April 29 to May 2, 2018 - Atlanta, GA

2018 US GCSG Conference

We had a lot of fun in Atlanta!  Joins us next time!

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Day

Day 1: Sunday, April 29
8:30 am - 4:00 pm
Boot Camp

Clinical Trial Supply Boot Camp

The attendee will be able to:



  1. Describe at least three (3) historical events that drove the development of GMPs

  2. Identify at least three (3) Quality rules to ensure IMP production meets global regulatory standards

  3. List three (3) regulatory requirements when shipping temperature controlled IMPs

8:30 am - 4:00 pm
Boot Camp

Introduction to Import/Export Boot Camp

The attendees will be able to:



  1. Understand the basics of different terminology used in import/export

  2. Explain the role of different agencies involved in the country and areas they regulate

  3. Identify different reasons why an international shipment might be on customs hold in a country

  4. Compare and contrast active and passive shippers and their value in successful import/export for clinical supplies

  5. List the government agencies utilizing Automated Commercial Environment (ACE) 

  6. Explain how ACE will expedite clinical supply clearance and delivery

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

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS6)

The attendee will be able to:



  1. Explain how involving the Clinical Supplies Group in protocol development can improve overall trial outcomes.

  2. Identify systems that increase Clinical Supply Chain transparency for Clinical Operations.

  3. Explain how business acumen of clinical supplies can positively influence the clinical stakeholders.

10:15 am - 11:15 am
Workshop

Novel Approaches to Blinding (WS18)

The attendee will be able to:



  1. Identify no fewer than 2 novel blinding techniques for Metered Dose Inhalers.

  2. Identify a novel manufacturing process to aid in blinding Oral Solid Dosage forms.

  3. Compare and contrast novel blinding techniques for injectable clinical trial materials.

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. Compare and contrast how the requirements for CT Supplies in EU Regulation 536/2014 differ from those in Directive 2001/20/EC. 

  2. Identify when EU Regulation 536/2014 became effective by law and when it will become effective in practice.

  3. Explain no fewer than two (2) reasons the Clinical Trial Regulation is being implemented.

10:15 am - 11:15 am
Workshop

Medical Devices (WS17)

The attendee will be able to:



  1. List no fewer than two (2) Code of Federal Regulations (CFR) that cover devices for approval.

  2. Explain what regulators are looking for to show device GMPs are in a state of control.

  3. Describe how devices can be blinded in order to ensure positive statistical significance at the end of the trial.

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)

The attendee will be able to:



  1. List the drivers of the Decentralised Model 

  2. Provide examples of the importance of strategic partnering in a Decentralized Model

  3. Give no fewer than 2 examples of IT strategy and landscape and technology enablers

  4. Articulate the achievements of the Decentralized Model to date


 

10:15 am - 11:15 am
Workshop

Working with Virtual Teams (WS8)

The attendee will be able to:



  1. List no fewer than 2 reasons why virtual teams lose motivation & engagement.

  2. Describe ways to increase and enhance communication to keep virtual teams productive.

  3. Compare and contrast virtual team leadership vs co-located team leadership.

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial.

  2. Identify at least two (2) risks for sponsors conducting direct to patient trials and develop effective mitigation strategies for these risks.

  3. Identify how use of Central Pharmacies can support delivery of medication closer to the patient thus minimizing waste.

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. Describe three (3) situations where knowledge of regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in global clinical trials.

10:15 am - 11:15 am
Workshop

I will not be attending a session at this time.

10:15 am - 11:15 am
Workshop

Building Quality into your Operations (WS15)

The attendee will be able to:



  1. Define the factors necessary in a quality culture.

  2. Identify the kind of high level operations that Quality would love to see in a Clinical Supply production. 

  3. Explain no fewer than 3 reasons why great partnerships exist between Clinical Supply Operations and the Quality units that support them.

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial.

  2. Identify at least two (2) risks for sponsors conducting direct to patient trials and develop effective mitigation strategies for these risks.

  3. List no fewer than 3 study characteristics that influence a decision to use a direct to patient strategy and why they should be considered.

10:15 am - 11:15 am
Workshop

Software for Clinical Supplies (WS14)

The attendee will be able to:



  1. Describe at least two ways technology can benefit our patients.

  2. Identify at least one way to show ROI for your clinical supply chain on a your technology investment.

  3. Compare and contrast technology solutions for clinical trials and commercial supply chains.

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

Supply Chain Security, Is it Important? (WS24)

The attendee will be able to:



  1. Explain how pedigree and the Supply Chain Security Act have an impact on your clinical supply chain. 

  2. Identify no fewer than 2 ways GDP helps to ensure clinical supply chain security.

  3. Describe how drug accountability, returns and destruction is important to the security of your supply chain.

Speakers
1:40 pm - 2:40 pm
Workshop

Temperature Excursion Analysis (WS29)

The attendee will be able to:



  1. Define temperature excursion for an Investigational Medicinal Product (IMP). 

  2. Identify no fewer than 2 ways to minimize risk of a temperature excursion. 

  3. Give at least 2 examples of ways to proactively and reactively manage temperature excursions.

1:40 pm - 2:40 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS31)

The attendee will be able to:



  1. Describe stocking and replenishment models used in the industry and how they are managed.

  2. Describe how far in advance an ancillary supply strategy should be considered and why.

  3. List special considerations for ancillary supplies managed outside the United States.

1:40 pm - 2:40 pm
Workshop

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

The attendee will be able to:



  1. Describe three (3) situations where knowledge of regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in global clinical trials.

Speakers
1:40 pm - 2:40 pm
Workshop

I will not be attending a session at this time.

1:40 pm - 2:40 pm
Workshop

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

The attendee will be able to:



  1. List the government agencies utilizing Automated Commercial Environment (ACE).

  2. Identify the key clinical supply chain stakeholders that need to be notified of ACE requirements. 

  3. Explain how ACE will expedite clinical supply clearance and delivery.

Speakers
1:40 pm - 2:40 pm
Workshop

Investigator Sponsored Trials (WS23)

The attendee will be able to:



  1. Explain the roles and responsibilities of the sponsor in an Investigator Sponsored Trial (IST). 

  2. List no fewer than 2 regulatory responsibilities of the investigator in an IST.

  3. Identify no fewer than 2 quality requirements for ISTs.

1:40 pm - 2:40 pm
Workshop

End to End Logistics (WS20)

The attendee will be able to:



  1. Identify at least 2 current logistics market and technology trends supporting clinical trials. 

  2. Discuss how the attributes of your target therapy drives logistics planning, including country and site selection.

  3. Define the roles and responsibilities with regards to material movement for all parties within the Clinical Supply Chain.

Speakers
1:40 pm - 2:40 pm
Workshop

A Culture of Engagement in the Workplace (WS21)

The attendee will be able to:



  1. Discuss reasons why employees have limited engagement or are disengaged. 

  2. Identify no fewer than 2 ways to improve employee engagement in your work stream.

  3. List no fewer than 3 ways to monitor and maintain employee engagement.

1:40 pm - 2:40 pm
Workshop

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

The attendee will be able to:



  1. Define personalized medicine.

  2. Describe the process of developing supply chains for personalized medicine.

  3. List two (2) major challenges or strategies employed for delivering a robust personalized medicine supply chain.

  4. Compare and contrast the logistics requirements of standard cold chain products versus cell and gene therapy products.

  5. List at least two (2) concerns in the handling of cell and gene therapy clinical materials.

  6. Describe the appropriate classification and labeling of cell and gene therapy products to ensure compliant transportation.

1:40 pm - 2:40 pm
Workshop

Identifying the Right IRT for Your Clinical Trial (WS25)

The attendee will be able to:



  1. Discuss factors necessary to set up quality specifications for your IRT study.

  2. Describe how early in clinical trial developments you should begin IRT discussions.

  3. Explain how the use of a quality technical agreement can ensure IRT system success.

Speakers
1:40 pm - 2:40 pm
Workshop

Tips and Tricks for Effective Communications (WS30)

The attendee will be able to:



  1. Identify no fewer than 2 strategies to use to clarify true intent in communications. 

  2. Give an example of ways technology can be used effectively to deliver your message. 

  3. Demonstrate ways to adjust your communication style to the situation to achieve better outcomes.

1:40 pm - 2:40 pm
Workshop

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

The attendee will be able to:



  1. Explain the characteristics and responsibilities of Importer of Record (IOR).

  2. Understand and describe the impact of the recent customs ruling on IOR / VAT reclamation.

  3. Identify the financial impact to VAT reclamation of not aligning IOR to the recent customs ruling.

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

Managing Translations (WS11)

The attendee will be able to:



  1. Explain the value of backward and forward translation for clinical supply labels.

  2. Summarize the importance of good translations for clinical labels when doing JIT labeling.

  3. Determine a standard timeline for translation of clinical supply labels into multiple languages.

10:05 am - 11:05 am
Workshop

Why Clinical Trial Supply Professionals Should Care About Site and Patient-Centricity (WS33)

The attendee will be able to:



  1. Understand the value of creating clinical supplies keeping patient centricity in mind to improve compliance and study outcomes.

  2. Identify no fewer than 2 ways patient centricity can positively impact clinical supply labeling.

  3. List no fewer than 3 ways clinical supply shippers can be adapted with patient and site centricity in mind.

10:05 am - 11:05 am
Workshop

Successful Sponsor Vendor Partnerships (WS35)

The attendee will be able to:



  1. List no fewer than three (3) competencies required to establish an optimal supplier/sponsor relationship.

  2. Compare and contrast the differences between successful and unsuccessful supplier/sponsor relationships.

  3. Explain no fewer than two (2) practices that keep sponsor companies from forming a good vendor/partner relationship and describe no fewer than two (2) ways to overcome those challenges.

10:05 am - 11:05 am
Workshop

I will not be attending a session at this time.

10:05 am - 11:05 am
Workshop

The Changing Role of the QP (WS12)

The attendee will be able to:



  1. Compare and contrast how the QP role may or may not be impacted based on the various BREXIT scenarios.

  2. Identify when the UK will have to exit the EU.

  3. Explain no less than two mitigations for QP release in a UK based Clinical Supply Chain.

10:05 am - 11:05 am
Workshop

Self development and Self Promotion (WS10)

The attendee will be able to:



  1. Develop a 1, 3 and 5 year personal development plan which will include training and reading materials.

  2. Identify why we are so reticent to "toot our own horns" but why it is essential for continued employment.

  3. List no fewer than 3 ways that you can promote your achievements to your leadership to get the recognition you deserve.

10:05 am - 11:05 am
Workshop

Japan Trials (WS13)

The attendee will be able to:



  1. Describe three (3) situations where knowledge of Japanese regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in Japanese regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in Japanese Clinical Trials.

10:05 am - 11:05 am
Workshop

Just in Time Services, a Custom Solution for Clinical Supplies (WS1)

The attendee will be able to:



  1. Explain JIT labeling for clinical supplies.

  2. List two (2) situations where using JIT labeling is a benefit to clinical studies.

  3. Identify the point in the supply chain where JIT labeling is executed.

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)

The attendee will be able to:



  1. List the drivers of the Decentralised Model 

  2. Provide examples of the importance of strategic partnering in a Decentralized Model

  3. Give no fewer than 2 examples of IT strategy and landscape and technology enablers

  4. Articulate the achievements of the Decentralized Model to date

10:05 am - 11:05 am
Workshop

Commercial Drug Sourcing Centrally vs Locally – Which is best? (WS36)

The attendee will be able to:



  1. Define central and local sourcing commercial drug product.

  2. List no fewer than 2 factors involved in decision on sourcing.

  3. Compare & contrast the best situations to use central vs local sourcing.

10:05 am - 11:05 am
Workshop

Releasing JIT in an On Demand Distribution Supply Chain (WS3)

The attendee will be able to:



  1. Understand an on demand quality risk based system.

  2. Describe the best way to utilize On Demand Labeling as a viable option to speed up the clinical supply chain.

  3. Identify ways to mitigate quality issues in an on demand clinical supply chain.

10:05 am - 11:05 am
Workshop

Import Export for Temperature Controlled Clinical Supplies (WS32)

The attendee will be able to:



  1. Detail options to maintain temperature during customs hold.

  2. Identify no fewer than 2 reasons why temperature controlled shipments are delayed. 

  3. Explain the documentation that needs to be in place in order to prevent delays when moving product internationally.

11:05 am - 11:20 am
Break

Room Transfer / Break

11:20 am - 12:20 pm
Workshop

Medical Devices (WS17)

The attendee will be able to:



  1. List no fewer than two (2) Code of Federal Regulations (CFR) that cover devices for approval.

  2. Explain what regulators are looking for to show device GMPs are in a state of control.

  3. Describe how devices can be blinded in order to ensure positive statistical significance at the end of the trial.

11:20 am - 12:20 pm
Workshop

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS6)

The attendee will be able to:



  1. Explain how involving the Clinical Supplies Group in protocol development can improve overall trial outcomes.

  2. Identify systems that increase Clinical Supply Chain transparency for Clinical Operations.

  3. Explain how business acumen of clinical supplies can positively influence the clinical stakeholders.

11:20 am - 12:20 pm
Workshop

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

The attendee will be able to:



  1. List the government agencies utilizing Automated Commercial Environment (ACE).

  2. Identify the key clinical supply chain stakeholders that need to be notified of ACE requirements. 

  3. Explain how ACE will expedite clinical supply clearance and delivery.

Speakers
11:20 am - 12:20 pm
Workshop

Software for Clinical Supplies (WS14)

The attendee will be able to:



  1. Describe at least two ways technology can benefit our patients.

  2. Identify at least one way to show ROI for your clinical supply chain on a your technology investment.

  3. Compare and contrast technology solutions for clinical trials and commercial supply chains.

11:20 am - 12:20 pm
Workshop

End to End Clinical Supply Planning (WS38)

The attendee will be able to:



  1. Explain the best way to plan for the end to end clinical supply requirements during every stage of product development. 

  2. List no fewer than 2 tools that can be used to expedite end to end clinical supply planning. 

  3. Identify all key stakeholders that must be involved during end to end clinical supply planning.

11:20 am - 12:20 pm
Workshop

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

The attendee will be able to:



  1. Explain the characteristics and responsibilities of Importer of Record (IOR).

  2. Understand and describe the impact of the recent customs ruling on IOR / VAT reclamation.

  3. Identify the financial impact to VAT reclamation of not aligning IOR to the recent customs ruling.

11:20 am - 12:20 pm
Workshop

I will not be attending a session at this time.

11:20 am - 12:20 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS31)

The attendee will be able to:



  1. Describe stocking and replenishment models used in the industry and how they are managed.

  2. Describe how far in advance an ancillary supply strategy should be considered and why.

  3. List special considerations for ancillary supplies managed outside the United States.

11:20 am - 12:20 pm
Workshop

ISPE: Metrics for the Clinical Supply Chain (WS39)

The attendee will be able to:



  1. Understand the metrics found to be most useful in organizations

  2. Identify best practices for data gathering 

  3. Understand the results of ongoing inter-company comparative measures

  4. Articulate additional metrics that would be beneficial to benchmark and why

11:20 am - 12:20 pm
Workshop

Supply Chain Security, Is it Important? (WS24)

The attendee will be able to:



  1. Explain how pedigree and the Supply Chain Security Act have an impact on your clinical supply chain. 

  2. Identify no fewer than 2 ways GDP helps to ensure clinical supply chain security.

  3. Describe how drug accountability, returns and destruction is important to the security of your supply chain.

Speakers
11:20 am - 12:20 pm
Workshop

End to End Logistics (WS20)

The attendee will be able to:



  1. Identify at least 2 current logistics market and technology trends supporting clinical trials. 

  2. Discuss how the attributes of your target therapy drives logistics planning, including country and site selection.

  3. Define the roles and responsibilities with regards to material movement for all parties within the Clinical Supply Chain.

Speakers
11:20 am - 12:20 pm
Workshop

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

The attendee will be able to:



  1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial.

  2. Identify at least two (2) risks for sponsors conducting direct to patient trials and develop effective mitigation strategies for these risks.

  3. Identify how use of Central Pharmacies can support delivery of medication closer to the patient thus minimizing waste.

11:20 am - 12:20 pm
Workshop

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

The attendee will be able to:



  1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial.

  2. Identify at least two (2) risks for sponsors conducting direct to patient trials and develop effective mitigation strategies for these risks.

  3. List no fewer than 3 study characteristics that influence a decision to use a direct to patient strategy and why they should be considered.

1:30 pm - 1:40 pm
Break

Room Transfer / Break

1:40 pm - 2:40 pm
Workshop

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

The attendee will be able to:



  1. Define personalized medicine.

  2. Describe the process of developing supply chains for personalized medicine.

  3. List two (2) major challenges or strategies employed for delivering a robust personalized medicine supply chain.

  4. Compare and contrast the logistics requirements of standard cold chain products versus cell and gene therapy products.

  5. List at least two (2) concerns in the handling of cell and gene therapy clinical materials.

  6. Describe the appropriate classification and labeling of cell and gene therapy products to ensure compliant transportation.

1:40 pm - 2:40 pm
Workshop

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

The attendee will be able to:



  1. Describe three (3) situations where knowledge of regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in global clinical trials.

1:40 pm - 2:40 pm
Workshop

A Culture of Engagement in the Workplace (WS21)

The attendee will be able to:



  1. Discuss reasons why employees have limited engagement or are disengaged. 

  2. Identify no fewer than 2 ways to improve employee engagement in your work stream.

  3. List no fewer than 3 ways to monitor and maintain employee engagement.

1:40 pm - 2:40 pm
Workshop

Building Quality into your Operations (WS15)

The attendee will be able to:



  1. Define the factors necessary in a quality culture.

  2. Identify the kind of high level operations that Quality would love to see in a Clinical Supply production. 

  3. Explain no fewer than 3 reasons why great partnerships exist between Clinical Supply Operations and the Quality units that support them.

1:40 pm - 2:40 pm
Workshop

How to Plan and Implement an Expanded Access Program (WS28)

The attendee will be able to:



  1. Identify 3 access considerations and be able to distinguish between considerations that are strategic verses operational.

  2. Know 3 regulatory requirements that influence how an Expanded Access program should be set up.

  3. Identify 3 aspects of a supply plan for an EA study that must be monitored for change.

1:40 pm - 2:40 pm
Workshop

Identifying the Right IRT for Your Clinical Trial (WS25)

The attendee will be able to:



  1. Discuss factors necessary to set up quality specifications for your IRT study.

  2. Describe how early in clinical trial developments you should begin IRT discussions.

  3. Explain how the use of a quality technical agreement can ensure IRT system success.

Speakers
1:40 pm - 2:40 pm
Workshop

Tips and Tricks for Effective Communications (WS30)

The attendee will be able to:



  1. Identify no fewer than 2 strategies to use to clarify true intent in communications. 

  2. Give an example of ways technology can be used effectively to deliver your message. 

  3. Demonstrate ways to adjust your communication style to the situation to achieve better outcomes.

1:40 pm - 2:40 pm
Workshop

Novel Approaches to Blinding (WS18)

The attendee will be able to:



  1. Identify no fewer than 2 novel blinding techniques for Metered Dose Inhalers.

  2. Identify a novel manufacturing process to aid in blinding Oral Solid Dosage forms.

  3. Compare and contrast novel blinding techniques for injectable clinical trial materials.

1:40 pm - 2:40 pm
Workshop

I will not be attending a session at this time.

1:40 pm - 2:40 pm
Workshop

Temperature Excursion Analysis (WS29)

The attendee will be able to:



  1. Define temperature excursion for an Investigational Medicinal Product (IMP). 

  2. Identify no fewer than 2 ways to minimize risk of a temperature excursion. 

  3. Give at least 2 examples of ways to proactively and reactively manage temperature excursions.

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

Working with Virtual Teams (WS8)

The attendee will be able to:



  1. List no fewer than 2 reasons why virtual teams lose motivation & engagement.

  2. Describe ways to increase and enhance communication to keep virtual teams productive.

  3. Compare and contrast virtual team leadership vs co-located team leadership.

9:00 am - 10:00 am
Workshop

End to End Clinical Supply Planning (WS38)

The attendee will be able to:



  1. Explain the best way to plan for the end to end clinical supply requirements during every stage of product development. 

  2. List no fewer than 2 tools that can be used to expedite end to end clinical supply planning. 

  3. Identify all key stakeholders that must be involved during end to end clinical supply planning.

9:00 am - 10:00 am
Workshop

Commercial Drug Sourcing Centrally vs Locally – Which is best? (WS36)

The attendee will be able to:



  1. Define central and local sourcing commercial drug product.

  2. List no fewer than 2 factors involved in decision on sourcing.

  3. Compare & contrast the best situations to use central vs local sourcing.

9:00 am - 10:00 am
Workshop

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

The attendee will be able to:



  1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial.

  2. Identify at least two (2) risks for sponsors conducting direct to patient trials and develop effective mitigation strategies for these risks.

  3. List no fewer than 3 study characteristics that influence a decision to use a direct to patient strategy and why they should be considered.

9:00 am - 10:00 am
Workshop

Pharmacist Networking

Speakers
9:00 am - 10:00 am
Workshop

Tips and Tricks for Effective Communications (WS30)

The attendee will be able to:



  1. Identify no fewer than 2 strategies to use to clarify true intent in communications. 

  2. Give an example of ways technology can be used effectively to deliver your message. 

  3. Demonstrate ways to adjust your communication style to the situation to achieve better outcomes.

9:00 am - 10:00 am
Workshop

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

The attendee will be able to:



  1. Explain the characteristics and responsibilities of Importer of Record (IOR).

  2. Understand and describe the impact of the recent customs ruling on IOR / VAT reclamation.

  3. Identify the financial impact to VAT reclamation of not aligning IOR to the recent customs ruling.

9:00 am - 10:00 am
Workshop

Investigator Sponsored Trials (WS23)

The attendee will be able to:



  1. Explain the roles and responsibilities of the sponsor in an Investigator Sponsored Trial (IST). 

  2. List no fewer than 2 regulatory responsibilities of the investigator in an IST.

  3. Identify no fewer than 2 quality requirements for ISTs.

9:00 am - 10:00 am
Workshop

Releasing JIT in an On Demand Distribution Supply Chain (WS3)

The attendee will be able to:



  1. Understand an on demand quality risk based system.

  2. Describe the best way to utilize On Demand Labeling as a viable option to speed up the clinical supply chain.

  3. Identify ways to mitigate quality issues in an on demand clinical supply chain.

9:00 am - 10:00 am
Workshop

Self development and Self Promotion (WS10)

The attendee will be able to:



  1. Develop a 1, 3 and 5 year personal development plan which will include training and reading materials.

  2. Identify why we are so reticent to "toot our own horns" but why it is essential for continued employment.

  3. List no fewer than 3 ways that you can promote your achievements to your leadership to get the recognition you deserve.

9:00 am - 10:00 am
Workshop

Why Clinical Trial Supply Professionals Should Care About Site and Patient-Centricity (WS33)

The attendee will be able to:



  1. Understand the value of creating clinical supplies keeping patient centricity in mind to improve compliance and study outcomes.

  2. Identify no fewer than 2 ways patient centricity can positively impact clinical supply labeling.

  3. List no fewer than 3 ways clinical supply shippers can be adapted with patient and site centricity in mind.

9:00 am - 10:00 am
Workshop

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

The attendee will be able to:



  1. Describe three (3) situations where knowledge of regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in global clinical trials.

Speakers
9:00 am - 10:00 am
Workshop

The Changing Role of the QP (WS12)

The attendee will be able to:



  1. Compare and contrast how the QP role may or may not be impacted based on the various BREXIT scenarios.

  2. Identify when the UK will have to exit the EU.

  3. Explain no less than two mitigations for QP release in a UK based Clinical Supply Chain.

9:00 am - 10:00 am
Workshop

I will not be attending a session at this time.

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)

The attendee will be able to:



  1. List the drivers of the Decentralised Model 

  2. Provide examples of the importance of strategic partnering in a Decentralized Model

  3. Give no fewer than 2 examples of IT strategy and landscape and technology enablers

  4. Articulate the achievements of the Decentralized Model to date

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. List the government agencies utilizing Automated Commercial Environment (ACE).

  2. Identify the key clinical supply chain stakeholders that need to be notified of ACE requirements. 

  3. Explain how ACE will expedite clinical supply clearance and delivery.

Speakers
10:15 am - 11:15 am
Workshop

Medical Devices (WS17)

The attendee will be able to:



  1. List no fewer than two (2) Code of Federal Regulations (CFR) that cover devices for approval.

  2. Explain what regulators are looking for to show device GMPs are in a state of control.

  3. Describe how devices can be blinded in order to ensure positive statistical significance at the end of the trial.

10:15 am - 11:15 am
Workshop

Successful Sponsor Vendor Partnerships (WS35)

The attendee will be able to:



  1. List no fewer than three (3) competencies required to establish an optimal supplier/sponsor relationship.

  2. Compare and contrast the differences between successful and unsuccessful supplier/sponsor relationships.

  3. Explain no fewer than two (2) practices that keep sponsor companies from forming a good vendor/partner relationship and describe no fewer than two (2) ways to overcome those challenges.

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. Define personalized medicine.

  2. Describe the process of developing supply chains for personalized medicine.

  3. List two (2) major challenges or strategies employed for delivering a robust personalized medicine supply chain.

  4. Compare and contrast the logistics requirements of standard cold chain products versus cell and gene therapy products.

  5. List at least two (2) concerns in the handling of cell and gene therapy clinical materials.

  6. Describe the appropriate classification and labeling of cell and gene therapy products to ensure compliant transportation.

10:15 am - 11:15 am
Workshop

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

The attendee will be able to:



  1. Compare and contrast how the requirements for CT Supplies in EU Regulation 536/2014 differ from those in Directive 2001/20/EC. 

  2. Identify when EU Regulation 536/2014 became effective by law and when it will become effective in practice.

  3. Explain no fewer than two (2) reasons the Clinical Trial Regulation is being implemented.

10:15 am - 11:15 am
Workshop

Supply Chain Security, Is it Important? (WS24)

The attendee will be able to:



  1. Explain how pedigree and the Supply Chain Security Act have an impact on your clinical supply chain. 

  2. Identify no fewer than 2 ways GDP helps to ensure clinical supply chain security.

  3. Describe how drug accountability, returns and destruction is important to the security of your supply chain.

Speakers
10:15 am - 11:15 am
Workshop

How to Plan and Implement an Expanded Access Program (WS28)

The attendee will be able to:



  1. Identify 3 access considerations and be able to distinguish between considerations that are strategic verses operational.

  2. Know 3 regulatory requirements that influence how an Expanded Access program should be set up.

  3. Identify 3 aspects of a supply plan for an EA study that must be monitored for change.

10:15 am - 11:15 am
Workshop

Japan Trials (WS13)

The attendee will be able to:



  1. Describe three (3) situations where knowledge of Japanese regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in Japanese regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in Japanese Clinical Trials.

10:15 am - 11:15 am
Workshop

Software for Clinical Supplies (WS14)

The attendee will be able to:



  1. Describe at least two ways technology can benefit our patients.

  2. Identify at least one way to show ROI for your clinical supply chain on a your technology investment.

  3. Compare and contrast technology solutions for clinical trials and commercial supply chains.

10:15 am - 11:15 am
Workshop

I will not be attending a session at this time.

10:15 am - 11:15 am
Workshop

Managing Translations (WS11)

The attendee will be able to:



  1. Explain the value of backward and forward translation for clinical supply labels.

  2. Summarize the importance of good translations for clinical labels when doing JIT labeling.

  3. Determine a standard timeline for translation of clinical supply labels into multiple languages.

11:15 am - 11:30 am
Break

Room Transfer / Break

11:30 am - 12:30 pm
Workshop

Improving Communication: Getting Clinical Trial Supplies a Seat at the Table (WS6)

The attendee will be able to:



  1. Explain how involving the Clinical Supplies Group in protocol development can improve overall trial outcomes.

  2. Identify systems that increase Clinical Supply Chain transparency for Clinical Operations.

  3. Explain how business acumen of clinical supplies can positively influence the clinical stakeholders.

11:30 am - 12:30 pm
Workshop

Import Export for Temperature Controlled Clinical Supplies (WS32)

The attendee will be able to:



  1. Detail options to maintain temperature during customs hold.

  2. Identify no fewer than 2 reasons why temperature controlled shipments are delayed. 

  3. Explain the documentation that needs to be in place in order to prevent delays when moving product internationally.

11:30 am - 12:30 pm
Workshop

Just in Time Services, a Custom Solution for Clinical Supplies (WS1)

The attendee will be able to:



  1. Explain JIT labeling for clinical supplies.

  2. List two (2) situations where using JIT labeling is a benefit to clinical studies.

  3. Identify the point in the supply chain where JIT labeling is executed.

11:30 am - 12:30 pm
Workshop

I will not be attending a session at this time.

11:30 am - 12:30 pm
Workshop

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

The attendee will be able to:



  1. Describe three (3) situations where knowledge of regulatory requirements can positively influence clinical supply chain outcomes.

  2. Summarize how differences in regulatory requirements can affect shipping and distribution channels.

  3. Present the best way to be aware of and access changing regulations for clinical supplies used in global clinical trials.

11:30 am - 12:30 pm
Workshop

ISPE: Metrics for the Clinical Supply Chain (WS39)

The attendee will be able to:



  1. Understand the metrics found to be most useful in organizations

  2. Identify best practices for data gathering 

  3. Understand the results of ongoing inter-company comparative measures

  4. Articulate additional metrics that would be beneficial to benchmark and why

11:30 am - 12:30 pm
Workshop

End to End Clinical Supply Planning (WS38)

The attendee will be able to:



  1. Explain the best way to plan for the end to end clinical supply requirements during every stage of product development. 

  2. List no fewer than 2 tools that can be used to expedite end to end clinical supply planning. 

  3. Identify all key stakeholders that must be involved during end to end clinical supply planning.

11:30 am - 12:30 pm
Workshop

Temperature Excursion Analysis (WS29)

The attendee will be able to:



  1. Define temperature excursion for an Investigational Medicinal Product (IMP). 

  2. Identify no fewer than 2 ways to minimize risk of a temperature excursion. 

  3. Give at least 2 examples of ways to proactively and reactively manage temperature excursions.

11:30 am - 12:30 pm
Workshop

Building Quality into your Operations (WS15)

The attendee will be able to:



  1. Define the factors necessary in a quality culture.

  2. Identify the kind of high level operations that Quality would love to see in a Clinical Supply production. 

  3. Explain no fewer than 3 reasons why great partnerships exist between Clinical Supply Operations and the Quality units that support them.

11:30 am - 12:30 pm
Workshop

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

The attendee will be able to:



  1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial.

  2. Identify at least two (2) risks for sponsors conducting direct to patient trials and develop effective mitigation strategies for these risks.

  3. Identify how use of Central Pharmacies can support delivery of medication closer to the patient thus minimizing waste.

11:30 am - 12:30 pm
Workshop

Strategies for the Handling of Ancillary Supplies (WS31)

The attendee will be able to:



  1. Describe stocking and replenishment models used in the industry and how they are managed.

  2. Describe how far in advance an ancillary supply strategy should be considered and why.

  3. List special considerations for ancillary supplies managed outside the United States.

1:30 pm - 1:45 pm
Break

Room Transfer / Break

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