October 17th - 19th, 2017

The 2017 European GCSG Knowledge Forum

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Topic

Day 1: Tuesday, October 17
8:30 am - 9:30 am
Conference Logistics

Bootcamp Registration Open

Come visit us at the registration booth for your welcome pack and info on anything and everything to do with the conference.

Topic
Registration Times
9:00 am - 4:00 pm
Boot Camp

Pre-Conference Workshop – Clinical Supplies Foundations Boot Camp

The attendee will be able to:
1.) Describe at least three (3) historical events that drove the development of GMPs
2.) Identify no fewer than three (3) quality rules to ensure IMP production meets global regulatory standards
3.) List three (3) regulatory requirements when shipping temperature-controlled IMPs

Topic
Pre-Conference Workshop - Clinical Supplies Foundations Boot Camp
Speakers
Steven Jacobs, Angus MacLeod, Jan Pieter Kappelle, Bev Nicol,
Location

The GCSG committee is delighted to introduce a clinical trial supplies Boot Camp, to be held in conjunction with the GCSG 2016 European Conference.

This concentrated 6 hour session will be held on Tuesday 18th October from 09:00 – 15:00, prior to the start of the main conference, and will give new-comers to our industry the opportunity to learn about key clinical supply concepts from experienced professionals.

The fundamentals of clinical supply management will be presented, allowing attendees to grow their knowledge base while meeting and networking with their peers in an interactive classroom setting.

During this interactive training, the following topics will be reviewed:

  • An overview of drug development and where Clinical Supplies fits in
  • Definitions of terminology and acronyms, to demystify our IMP world
  • Where cGMPs come from and why they are essential in all we do
  • Quality and risk management for manufacturing drug product, packaging, labeling, storing and distributing Clinical Supplies globally
  • The relationships between Production, Project Management, Quality, Regulatory Affairs, Pharmaceutical Development and Analytical Development and why collaboration is a requirement for managing timelines and deliverables
  • New trends in Good Distribution Practices (GDPs) and the Clinical Trial Regulation

Bring your questions! Questions are welcome and encouraged throughout the entire Boot Camp!

3:00 pm - 5:00 pm
Conference Logistics

Conference Registration Open

3:00 pm - 5:00 pm
Conference Logistics

Exhibitor Set Up

5:00 pm - 5:30 pm
Conference Logistics

Presenters / WS Facilitators Orientation

5:30 pm - 6:00 pm
Networking

New Member Orientation

6:00 pm - 8:00 pm
Networking

Meet & Greet: GCSG Networking Event

Day 2: Wednesday, October 18
7:30 am - 8:30 am
Networking

Breakfast – Registration Open – Exhibitor Displays Open

8:30 am - 9:00 am
Presentation

Welcome & Opening Remarks

9:00 am - 10:00 am
Presentation

Rainer Hersch, Keynote Presentation: “Peak Performance – what can business learn from a symphony orchestra”

The British conductor, actor, writer and comedian Rainer Hersch is known for his comical take on classical music. He has toured in more than 30 countries and has broadcast extensively, principally for the BBC. Rainer Hersch is unique – he is both an internationally recognised conductor and a stand-up comic who has regularly closed the show at London’s famous Comedy Store. In music he has worked with some of the great ensembles of the world – conducting orchestras from the London Philharmonia to the St Petersburg Philharmonic and Queensland Symphony. In his inspirational talk he presents structured module titled “Peak Performance – what can business learn from a symphony orchestra”. He uses his skills as a comedian, a PowerPoint presentation and plenty of musical examples to completely engage the audience in his discussion of leadership from the standpoint of the orchestral conductor.

Topic
Keynote Presentation
Speakers
Rainer Hersch
10:00 am - 10:15 am
Break

Room transfer- tea/coffee break

10:15 am - 11:15 am
Workshop

BREXIT Update -Impact to Clinical Supplies

The attendee will be able to:
1.) Define BREXIT
2.) Identify next steps in the BREXIT process
3.) Identify two (2) key aspects of how BREXIT will impact Clinial Trials

Topic
Innovation of the clinical supply chain: e-meds
Speakers
Paul O'Connor, Adrian Peskett,
10:15 am - 11:15 am
Workshop

Defining patient experience (site nurse)

The attendee will be able to:
1.) Compare and contrast the differences in clinical supplies requirements of the site versus the patient
2.) Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial
3.) Summarize the negative patient experiences with clinical supplies and identify no fewer than two (2) ways to address them

Topic
Defining patient experience (site nurse)
Speakers
Naomi Litchfield
10:15 am - 11:15 am
Workshop

Leadership vs management

The attendee will be able to:
1.) Discuss the key differences between a manager and a leader
2.) List no fewer than three (3) repercussions of acting only as a manager or only as a leader
3.) Give no fewer than three (3) situational examples of when it’s best to lead or to manage

Topic
Leadership vs management
Speakers
Jan Pieter Kappelle
10:15 am - 11:15 am
Workshop

Retaining talent

The attendee will be able to:
1.) Summarize the importance of retaining clinical supplies (CS) employees and the impact of losing them
2.) Explain why retention is more important than recruitment
3.) Identify ways to motivate CS employees to increase retention within the Clinical Supplies Unit (CSU)

Topic
Retaining talent
Speakers
Nike Lawal
10:15 am - 11:15 am
Workshop

Vendor / sponsor relationship excellence

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

Topic
Vendor / sponsor relationship excellence
Speakers
Bev Nicol, Roel de Nobel, Hope Foudoulakis, Brian Keesee,
11:15 am - 11:30 am
Break

Room transfer

11:30 am - 12:30 pm
Workshop

BREXIT Update -Impact to Clinical Supplies

The attendee will be able to:
1.) Define BREXIT
2.) Identify next steps in the BREXIT process
3.) Identify two (2) key aspects of how BREXIT will impact Clinial Trials

Topic
BREXIT Update -Impact to Clinical Supplies
Speakers
Paul O'Connor, Adrian Peskett,
11:30 am - 12:30 pm
Workshop

Globalization of clinical trials and impact on supply chain

The attendee will be able to:
1.) Identify new and emerging countries and list no fewer than two (2) ways the clinical supply chain can be interrupted in these countries
2.) List no fewer than two (2) ways the supply chain process can be improved to support globalization
3.) Explain no fewer than two (2) ways to enhance regulatory knowledge to expedite clinical supply chain globalization

Topic
Globalization of clinical trials and impact on supply chain
Speakers
Dan Bell
11:30 am - 12:30 pm
Workshop

Optimizing CTM Supply Chain Design

The attendee will be able to:
1.) Identify challenges faced by using the current “Push” Clinical Supply Chain model
2.) Describe why changes must be made to evolve to a “Pull” supply chain model with the impending launch of the Clinical Trial Regulation (CTR)
3.) Give no fewer than two (2) examples of optimization methods and how to implement those methods

Topic
Optimizing CTM Supply Chain Design
11:30 am - 12:30 pm
Workshop

Practical aspects of shipping Cell Gene Therapy

The attendee will be able to:
1.) Define the differences between Cell and Gene Therapy (CGT) products and small molecule products
2.) Identify the challenges of shipping CGT compared to standard shipments
3.) List no fewer than three (3) ways to overcome those shipping challenges

Topic
Practical aspects of shipping Cell Gene Therapy
11:30 am - 12:30 pm
Workshop

Retaining talent

The attendee will be able to:
1.) Summarize the importance of retaining clinical supplies (CS) employees and the impact of losing them
2.) Explain why retention is more important than recruitment
3.) Identify ways to motivate CS employees to increase retention within the Clinical Supplies Unit (CSU)

Topic
Retaining talent
Speakers
Nike Lawal
12:30 pm - 1:45 pm
Networking

Lunch – Exhibitor Displays Open

1:45 pm - 2:45 pm
Workshop

Defining patient experience (site nurse)

The attendee will be able to:
1.) Compare and contrast the differences in clinical supplies requirements of the site versus the patient
2.) Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial
3.) Summarize the negative patient experiences with clinical supplies and identify no fewer than two (2) ways to address them

Topic
Defining patient experience (site nurse)
Speakers
Naomi Litchfield
1:45 pm - 2:45 pm
Workshop

Future of IRT

The attendee will be able to:
1.) Explain the advantages and limitations of the current IRT model
2.) List no fewer than three (3) key changes anticipated that will improve current IRT systems
3.) Explain ways in which companies can prepare for these changes and leverage those updates

Speakers
Marc Lisi
1:45 pm - 2:45 pm
Workshop

Innovation of the clinical supply chain: e-meds

The attendee will be able to:
1.) Summarize how the e-meds concept can transform the traditional clinical supply chain requirements
2.) Identify no fewer than two (2) key components of this innovative supply chain solution that may enhance patient compliance
3.) Explain the regulatory challenges of implementing this new clinical supply chain technology

Topic
Innovation of the clinical supply chain: e-meds
Speakers
Hilde Vanaken
1:45 pm - 2:45 pm
Workshop

Leadership vs management

The attendee will be able to:
1.) Discuss the key differences between a manager and a leader
2.) List no fewer than three (3) repercussions of acting only as a manager or only as a leader
3.) Give no fewer than three (3) situational examples of when it’s best to lead or to manage

Topic
Leadership vs management
Speakers
Jan Pieter Kappelle
1:45 pm - 2:45 pm
Workshop

Vendor / sponsor relationship excellence

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

Topic
Vendor / sponsor relationship excellence
Speakers
Bev Nicol, Roel de Nobel, Brian Keesee, Hope Foudoulakis,
2:45 pm - 3:00 pm
Break

Room transfer – tea/coffee break

4:00 pm - 4:15 pm
Break

Room transfer

4:15 pm - 5:15 pm
Networking

Vendor Reception & Vendor Competitions

5:15 pm - 6:00 pm
Conference Logistics

Closing Remarks, Survey Completion and Prize Draws

6:30 pm - 11:00 pm
Networking

Evening Entertainment

Day 3: Thursday, October 19
7:30 am - 8:30 am
Networking

Breakfast – Registration Open – Exhibitor Displays Open

Topic
Registration Times
8:30 am - 9:00 am
Conference Logistics

Opening Remarks / Committee Recognition

9:00 am - 10:00 am
Presentation

Patient Centricity – Keeping the patient front and center in clinical and commercial development

By the end of this presentation, you should be able to:
1.) Compare and contrast how this innovative concept is different from the traditional clinical supply chain
2. ) List the advantages and the disadvantage of this new concept and identify two (2) ways to overcome the disadvantages
3.) Explain no fewer than two (2) ways this concept could positively impact the clinical supply chain in the future

Speakers
Justin Schroeder
10:00 am - 10:15 am
Break

Room transfer – tea/coffee break

10:15 am - 11:15 am
Workshop

Defining patient experience (site nurse)

The attendee will be able to:
1.) Compare and contrast the differences in clinical supplies requirements of the site versus the patient
2.) Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial
3.) Summarize the negative patient experiences with clinical supplies and identify no fewer than two (2) ways to address them

Topic
Defining patient experience (site nurse)
Speakers
Naomi Litchfield
10:15 am - 11:15 am
Workshop

Optimizing CTM Supply Chain Design

The attendee will be able to:
1.) Identify challenges faced by using the current “Push” Clinical Supply Chain model
2.) Describe why changes must be made to evolve to a “Pull” supply chain model with the impending launch of the Clinical Trial Regulation (CTR)
3.) Give no fewer than two (2) examples of optimization methods and how to implement those methods

Topic
Optimizing CTM Supply Chain Design
10:15 am - 11:15 am
Workshop

Practical aspects of shipping Cell Gene Therapy

The attendee will be able to:
1.) Define the differences between Cell and Gene Therapy (CGT) products and small molecule products
2.) Identify the challenges of shipping CGT compared to standard shipments
3.) List no fewer than three (3) ways to overcome those shipping challenges

Topic
Practical aspects of shipping Cell Gene Therapy
10:15 am - 11:15 am
Workshop

Retaining talent

The attendee will be able to:
1.) Summarize the importance of retaining clinical supplies (CS) employees and the impact of losing them
2.) Explain why retention is more important than recruitment
3.) Identify ways to motivate CS employees to increase retention within the Clinical Supplies Unit (CSU)

Topic
Retaining talent
Speakers
Nike Lawal
10:15 am - 11:15 am
Workshop

Vendor / sponsor relationship excellence

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

Topic
Vendor / sponsor relationship excellence
Speakers
Bev Nicol, Brian Keesee, Hope Foudoulakis, Roel de Nobel,
11:15 am - 11:30 am
Break

Room transfer

11:30 am - 12:30 pm
Workshop

BREXIT Update -Impact to Clinical Supplies

The attendee will be able to:
1.) Define BREXIT
2.) Identify next steps in the BREXIT process
3.) Identify two (2) key aspects of how BREXIT will impact Clinial Trials

Topic
BREXIT Update -Impact to Clinical Supplies
Speakers
Paul O'Connor, Adrian Peskett,
11:30 am - 12:30 pm
Workshop

Future of IRT

The attendee will be able to:
1.) Explain the advantages and limitations of the current IRT model
2.) List no fewer than three (3) key changes anticipated that will improve current IRT systems
3.) Explain ways in which companies can prepare for these changes and leverage those updates

Topic
Future of IRT
Speakers
Marc Lisi
11:30 am - 12:30 pm
Workshop

Globalization of clinical trials and impact on supply chain

The attendee will be able to:
1.) Identify new and emerging countries and list no fewer than two (2) ways the clinical supply chain can be interrupted in these countries
2.) List no fewer than two (2) ways the supply chain process can be improved to support globalization
3.) Explain no fewer than two (2) ways to enhance regulatory knowledge to expedite clinical supply chain globalization

Topic
Globalization of clinical trials and impact on supply chain
Speakers
Dan Bell
11:30 am - 12:30 pm
Workshop

Innovation of the clinical supply chain: e-meds

The attendee will be able to:
1.) Summarize how the e-meds concept can transform the traditional clinical supply chain requirements
2.) Identify no fewer than two (2) key components of this innovative supply chain solution that may enhance patient compliance
3.) Explain the regulatory challenges of implementing this new clinical supply chain technology

Topic
Innovation of the clinical supply chain: e-meds
Speakers
Hilde Vanaken
11:30 am - 12:30 pm
Workshop

Leadership vs management

The attendee will be able to:
1.) Discuss the key differences between a manager and a leader
2.) List no fewer than three (3) repercussions of acting only as a manager or only as a leader
3.) Give no fewer than three (3) situational examples of when it’s best to lead or to manage

Topic
Leadership vs management
Speakers
Jan Pieter Kappelle
12:30 pm - 1:45 pm
Networking

Lunch – Exhibitor Displays Open

1:45 pm - 2:45 pm
Presentation

Presentation- Non-pharma Supply Chain

By the end of this presentation, you should be able to:
1.) Compare and contrast the supply chains and identify two (2) ways the clinical supply chain might learn from the non-pharma supply chain
2.) Differentiate the supply chain critical path items and how they can be overcome on the clinical supply chain
3.) List at least two (2) ways the non-pharma supply chain was able to overcome key country challenges in order to expedite customer delivery

Topic
Non-pharma Supply Chain
Speakers
Peter R. Bobbe
2:45 pm - 3:00 pm
Conference Logistics

Closing Remarks, Survey Completion and Prize Draws

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