Tuesday June 3, 2008, San Francisco, CA

Clinical supplies: tools and strategies for a best in class approach

Led and sponsored by ALMAC
www.almacgroup.com

The clinical supply chain is now truly global and complex. This workshop aims to address some of the current areas of interest/difficulty for individuals involved in the task of global clinical supply delivery and who wish to gain take-away knowledge of the key issues. Covering available technologies to enhance the supply chain, manage change and an overview of the EU requirements for IMP delivery, this will be an extremely beneficial session for the aspiring IMP professional.

The use of technologies in the clinical supply chain

• Current technologies available to support the supply chain
• Ways to increase efficiencies within the supply chain
• Applying it to your trial - planning and technology integration

Change management in the supply chain - a case study

• Planning and system set-up
• Packaging and labeling considerations for IMPs
• Ease and flexibility of incorporating design changes
• Inventory monitoring and management

EU regulatory issues affecting clinical trials – role of the QP and challenges for IMP supply

• Overview of the regulatory framework
• Identifying responsibilities and interpreting/ implementing GMP
• Remit of the QP within the clinical supply chain
• Managing the process between different parties