Day 1 : Tuesday, October 22
Bootcamp Registration Open
Boot Camp - Import/Export
The class is designed for clinical supply professionals who want to learn more about shipping and distribution for global clinical trials. This boot camp will cover regulations, temperature control, customs challenges, and logistics supply chain partnerships to ensure success with international distribution
Speakers:
Boot Camp - Interactive Response Technology (IRT), Randomization and Trial Supply Management (RTSM)
Training will include, system build from protocol assessment and creating the user requirement specification (URS) to coding/configuring, validating, testing (UAT) and go live as well as operational management of the system.
Training will also include when (and when not) to use an IRT RTSM; key users and their roles; timelines from concept development to go live; critical functionalities such as blinding, randomization techniques, supply strategies and related parameter settings; drug reconciliation and operational aspects such as batch/kit management, country/site management, product status management and returns/destruction management.
Speakers:
Boot Camp - Understanding the Essentials of the Clinical Supply Chain
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 IMP 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.
Speakers:
Exhibitor Set Up
Registration Open
Presenters / WS Facilitators Orientation
New Member Orientation
GCSG Meet & Greet Networking Event
Xerimis Port Tasting
Day 2 : Wednesday, October 23
Registration Open - Exhibitor Displays Open
Welcome & Opening Remarks
Speakers:
Keynote Presentation
Speakers:
Scholarship Announcement
Room transfer- Tea/Coffee Break
Cell Gene Therapy Supply Chain Strategies (WS3)
Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments. We expect to see this therapeutic area grow exponentially in the future. Come to this workshop to learn about the strategies being employed for cell & gene therapies, their unique supply chain challenges and how to overcome them.
Speakers:
How to Partner with Your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS5)
In our ever evolving clinical development world, we are realizing the value of a site-centric approach to clinical trials and clinical supplies. This workshop will identify ways to better collaborate with clinical sites to enhance patient enrollment, patient retention throughout the clinical trial and decrease in clinical supply dosing and maintenance.
Speakers:
I will not be attending a workshop at this time
Leveraging Social Media to Enhance Clinical Trial Outcomes (WS1)
Social media is having a paradigm shifting effect on clinical trials by facilitating cross-cutting, multi-directional communication among patient, advocate, researcher and clinician communities. This workshop will discuss the impact of social media on drug development and explore ways we can use it to increase patient enrollment, education, retention and compliance.
Speakers:
Supply Chain Challenges when going into Emerging Markets (WS10)
As clinical trials grow and more and more sites must be found to accelerate enrollment and trial completion the use of emerging markets has been growing over the past 5 years. This workshop will explore the planning needed when entering into emerging markets, the challenges of flexing with new regulatory requirements that occur often and the best way to leverage your courier service partners to get into new countries.
Speakers:
The Evolving Regulatory Landscape - Including the Impact of Brexit and the Clinical Trial Regulation 536/2014 (WS2)
Clinical supply chains are evolving in accordance with the potential implications of Brexit and the Clinical Trial Regulation. This workshop will provide an opportunity to discuss that evolution and get answers to your questions.
Speakers:
Room transfer- Tea/Coffee Break
Accelerating Enrollment, Improving Retention and Shortening Clinical Trials Using Direct to Patient Clinical Supply Chain Strategies (WS9)
Improving access to patient populations, accelerating 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 ways to implement a direct to patient supply chain model.
Speakers:
Compassionate Use/Expanded Access Programs - Understanding Supply Chain Requirements, Planning and Forecasting (WS4)
This interactive presentation will give an overview of expanded access and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.
Speakers:
I will not be attending a workshop at this time
Linking Simulation to IRT (WS7)
Simulations, to identify the probable outcomes of trial enrollment which will impact the clinical supply chain, are the way of the near term future. Linking the IRT to simulation software/systems can help predict clinical supply requirements while adjusting quickly to enrollment outcomes. In this wokshop we will discuss the value of linking simulation to your IRT, how to show the value of doing it to Clinical Operations and the impact on savings this linkage can create.
Speakers:
Preparing for Regulatory Inspections (WS6)
Regulatory inspections don't always have to be a stressful situation. With the proper training, planning, technology and self auditing programs in place they can be much easier and faster. This workshop will examine ways to ensure regulatory audits and inspections will be as smooth as possible while creating finding free outcomes.
Speakers:
Strategies for Returns, Reconciliation and Destruction (WS8)
Returns and reconciliation have come under greater scrutiny as we get closer to complying with the clinical trial regulation. Performing the final reconciliation and disposition of material, being returned from a clinical site, is typically one of the most challenging aspects of clinical supplies because it requires a collaborative bridge between Clinical Operations and Clinical Supplies. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
Speakers:
Lunch - Exhibitor Displays Open
Cell Gene Therapy Supply Chain Strategies (WS3)
Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments. We expect to see this therapeutic area grow exponentially in the future. Come to this workshop to learn about the strategies being employed for cell & gene therapies, their unique supply chain challenges and how to overcome them.
Speakers:
How to Partner with Your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS5)
In our ever evolving clinical development world, we are realizing the value of a site-centric approach to clinical trials and clinical supplies. This workshop will identify ways to better collaborate with clinical sites to enhance patient enrollment, patient retention throughout the clinical trial and decrease in clinical supply dosing and maintenance.
Speakers:
I will not be attending a workshop at this time
Leveraging Social Media to Enhance Clinical Trial Outcomes (WS1)
Social media is having a paradigm shifting effect on clinical trials by facilitating cross-cutting, multi-directional communication among patient, advocate, researcher and clinician communities. This workshop will discuss the impact of social media on drug development and explore ways we can use it to increase patient enrollment, education, retention and compliance.
Speakers:
Supply Chain Challenges when going into Emerging Markets (WS10)
As clinical trials grow and more and more sites must be found to accelerate enrollment and trial completion the use of emerging markets has been growing over the past 5 years. This workshop will explore the planning needed when entering into emerging markets, the challenges of flexing with new regulatory requirements that occur often and the best way to leverage your courier service partners to get into new countries.
Speakers:
The Evolving Regulatory Landscape - Including the Impact of Brexit and the Clinical Trial Regulation 536/2014 (WS2)
Clinical supply chains are evolving in accordance with the potential implications of Brexit and the Clinical Trial Regulation. This workshop will provide an opportunity to discuss that evolution and get answers to your questions.
Speakers:
Room transfer - Tea/Coffee break
Patient Testimonial
Speakers:
GCSG Membership and Benefits
Vendor Reception
Closing Remarks, Survey Completion and Vendor Reception Prize Draws
Speakers:
Personal Time to get ready for evening
Departure for evening entertainment
GCSG Night Out
Departure back to the hotel
Day 3 : Thursday, October 24
Registration Open - Exhibitor Displays Open
Opening Remarks
Speakers:
Pharmaceutical Industry in the 22nd Century
Speakers:
Room transfer - Tea/Coffee break
Accelerating Enrollment, Improving Retention and Shortening Clinical Trials Using Direct to Patient Clinical Supply Chain Strategies (WS9)
Improving access to patient populations, accelerating 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 ways to implement a direct to patient supply chain model.
Speakers:
Compassionate Use/Expanded Access Programs - Understanding Supply Chain Requirements, Planning and Forecasting (WS4)
This interactive presentation will give an overview of expanded access and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.
Speakers:
Culture of Accountability (WS11) - Part 1 of 2 (Select Part 2 of 2 in the Session 5 Workshops. This is a 2-hour session)
This is a two session workshop. If you sign up for Part 1 of 2 (10:15 - 11:15 AM on 24 October 2015), you must also sign up for Part 2 of 2 (11:30 AM - 12:30 PM on 24 October 2015)
In this session, we will discuss and define accountability and case studies will be provided to demonstrate techniques and concepts to instill a culture of accountability within your team.
Speakers:
I will not be attending a workshop at this time
Linking Simulation to IRT (WS7)
Simulations, to identify the probable outcomes of trial enrollment which will impact the clinical supply chain, are the way of the near term future. Linking the IRT to simulation software/systems can help predict clinical supply requirements while adjusting quickly to enrollment outcomes. In this wokshop we will discuss the value of linking simulation to your IRT, how to show the value of doing it to Clinical Operations and the impact on savings this linkage can create.
Speakers:
Preparing for Regulatory Inspections (WS6)
Regulatory inspections don't always have to be a stressful situation. With the proper training, planning, technology and self auditing programs in place they can be much easier and faster. This workshop will examine ways to ensure regulatory audits and inspections will be as smooth as possible while creating finding free outcomes.
Speakers:
Room transfer- Tea/Coffee Break
Cell Gene Therapy Supply Chain Strategies (WS3)
Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments. We expect to see this therapeutic area grow exponentially in the future. Come to this workshop to learn about the strategies being employed for cell & gene therapies, their unique supply chain challenges and how to overcome them.
Speakers:
Compassionate Use/Expanded Access Programs - Understanding Supply Chain Requirements, Planning and Forecasting (WS4)
This interactive presentation will give an overview of expanded access and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.
Speakers:
Culture of Accountability (WS11) - Part 2 of 2 (This is the second half of a 2-hour session. Select Part 1 of 2 from the Session 4 Workshops.)
This is a two session workshop. If you sign up for Part 1 of 2 (10:15 - 11:15 AM on 24 October 2015), you must also sign up for Part 2 of 2 (11:30 AM - 12:30 PM on 24 October 2015)
In this session, we will discuss and define accountability and case studies will be provided to demonstrate techniques and concepts to instill a culture of accountability within your team.
Speakers:
How to Partner with Your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS5)
In our ever evolving clinical development world, we are realizing the value of a site-centric approach to clinical trials and clinical supplies. This workshop will identify ways to better collaborate with clinical sites to enhance patient enrollment, patient retention throughout the clinical trial and decrease in clinical supply dosing and maintenance.
Speakers:
I will not be attending a workshop at this time
Strategies for Returns, Reconciliation and Destruction (WS8)
Returns and reconciliation have come under greater scrutiny as we get closer to complying with the clinical trial regulation. Performing the final reconciliation and disposition of material, being returned from a clinical site, is typically one of the most challenging aspects of clinical supplies because it requires a collaborative bridge between Clinical Operations and Clinical Supplies. In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
Speakers:
Lunch - Exhibitor Displays Open
What can we learn about innovation from the Non-Pharma Supply Chain
Speakers:
Closing Remarks, Survey Completion, Prize Draws
Speakers:
