| 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 |
|
|
|
 |
|  |