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Conference Documentation: Clinical Trial Logistics (2010)

SMI Publishing, Ltd
May 17, 2010
SKU: SMI2771803

Abstract Table of Contents Related Reports

With the high costs of development for a new drug, no company can afford to further increase costs through inefficiencies in the clinical trial supply chain. As an attempt is made to reduce expenses through conducting clinical trials in the emerging markets of Asia, India, South America and Eastern Europe there is an increasing need to ensure that your logistics procedures are as efficient and cost effective as possible.

SMi's 4th annual Clinical Trial Logistics conference will address your concerns and provide you with the tools to safely and efficiently resolve your clinical trials logistical challenges on a global scale. This conference will also analyse the latest developments in labelling, packaging, inventory management, security, forecasting, partnering and outsourcing.

DAY 1
8.30 Registration and coffee
9.00 Chairman's opening remarks: Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services.
9.10 Effectively managing clinical trials with limited drug supplies: Working with stakeholders; Maximising efficiency; Developing flexible supply plans; Robert Silber, Director, Supply Chain Management, FibroGen.
9.50 Clinical supply chain and cycle time reduction: The challenges of logistics in emerging markets with a particular focus on India and China; Technologies to aid clinical supply chain in emerging markets; Financial comparisons and advantages, study examples; Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services.
10.30 Morning coffee: Sponsored by
11.00 Integrated cold chain solution: What to consider for a model to manage end-to-end (E2E) temperature controlled transportation to prevent disturbance of clinical trials: Logistics and process management integrated with geographic, climatic, packaging and supplier data; Criticality of standardisation and proactive intervention in a process; Quality agreement, control and assurance; Peace of mind in global cold supply chain; Federico Lupp, Director of Sales Europe and Latin America, LifeConEx.
11.40 Supply chain management best practices in end-to-end clinical trial supply chain management: Strategies to reduce overages and optimising the supply chain for clinical trials; Adopting new business models; Leveraging best practice IT solutions; Geert Crauwels, Director, Lodestone Management Consultants.
12.20 Networking lunch
1.50 Clarifying the role of the clinical supplies coordinator: The role and responsibilities; Challenges; Case studies; Nette Falkenberg, Clinical Supplies Co-Ordinator, Novo Nordisk.
2.30 Innovative packaging strategies for clinical trial supplies: Security; Integrity; Traceability; David Revel, Technology and Innovation Specialist, Sanofi-Aventis.
3.10 Afternoon tea: Sponsored by
3.40 Lean manufacturing and effective supply chain management to expedite an NDA: Using a clinical supplies team to manage manufacturing and packaging vendors; Effective planning and forecasting; Regulatory hurdles; Benefits to the industry; Rick Mann, Associate Director, Product Development, Clinical Supplies and Logistics, Sepracor.
4.20 Legal and regulatory aspects of clinical trials in the EU and outsourcing logistics: Overview of clinical research and logistics regulation in the EU; Key legal issues in logistics/outsourcing; Developing outsourcing practices and agreements to manage the risks; Paul Ranson, Partner, Fasken Martineau LLP.
5.00 Chairman's closing remarks
5.10 Drinks reception: Please join us for a drinks reception immediately after the last presentation on the first day. This will be a relaxed and social setting for you to network with delegates and sponsors, to follow up any questions you may have with speakers, and to meet some of the SMi team responsible for organising the event.
6.30 End of day one
Day 2
8.30 Re-registration and coffee
9.00 Chairman's opening remarks: Tony Wright, Managing Director, Exelsius Cold Chain Management.
9.10 Supply of investigational medicinal products - the CMC perspective: Summary of CMC activities associated with IMP supply; Advantages and disadvantages of in-house supply management; The CRO option; Dawn Padfield, Director of Technical Development and Clinical Supply, Norgine.
9.50 Labelling of investigational medicinal products: Label Text Requirement according to Annex 13 of the GMP; Translation and local requirement; Expiry date; Pooling supplies, just in time labelling; Heike Roeder, Director, Head of Global SOPs & Training, UCB.
10.30 Morning coffee: Sponsored by
11.00 Comparator sourcing strategies: Sourcing options; Procurement design and provider selection; Reliable supply to trial sites; Kay-Christian Karstadt, Executive Director, Multipharma.
11.40 Avoiding disappointment with your logistics partner: Agree relationship terms; Identify core teams; Project management; Study set up; Operational processes; Audit; KPIs; Tim Saint, Business Development Manager, Marken.
12.20 Networking lunch
1.50 Running successful clinical trials in China: Infrastructure; Facilities; 'Guxi'; Where are clinical trials allowed by the authorities?; Mike Bradshaw, Senior Vice President, Ocasa.
2.30 Logistical challenges of conducting clinical trials in emerging economies: What are the new challenges that face sponsors running trials in new countries and emerging economies?; How do you ensure smooth transit through customs and government agencies?; How do you guarantee temperature compliance in climate extremes?; How can depot strategies improve the supply chain?; Sue Lee, Manager BioPharm Systems R&D, World Courier.
3.10 IVR/IWR - Specification, validation and implementation: Managing drug supply efficiently; Guaranteeing the system meets business requirements; Getting the system live - plainning ahead to avoid start-up problems; Ensuring compliance; Mark Wright, Validation Consultant, GxPi.
3.50 Chairman's closing remarks
4.00 Afternoon tea and networking with sponsors and delegates: A final opportunity to network with any speakers, sponsors and delegates with whom you have yet to connect.
4.30 Close of conference

Conference Documentation: Clinical Trial Logistics (2010)

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