Expanded Access Programs.

11:15 am - 11:30 am
Break

Room Transfer

11:30 am - 12:30 pm
Workshop

Aligning Clinical Supplies Documentation with Trial Master File Expectations (MP4)

A Trial Master File (TMF) should be set up at the beginning of a trial. A well maintained TMF can help with efficient trial management and can facilitate the reconstruction of the conduct of the trial during the audit/inspection process.  Requirements for handling IP to be included in a TMF can be located in ICH E6.

11:30 am - 12:30 pm
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (WS5)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging.  Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region.   This workshop will discuss best practices for storage, distribution, import/ export and reverse logisitics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines.  You will also get some hands on experience by working through a scenario for an Asia Pac study! 

11:30 am - 12:30 pm
Workshop

Clinical Operations / CRO Discussion (WS2)

As clinical trial supplies specialists we can get so focussed on "right drug, right place, right time" that we forget that there are many other people and activities involved in conducting a clinical trial.  This session will provide an insight into one of those other areas by discussing  the variety of activities a clinical site performs in addition to dispensing IP when processing a patient in a clinical trial. 

11:30 am - 12:30 pm
Workshop

Quality Assessment of Temperature Excursions (WS17)

Sponsors and CROs face a large number of challenges managing temperature data at clinical sites. The complexities of these challenges can range from dealing with manual logs (time consuming to review, difficult to read, etc.) to managing multiple temperature devices in a small refrigerator.

Finding the balance between getting the right data centralised for the Sponsor and ensuring site compliance with temperature data without burdening the clinical site or the CRA teams can be a difficult task to get accurate.

11:30 am - 12:30 pm
Workshop

Managing Importation Requirements for Your Product (WS13)

The global reach of today's clinical trials make 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 complext regulations involved in the import and export of clinical trial supplies. 

11:30 am - 12:30 pm
Workshop

Embedding a CRO within a Sponsor (WS37)

This workshop will discuss the advantages and challenges of outsourcing Clinical Supply Operations to a vendor while leaving the vendor embedded at the sponsor company location

11:30 am - 12:30 pm
Workshop

Best Practices for Adaptive Trials (WS8)

For over 10 years, adaptive clinical trials have been discussed as an amazing way to shorten clinical development timelines, eliminate huge enrollment delays and support speed to market. The challenges that come with Adaptive Trials mostly focus on the clinical supply chain and how clinical supplies need to be globally available, in support of every change an adaptive trial can make.  If not planned and forecasted well, these trials can cause huge amounts of clinical supplies to be packaged, left unused and wasted. This leads to huge cost overruns, expired supplies and comparators and supply chain interuptions. This workshop wil focus on best practices to avoid these challenges while improving supply chain efficacy and agility.

11:30 am - 12:30 pm
Workshop

Enrollment Accuracy & Forecasting (WS25)

This workshop will focus on industry best practices to improve and forecast study enrollment to positively impact the clinical supply chain.

11:30 am - 12:30 pm
Workshop

Team Dynamics (WS43)

The best teams can accomplish the most amazing things and are an asset to their organization.  The worst teams can waste thousands of manhours, cost millions of dollars and still accomplish nothing. This workshop will identify the stages of team dynamics and provide ways to move your team from forming to high performing.

11:30 am - 12:30 pm
Workshop

How to Get the Most Value from my GCSG Membership (WS21)

This workshop is a hands on session to work with GCSG team members to see, and try, membership perks such as getAbstract and SumTotal  as well as ask your questions / get help with the App 

11:30 am - 12:30 pm
Workshop

How to Partner with your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS23)

In our ever evolving clinical development world we are realizing the value of a site centric approach to clinicl trials and clinical supplies. This workshop will idneitfy ways to better collaborate with our clinical sites to enhance patient enrollment, patient sustainment throughout the clinicl trial and decrease in clinical supply dosing and maintenance.

11:30 am - 12:30 pm
Workshop

Best Practices for Demand Forecasting (Tools, Ways to Model, When to Use, How to Adjust During) (WS9)

Demand forecasting has become the industry norm in order to handle the growing costs and time constraints associated with comparator sourcing, packaging, labeling and temperature controlled distribution for global clinical trials.  

11:30 am - 12:30 pm
Workshop

Managing a Recall (WS40)

We've all heard about the nightmares associated with clinical supply recovery/recalls.  Thankfully, they are not common so many of us have been lucky enough to avoid having to actually implement a clinical supply recovery/recall. This workshop will provide the tools and recommended processes to prepare you for that worst case scenario.  Having a plan in place can help you sleep even if you are faced with having to bring clinical supplies back to your depots or company.

11:30 am - 12:30 pm
Workshop

Autologous Therapy Supply Chain Strategies (WS35)

Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments.  The outlook is positive, due in part to advancements in science and the availability of more sophisticated diagnostic tools, which are giving the medical community a better understanding of the human genome and making it easier to detect genetic mutations affecting individual patients. Come to this workshop to learn about the challenges of cell  & gene therapies, their unique supply chain challenges and how to overcome them. 

12:30 pm - 1:30 pm
Conference Logistics

Lunch / Exhibitor Displays Open

Location
RW Pavilion / Independence 1-3
1:30 pm - 1:40 pm
Break

Return to Main Hall

1:40 pm - 2:40 pm
Presentation

Pharmaceutical Industry in the 22nd Century: Journey into the Future

Where will new technologies take the Pharma industry?  How will advancements in technology such as artificial intelligence (AI), Internet of Things (IoT) and block chain influence clinical supplies?  Thought leaders in the industry will share some of their insight into where the industry is headed.

Location
Independence 4-5
2:40 pm - 3:15 pm
Presentation

Making the Most of Your GCSG Membership

There is so much going on at GCSG beyond our annual conference! This session will update you on the benefits of membership and updates we've made to better serve YOU, our members.

Location
Independence 4-5
3:15 pm - 3:30 pm
Conference Logistics

Closing Remarks and Raffle Drawings

Location
Independence 4-5
3:30 pm - 5:00 pm
Conference Logistics

Exhibitor Displays Open

Location
Independence 1-3
6:00 pm - 9:00 pm
Networking

GCSG Night Out: Boot Scootin’ Boogie

Location
Windmill Motor Court/ Independence Lawn & Foyer
9:00 pm - 11:59 pm
Networking

Speakeasy

Location
Windmill Plaza
Day 3: Tuesday, April 30
7:30 am - 8:20 am
Conference Logistics

Breakfast

Location
RW Pavilion/Independence Foyer
7:30 am - 4:30 pm
Conference Logistics

Registration/ Information/ Welcome Table Open

Location
Independence Foyer
7:30 am - 8:30 am
Conference Logistics

Exhibitor Displays Open

Location
Independence 1-3
8:20 am - 8:30 am
Break

Room Transfer to Main Hall

9:45 am - 10:00 am
Break

Room Transfer

10:00 am - 11:00 am
Workshop

Annex 13 and Annex VI Requirement Changes (WS38)

Although Regulation 536/2014 has not been fully implemented aspects have been incorporated into the Directive that is still in effect and with the publication of Guidelines 2017/1569 and 2017/1572. .  This workshop will discuss the changes that have been made in anticipation of the implementation of 536/2014 and how they are impacting clinical supplies.

10:00 am - 11:00 am
Workshop

Quality Agreements (WS1)

When Sponsor companies and vendors work together, ensuring clarity of expecations and roles and repsonsibilities is essential.  This workshop will explore why quality agreements are essential if not required by regulation as well as what goes into the best quality agreements and how to create transparency and a mutually beneficial partnership befor executing tasks and project goals in support of the clinical supply chain.

10:00 am - 11:00 am
Workshop

BREXIT’s Impact on Distribution (MP6A)

This session will give you an understanding of how BREXIT will impact the Distribution Strategy for your Clinical Supply Chain during transition and post implementation.

10:00 am - 11:00 am
Workshop

IRT Systems Development and Standards (WS36)

This workshop will discuss the development path for IRTs, the stages of build, from creating the User Requirement Specification to quoting, to coding, validation, user acceptance testing through to go live. 

10:00 am - 11:00 am
Workshop

Maintaining a Patients-First Perspective in Your Clinical Supply Chain (WS20)

As the industry shifts to a more site-centric perspective, ensuring that our clinical supplies are user-friendly to both site personnel and patients becomes essential.  This workshop will discuss techniques to improve a clinical supply site and patient-centric approach.

10:00 am - 11:00 am
Workshop

The Future of Automated Systems for Clinical Supplies (WS26)

As technology advances at an exponential pace, new automated systems are being produced that will greatly improve the clinical supply chain.  This workshop will discuss those possible technologies 

10:00 am - 11:00 am
Workshop

Insource or Outsource cGMP Batch Documentation (WS18)

Reviewing manufacturing and packaging batch records for release of investigational product is a integral part of the clinical supply chain.   The decision on whether to retain the responsibility at the sponsor company or to fully/ partially outsource can be challenging.  This session will look at the benefits and risks of outsourcing this key quality activity and how to appropriately manage communication of delegated responsibilities. 

10:00 am - 11:00 am
Workshop

Culture of Accountability – Part 1 (2 hour session) (MP5A)

This session is part one (1) of a two (2) mini presentation series, each at two (2) hours; geared towards Executives (VPs, Directors and Senior Managers).  Accountability will be defined and case studies will be provided to demonstrate techniques and concepts to instill a culture of accountability within your team.

10:00 am - 11:00 am
Workshop

Qualified Person (WS29)

The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations and the impact of Brexit.  This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU and UK.  

10:00 am - 11:00 am
Workshop

Ancillary Supplies – Partnering with CROs (WS6)

Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.

10:00 am - 11:00 am
Workshop

Best Practices for Demand Forecasting (Tools, Ways to Model, When to Use, How to Adjust During) (WS9)

Demand forecasting has become the industry norm in order to handle the growing costs and time constraints associated with comparator sourcing, packaging, labeling and temperature controlled distribution for global clinical trials.  

10:00 am - 11:00 am
Workshop

Social Media and Its Influence on Clinical Trials (Trial Recruitment) (WS14)

Social media has become a force to be reckoned with when it comes to pharma dn biotech product development.  People are more connected and informed than they ever have been in the history of the species.  Unfortunately, they are not always "well" informed as there is a staggering amount of information on the internet that is not even close to true.  This workshop will discuss the impact of social media on drug development as well as what to watch out for when conduscting Investigator Initiated Studies (IIS) studies or doing Expanded Access Programs (EAP).

10:00 am - 11:00 am
Workshop

Best in Class Temperature Controlled Distribution (WS24)

This workshop will discuss ways to ensure effective distribution of temperature controlled IMP.

10:00 am - 11:00 am
Workshop

Planning Returns & Reconciliations in a Global Trial Following Regulations in Latin America (WS33)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of returns and reconciliation in Latin American countriesand how they impact CT supplies timelines and planning.

11:00 am - 11:15 am
Break

Room Transfer

11:15 am - 12:15 pm
Workshop

Measuring Return on Investment (ROI) in Forecasting Clinical Supplies (WS30)

Methods for forecasting the IP requirements for a clinical trial range from a calulator and scratch pad to complex systems integrated with ERP and IXR.  Which level of detail is needed to ensure drug supplies are sufficient without creating excessive waste?  This workshop will discuss the various methods for determining clinical supply needs and their appropriate use.  

11:15 am - 12:15 pm
Workshop

BREXIT’s Impact on QP Release (MP6B)

This session will give you an understanding of how BREXIT impacts QP release and strategies to overcome challenges for your Clinical Supplies during transition and post implementation.

11:15 am - 12:15 pm
Workshop

Managing a Recall (WS40)

We've all heard about the nightmares associated with clinical supply recovery/recalls.  Thankfully, they are not common so many of us have been lucky enough to avoid having to actually implement a clinical supply recovery/recall. This workshop will provide the tools and recommended processes to prepare you for that worst case scenario.  Having a plan in place can help you sleep even if you are faced with having to bring clinical supplies back to your depots or company.

11:15 am - 12:15 pm
Workshop

Team Dynamics (WS43)

The best teams can accomplish the most amazing things and are an asset to their organization.  The worst teams can waste thousands of manhours, cost millions of dollars and still accomplish nothing. This workshop will identify the stages of team dynamics and provide ways to move your team from forming to high performing.

11:15 am - 12:15 pm
Workshop

Direct to Patient (WS11)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct to patient clinical trial models.  This workshop is designed to discuss use of central pharmacies  in a direct to patient supply chain model.

11:15 am - 12:15 pm
Workshop

Comparator Sourcing Strategies (WS39)

This session will discuss the options for establishing a successful comparator program that will include acquisition, pedigree, distribution and reconciliation.

11:15 am - 12:15 pm
Workshop

Speed, Quality & Cost – Why You Should Be Conducting Your Clinical Trials in Australia (WS22)

Over the last 20 years Australia has grown to become a destination of choice for the conduct of early phase clinical trials. Rapid ethics approval and a simple notification to the Therapeutic Goods Administrations (TGA) means that from submission to FPFD it will only take on average 6 weeks.  Coupled with the attractive R&D tax incentive program offered by the Australian Government this swift to study data can then be used to support an IND or IMPD application allowing companies to speed up their drug development process

11:15 am - 12:15 pm
Workshop

Culture of Accountability – Part 1 (2 hour session) (MP5A)

This session is part one (1) of a two (2) mini presentation series, each at two (2) hours; geared towards Executives (VPs, Directors and Senior Managers).  Accountability will be defined and case studies will be provided to demonstrate techniques and concepts to instill a culture of accountability within your team.

11:15 am - 12:15 pm
Workshop

Dealing with gaps in the clinical supply chain and managing personas (WS44)

Dealing with gaps in the clinical supply chain and managing personas along the way to ensure patients receive safe and efficacious IMPs

11:15 am - 12:15 pm
Workshop

Vendor Management (WS7)

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.

11:15 am - 12:15 pm
Workshop

EU Regulation 536/2014 (Clinical Trial Regulation) and the Regulatory Impact on Clinical Supplies (WS3)

Clinical Supply Chains are adjusting to recent changes in the regulations.  This workshop will discuss as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.

11:15 am - 12:15 pm
Workshop

Enrollment Accuracy & Forecasting (WS25)

This workshop will focus on industry best practices to improve and forecast study enrollment to positively impact the clinical supply chain.

11:15 am - 12:15 pm
Workshop

CMC Regulatory Workshop @ filings and how they relate to IP (WS10)

The CMC section of the IND contains information that has a direct influence on clinical trial supplies and failure to prepare IP that follows the requirements listed in that section can cause significant impact to 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 wth clinical supplies.

11:15 am - 12:15 pm
Workshop

How to Develop SOP’s to Meet Regulatory Expectations (WS19)

SOPs evolve as a company grows with the development of the drug being studied.  Processes that may work for a small company will not function reliably for a larger company with a more established pipeline.  This workshop will discuss the ways SOP details change as companies grow with the drug's development and how to maintain well controlled processes. 

12:15 pm - 1:30 pm
Conference Logistics

Lunch/Exhibitor Displays Open

Location
RW Pavilion/Independence 1-3
1:30 pm - 1:40 pm
Break

Room Transfer

1:45 pm - 2:45 pm
Workshop

Horror Stories – How They Were Handled and How to Prevent Them (WS12)

Horror stories in clinical supplies…we've all had them!  Share your stories and mitigations with your colleagues.

1:45 pm - 2:45 pm
Workshop

Artificial Intelligence in Clinical Supplies (WS4)

Artficial Intelligence (AI) is a term being bandied about the pharma dn biotech industry. So many companies say they use AI to help them perform an action or to identify trends and patterns in huge amounts of data.  Is it all that it's cracked up to be? This workshop will identify what it is, how it can be used to support clinical development and what are the myths of AI.

1:45 pm - 2:45 pm
Workshop

How to Partner with your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS23)

In our ever evolving clinical development world we are realizing the value of a site centric approach to clinicl trials and clinical supplies. This workshop will idneitfy ways to better collaborate with our clinical sites to enhance patient enrollment, patient sustainment throughout the clinicl trial and decrease in clinical supply dosing and maintenance.

1:45 pm - 2:45 pm
Workshop

Managing Importation Requirements for Your Product (WS13)

The global reach of today's clinical trials make 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 complext regulations involved in the import and export of clinical trial supplies. 

1:45 pm - 2:45 pm
Workshop

Embedding a CRO within a Sponsor (WS37)

This workshop will discuss the advantages and challenges of outsourcing Clinical Supply Operations to a vendor while leaving the vendor embedded at the sponsor company location

1:45 pm - 2:45 pm
Workshop

Flexible Solutions in a Changing Market (WS41)

In this session the delegate will learn:


(1) List three market drivers changing the Clinical Supplies Market


(2) List three challenges facing sponsors in changing Clinical Supplies Market


(3) List three ways the JIT Manufacturing Solution can help overcome these challenges

1:45 pm - 2:45 pm
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (WS5)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging.  Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region.   This workshop will discuss best practices for storage, distribution, import/ export and reverse logisitics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines.  You will also get some hands on experience by working through a scenario for an Asia Pac study! 

1:45 pm - 2:45 pm
Workshop

Best Practices for Adaptive Trials (WS8)

For over 10 years, adaptive clinical trials have been discussed as an amazing way to shorten clinical development timelines, eliminate huge enrollment delays and support speed to market. The challenges that come with Adaptive Trials mostly focus on the clinical supply chain and how clinical supplies need to be globally available, in support of every change an adaptive trial can make.  If not planned and forecasted well, these trials can cause huge amounts of clinical supplies to be packaged, left unused and wasted. This leads to huge cost overruns, expired supplies and comparators and supply chain interuptions. This workshop wil focus on best practices to avoid these challenges while improving supply chain efficacy and agility.

1:45 pm - 2:45 pm
Workshop

How to Get the Most Value from my GCSG Membership (WS21)

This workshop is a hands on session to work with GCSG team members to see, and try, membership perks such as getAbstract and SumTotal  as well as ask your questions / get help with the App 

1:45 pm - 2:45 pm
Workshop

Strategies When Using Pooled Supplies (WS31)

This workshop will discuss the situations where establishing a pooled supply strategy is advantageous as in the case of limited supplies.

1:45 pm - 2:45 pm
Workshop

Bridging the Cultural & Regulatory Gaps in Japan (WS27)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of Japan for packaging, labeling and distribution as well as how they impact CT supplies timelines and planning. 

1:45 pm - 2:45 pm
Workshop

Import and Export of Controlled Substances (WS16)

International shipping of IP can be an intricate process under normal circumstances but becomes exceptionally  complex when dealing with controlled substances.  This workshop will discuss the requirements for shipping controlled substances that go beyond those required for other shipments.

1:45 pm - 2:45 pm
Workshop

Autologous Therapy Supply Chain Strategies (WS35)

Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments.  The outlook is positive, due in part to advancements in science and the availability of more sophisticated diagnostic tools, which are giving the medical community a better understanding of the human genome and making it easier to detect genetic mutations affecting individual patients. Come to this workshop to learn about the challenges of cell  & gene therapies, their unique supply chain challenges and how to overcome them. 

2:45 pm - 3:00 pm
Break

Return to Main Hall

3:00 pm - 4:00 pm
Presentation

Brexit: Impact to Pharmaceutical Regulations

BREXIT has officially happened. Now what?

Location
Independence 4-5
4:15 pm - 4:30 pm
Conference Logistics

Closing Remarks and Raffle Drawings

Location
Independence 4-5
4:30 pm - 6:00 pm
Conference Logistics

Vendor reception / Exhibitor Displays Open

Location
Independence 1-3 & Foyer
9:00 pm - 11:59 pm
Networking

Speakeasy

Location
Windmill Plaza
Day 4: Wednesday, May 1
7:30 am - 9:00 am
Conference Logistics

Breakfast

Location
RW Pavilion/Independence Foyer
7:30 am - 2:30 pm
Conference Logistics

Registration/ Information/ Welcome Table Open

Location
Independence Foyer
7:30 am - 8:30 am
Conference Logistics

Exhibitor Displays Open

Location
Independence 1-3
8:30 am - 9:10 am
Conference Logistics

Exhibitor Display Breakdown

Location
Independence 1-3
9:00 am - 9:10 am
Conference Logistics

Welcome & Opening Remarks

Location
Independence 4-5
9:10 am - 10:15 am
Presentation

The Power of Understanding Yourself

Back by popular demand!! Dave Mitchell, our 2018 keynote speaker, returns to take you on a journey of self awareness and self discovery. The ability to understand yourself and others and what makes each of us tick wil help you better communicate, interact and collaborate with people who think differently than you. Dave has divided people into different groups and once you understand his humorous, yet scientifically based categories, you will have greater insight into how to better connect and work with others.

Location
Independence 4-5
10:15 am - 10:30 am
Break

Room Transfer

10:30 am - 11:30 am
Workshop

The Future of Automated Systems for Clinical Supplies (WS26)

As technology advances at an exponential pace, new automated systems are being produced that will greatly improve the clinical supply chain.  This workshop will discuss those possible technologies 

10:30 am - 11:30 am
Workshop

Challenges of Developing a Clinical Supply Chain in Asia Pac (WS5)

Developing and maintaining a robust clinical supply chain in Asia Pac doesn't have to be challenging.  Planning up front for your Asia Pac distribution and import/ export strategy can greatly increase your chances of success within the region.   This workshop will discuss best practices for storage, distribution, import/ export and reverse logisitics in South Korea, Thailand, Malaysia, Singapore, China, New Zealand and Philippines.  You will also get some hands on experience by working through a scenario for an Asia Pac study! 

10:30 am - 11:30 am
Workshop

Quality Agreements (WS1)

When Sponsor companies and vendors work together, ensuring clarity of expecations and roles and repsonsibilities is essential.  This workshop will explore why quality agreements are essential if not required by regulation as well as what goes into the best quality agreements and how to create transparency and a mutually beneficial partnership befor executing tasks and project goals in support of the clinical supply chain.

10:30 am - 11:30 am
Workshop

Annex 13 and Annex VI Requirement Changes (WS38)

Although Regulation 536/2014 has not been fully implemented aspects have been incorporated into the Directive that is still in effect and with the publication of Guidelines 2017/1569 and 2017/1572. .  This workshop will discuss the changes that have been made in anticipation of the implementation of 536/2014 and how they are impacting clinical supplies.

10:30 am - 11:30 am
Workshop

Quality Assessment of Temperature Excursions (WS17)

Sponsors and CROs face a large number of challenges managing temperature data at clinical sites. The complexities of these challenges can range from dealing with manual logs (time consuming to review, difficult to read, etc.) to managing multiple temperature devices in a small refrigerator.

Finding the balance between getting the right data centralised for the Sponsor and ensuring site compliance with temperature data without burdening the clinical site or the CRA teams can be a difficult task to get accurate.

10:30 am - 11:30 am
Workshop

Best in Class Temperature Controlled Distribution (WS24)

This workshop will discuss ways to ensure effective distribution of temperature controlled IMP.

10:30 am - 11:30 am
Workshop

BREXIT’s Impact on VAT Reclamation (MP6C)

This session will discuss how BREXIT may change your ability to reclaim Value Added Tax (VAT) within the UK and EU for your clinical supplies during transition and post-implementation.

10:30 am - 11:30 am
Workshop

Culture of Accountability – Part 2 (2 hour session) (MP5B)

A continuation of A Culture of Accountability - Part 1, this session is part two of a two-part mini-presentation series.  Each part will have a duration of two (2) hours and is geared towards Executives, VPs, Directors and Senior Managers. 


In this session, we will continue our discussions about case studies demonstrating techniques and concepts to instill a culture of accountability within your team.

10:30 am - 11:30 am
Workshop

How to Develop SOP’s to Meet Regulatory Expectations (WS19)

SOPs evolve as a company grows with the development of the drug being studied.  Processes that may work for a small company will not function reliably for a larger company with a more established pipeline.  This workshop will discuss the ways SOP details change as companies grow with the drug's development and how to maintain well controlled processes. 


 

10:30 am - 11:30 am
Workshop

IRT Systems Development and Standards (WS36)

This workshop will discuss the development path for IRTs, the stages of build, from creating the User Requirement Specification to quoting, to coding, validation, user acceptance testing through to go live. 

10:30 am - 11:30 am
Workshop

The Power of Understanding Yourself (WS42)

Attend this workshop presented by Dave Mitchell, our 2018 Keynote speaker, for a closer look at understanding yourself.  Explore personal attributes related to interactive style, diving deeper into the concepts from the author's book,  Explore how to connect your current life status to a desired future state.  During this workshop, Mr Mitchell encourages attendees to engage in a deep exploration of their core values, beliefs, mission and vision in order to become their best self.

10:30 am - 11:30 am
Workshop

Social Media and Its Influence on Clinical Trials (Trial Recruitment) (WS14)

Social media has become a force to be reckoned with when it comes to pharma dn biotech product development.  People are more connected and informed than they ever have been in the history of the species.  Unfortunately, they are not always "well" informed as there is a staggering amount of information on the internet that is not even close to true.  This workshop will discuss the impact of social media on drug development as well as what to watch out for when conduscting Investigator Initiated Studies (IIS) studies or doing Expanded Access Programs (EAP).

10:30 am - 11:30 am
Workshop

Clinical Operations / CRO Discussion (WS2)

As clinical trial supplies specialists we can get so focussed on "right drug, right place, right time" that we forget that there are many other people and activities involved in conducting a clinical trial.  This session will provide an insight into one of those other areas by discussing  the variety of activities a clinical site performs in addition to dispensing IP when processing a patient in a clinical trial. 

11:30 am - 12:45 pm
Conference Logistics

Lunch

Location
RW Pavilion/Independence 1-3
12:45 pm - 1:00 pm
Break

Room Transfer

1:00 pm - 2:00 pm
Workshop

Ancillary Supplies – Partnering with CROs (WS6)

Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.

1:00 pm - 2:00 pm
Workshop

Measuring Return on Investment (ROI) in Forecasting Clinical Supplies (WS30)

Methods for forecasting the IP requirements for a clinical trial range from a calulator and scratch pad to complex systems integrated with ERP and IXR.  Which level of detail is needed to ensure drug supplies are sufficient without creating excessive waste?  This workshop will discuss the various methods for determining clinical supply needs and their appropriate use.  

1:00 pm - 2:00 pm
Workshop

Dealing with gaps in the clinical supply chain and managing personas (WS44)

Dealing with gaps in the clinical supply chain and managing personas along the way to ensure patients receive safe and efficacious IMPs

1:00 pm - 2:00 pm
Workshop

Best Practices for Demand Forecasting (Tools, Ways to Model, When to Use, How to Adjust During) (WS9)

Demand forecasting has become the industry norm in order to handle the growing costs and time constraints associated with comparator sourcing, packaging, labeling and temperature controlled distribution for global clinical trials.  

1:00 pm - 2:00 pm
Workshop

Cell Gene Therapy Supply Chain (MP2)

Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments.  The outlook is positive, due in part to advancements in science and the availability of more sophisticated diagnostic tools, which are giving the medical community a better understanding of the human genome and making it easier to detect genetic mutations affecting individual patients. Come to this mini presentation to learn about the challenges of cell & gene therapies, the challenges of their unique supply chains and how to overcome them. 

1:00 pm - 2:00 pm
Workshop

Maintaining a Patients-First Perspective in Your Clinical Supply Chain (WS20)

As the industry shifts to a more site-centric perspective, ensuring that our clinical supplies are user-friendly to both site personnel and patients becomes essential.  This workshop will discuss techniques to improve a clinical supply site and patient-centric approach.

1:00 pm - 2:00 pm
Workshop

Culture of Accountability – Part 2 (2 hour session) (MP5B)

A continuation of A Culture of Accountability - Part 1, this session is part two of a two-part mini-presentation series.  Each part will have a duration of two (2) hours and is geared towards Executives, VPs, Directors and Senior Managers. 


In this session, we will continue our discussions about case studies demonstrating techniques and concepts to instill a culture of accountability within your team.

1:00 pm - 2:00 pm
Workshop

Horror Stories – How They Were Handled and How to Prevent Them (WS12)

Horror stories in clinical supplies…we've all had them!  Share your stories and mitigations with your colleagues.

1:00 pm - 2:00 pm
Workshop

Direct to Patient (WS11)

Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct to patient clinical trial models.  This workshop is designed to discuss use of central pharmacies  in a direct to patient supply chain model.

1:00 pm - 2:00 pm
Workshop

Enrollment Accuracy & Forecasting (WS25)

This workshop will focus on industry best practices to improve and forecast study enrollment to positively impact the clinical supply chain.

1:00 pm - 2:00 pm
Workshop

EU Regulation 536/2014 (Clinical Trial Regulation) and the Regulatory Impact on Clinical Supplies (WS3)

Clinical Supply Chains are adjusting to recent changes in the regulations.  This workshop will discuss as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.

1:00 pm - 2:00 pm
Workshop

Planning Returns & Reconciliations in a Global Trial Following Regulations in Latin America (WS33)

Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of returns and reconciliation in Latin American countriesand how they impact CT supplies timelines and planning.

1:00 pm - 2:00 pm
Workshop

Comparator Sourcing Strategies (WS39)

This session will discuss the options for establishing a successful comparator program that will include acquisition, pedigree, distribution and reconciliation.

2:00 pm - 2:15 pm
Break

Return to Main Hall

2:15 pm - 2:30 pm
Conference Logistics

Closing Remarks and Raffle Drawings

Location
Independence 4-5

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