22nd – 24th October, 2019

The GCSG 2019 European Knowledge Forum

This year we welcomed our guests to the historic town of Cascais, Portugal for our 6th Annual GCSG European Knowledge Forum!

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This year we welcomed our guests to the historic town of Cascais, Portugal for our 6th Annual GCSG European Knowledge Forum!

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Workshop Summary

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Virtual sessions only
Day 1: Tuesday, October 22
9:00 am - 4:00 pm
Boot Camp / Seminar

Boot Camp – Import/Export

The class is designed for clinical supply professionals who want to learn more about shipping and distribution for global clinical trials.  This boot camp will cover regulations, temperature control, customs challenges, and logistics supply chain partnerships to ensure success with international distribution

Objectives:

The attendee will be able to:

(1) Identify four roles necessary for completing an international shipment and the responsibilities of each of the roles

(2) Identify at least 3 documents needed to be maintained for recordkeeping and explain why they must be kept.

(3) Name the global association that has responsibility for writing customs valuations guidance

9:00 am - 4:00 pm
Boot Camp / Seminar

Boot Camp – Interactive Response Technology (IRT), Randomization and Trial Supply Management (RTSM)

This class is geared towards people that have some experience in the clinical trial supplies world. Attendees will be provided with an overview of Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) techniques and their real-life usage. Utilizing case studies and an interactive approach, attendees will learn the basics of IRT/RTSM in all stages of study execution and be able to independently apply this knowledge back in the office.

Training will include, system build from protocol assessment and creating the user requirement specification (URS) to coding/configuring, validating, testing (UAT) and go live as well as operational management of the system.

Training will also include when (and when not) to use an IRT RTSM; key users and their roles; timelines from concept development to go live; critical functionalities such as blinding, randomization techniques, supply strategies and related parameter settings; drug reconciliation and operational aspects such as batch/kit management, country/site management, product status management and returns/destruction management.

Objectives:

The attendee will be able to:

(1) Identify how IRT integrates into the Clinical Supply Plan

(2) Define the required timelines and stakeholders for successful setup and operation of an IRT system

(3) Explain the challenges of User Acceptance Testing (UAT) and IRT validation

(4) Summarize the required content, details and potential pitfalls to implement an IRT system

9:00 am - 4:00 pm
Boot Camp / Seminar

Boot Camp – Understanding the Essentials of the Clinical Supply Chain

This class is geared toward people new to the clinical trial supplies world.  Attendees will be provided with an overview of drug development and what goes into planning for and delivering the study drug for a clinical trial.  Included in the training will be the reason behind cGMPs, phases of new drug development and approval, randomizing and blinding clinical trial materials, Quality Assurance & documentation, protocol interpretation, patient IMP compliance, labeling, SOPs, stability, Good Distribution Practices, returned drug accountability, and changing regulations in the EU and ROW. This is an informal workshop that will give attendees a massive amount of information in a fun and interactive atmosphere.

Objectives:

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

9:30 pm - 11:00 pm
Networking

Xerimis Port Tasting

Day 2: Wednesday, October 23
7:30 am - 8:30 am
Conference Logistics

Registration Open – Exhibitor Displays Open

How to use your GCSG gift:

Location
10:15 am - 11:15 am
Workshop

Supply Chain Challenges when going into Emerging Markets (WS10)

As clinical trials grow and more and more sites must be found to accelerate enrollment and trial completion the use of emerging markets has been growing over the past 5 years.  This workshop will explore the planning needed when entering into emerging markets, the challenges of flexing with new regulatory requirements that occur often and the best way to leverage your courier service partners to get into new countries.

Objectives:

The attendee will be able to:

(1) Compare and contrast the requirements of established clinical trial country sites and emerging market countries

(2) Give examples of what can go wrong in getting IMPs into emerging markets and how to avoid them

(3) Identify Three (3) things you must do to decrease the risk of temeprature excursions and import delays when dealing with emerging market countries

10:15 am - 11:15 am
Workshop

The Evolving Regulatory Landscape – Including the Impact of Brexit and the Clinical Trial Regulation 536/2014 (WS2)

Clinical supply chains are evolving in accordance with the potential implications of Brexit and the Clinical Trial Regulation.  This workshop will provide an opportunity to discuss that evolution and get answers to your questions.

Objectives:

The attendee will be able to:

(1) Understand the latest implications of Brexit and ways in which continuity of supply can be maintained. 

(2) Summarize the rationale for replacing Directive 2003/94 with Regulation 536/2014.

(3) Describe at least three (3) changes made in the amended Annex 13 and how they impact clinical supplies.

10:15 am - 11:15 am
Workshop

Leveraging Social Media to Enhance Clinical Trial Outcomes (WS1)

Social media is having a paradigm shifting effect on clinical trials by facilitating cross-cutting, multi-directional communication among patient, advocate, researcher and clinician communities.  This workshop will discuss the impact of social media on drug development and explore ways we can use it to increase patient enrollment, education, retention and compliance.

Objectives:

The attendee will be able to:

(1) Summarize the latest impact of Social media on educating the patient and improving compliance

(2) Identify no fewer than three (3) ways social media will improve patient retention

(3) Describe no fewer than two (2) ways that social media improves the link between the patient, investigator and patient advocacy groups

10:15 am - 11:15 am
Workshop

I will not be attending a workshop at this time

10:15 am - 11:15 am
Workshop

Cell Gene Therapy Supply Chain Strategies (WS3)

Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments.  We expect to see this therapeutic area grow exponentially in the future. Come to this workshop to learn about the strategies being employed for cell & gene therapies, their unique supply chain challenges and how to overcome them.

Objectives:

The attendee will be able to:

(1) Describe the process of developing supply chains for cell & gene therapies.

(2) Compare and contrast the logistics requirements of standard cold chain products versus cell & gene therapy products

(3) List at least two (2) concerns in the handling of cell & gene therapy clinical materials and how to mitigate those concerns.

10:15 am - 11:15 am
Workshop

How to Partner with Your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS5)

In our ever evolving clinical development world, we are realizing the value of a site-centric approach to clinical trials and clinical supplies. This workshop will identify ways to better collaborate with  clinical sites to enhance patient enrollment, patient retention throughout the clinical trial and decrease in clinical supply dosing and maintenance.

Objectives:

The attendee will be able to:

(1) Describe the clinical site’s challenges when using clinical supplies in support of a clinical trial

(2) Explain at least three (3) ways a clinical trial can experience a deviation at the site due to clinical supply issues

(3) Summarize how clinical supplies can negatively impact site enrollment and what can be done to reverse those issues

11:30 am - 12:30 pm
Workshop

Compassionate Use/Expanded Access Programs – Understanding Supply Chain Requirements, Planning and Forecasting (WS4)

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

Objectives:

The attendee will be able to:

(1)  Distinguish between ‘Continued Access’ and ‘Expanded Access’

(2) Identify three (3) challenges associated with supplying an Expanded Access request

(3) Describe two (2) types of Expanded Access scenarios and distinguish the difference(s) between their classifications

11:30 am - 12:30 pm
Workshop

Linking Simulation to IRT (WS7)

Simulations, to identify the probable outcomes of trial enrollment which will impact the clinical supply chain, are the way of the near term future. Linking the IRT to simulation software/systems can help predict clinical supply requirements while adjusting quickly to enrollment outcomes.  In this wokshop we will discuss the value of linking simulation to your IRT, how to show the value of doing it to Clinical Operations and the impact on savings this linkage can create.

Objectives:

The attendee will be able to:

(1) Identify how IRT and simulation software can be integrated into the clinical supply planning & forecasting

(2) Define the required timelines and stakeholders for successful setup and integration of Simulation software to your IRT system

(3) Summarize the potential pitfalls of implementing simulation software into your clinical supply chain

11:30 am - 12:30 pm
Workshop

Accelerating Enrollment, Improving Retention and Shortening Clinical Trials Using Direct to Patient Clinical Supply Chain Strategies (WS9)

Improving access to patient populations, accelerating recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct to patient clinical trial models.  This workshop is designed to discuss ways to implement a direct to patient supply chain model.

Objectives:

The attendee will be able to:

(1) Describe two (2) benefits each for the clinical site, sponsor, and patient of a direct to patient (DtP) 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 to integrate an IMP network of delivery companies, central pharmacies and visiting nurses to support delivery and dosing of IMPs

11:30 am - 12:30 pm
Workshop

Preparing for Regulatory Inspections (WS6)

Regulatory inspections don't always have to be a stressful situation.  With the proper training, planning, technology and self auditing programs in place they can be much easier and faster. This workshop will examine ways to ensure regulatory audits and inspections will be as smooth as possible while creating finding free outcomes.

Objectives:

The attendee will be able to:

1. Compare and contrast the areas of focus one would expect to see in a cGMP audit versus a cGCP audit.

2. List three (3) key areas of focus when preparing for a regulatory audit.

3. Explain two (2) benefits of conducting a self-audit.

11:30 am - 12:30 pm
Workshop

Strategies for Returns, Reconciliation and Destruction (WS8)

Returns and reconciliation have come under greater scrutiny as we get closer to complying with the clinical trial regulation.  Performing the final reconciliation and disposition of material, being returned from a clinical site, is typically one of the most challenging aspects of clinical supplies because it requires a collaborative bridge between Clinical Operations and Clinical Supplies.  In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Objectives:

The attendee will be able to:

(1) List the elements of IMP reconciliation and destruction for clinical supplies.

(2) Explain how to overcome the challenges of reconciliation regarding site accountability.

(3) Describe the advantages and disadvantages of local (site/ country) destruction vs centralized destruction.

11:30 am - 12:30 pm
Workshop

I will not be attending a workshop at this time

1:45 pm - 2:45 pm
Workshop

Supply Chain Challenges when going into Emerging Markets (WS10)

As clinical trials grow and more and more sites must be found to accelerate enrollment and trial completion the use of emerging markets has been growing over the past 5 years.  This workshop will explore the planning needed when entering into emerging markets, the challenges of flexing with new regulatory requirements that occur often and the best way to leverage your courier service partners to get into new countries.

Objectives:

The attendee will be able to:

(1) Compare and contrast the requirements of established clinical trial country sites and emerging market countries

(2) Give examples of what can go wrong in getting IMPs into emerging markets and how to avoid them

(3) Identify Three (3) things you must do to decrease the risk of temeprature excursions and import delays when dealing with emerging market countries

1:45 pm - 2:45 pm
Workshop

The Evolving Regulatory Landscape – Including the Impact of Brexit and the Clinical Trial Regulation 536/2014 (WS2)

Clinical supply chains are evolving in accordance with the potential implications of Brexit and the Clinical Trial Regulation.  This workshop will provide an opportunity to discuss that evolution and get answers to your questions.

Objectives:

The attendee will be able to:

(1) Understand the latest implications of Brexit and ways in which continuity of supply can be maintained. 

(2) Summarize the rationale for replacing Directive 2003/94 with Regulation 536/2014.

(3) Describe at least three (3) changes made in the amended Annex 13 and how they impact clinical supplies.

1:45 pm - 2:45 pm
Workshop

Leveraging Social Media to Enhance Clinical Trial Outcomes (WS1)

Social media is having a paradigm shifting effect on clinical trials by facilitating cross-cutting, multi-directional communication among patient, advocate, researcher and clinician communities.  This workshop will discuss the impact of social media on drug development and explore ways we can use it to increase patient enrollment, education, retention and compliance.

Objectives:

The attendee will be able to:

(1) Summarize the latest impact of Social media on educating the patient and improving compliance

(2) Identify no fewer than three (3) ways social media will improve patient retention

(3) Describe no fewer than two (2) ways that social media improves the link between the patient, investigator and patient advocacy groups

1:45 pm - 2:45 pm
Workshop

Cell Gene Therapy Supply Chain Strategies (WS3)

Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments.  We expect to see this therapeutic area grow exponentially in the future. Come to this workshop to learn about the strategies being employed for cell & gene therapies, their unique supply chain challenges and how to overcome them.

Objectives:

The attendee will be able to:

(1) Describe the process of developing supply chains for cell & gene therapies.

(2) Compare and contrast the logistics requirements of standard cold chain products versus cell & gene therapy products

(3) List at least two (2) concerns in the handling of cell & gene therapy clinical materials and how to mitigate those concerns.

1:45 pm - 2:45 pm
Workshop

How to Partner with Your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS5)

In our ever evolving clinical development world, we are realizing the value of a site-centric approach to clinical trials and clinical supplies. This workshop will identify ways to better collaborate with  clinical sites to enhance patient enrollment, patient retention throughout the clinical trial and decrease in clinical supply dosing and maintenance.



Objectives:

The attendee will be able to:

(1) Describe the clinical site’s challenges when using clinical supplies in support of a clinical trial

(2) Explain at least three (3) ways a clinical trial can experience a deviation at the site due to clinical supply issues

(3) Summarize how clinical supplies can negatively impact site enrollment and what can be done to reverse those issues

1:45 pm - 2:45 pm
Workshop

I will not be attending a workshop at this time

5:45 pm - 6:15 pm
Break

Personal Time to get ready for evening

6:15 pm - 6:30 pm
Conference Logistics

Departure for evening entertainment

6:30 pm - 11:59 pm
Networking

GCSG Night Out

10:30 pm - 11:59 pm
Conference Logistics

Departure back to the hotel

Day 3: Thursday, October 24
7:30 am - 8:30 am
Conference Logistics

Registration Open – Exhibitor Displays Open

How to use your GCSG gift:

Location
9:00 am - 10:00 am
Presentation

Pharmaceutical Industry in the 22nd Century

Where will new technologies take the Pharma industry? How will advancements in technology such as artificial intelligence (AI), Internet of Things (IoT) and block chain influence clinical supplies? Thought leaders in the industry will share some of their insight into where the industry is headed.

Speakers
Location
10:15 am - 11:15 am
Workshop

Linking Simulation to IRT (WS7)

Simulations, to identify the probable outcomes of trial enrollment which will impact the clinical supply chain, are the way of the near term future. Linking the IRT to simulation software/systems can help predict clinical supply requirements while adjusting quickly to enrollment outcomes.  In this wokshop we will discuss the value of linking simulation to your IRT, how to show the value of doing it to Clinical Operations and the impact on savings this linkage can create.

Objectives:

The attendee will be able to:

(1) Identify how IRT and simulation software can be integrated into the clinical supply planning & forecasting

(2) Define the required timelines and stakeholders for successful setup and integration of Simulation software to your IRT system

(3) Summarize the potential pitfalls of implementing simulation software into your clinical supply chain

10:15 am - 11:15 am
Workshop

Preparing for Regulatory Inspections (WS6)

Regulatory inspections don't always have to be a stressful situation.  With the proper training, planning, technology and self auditing programs in place they can be much easier and faster. This workshop will examine ways to ensure regulatory audits and inspections will be as smooth as possible while creating finding free outcomes.

Objectives:

The attendee will be able to:

(1) Compare and contrast the areas of focus one would expect to see in a cGMP audit versus a cGCP audit.

(2) List three (3) key areas of focus when preparing for a regulatory audit.

(3) Explain two (2) benefits of conducting a self-audit.

10:15 am - 11:15 am
Workshop

I will not be attending a workshop at this time

10:15 am - 11:15 am
Workshop

Accelerating Enrollment, Improving Retention and Shortening Clinical Trials Using Direct to Patient Clinical Supply Chain Strategies (WS9)

Improving access to patient populations, accelerating recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct to patient clinical trial models.  This workshop is designed to discuss ways to implement a direct to patient supply chain model.

Objectives:

The attendee will be able to:

(1) Describe two (2) benefits each for the clinical site, sponsor, and patient of a direct to patient (DtP) 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 to integrate an IMP network of delivery companies, central pharmacies and visiting nurses to support delivery and dosing of IMPs

10:15 am - 11:15 am
Workshop

Compassionate Use/Expanded Access Programs – Understanding Supply Chain Requirements, Planning and Forecasting (WS4)

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

Objectives:

The attendee will be able to:

(1)  Distinguish between ‘Continued Access’ and ‘Expanded Access’

(2) Identify three (3) challenges associated with supplying an Expanded Access request

(3) Describe two (2) types of Expanded Access scenarios and distinguish the difference(s) between their classifications

10:15 am - 11:15 am
Workshop

Culture of Accountability (WS11) – Part 1 of 2 (Select Part 2 of 2 in the Session 5 Workshops. This is a 2-hour session)

This is a two session workshop.  If you sign up for Part 1 of 2 (10:15 - 11:15 AM on 24 October 2015), you must also sign up for Part 2 of 2 (11:30 AM - 12:30 PM on 24 October 2015)
In this session, we will discuss and define accountability and case studies will be provided to demonstrate techniques and concepts to instill a culture of accountability within your team.

Objectives:

The attendee will be able to:

(1) Explain how accountability can have a direct and positive impact on quality and production

(2) List three (3) tools that can be used to increase accountability in your teams

(3) Give one (1) example of how building accountability into your team can directly impact patient safety

11:30 am - 12:30 pm
Workshop

Cell Gene Therapy Supply Chain Strategies (WS3)

Over the course of the last decade, there has been an increased emphasis on research and development into cell, gene and immunotherapy treatments.  We expect to see this therapeutic area grow exponentially in the future. Come to this workshop to learn about the strategies being employed for cell & gene therapies, their unique supply chain challenges and how to overcome them.

Objectives:

The attendee will be able to:

(1) Describe the process of developing supply chains for cell & gene therapies.

(2) Compare and contrast the logistics requirements of standard cold chain products versus cell & gene therapy products

(3) List at least two (2) concerns in the handling of cell & gene therapy clinical materials and how to mitigate those concerns.

11:30 am - 12:30 pm
Workshop

Compassionate Use/Expanded Access Programs – Understanding Supply Chain Requirements, Planning and Forecasting (WS4)

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

Objectives:

The attendee will be able to:

(1)  Distinguish between ‘Continued Access’ and ‘Expanded Access’

(2) Identify three (3) challenges associated with supplying an Expanded Access request

(3) Describe two (2) types of Expanded Access scenarios and distinguish the difference(s) between their classifications

11:30 am - 12:30 pm
Workshop

Culture of Accountability (WS11) – Part 2 of 2 (This is the second half of a 2-hour session. Select Part 1 of 2 from the Session 4 Workshops.)

This is a two session workshop.  If you sign up for Part 1 of 2 (10:15 - 11:15 AM on 24 October 2015), you must also sign up for Part 2 of 2 (11:30 AM - 12:30 PM on 24 October 2015)
In this session, we will discuss and define accountability and case studies will be provided to demonstrate techniques and concepts to instill a culture of accountability within your team.

Objectives:

The attendee will be able to:

(1) Explain how accountability can have a direct and positive impact on quality and production

(2) List three (3) tools that can be used to increase accountability in your teams

(3) Give one (1) example of how building accountability into your team can directly impact patient safety

11:30 am - 12:30 pm
Workshop

How to Partner with Your Clinical Sites, a Shared Perspective from a Site Pharmacist and CMO (WS5)

In our ever evolving clinical development world, we are realizing the value of a site-centric approach to clinical trials and clinical supplies. This workshop will identify ways to better collaborate with  clinical sites to enhance patient enrollment, patient retention throughout the clinical trial and decrease in clinical supply dosing and maintenance.

Objectives:

The attendee will be able to:

(1) Describe the clinical site’s challenges when using clinical supplies in support of a clinical trial

(2) Explain at least three (3) ways a clinical trial can experience a deviation at the site due to clinical supply issues

(3) Summarize how clinical supplies can negatively impact site enrollment and what can be done to reverse those issues

11:30 am - 12:30 pm
Workshop

I will not be attending a workshop at this time

11:30 am - 12:30 pm
Workshop

Strategies for Returns, Reconciliation and Destruction (WS8)

Returns and reconciliation have come under greater scrutiny as we get closer to complying with the clinical trial regulation.  Performing the final reconciliation and disposition of material, being returned from a clinical site, is typically one of the most challenging aspects of clinical supplies because it requires a collaborative bridge between Clinical Operations and Clinical Supplies.  In this workshop options for completing the return process and ways to reconcile the returns will be discussed.

Objectives:

The attendee will be able to:

(1) List the elements of IMP reconciliation and destruction for clinical supplies.

(2) Explain how to overcome the challenges of reconciliation regarding site accountability.

(3) Describe the advantages and disadvantages of local (site/ country) destruction vs centralized destruction.

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2019 European Knowledge Forum

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Agenda

View the agenda as a PDF

download now
Workshop Summary

Want to learn more about our bootcamps and workshops?

download now

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