GCSG – Global Clinical Supplies Group

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

Objectives:

• 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.

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

Objectives:

• 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. 

Exhibitor Setup

Location

Grand Ballroom 3 See Location map

  Close

Registration/ Information/ Welcome Table Open

Location

Grand Ballroom Foyer See Location map

  Close

Speaker / Facilitator Tour of Workshop Rooms

Location

Grand Ballroom 1 & 2 See Location map

  Close

New Member Orientation

Location

Highland I->V See Location map

  Close

Meet & Greet GCSG Networking Event

Location

Terrace (3rd Level) See Location map

  Close

GCSG Speak Easy

Location

Library Lounge See Location map

  Close

Registration / Information / Welcome Table Open

Location

Grand Ballroom Foyer See Location map

  Close

Full Breakfast / Exhibitor Displays Open

Location

Azaela & Library See Location map

  Close

Welcome & Opening Remarks

Location

Grand Ballroom See Location map

  Close

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

Grand Ballroom See Location map

  Close

Room Transfer / Break

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.

Objectives:

Identify how to increase the influence of clinical supplies so that it has the best benefit in the clinical trial process.

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.

Objectives:

Blinding is an integral part of many clinical trials yet few new approaches to blinding exist.   
This workshop will identify some new and unique ways to blind clinical supplies.

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.

Objectives:

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.

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.

Objectives:

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.

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

Objectives:

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.

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.

Objectives:

Leading virtual teams brings much greater challenges than co-located teams. 
This session will provide ways to successfully lead virtual global teams.

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.

Objectives:

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.

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.

Objectives:

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.

BREXIT Update – Impact to Clinical Supplies (WS9)

The attendee will be able to:

1. Define BREXIT.


2. Identify next steps in the BREXIT process.


3. Identify two (2) key ways that BREXIT will impact Clinical Trials.

Objectives:

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.

I will not be attending a session at this time.

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.

Objectives:

Quality is everyone’s responsibility. 
This workshop will discuss the importance of building a quality culture led by Operations in partnership with Quality

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.

Objectives:

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.

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.

Objectives:

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.

Return to Main Hall / Break

Expanded Access: Yesterday, Today and Challenges of Tomorrow

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

Objectives:

1- Be able to distinguish between Continued Access and Expanded Access
2- Identify three challenges associated with Supplying an Expanded Access Request
3- Be able to name two types of Access Scenarios and distinguish the difference of their classification

Location

Grand Ballroom See Location map

  Close

Lunch / Exhibitor Displays Open

Location

Azaela & Library See Location map

  Close

Room Transfer / Break

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.

Objectives:

This session will discuss ways to ensure your sourcing and distribution network is secure, minimizing touch points & Good Distribution Practice.

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.

Objectives:

The number of temperature excursions our industry experiences is still too high.
This workshop will provide a forum for discussing the various ways the time “out of label storage conditions” can be better established and managed.

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.

Objectives:

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.

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.

Objectives:

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.

I will not be attending a session at this time.

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.

Objectives:

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.

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.

Objectives:

This session will discuss the requirements, expectations and challenges for Clinical Supplies when conducting Investigator Sponsored Trials globally,

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.

Objectives:

In this workshop a high level overview, from planning to the last mile delivery, of the clinical supply logistics chain will be examined and explored.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

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.

Return to Main Hall / Break

Panel Discussion: BREXIT

What does the UK exiting the EU mean to our Clinical Trial Supply Chain?  Come to this presentation to hear about points to consider as we evaluate ways our companies can work through this change.

Objectives:

(1) Define BREXIT
(2) Identify recent developments in the BREXIT process
(3) Identify two (2) key ways that BREXIT will impact Clinical Trials

Location

Grand Ballroom See Location map

  Close

Getting More from Your GCSG Membership

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

Location

Grand Ballroom See Location map

  Close

Closing Remarks and Raffle Drawings

Location

Grand Ballroom See Location map

  Close

Evening Entertainment -GCSG Sponsored Event

Buses will leave from the lower lobby circle.

GCSG Speak Easy

Location

Library Lounge See Location map

  Close

Registration / Information / Welcome Table Open

Location

Grand Ballroom Foyer See Location map

  Close

Full Breakfast / Exhibitor Displays Open

Location

Azaela & Library See Location map

  Close

Opening Remarks

Location

Grand Ballroom See Location map

  Close

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.

Objectives:

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.    Learn what patient engagement means to the patient.

Location

Grand Ballroom See Location map

  Close

Room Transfer / Break

Tips for running Oncology ‘Basket’ Studies (WS34)

The attendee will be able to:

1. Define what basket studies are and how they are used in clinical trials.


2. Discuss regulatory nuances specific to basket studies.


3. Options for maintaining supplies for these adaptive trials.

Objectives:

The design of clinical studies for oncology development is evolving as we partner to cure cancer. 
This session will discuss more about this type of adaptive trial in oncology.

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.

Objectives:

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. 
This session will discuss the ins and outs of best practices in label translation.

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.

Objectives:

What is this movement of Patient Centricity? 
Why should we as Clinical Supply Professionals care about this and what we can do about it?

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.

Objectives:

Building successful partnerships between sponsors and vendors require investment. 
This workshop will discuss the ways to take the relationship beyond the contract to a true partnership.

I will not be attending a session at this time.

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.

Objectives:

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.

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.

Objectives:

Understand that you are responsible for your own development.   
This workshop will explain ways to positively evolve as well as make sure your leadership recognizes your value to the team.

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.

Objectives:

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.

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.

Objectives:

This workshop will demonstrate use of unlabelled primary packaged materials and JIT labeling in your clinical supply chain. 
Learn how to mitigate risk and gain quality endorsement!

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

Objectives:

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.

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.

Objectives:

Not sure when it makes sense to source centrally or source at the site? 
This workshop will help you to determine when each of the methods makes the most sense to use in your clinical trial.

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.

Objectives:

JIT/ On Demand supply chains bring quality challenges to the forefront.
Come to this workshop to learn from a QP who releases IMP in an on demand system.

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.

Objectives:

This informative session will discuss the risks and mitigations to consider when shipping temperature controlled products internationally.

Room Transfer / Break

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.

Objectives:

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.

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.

Objectives:

Identify how to increase the influence of clinical supplies so that it has the best benefit in the clinical trial process.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

Understanding the requirements of clinical supplies at every stage of product development will be explored and explained during this session.

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.

Objectives:

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.

I will not be attending a session at this time.

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.

Objectives:

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.

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

Objectives:

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?

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.

Objectives:

This session will discuss ways to ensure your sourcing and distribution network is secure, minimizing touch points & Good Distribution Practice.

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.

Objectives:

In this workshop a high level overview, from planning to the last mile delivery, of the clinical supply logistics chain will be examined and explored.

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.

Objectives:

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.

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.

Objectives:

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.

Lunch

Location

Azaela & Library See Location map

  Close

Room Transfer / Break

BREXIT Update – Impact to Clinical Supplies (WS9)

The attendee will be able to:

1. Define BREXIT.


2. Identify next steps in the BREXIT process.


3. Identify two (2) key ways that BREXIT will impact Clinical Trials.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

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.

Tips for running Oncology ‘Basket’ Studies (WS34)

The attendee will be able to:

1. Define what basket studies are and how they are used in clinical trials.


2. Discuss regulatory nuances specific to basket studies.


3. Options for maintaining supplies for these adaptive trials.

Objectives:

The design of clinical studies for oncology development is evolving as we partner to cure cancer. 
This session will discuss more about this type of adaptive trial in oncology.

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.

Objectives:

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.

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.

Objectives:

Quality is everyone’s responsibility. 
This workshop will discuss the importance of building a quality culture led by Operations in partnership with Quality

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.

Objectives:

Expanded Access, Named Patient, Compassionate Use… the names for the process are as varied as the options for supporting them. 
Come to this workshop to discuss the regulations for Expanded Access and how they impact your operational and strategic supply planning.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

Blinding is an integral part of many clinical trials yet few new approaches to blinding exist.   
This workshop will identify some new and unique ways to blind clinical supplies.

I will not be attending a session at this time.

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.

Objectives:

The number of temperature excursions our industry experiences is still too high.
This workshop will provide a forum for discussing the various ways the time “out of label storage conditions” can be better established and managed.

Return to Main Hall / Break

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.

Objectives:

1) Gain a fundamental understanding of Data Integrity requirements
2) Explain how Data Integrity is integral to the PQS
3) Outline at least two continuous improvement initiatives that your organisation should be adopting to improve Data Integrity

Location

Grand Ballroom See Location map

  Close

Closing Remarks and Raffle Drawings

Location

Grand Ballroom See Location map

  Close

Vendor Reception / Exhibitor Displays Open

Location

Grand Ballroom 3 See Location map

  Close

GCSG Speak Easy

Location

Library Lounge See Location map

  Close

Registration / Information / Welcome Table Open

Location

Grand Ballroom Foyer See Location map

  Close

Full Breakfast / Exhibitor Displays Open

Location

Azaela & Library See Location map

  Close

Room Transfer / Break

Exhibitor Display Breakdown

Location

Grand Ballroom 3 See Location map

  Close

Welcome & Opening Remarks

Location

Grand Ballroom See Location map

  Close

Room Transfer / Break

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.

Objectives:

Leading virtual teams brings much greater challenges than co-located teams. 
This session will provide ways to successfully lead virtual global teams.

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.

Objectives:

Understanding the requirements of clinical supplies at every stage of product development will be explored and explained during this session.

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.

Objectives:

Not sure when it makes sense to source centrally or source at the site? 
This workshop will help you to determine when each of the methods makes the most sense to use in your clinical trial.

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.

Objectives:

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.

Pharmacist Networking

Objectives:

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

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

This session will discuss the requirements, expectations and challenges for Clinical Supplies when conducting Investigator Sponsored Trials globally,

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.

Objectives:

JIT/ On Demand supply chains bring quality challenges to the forefront.
Come to this workshop to learn from a QP who releases IMP in an on demand system.

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.

Objectives:

Understand that you are responsible for your own development.   
This workshop will explain ways to positively evolve as well as make sure your leadership recognizes your value to the team.

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.

Objectives:

What is this movement of Patient Centricity? 
Why should we as Clinical Supply Professionals care about this and what we can do about it?

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.

Objectives:

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.

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.

Objectives:

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.

I will not be attending a session at this time.

Room Transfer / Break

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

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

Building successful partnerships between sponsors and vendors require investment. 
This workshop will discuss the ways to take the relationship beyond the contract to a true partnership.

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.

Objectives:

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.

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.

Objectives:

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.

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.

Objectives:

This session will discuss ways to ensure your sourcing and distribution network is secure, minimizing touch points & Good Distribution Practice.

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.

Objectives:

Expanded Access, Named Patient, Compassionate Use… the names for the process are as varied as the options for supporting them. 
Come to this workshop to discuss the regulations for Expanded Access and how they impact your operational and strategic supply planning.

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.

Objectives:

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.

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.

Objectives:

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.

I will not be attending a session at this time.

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.

Objectives:

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. 
This session will discuss the ins and outs of best practices in label translation.

Room Transfer / Break

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.

Objectives:

Identify how to increase the influence of clinical supplies so that it has the best benefit in the clinical trial process.

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.

Objectives:

This informative session will discuss the risks and mitigations to consider when shipping temperature controlled products internationally.

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.

Objectives:

This workshop will demonstrate use of unlabelled primary packaged materials and JIT labeling in your clinical supply chain. 
Learn how to mitigate risk and gain quality endorsement!

Tips for running Oncology ‘Basket’ Studies (WS34)

The attendee will be able to:

1. Define what basket studies are and how they are used in clinical trials.


2. Discuss regulatory nuances specific to basket studies.


3. Options for maintaining supplies for these adaptive trials.

Objectives:

The design of clinical studies for oncology development is evolving as we partner to cure cancer. 
This session will discuss more about this type of adaptive trial in oncology.

I will not be attending a session at this time.

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.

Objectives:

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.

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

Objectives:

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?

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.

Objectives:

Understanding the requirements of clinical supplies at every stage of product development will be explored and explained during this session.

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.

Objectives:

The number of temperature excursions our industry experiences is still too high.
This workshop will provide a forum for discussing the various ways the time “out of label storage conditions” can be better established and managed.

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.

Objectives:

Quality is everyone’s responsibility. 
This workshop will discuss the importance of building a quality culture led by Operations in partnership with Quality

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.

Objectives:

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.

BREXIT Update – Impact to Clinical Supplies (WS9)

The attendee will be able to:

1. Define BREXIT.


2. Identify next steps in the BREXIT process.


3. Identify two (2) key ways that BREXIT will impact Clinical Trials.

Objectives:

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.

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.

Objectives:

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.

Lunch

Location

Azaela & Library See Location map

  Close

Room Transfer / Break

E-labeling: A Demonstration

Get the latest information on various types of e-Labels and their potential uses in a demonstration of ways e-labeling has been piloted/ implemented in some companies.

Objectives:

(1) Define an eLabel and describe the benefits that patients, sites and sponsors will receive
(2) Understand the regulatory and technology landscape for eLabel implementation
(3) Articulate implementation challenges

Location

Grand Ballroom See Location map

  Close

Closing Remarks and Raffle Drawings

Location

Grand Ballroom See Location map

  Close