Conference Day 2 - Wednesday 24th January 2018

8:30 AM - 9:00 AM Coffee and Registration

9:00 AM - 9:10 AM Chairman's Opening Remarks

Steven Jacobs, Board Chairman, Global Clinical Supplies Group

Steven Jacobs

Board Chairman
Global Clinical Supplies Group

9:15 AM - 9:50 AM Clinical Trial Supply Chain Efficiency: Expediting The Timelines and Reestablishing The Plan

Elisaveta Frenkel, Global Clinical Supply Coordinator & Master Production Planner, Hoffmann-La Roche
  • Discuss how to maintain a high service level with ever changing demands
  • Evaluate how to combine stability and flexibility in clinical supply
  • Plan how to meet challenges of adaptive trials

Elisaveta Frenkel

Global Clinical Supply Coordinator & Master Production Planner
Hoffmann-La Roche

9:50 AM - 10:30 AM Next Generation IRT - What Do We Need?

Nimer Yusef, CEO, Trial-Brain
-Interpret the integration of digital apps in management systems
-Understand where digital innovation becomes a nice to have rather than a need to have
-Determine what updates are required to improve efficiency of IRT programmes

Nimer Yusef


9:15 AM - 9:55 AM Case Study: Tracking Reconciliations and Destruction

- Understand how to improve traceability through country specific regulations
- Determine the key costs associated with reconciliations and destructions
- Forecast how to improve the supply chain to minimise destruction

9:50 AM - 10:30 AM Determine The Regulatory Changes Affecting Clinical Trial Supply

Claudio Lorck, Associate Director Clinical Product Supply EU, QP Lead, Abbvie
  • Understand the new regulation affecting the GMP environment of products in clinical supply
  • Analyse the main challenges in the new regulations and how they will affect your company
  • Explore solutions to take the initial steps in implementation of changed regulatory standards

Claudio Lorck

Associate Director Clinical Product Supply EU, QP Lead

10:30 AM - 11:00 AM Coffee and Networking Break

11:00 AM - 11:40 AM Implement Clinical Forecast Accuracy Metrics And Turn Them Into Actionable Supply Decisions

Sébastien Coppe, Head of Consulting Group, N-SIDE
  • Build the right metrics to assess your clinical assumptions
  • Track forecast accuracy automatically through machine learning algorithms
  • Identify strategic decisions and translate them into operational actions.

Sébastien Coppe

Head of Consulting Group
  • Determine the right balance between cost and optimising efficiency
  • Qualify the critical investments needed to improve your supply chain
  • Understand how costs can be reduced and the management of supply chains remains high

Michael Elmshøj

Principal Clinical Trial Supply Chain Manager

Elisaveta Frenkel

Global Clinical Supply Coordinator & Master Production Planner
Hoffmann-La Roche

12:20 PM - 12:30 PM Live Poll!

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:10 PM Understanding End To End Management And Planning Of Clinical Supply

Amer Alghabban, Managing Director, GxP Consultant & Trainer, GXP complaince and training
- IMP Journey from Manufacturing site to Clinical site.
- IMP Management at Clinical Trial Sites: Case Studies.
- Lessons learnt

Amer Alghabban

Managing Director, GxP Consultant & Trainer
GXP complaince and training

2:10 PM - 2:50 PM Case Study: Overcoming Hurdles In Patient Site Centricity

Andrea Zobel, Global Senior Portfolio Director Clinical Logistics, PAREXEL
  • Determine the unique challenges associated with delivering clinical supplies directly to the patient
  • Understand regulations directly associated with direct to patient services
  • Optimise visibility of the supply chain that involves patient site centricity

Andrea Zobel

Global Senior Portfolio Director Clinical Logistics

2:50 PM - 3:00 PM Live Poll!

3:00 PM - 3:30 PM Coffee and Networking Break

Each round table will discuss a different "what if scenario" that mirrors a real CTS situation. Develop strategies to overceom these likely scenarios and share past experiences and ideas!

1) You are trying to get a product to Russia but there is a problem with the documentation and you cannot get into the country – what do you do?
This scenario is set so that you can explore how to overcome hurdles in navigating the different regulations from country to country and determining what your next steps will be

2)There is an unexpected volume increase in your pipeline, how will you deliver the new increase volume on time?
Here, the scenario is looking at how to mange peaks and troughs in the clinical trial supply chain

3)An audit is approaching and you need to show your GMP practices, what do you include?
This scenario is designed to look at how to differentiate between what is and is not usually required in an audit

4)Your vendor is not taking responsibility of an error in your supply chain but you know this is under their remit what do you do?
Vendor management is a key ongoing challenge. This looks at how to manage expectations and accountability across suppliers

5)Brexit: Can we predict how Brexit is going to affect clinical trial supply across the EU?
With many sites now not being built in the UK due to the uncertainty of Brexit – how will this change the regulations from country to country

Ana-Zeralda Canals

Clinical Operations Manager

Amer Alghabban

Managing Director, GxP Consultant & Trainer
GXP complaince and training

4:40 PM - 4:50 PM Chairman's Closing Remarks