Attending this conference will allow you to
- Identify inefficiencies in your supply chain and develop strategies to remedy them
- Understand the legislative requirements around clinical trial logistics
- Learn from and network with senior figures in this area
- Improve your labeling and packaging procedures
- Understand the intricacies of performing clinical trials in emerging markets
Attendees at our previous conferences said
"Very good" Senior Representative, Wyeth
"Very good. Well organised" Senior Representative, Antisoma Research
"Informative and good networking opportunities" Senior Representative, Unichem
"Well organised and efficiently run and chaired" Senior Representative, DHL Express Europe
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Conference agenda
Welcome and introductions The Theory: GCP/GMP requirements for IMPs
Delivering IMP to the site - which green lights are required?
Receiving IMP at site - what checks are necessary?
Storing IMP - but where and how?
Reconstituting IMP - what is indispensable?
Blinding - how can it be maintained?
Randomisation - what are the options?
Documentation - the necessary evil?
Observations made during investigator site audits
Deficiencies identified during inspections
Welcome and introductions Trends and developments in clinical supply chain design: presentation by BCI Discussion session: definition of main challenges in the coming 5 years Clinical supply chain development in practice: presentation by a leading pharmaceutical company (to be confirmed) Discussion session: main solutions for the coming 5 years A solution in practice: presentation by a leading logistics service provider Chairman's opening remarks Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services Effectively managing clinical trials with limited drug supplies Robert Silber, Director, Supply Chain Management, FibroGen
Working with stakeholders
Maximising efficiency
Developing flexible supply plans
Clinical supply chain and cycle time reduction Sean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services
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
Sponsored by
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 Federico Lupp, Director of Sales Europe and Latin America, LifeConEx
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
Supply chain management best practices in end-to-end clinical trial supply chain management Geert Crauwels, Director, Lodestone Management Consultants
Strategies to reduce overages and optimising the supply chain for clinical trials
Adopting new business models
Leveraging best practice IT solutions
Clarifying the role of the clinical supplies coordinator Nette Falkenberg, Clinical Supplies Co-Ordinator, Novo Nordisk
The role and responsibilities
Challenges
Case studies
Innovative packaging strategies for clinical trial supplies David Revel, Technology and Innovation Specialist, Sanofi-Aventis
Security
Integrity
Traceability
Sponsored by
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 Legal and regulatory aspects of clinical trials in the EU and outsourcing logistics Paul Ranson, Partner, Fasken Martineau LLP
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
Chairman's closing remarks 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. Re-registration and coffee Chairman's opening remarks Tony Wright, Managing Director, Exelsius Cold Chain Management Supply of investigational medicinal products - the CMC perspective Dawn Padfield, Director of Technical Development and Clinical Supply, Norgine
Summary of CMC activities associated with IMP supply
Advantages and disadvantages of in-house supply management
The CRO option
Labelling of investigational medicinal products Heike Roeder, Director, Head of Global SOPs & Training, UCB
Label Text Requirement according to Annex 13 of the GMP
Translation and local requirement
Expiry date
Pooling supplies, just in time labelling
Sponsored by
Comparator sourcing strategies Kay-Christian Karstadt, Executive Director, Multipharma
Sourcing options
Procurement design and provider selection
Reliable supply to trial sites
Avoiding disappointment with your logistics partner Tim Saint, Business Development Manager, Marken
Agree relationship terms
Identify core teams
Project management
Study set up
Operational processes
Audit
KPIs
Running successful clinical trials in China Mike Bradshaw, Senior Vice President, Ocasa
Infrastructure
Facilities
'Guxi'
Where are clinical trials allowed by the authorities?
Logistical challenges of conducting clinical trials in emerging economies Sue Lee, Manager BioPharm Systems R&D, World Courier
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?
IVR/IWR - Specification, validation and implementation Mark Wright, Validation Consultant, GxPi
Managing drug supply efficiently
Guaranteeing the system meets business requirements
Getting the system live - plainning ahead to avoid start-up problems
Ensuring compliance
Chairman's closing remarks 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.
Workshops
Marriott Hotel Regents Park 19 May 2010 London, United Kingdom
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