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 programme
8:30 Registration and coffee9:00 Chairman's opening remarksSean Smith, Vice President Clinical Supply Chain, Fisher Clinical Services 9:10 Effectively managing clinical trials with limited drug suppliesRobert Silber, Director, Supply Chain Management, FibroGen
Working with stakeholders
Maximising efficiency
Developing flexible supply plans
9:50 Clinical supply chain and cycle time reductionSean 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
10:30 Morning coffee11:00 Integrated cold chain solution: What to consider for a model to manage end-to-end (E2E) temperature controlled transportation to prevent disturbance of clinical trialsFederico 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
11:40 Supply chain management best practices in end-to-end clinical trial supply chain managementGeert 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
12:20 Networking lunch13:50 Clarifying the role of the clinical supplies coordinatorNette Falkenberg, Clinical Supplies Co-Ordinator, Novo Nordisk
The role and responsibilities
Challenges
Case studies
14:30 Innovative packaging strategies for clinical trial supplies David Revel, Technology and Innovation Specialist, Sanofi-Aventis
Security
Integrity
Traceability
15:10 Afternoon tea15:40 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 16:20 Legal and regulatory aspects of clinical trials in the EU and outsourcing logisticsPaul 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
17:00 Chairman's closing remarks17:10 Drinks reception18:30 End of day one8:30 Re-registration and coffee9:00 Chairman's opening remarksTony Wright, Managing Director, Exelsius Cold Chain Management 9:10 Supply of investigational medicinal products - the CMC perspectiveDawn 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
9:50 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
10:30 Morning coffee11:00 Comparator sourcing strategiesKay-Christian Karstadt, Executive Director, Multipharma
Sourcing options
Procurement design and provider selection
Reliable supply to trial sites
11:40 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
12:20 Networking lunch13:50 Running successful clinical trials in ChinaMike Bradshaw, Senior Vice President, Ocasa
Infrastructure
Facilities
'Guxi'
Where are clinical trials allowed by the authorities?
14:30 Logistical challenges of conducting clinical trials in emerging economiesSue 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?
15:10 IVR/IWR - Specification, validation and implementationMark 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
15:50 Chairman's closing remarks16:00 Afternoon tea and networking with sponsors and delegates16:30 Close of conference
Workshops
Workshop Marriott Hotel Regents Park 19th May 2010 London, United Kingdom
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