Pre-Conference Workshop Day
8:30 am - 9:00 am Registration and Welcome Coffee
9:00 am - 11:00 am Trade Compliance Workshop – Navigating the Regulatory and Import/Export LandscapeBernard Jaucot - Director Strategic Solution, Global Clinical Supplies (GCS, PPD
The Clinical Trial Supply arena is a highly regulated environment. Navigating these troubled and unpredictable
waters is challenging, and requires constant process updates.
Just when you thought an international shipment was easy & straightforward, you discover that you or
someone else is carrying the responsibility to ensure the content of this shipment leaves the country of
departure and enters the destination country with the accurate documentation, mentioning the right
description (vs. the Import or Export License e.g.), the right classification (equals right taxes), the correct value
(1USD? Really?), the agreed Incoterm, the Importer of Record (IOR)…
But do you know who the IOR really is, or are you just putting your local affiliate because you always to it for
every trial? Is there a CRO involved, and is the CRO the IOR?
What strategy do you put in place to address these responsibilities, discover who the IOR really is, or be sure
you have your documents reviewed by the responsible party?
This session will provide you with an understanding of Trade Compliance, and the roles & responsibilities
needed to safely navigate international Clinical Trial Supplies waters.
After the Workshop you should:
- Understand what the Importer of Record (IOR) responsibilities are
- Examine how to find out who the IOR is
- Assess a few different methods to ensuring a compliant shipping document
- Identify the main Incoterms and how they interrelate
- Set-up a Trade Compliance department, if you don’t have one yet…
Bernard JaucotDirector Strategic Solution, Global Clinical Supplies (GCS
11:00 am - 11:30 am Morning Coffee Break
11:30 am - 1:00 pm Mapping the Evolution of Clinical Trial Supply Chain FlexibilityNatalie Balanovsky - JIT Manufacturing Solutions Manager, Almac
This fun and interactive workshop will take the participant on a journey through time as it relates to Clinical Trial Supply (CTS). This session will provide an understanding of key milestones that directly impact CTS, and will explore current and projected shifts in the Clinical Trial landscape, requiring sponsors to be more adaptive and responsive to change. Participants will be invited to apply their learnings throughout the workshop, utilizing the tools presented to gain an appreciation of where we’ve been, where we are and where we’re going in CTS.
In this session you will:
• Understand the metamorphosis Clinical Trial Supply has undergone over the past 20years
• Analyse shifts in the current market and their inherent supply challenges
• Identify and apply various strategies to incorporate flexibility into the supply chain
Natalie BalanovskyJIT Manufacturing Solutions Manager
1:00 pm - 2:00 pm Networking Lunch
2:00 pm - 3:30 pm Clinical Trials At The Patient’s Home : How To Practically Manage Direct To Patient Models For Patient Centric CTSAndrea Zobel - Global Senior Portfolio Director Clinical Logistics, PAREXEL
Dr. Pia Schmidt - Client Relationship Director, Parexel
In this interactive and hands on workshop, participants are invited to consider the changing nature of clinical trial
delivery and patient involvement. The rising use of virtual trial and direct to patient models will be examined and
practical takeaways identified for any type of company. Participants will also be taken through a series of real life case
studies to clearly define the implementation process and challenges for all types of pharma and CT companies.
In this session you will:
- Analyse where the industry currently is in adopting in-home and virtual trials
- Understand the practicalities of the regulatory and data privacy situation
- Identify technical solutions to enable in-home trials
- Examine a series of real life case studies: Participants will develop clinical supply strategies and solutions for
real in-home clinical trials
Andrea ZobelGlobal Senior Portfolio Director Clinical Logistics
Dr. Pia SchmidtClient Relationship Director
3:30 pm - 4:00 pm Afternoon Coffee Break
4:00 pm - 5:30 pm Planning For The Future Of Clinical Trial Supply – Politics, Leadership, New Markets and Budget CutsSteven Jacobs - Board Chairman, Global Clinical Supplies Group
In this interactive afternoon seminar attendees will discuss the changing landscape of clinical trial supply and the external influences set to impact our supply chain over the next 12-24 months. With a focus on the impact of Brexit and other political factors, the increasing industry pressure on lean supply chain management, budget cuts, smaller headcount expected to do more with less, as well as the increasingly digital nature of our supply chain management – participants will be tested to identify their biggest challenge of the next 12 months and the questions they need to answer over the next two days to put in place a sustainable roadmap to success to manage the change with their people and stakeholders.
In this session you will understand:
- How the global political climate has altered our clinical trial supply strategy, the challenges that this has presented and the importance of agility, listening, teamwork and innovation
- How to plan for the increasingly digitalised nature (AI and Blockchain) of our supply chains – and how to internally manage the changes that this supply chain transformation requires and the stress it creates
- Where our standard protocols need to be adjusted, our stakeholders influenced, and our sponsor-vendor relationships improved to prepare for the supply landscape of the future
Steven JacobsBoard Chairman
Global Clinical Supplies Group