April 29 to May 2, 2018 - Atlanta, GA

2018 US GCSG Conference

We had a lot of fun in Atlanta. Now, join us in Octobre in Barcelona for the 2018 EU Knowledge Forum!

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Day

Day 1: Sunday, April 29
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

Introduction to Import/Export Boot Camp

 


  • This session 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.

Day 2: Monday, April 30
8:40 am - 10:00 am
Presentation

Keynote: The Power of Understanding People

What is the single most important factor to being a more effective leader, having more success, experiencing more happiness? Simple. It is the ability to develop more effective relationships. “The Power of Understanding People” provides the tools to understand each participant’s own unique communication style and develop the competencies necessary to build stronger and more effective relationships with others. This info-filled, energizing and award winning training event provides an ideal combination of strong content, laugh-out-loud humor and audience interaction. In December 2013, the book of the same name was released and was immediately named Best Business Book of the Month by Amazon. Previous clients have credited The Power of Understanding People with more sales, more teamwork and a more effective organizational culture.

Location
10:00 am - 10:15 am
Break

Room Transfer / Break

10:15 am - 11:15 am
Workshop

Developing a Global, Decentralized Model for the Supply of Clinical Trial Material in a Demand Led Environment (WS2)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

10:15 am - 11:15 am
Workshop

Direct to Patient – Working With Your Investigator Sites & Courier to Create a Successful Partnership (WS5)

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 best practices to engage your clinical teams, sites & couriers to ensure a successful partnership in a  direct to patient supply chain model.

10:15 am - 11:15 am
Workshop

Regulatory Labeling and Customs Requirements for CTM in Latin American Countries (WS7)

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.

10:15 am - 11:15 am
Workshop

Software for Clinical Supplies (WS14)

As new pressures and concerns emerge within the clinical supply chain, technology is starting to take a bigger role in clinical supplies.
Taking advantage of the systems available out there and their tremendous power is sometimes inhibited by the flexibility needed to execute clinical trials from API/ Drug substance through to packaged and labeled goods.
This workshop will discuss the intricacies of managing data for clinical supply chain across internal and external supply chains, how you can measure your return on investment and the key benefits technology benefits can deliver for our clinical teams, sites and most importantly our patients.

Location
10:15 am - 11:15 am
Workshop

The Impact of EU Regulation 536/2014 (Clinical Trial Regulation) (WS19)

Clinical Supply Chains 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.

Location
Buckhead Ballroom II See Location map
10:15 am - 11:15 am
Workshop

Use of Central Pharmacies for Direct to Patient in your Clinical Supply Chain (WS4)

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.

Location
Buckhead Ballroom I See Location map
11:15 am - 11:30 am
Break

Return to Main Hall / Break

1:30 pm - 1:40 pm
Break

Room Transfer / Break

1:40 pm - 2:40 pm
Workshop

A Culture of Engagement in the Workplace (WS21)

As the clinical supply chain continues to grow in complexity, an engaged workforce is absolutely essential to the success of each company.
This workshop will discuss ways to implement  or enhance your team members engagement in the supply chain process.

1:40 pm - 2:40 pm
Workshop

Challenges of Cell, Gene, CAR-T and the Personalized Medicine Supply Chain (WS26)

 

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including 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, CAR-T and the Personalized Medicine Supply Chain.

Location
1:40 pm - 2:40 pm
Workshop

Identifying the Right IRT for Your Clinical Trial (WS25)

Identify the appropriate specifications for your study, including resupply strategies, reporting and testing within Interactive Response Technology.
This workshop will discuss how to ensure your IRT specifications are clearly created and documented to support the needs your clinical trial.

Speakers
1:40 pm - 2:40 pm
Workshop

Impact of Automated Commercial Environment (ACE) on US Imports (WS22)

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
1:40 pm - 2:40 pm
Workshop

Importer of Record (IOR) and VAT risk (WS27)

Recent clarity of the importation / VAT regulations by Her Majesty's Royal Customs Agency (HMRC) have impacted vendor support models for importing into the UK.
This workshop will clarify the relationship between IOR and VAT reclamation in the UK.

Location
Buckhead Ballroom II See Location map
1:40 pm - 2:40 pm
Workshop

Regulatory Labeling and Customs Requirements for CTM in Asia (WS37)

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.

Speakers
Location
1:40 pm - 2:40 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS31)

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.

1:40 pm - 2:40 pm
Workshop

Tips and Tricks for Effective Communications (WS30)

Top Tips and Tricks  for Collision Avoidance when communicating with individuals within or outside your organization.
This workshop will discuss best practices that support effective communications leading to more productive outcomes/ results with less ambiguity, misinterpretation and frustration surrounding business interactions.

Location
2:40 pm - 2:55 pm
Break

Return to Main Hall / Break

5:00 pm - 10:00 pm
Networking

Evening Entertainment -GCSG Sponsored Event

Buses will leave from the lower lobby circle.

Location
Offsite
Day 3: Tuesday, May 1
8:50 am - 9:50 am
Presentation

Patient Testimonial: Perspective from a Poly Juvenile Arthritis Patient

Hear directly from a Juvinille Arthritis patient about her experiences from her front-row seat to the incredible impact of drug discovery and development—the thrill of victory and the agony of defeat.

Location
9:50 am - 10:05 am
Break

Room Transfer / Break

10:05 am - 11:05 am
Workshop

Developing a Global, Decentralized Model for the Supply of Clinical Trial Material in a Demand Led Environment (WS2)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

10:05 am - 11:05 am
Workshop

Japan Trials (WS13)

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.

10:05 am - 11:05 am
Workshop

The Changing Role of the QP (WS12)

The quality units and Qualified Persons (QPs) in the EU are adjusting to prepare for BREXIT.
This workshop will provide an opportunity to discuss the QP role post BREXIT as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.

Location
11:05 am - 11:20 am
Break

Room Transfer / Break

11:20 am - 12:20 pm
Workshop

Direct to Patient – Working With Your Investigator Sites & Courier to Create a Successful Partnership (WS5)

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 best practices to engage your clinical teams, sites & couriers to ensure a successful partnership in a  direct to patient supply chain model.

Location
11:20 am - 12:20 pm
Workshop

Impact of Automated Commercial Environment (ACE) on US Imports (WS22)

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
Location
11:20 am - 12:20 pm
Workshop

Importer of Record (IOR) and VAT risk (WS27)

Recent clarity of the importation / VAT regulations by Her Majesty's Royal Customs Agency (HMRC) have impacted vendor support models for importing into the UK.
This workshop will clarify the relationship between IOR and VAT reclamation in the UK.

Location
Buckhead Ballroom II See Location map
11:20 am - 12:20 pm
Workshop

ISPE: Metrics for the Clinical Supply Chain (WS39)

A discussion of both internal company metrics and inter-company metrics. Results from the ongoing inter-company ISPE metrics survey will be shared.

What works to drive better performance?  What doesn't?
What are the biggest challenges?
What might be most useful to measure?
What are the keys to success?

Location
11:20 am - 12:20 pm
Workshop

Software for Clinical Supplies (WS14)

As new pressures and concerns emerge within the clinical supply chain, technology is starting to take a bigger role in clinical supplies.
Taking advantage of the systems available out there and their tremendous power is sometimes inhibited by the flexibility needed to execute clinical trials from API/ Drug substance through to packaged and labeled goods.
This workshop will discuss the intricacies of managing data for clinical supply chain across internal and external supply chains, how you can measure your return on investment and the key benefits technology benefits can deliver for our clinical teams, sites and most importantly our patients.

11:20 am - 12:20 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS31)

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.

11:20 am - 12:20 pm
Workshop

Use of Central Pharmacies for Direct to Patient in your Clinical Supply Chain (WS4)

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.

Location
1:30 pm - 1:40 pm
Break

Room Transfer / Break

1:40 pm - 2:40 pm
Workshop

A Culture of Engagement in the Workplace (WS21)

As the clinical supply chain continues to grow in complexity, an engaged workforce is absolutely essential to the success of each company.
This workshop will discuss ways to implement  or enhance your team members engagement in the supply chain process.

Location
1:40 pm - 2:40 pm
Workshop

Challenges of Cell, Gene, CAR-T and the Personalized Medicine Supply Chain (WS26)

 

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including 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, CAR-T and the Personalized Medicine Supply Chain.

Location
1:40 pm - 2:40 pm
Workshop

Identifying the Right IRT for Your Clinical Trial (WS25)

Identify the appropriate specifications for your study, including resupply strategies, reporting and testing within Interactive Response Technology.
This workshop will discuss how to ensure your IRT specifications are clearly created and documented to support the needs your clinical trial.

Speakers
1:40 pm - 2:40 pm
Workshop

Regulatory Labeling and Customs Requirements for CTM in Latin American Countries (WS7)

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.

1:40 pm - 2:40 pm
Workshop

Tips and Tricks for Effective Communications (WS30)

Top Tips and Tricks  for Collision Avoidance when communicating with individuals within or outside your organization.
This workshop will discuss best practices that support effective communications leading to more productive outcomes/ results with less ambiguity, misinterpretation and frustration surrounding business interactions.

Location
2:40 pm - 2:55 pm
Break

Return to Main Hall / Break

2:55 pm - 3:55 pm
Presentation

The Importance of Data Integrity in the Clinical Supply Chain

As the world of clinical supplies becomes increasingly complex it is essential that Clinical Supply teams partner with Quality to prepare for and achieve positive inspection outcomes.  An essential step in this process is to ensure data integrity throughout your clinical supply chain.  This presentation will discuss key aspects of ensuring the integrity of both electronic and paper records.

Location
Day 4: Wednesday, May 2
8:20 am - 8:30 am
Break

Room Transfer / Break

8:45 am - 9:00 am
Break

Room Transfer / Break

9:00 am - 10:00 am
Workshop

Direct to Patient – Working With Your Investigator Sites & Courier to Create a Successful Partnership (WS5)

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 best practices to engage your clinical teams, sites & couriers to ensure a successful partnership in a  direct to patient supply chain model.

Location
Buckhead Ballroom I See Location map
9:00 am - 10:00 am
Workshop

Importer of Record (IOR) and VAT risk (WS27)

Recent clarity of the importation / VAT regulations by Her Majesty's Royal Customs Agency (HMRC) have impacted vendor support models for importing into the UK.
This workshop will clarify the relationship between IOR and VAT reclamation in the UK.

9:00 am - 10:00 am
Workshop

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
9:00 am - 10:00 am
Workshop

Regulatory Labeling and Customs Requirements for CTM in Asia (WS37)

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.

Speakers
Location
9:00 am - 10:00 am
Workshop

The Changing Role of the QP (WS12)

The quality units and Qualified Persons (QPs) in the EU are adjusting to prepare for BREXIT.
This workshop will provide an opportunity to discuss the QP role post BREXIT as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.

Location
9:00 am - 10:00 am
Workshop

Tips and Tricks for Effective Communications (WS30)

Top Tips and Tricks  for Collision Avoidance when communicating with individuals within or outside your organization.
This workshop will discuss best practices that support effective communications leading to more productive outcomes/ results with less ambiguity, misinterpretation and frustration surrounding business interactions.

Location
10:00 am - 10:15 am
Break

Room Transfer / Break

10:15 am - 11:15 am
Workshop

Challenges of Cell, Gene, CAR-T and the Personalized Medicine Supply Chain (WS26)

 

Over the course of the last decade, there has been an increased emphasis on research and development into personalized medicines including 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, CAR-T and the Personalized Medicine Supply Chain.

10:15 am - 11:15 am
Workshop

Developing a Global, Decentralized Model for the Supply of Clinical Trial Material in a Demand Led Environment (WS2)

Traditionally structured clinical supply chains are inherently inefficient, relying upon large buffer inventories to offset variability in demand. However, by taking a fresh approach and making fundamental changes that allow the supply chain to be more responsive to changes in actual demand, efficiency can be improved. This session will explore the potential of using a demand-led approach to manage clinical supplies, reduce supply chain risk and improve flexibility.

Location
Buckhead Ballroom I See Location map
10:15 am - 11:15 am
Workshop

Impact of Automated Commercial Environment (ACE) on US Imports (WS22)

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
Location
10:15 am - 11:15 am
Workshop

Japan Trials (WS13)

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

Software for Clinical Supplies (WS14)

As new pressures and concerns emerge within the clinical supply chain, technology is starting to take a bigger role in clinical supplies.
Taking advantage of the systems available out there and their tremendous power is sometimes inhibited by the flexibility needed to execute clinical trials from API/ Drug substance through to packaged and labeled goods.
This workshop will discuss the intricacies of managing data for clinical supply chain across internal and external supply chains, how you can measure your return on investment and the key benefits technology benefits can deliver for our clinical teams, sites and most importantly our patients.

10:15 am - 11:15 am
Workshop

The Impact of EU Regulation 536/2014 (Clinical Trial Regulation) (WS19)

Clinical Supply Chains 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.

Location
11:15 am - 11:30 am
Break

Room Transfer / Break

11:30 am - 12:30 pm
Workshop

ISPE: Metrics for the Clinical Supply Chain (WS39)

A discussion of both internal company metrics and inter-company metrics. Results from the ongoing inter-company ISPE metrics survey will be shared.

What works to drive better performance? What doesn't?
What are the biggest challenges?
What might be most useful to measure?
What are the keys to success?

Location
Buckhead Ballroom I See Location map
11:30 am - 12:30 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS31)

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.

11:30 am - 12:30 pm
Workshop

Use of Central Pharmacies for Direct to Patient in your Clinical Supply Chain (WS4)

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.

Location
1:30 pm - 1:45 pm
Break

Room Transfer / Break

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