Soaring to New Standards!

2017 US Conference in Albuquerque, NM

Our annual US GCSG conference from April 23rd – 26th, 2017 has now past.

Join us for the European GCSG Knowledge Forum in Oct 2017!

Info on EU GCSG FORUM
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Day

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Day 1: Sunday, April 23
8:30 am - 4:00 pm
Boot Camp

Clinical Supplies 101 (Boot Camp)

This 6 hour long 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
    • 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
Mike Dallman
3:00 pm - 6:00 pm
Conference Logistics

Registration / Information / Welcome Table Open

Stop by for any questions you have about the GCSG Conference.

Location
5:00 pm - 5:30 pm
Conference Logistics

New Member Orientation

If you're new to GCSG or just want a refresher on everything GCSG has to offer; come stop by.

Speakers
Steven Jacobs
Location
5:30 pm - 8:30 pm
Conference Logistics

Meet & Greet – GCSG Networking Event

Location
Hummingbird Garden
Day 2: Monday, April 24
7:30 am - 4:30 pm
Conference Logistics

Registration/ Information/Welcome Table Open

Stop by for any questions you have about the GCSG Conference.

Location
8:20 am - 8:30 am
Break

Coffee Break

Head to the Main Hall for the Welcome and Opening Remarks.

10:15 am - 10:25 am
Break

Coffee Break

It's time to head to your first workshop. Check your 'Personal Schedule' to see where you should be going.

10:25 am - 11:25 am
Workshop

BioSimilars and BioBetters: More than Generic Biologicals (WS15)

This workshop will discuss the biosimilar/ biobetter development process, how they differ from innovator products and the challenges with development and clinical trials.

Speakers
Mike Dallman
10:25 am - 11:25 am
Workshop

BREXIT Update -Impact to Clinical Supplies (WS24)

What does the UK exiting the EU mean to our Clinical Trial Supply Chain?  Come to this session to discuss ways to work through this change.

Speakers
Adrian Peskett, Paul O'Connor,
10:25 am - 11:25 am
Workshop

Building a Quality Culture (WS29)

As the world of clinical supplies becomes increasingly complex it is essential that clinical supply partners with Quality to achieve the best outcomes.  An essential step in this process is to build a quality culture within the clinical supply unit.  This session will discuss ways to build that culture within your own organization.

Speakers
Nancy Borgeson, Sharon McCarthy,
10:25 am - 11:25 am
Workshop

Clarifying Roles and Responsibilities through RACI chart (WS13)

Knowing everyone's role & responsibilities is an essential requirement for successful teams.  This workshop will provide an overview and process methods for deploying a RACI (Responsible, Accountable, Consulted, Informed)  chart in support of those outcomes.

Speakers
Barbara Campbell, Lisa Georgen,
10:25 am - 11:25 am
Workshop

Drug Reconciliation, International Returns & Destruction (WS1)

Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries.  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 better bridge between the GMP and GCP sides of the house.  In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Speakers
Greg Hottel
10:25 am - 11:25 am
Workshop

Global Trends in Clinical Supply Logistics (WS21)

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 countries as well as how they impact CT supplies timelines and planning.

10:25 am - 11:25 am
Workshop

Managing Translations for Global Studies (WS11)

Providing printed materials with text properly translated into the local language can be exceptionally challenging.  Language and cultural nuances create difficulties that can cause interruptions in clinical supplies.

10:25 am - 11:25 am
Workshop

Strategies for the Handling of Ancillary Supplies (WS19)

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.

Speakers
, Steffani Szczuka,
10:25 am - 11:25 am
Workshop

Supplying Pediatric Trials (WS5)

Standard adult clinical supplies are challenging enough, adding a pediatric component to our trials and supply chain increases the complexity exponentially.  This session will share best practices on supplying clinical trial material that is tailored to our youngest patients and support regulatory decision making.

Speakers
Brian Fulling
10:25 am - 11:25 am
Workshop

The Benefit of Integrated Supply Chain Systems (WS30)

With the mergers and acquisitions standard within our industry, we sometimes find ourselves trying to integrate multiple clinical supply chain systems to create a functional platform within the new organization.  This session will discuss how to influence the decision making process and strategies for integration as well as bundled systems that solve these issues.

Speakers
Mark Hanly, Julia Hagan,
10:25 am - 11:25 am
Workshop

Utilizing Automated Forecasting Tools (WS9)

Sometimes a spreadsheet is just not enough!  This session will cover the latest technology for automated forecasting tools and how to integrate actual consumption to update your forecast. Leave the programming behind and see the system benefits.

Speakers
Melissa Gallardo, Michael Sparozic, Cyrille Lefevre,
10:25 am - 11:25 am
Workshop

Writing Robust Quality and Technical Agreements (WS23)

Writing robust quality and technical agreements with vendors & partners can be challenging.  How much detail to include?  What are the key items? Where to start?  Come to this session to have engaging discussions on the best practices when writing these key documents.

Speakers
Laurie McMahon
11:25 am - 11:35 am
Break

Return to Main Hall

Return to the main hall to hear our next presentation on 30 years of Clinical Supplies with a Focus on what's to come.

11:35 am - 12:35 pm
Presentation

30 Years of Clinical Supplies – Focus on the Future

A look at the past 30 years of CTM and where we are heading over the next 30 years.

Speakers
Janelle Sabo, David Volk, Michael Ku, Alexander Debets,
1:20 pm - 1:30 pm
Break

Room Transfer

It's time to head to your second workshop. Check your 'Personal Schedule' to see where you should be going.

1:30 pm - 2:30 pm
Workshop

Comparator Track & Trace and e-Pedigree (WS10)

Establishment of good distribution practices (GDP) globally and recent regulatory changes are driving the need to provide traceability of all materials used in a clinical trial.  This session will discuss the options for maintaining identification of comparators used in a trial from purchase to reconciliation.

Speakers
Mike Cohen, Jason Nolte,
1:30 pm - 2:30 pm
Workshop

Country Specific Import/Export Requirements (WS31)

Country Import/Export regulations are constantly changing. In order to expedite shipping of clinical supplies, this workshop will provide updates to specific geographic areas that will decrease delays and issues for CTM logistics.

Speakers
Roopal Patel
1:30 pm - 2:30 pm
Workshop

Impact of Automated Commercial Environment (ACE) on US Imports (WS20)

Don't have an Import Export team of experts for your clinical supply chain?  Come to this session to learn about the impact of the Automated Commercial Environment (ACE) on US Imports and what clinical supply chain can do to help build the information needed to clear your supplies.

Speakers
Kris Harah
1:30 pm - 2:30 pm
Workshop

Interactive Response Technology Configuration & Validation (WS14)

This session will provide guidelines for converting your trial design into a successful IRT configuration.  Validation, user acceptance criteria and testing will be explored.

Speakers
Nimer Yusef
1:30 pm - 2:30 pm
Workshop

Let’s Talk Medical Devices (WS26)

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

Speakers
Volker Niermann
1:30 pm - 2:30 pm
Workshop

QP Update: How are clinical trial requirements changing in the EU? (WS12)

The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations.  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.

Speakers
Shawn Murtough
1:30 pm - 2:30 pm
Workshop

Regulatory Labeling and Customs Requirements for CTM in Asia (WS18)

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 Asian countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

1:30 pm - 2:30 pm
Workshop

Sample Requirements for Bioavailability / Bioequivalence Studies (WS6)

Regulatory requirements for BA/BE studies are complex and are a source of contention between clinical supplies and regulatory affairs.  This session will share best practices on when samples are required and how best to handle them.

1:30 pm - 2:30 pm
Workshop

Supply Chain Requirements for Cell & Gene Therapy (WS16)

The distribution and handling of precious gene therapy supplies requires a higher level of controls to ensure quality and sustainability.

Speakers
Kevin O'Donnell, Krisztina Poda,
2:30 pm - 2:40 pm
Break

Coffee Break

It's time to head to your third workshop. Check your 'Personal Schedule' to see where you should be going.

2:40 pm - 3:40 pm
Workshop

BREXIT Update -Impact to Clinical Supplies (WS24)

What does the UK exiting the EU mean to our Clinical Trial Supply Chain?  Come to this session to discuss ways to work through this change.

Speakers
Adrian Peskett, Paul O'Connor,
2:40 pm - 3:40 pm
Workshop

BRRRR… It’s Cold in Here! Options for Packaging & Shipping Frozen Products (WS32)

This informative session will discuss the risks and mitigations to consider when packaging, labeling & shipping all levels of frozen product - from the mildly frozen to deep freeze products.   Come with your questions and your knowledge to make the most of this interactive session.

Speakers
Scott Jacoby
2:40 pm - 3:40 pm
Workshop

Building a Quality Culture (WS29)

As the world of clinical supplies becomes increasingly complex it is essential that clinical supply partners with Quality to achieve the best outcomes.  An essential step in this process is to build a quality culture within the clinical supply unit.  This session will discuss ways to build that culture within your own organization.

Speakers
Sharon McCarthy, Nancy Borgeson,
2:40 pm - 3:40 pm
Workshop

Clarifying Roles and Responsibilities Through RACI chart (WS13)

Knowing everyone's role & responsibilities is an essential requirement for successful teams.  This workshop will provide an overview and process methods for deploying a RACI (Responsible, Accountable, Consulted, Informed)  chart in support of those outcomes.

Speakers
Barbara Campbell, Lisa Georgen,
2:40 pm - 3:40 pm
Workshop

Deviation Handling – Getting to Root Cause (WS25)

In our highly regulated industry, one area that always needs focus seems to be investigation and deviation writing.  The only way to really reduce recurrence is to find true root cause and develop good preventative actions.  Come practice your skills and talk about how to really get to root cause.

Speakers
Paula Teixeira
2:40 pm - 3:40 pm
Workshop

Drug Reconciliation, International Returns & Destruction (WS1)

Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries.  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 better bridge between the GMP and GCP sides of the house.  In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Speakers
Greg Hottel
2:40 pm - 3:40 pm
Workshop

Impact of Automated Commercial Environment (ACE) on US Imports (WS20)

Don't have an Import Export team of experts for your clinical supply chain?  Come to this session to learn about the impact of the Automated Commercial Environment (ACE) on US Imports and what clinical supply chain can do to help build the information needed to clear your supplies.

Speakers
Kris Harah
2:40 pm - 3:40 pm
Workshop

Importer of Record: Tips and Techniques (WS4)

Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.

Speakers
Rich Nelson
2:40 pm - 3:40 pm
Workshop

Project Management (WS28)

Everyone in Clinical Supply Chain uses some sort of project management in their daily jobs.  Come to this session to discuss some project management best practices or share some of yours!  Whether you are new to Clinical Supplies or a seasoned professional, there is something for everyone in this workshop!

Speakers
Rob Pizzie, Lorna Briddick,
2:40 pm - 3:40 pm
Workshop

Regulatory Labeling and Customs Requirements for CTM in Latin American Countries (WS17)

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 Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

2:40 pm - 3:40 pm
Workshop

Understanding the Requirements of Direct to Patient Trials (WS7)

Ensuring safety and quality are maintained when direct to patient clinical supplies distribution occurs remains a major Supply Chain concern.  Dynamic enrollment, aggressive recruitment, confidentiality and drug supply/ cost are driving the industry to find alternative ways to supply IMP closer to the patient.  This workshop will provide a forum for discussing ideas and solutions to the overcome/ prevent issues with direct shipments to patients.

Speakers
Scott Ohanesian
3:40 pm - 3:50 pm
Break

Return to Main Hall

Head back to the Main Hall to hear an update from ISPE.

6:00 pm - 10:00 pm
Conference Logistics

Evening Entertainment- GCSG Sponsored Event

Come join your fellow GCSG attendees for a fun evening of networking and entertainment!

Location
Cottonwoods
Day 3: Tuesday, April 25
7:30 am - 4:30 pm
Conference Logistics

Registration/Information/Welcome Table Open

Stop by for any questions you have about the GCSG Conference.

Location
8:30 am - 8:40 am
Break

Coffee Break

It's time to head to the main hall as we kick of day 2 of the conference!

10:20 am - 10:30 am
Break

Coffee Break

It's time to head to your first workshop of day 2. Please check your 'personal schedule' to see where you should be going.

10:30 am - 11:30 am
Workshop

BRRRR… It’s Cold in Here! Options for Packaging & Shipping Frozen Products (WS32)

This informative session will discuss the risks and mitigations to consider when packaging, labeling & shipping all levels of frozen product - from the mildly frozen to deep freeze products.   Come with your questions and your knowledge to make the most of this interactive session.

Speakers
Scott Jacoby
10:30 am - 11:30 am
Workshop

Deviation Handling – Getting to Root Cause (WS25)

In our highly regulated industry, one area that always needs focus seems to be investigation and deviation writing.  The only way to really reduce recurrence is to find true root cause and develop good preventative actions.  Come practice your skills and talk about how to really get to root cause.

Speakers
Paula Teixeira
10:30 am - 11:30 am
Workshop

Project Management (WS28)

Everyone in Clinical Supply Chain uses some sort of project management in their daily jobs.  Come to this session to discuss some project management best practices or share some of yours!  Whether you are new to Clinical Supplies or a seasoned professional, there is something for everyone in this workshop!

Speakers
Lorna Briddick, Rob Pizzie,
10:30 am - 11:30 am
Workshop

QP Update: How are clinical trial requirements changing in the EU? (WS12)

The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations.  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.

Speakers
Shawn Murtough
10:30 am - 11:30 am
Workshop

Regulatory Labeling and Customs Requirements for CTM in Latin American Countries (WS17)

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 Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

10:30 am - 11:30 am
Workshop

Sample Requirements for Bioavailability / Bioequivalence Studies (WS6)

Regulatory requirements for BA/BE studies are complex and are a source of contention between clinical supplies and regulatory affairs.  This session will share best practices on when samples are required and how best to handle them.

10:30 am - 11:30 am
Workshop

Strategies for the Handling of Ancillary Supplies (WS19)

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.

Speakers
, Steffani Szczuka,
10:30 am - 11:30 am
Workshop

Supply Chain Requirements for Cell & Gene Therapy (WS16)

The distribution and handling of precious gene therapy supplies requires a higher level of controls to ensure quality and sustainability.

Speakers
Kevin O'Donnell, Krisztina Poda,
10:30 am - 11:30 am
Workshop

The Benefit of Integrated Supply Chain Systems (WS30)

With the mergers and acquisitions standard within our industry, we sometimes find ourselves trying to integrate multiple clinical supply chain systems to create a functional platform within the new organization.  This session will discuss how to influence the decision making process and strategies for integration as well as bundled systems that solve these issues.

Speakers
Mark Hanly, Julia Hagan,
10:30 am - 11:30 am
Workshop

Writing Robust Quality and Technical Agreements (WS23)

Writing robust quality and technical agreements with vendors & partners can be challenging.  How much detail to include?  What are the key items? Where to start?  Come to this session to have engaging discussions on the best practices when writing these key documents.

Speakers
Laurie McMahon
11:30 am - 11:40 am
Break

Coffee Break

It's time to head to your second workshop of day 2. Please check your 'personal schedule' to see where you are headed.

11:40 am - 12:40 pm
Workshop

BioSimilars and BioBetters: More than Generic Biologicals (WS15)

This workshop will discuss the biosimilar/ biobetter development process, how they differ from innovator products and the challenges with development and clinical trials.

Speakers
Mike Dallman
11:40 am - 12:40 pm
Workshop

BREXIT Update -Impact to Clinical Supplies (WS24)

What does the UK exiting the EU mean to our Clinical Trial Supply Chain?  Come to this session to discuss ways to work through this change.

Speakers
Adrian Peskett, Paul O'Connor,
11:40 am - 12:40 pm
Workshop

Building a Quality Culture (WS29)

As the world of clinical supplies becomes increasingly complex it is essential that clinical supply partners with Quality to achieve the best outcomes.  An essential step in this process is to build a quality culture within the clinical supply unit.  This session will discuss ways to build that culture within your own organization.

Speakers
Sharon McCarthy, Nancy Borgeson,
11:40 am - 12:40 pm
Workshop

Comparator Track & Trace and e-Pedigree (WS10)

Establishment of good distribution practices (GDP) globally and recent regulatory changes are driving the need to provide traceability of all materials used in a clinical trial.  This session will discuss the options for maintaining identification of comparators used in a trial from purchase to reconciliation.

Speakers
Mike Cohen, Jason Nolte,
11:40 am - 12:40 pm
Workshop

Drug Reconciliation, International Returns & Destruction (WS1)

Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries.  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 better bridge between the GMP and GCP sides of the house.  In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Speakers
Greg Hottel
11:40 am - 12:40 pm
Workshop

Global Trends in Clinical Supply Logistics (WS21)

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 countries as well as how they impact CT supplies timelines and planning.

11:40 am - 12:40 pm
Workshop

Interactive Response Technology Configuration & Validation (WS14)

This session will provide guidelines for converting your trial design into a successful IRT configuration.  Validation, user acceptance criteria and testing will be explored.

Speakers
Nimer Yusef
11:40 am - 12:40 pm
Workshop

Let’s Talk Medical Devices (WS26)

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

Speakers
Volker Niermann
11:40 am - 12:40 pm
Workshop

Managing Translations for Global Studies (WS11)

Providing printed materials with text properly translated into the local language can be exceptionally challenging.  Language and cultural nuances create difficulties that can cause interruptions in clinical supplies.

11:40 am - 12:40 pm
Workshop

Regulatory Labeling and Customs Requirements for CTM in Asia (WS18)

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 Asian countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

11:40 am - 12:40 pm
Workshop

Supplying Pediatric Trials (WS5)

Standard adult clinical supplies are challenging enough, adding a pediatric component to our trials and supply chain increases the complexity exponentially.  This session will share best practices on supplying clinical trial material that is tailored to our youngest patients and support regulatory decision making.

Speakers
Brian Fulling
1:40 pm - 1:50 pm
Break

Coffee Break

It's now time to head to your third and final workshop of day 2. Please check your 'personal schedule' to see where you should be headed.

1:50 pm - 2:50 pm
Workshop

BRRRR… It’s Cold in Here! Options for Packaging & Shipping Frozen Products (WS32)

This informative session will discuss the risks and mitigations to consider when packaging, labeling & shipping all levels of frozen product - from the mildly frozen to deep freeze products.   Come with your questions and your knowledge to make the most of this interactive session.

Speakers
Scott Jacoby
1:50 pm - 2:50 pm
Workshop

Clarifying Roles and Responsibilities Through RACI chart (WS13)

Knowing everyone's role & responsibilities is an essential requirement for successful teams.  This workshop will provide an overview and process methods for deploying a RACI (Responsible, Accountable, Consulted, Informed)  chart in support of those outcomes.

Speakers
Barbara Campbell, Lisa Georgen,
1:50 pm - 2:50 pm
Workshop

Country Specific Import/Export Requirements (WS31)

Country Import/Export regulations are constantly changing. In order to expedite shipping of clinical supplies, this workshop will provide updates to specific geographic areas that will decrease delays and issues for CTM logistics.

Speakers
Roopal Patel
1:50 pm - 2:50 pm
Workshop

Deviation Handling – Getting to Root Cause (WS25)

In our highly regulated industry, one area that always needs focus seems to be investigation and deviation writing.  The only way to really reduce recurrence is to find true root cause and develop good preventative actions.  Come practice your skills and talk about how to really get to root cause.

Speakers
Paula Teixeira
1:50 pm - 2:50 pm
Workshop

Importer of Record: Tips and Techniques (WS4)

Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.

Speakers
Rich Nelson
1:50 pm - 2:50 pm
Workshop

NEW! Pharmacist Networking

This is a one hour session to provide Pharmacists a chance to meet and discuss current opportunities and trends in Clinical Supplies.

Speakers
Location
1:50 pm - 2:50 pm
Workshop

Project Management (WS28)

Everyone in Clinical Supply Chain uses some sort of project management in their daily jobs.  Come to this session to discuss some project management best practices or share some of yours!  Whether you are new to Clinical Supplies or a seasoned professional, there is something for everyone in this workshop!

Speakers
Rob Pizzie, Lorna Briddick,
1:50 pm - 2:50 pm
Workshop

QP Update: How are clinical trial requirements changing in the EU? (WS12)

The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations.  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.

Speakers
Shawn Murtough
1:50 pm - 2:50 pm
Workshop

Sample Requirements for Bioavailability / Bioequivalence Studies (WS6)

Regulatory requirements for BA/BE studies are complex and are a source of contention between clinical supplies and regulatory affairs.  This session will share best practices on when samples are required and how best to handle them.

1:50 pm - 2:50 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS19)

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.

Speakers
, Steffani Szczuka,
1:50 pm - 2:50 pm
Workshop

Supply Chain Requirements for Cell & Gene Therapy (WS16)

The distribution and handling of precious gene therapy supplies requires a higher level of controls to ensure quality and sustainability.

Speakers
Kevin O'Donnell, Krisztina Poda,
1:50 pm - 2:50 pm
Workshop

Understanding the Requirements of Direct to Patient Trials (WS7)

Ensuring safety and quality are maintained when direct to patient clinical supplies distribution occurs remains a major Supply Chain concern.  Dynamic enrollment, aggressive recruitment, confidentiality and drug supply/ cost are driving the industry to find alternative ways to supply IMP closer to the patient.  This workshop will provide a forum for discussing ideas and solutions to the overcome/ prevent issues with direct shipments to patients.

Speakers
Scott Ohanesian
1:50 pm - 2:50 pm
Workshop

Utilizing Automated Forecasting Tools (WS9)

Sometimes a spreadsheet is just not enough!  This session will cover the latest technology for automated forecasting tools and how to integrate actual consumption to update your forecast. Leave the programming behind and see the system benefits.

Speakers
Melissa Gallardo, Michael Sparozic, Cyrille Lefevre,
2:50 pm - 3:00 pm
Break

Coffee Break then Return to the Main Hall

It's now time to gather as a full group and hear an update on ELabeling.

4:30 pm - 6:30 pm
Conference Logistics

Vendor Reception / Exhibitor Displays Open

Join us for a reception hosted by our vendors as you peruse all of their latest offerings.

Location
Day 4: Wednesday, April 26
7:30 am - 2:30 pm
Conference Logistics

Registration / Information / Welcome Table Open

Stop by for any questions you have about the GCSG Conference.

Location
8:20 am - 8:30 am
Break

Coffee Break

It's time to head to the main hall to kick-off day 3!

8:30 am - 8:45 am
Conference Logistics

Welcome & Opening Remarks

Speakers
Steven Jacobs
9:45 am - 9:55 am
Break

Coffee Break

It's time to head to your first workshop of day 3. Please check your 'personal schedule' to see where you are headed.

9:55 am - 10:55 am
Workshop

BioSimilars and BioBetters: More than Generic Biologicals (WS15)

This workshop will discuss the biosimilar/ biobetter development process, how they differ from innovator products and the challenges with development and clinical trials.

Speakers
Mike Dallman
9:55 am - 10:55 am
Workshop

Comparator Track & Trace and e-Pedigree (WS10)

Establishment of good distribution practices (GDP) globally and recent regulatory changes are driving the need to provide traceability of all materials used in a clinical trial.  This session will discuss the options for maintaining identification of comparators used in a trial from purchase to reconciliation.

Speakers
Mike Cohen, Jason Nolte,
9:55 am - 10:55 am
Workshop

Global Trends in Clinical Supply Logistics (WS21)

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 countries as well as how they impact CT supplies timelines and planning.

9:55 am - 10:55 am
Workshop

Regulatory Labeling and Customs Requirements for CTM in Asia (WS18)

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 Asian countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

9:55 am - 10:55 am
Workshop

Supplying Pediatric Trials (WS5)

Standard adult clinical supplies are challenging enough, adding a pediatric component to our trials and supply chain increases the complexity exponentially.  This session will share best practices on supplying clinical trial material that is tailored to our youngest patients and support regulatory decision making.

Speakers
Brian Fulling
9:55 am - 10:55 am
Workshop

The Benefit of Integrated Supply Chain Systems (WS30)

With the mergers and acquisitions standard within our industry, we sometimes find ourselves trying to integrate multiple clinical supply chain systems to create a functional platform within the new organization.  This session will discuss how to influence the decision making process and strategies for integration as well as bundled systems that solve these issues.

Speakers
Mark Hanly, Julia Hagan,
1:20 pm - 2:15 pm
Presentation

Understanding Cultural Differences and Avoiding Communication Disasters

Delays and failures in global projects are numerous due to our inability to navigate the cultural differences between team members located across the globe. Knowledge of cultural norms in the countries where your clinical trial activities are occurring can go a long way in preventing issues from happening.  This presentation will discuss aspects on how to recognize when cultural differences may be a factor, where to find cultural differences of people from all over the world, and how to differentiate between stereotyping and generalizing on cultural criteria.

Speakers
Steven Jacobs
10:55 am - 11:10 am
Break

Coffee Break

It's now time to head to your final workshop of the 2017 US Conference. Once again, please check your 'personal schedule' to see where you are headed.

11:10 am - 12:10 pm
Workshop

Country Specific Import/Export Requirements (WS31)

Country Import/Export regulations are constantly changing. In order to expedite shipping of clinical supplies, this workshop will provide updates to specific geographic areas that will decrease delays and issues for CTM logistics.

Speakers
Roopal Patel
11:10 am - 12:10 pm
Workshop

Impact of Automated Commercial Environment (ACE) on US Imports (WS20)

Don't have an Import Export team of experts for your clinical supply chain?  Come to this session to learn about the impact of the Automated Commercial Environment (ACE) on US Imports and what clinical supply chain can do to help build the information needed to clear your supplies.

Speakers
Kris Harah
11:10 am - 12:10 pm
Workshop

Importer of Record: Tips and Techniques (WS4)

Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.

Speakers
Rich Nelson
11:10 am - 12:10 pm
Workshop

Interactive Response Technology Configuration & Validation (WS14)

This session will provide guidelines for converting your trial design into a successful IRT configuration.  Validation, user acceptance criteria and testing will be explored.

Speakers
Nimer Yusef
11:10 am - 12:10 pm
Workshop

Let’s Talk Medical Devices (WS26)

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

Speakers
Volker Niermann
11:10 am - 12:10 pm
Workshop

Managing Translations for Global Studies (WS11)

Providing printed materials with text properly translated into the local language can be exceptionally challenging.  Language and cultural nuances create difficulties that can cause interruptions in clinical supplies.

11:10 am - 12:10 pm
Workshop

Regulatory Labeling and Customs Requirements for CTM in Latin American Countries (WS17)

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 Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.

11:10 am - 12:10 pm
Workshop

Understanding the Requirements of Direct to Patient Trials (WS7)

Ensuring safety and quality are maintained when direct to patient clinical supplies distribution occurs remains a major Supply Chain concern.  Dynamic enrollment, aggressive recruitment, confidentiality and drug supply/ cost are driving the industry to find alternative ways to supply IMP closer to the patient.  This workshop will provide a forum for discussing ideas and solutions to the overcome/ prevent issues with direct shipments to patients.

Speakers
Scott Ohanesian
11:10 am - 12:10 pm
Workshop

Utilizing Automated Forecasting Tools (WS9)

Sometimes a spreadsheet is just not enough!  This session will cover the latest technology for automated forecasting tools and how to integrate actual consumption to update your forecast. Leave the programming behind and see the system benefits.

Speakers
Melissa Gallardo, Michael Sparozic, Cyrille Lefevre,
11:10 am - 12:10 pm
Workshop

Writing Robust Quality and Technical Agreements (WS23)

Writing robust quality and technical agreements with vendors & partners can be challenging.  How much detail to include?  What are the key items? Where to start?  Come to this session to have engaging discussions on the best practices when writing these key documents.

Speakers
Laurie McMahon
1:10 pm - 1:20 pm
Break

Coffee Break

It's time to head back to the main hall as we hear one last presentation on Understanding Cultural Differences and Avoiding Communication Disasters.

2:15 pm - 2:30 pm
Conference Logistics

Closing Remarks and Raffle Drawings

Speakers
Steven Jacobs
Location

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