The Programme

Program Day One Tuesday October 21 2008

Registration

Opening remarks from the Chair

Leveraging software technology to improve the management
of clinical supplies during clinical trials

• Study planning and setup considerations
• Study tracking and alignment of supplies with site/patient status
• Adapting to changing trial conditions and supply requirements
• Embedding process within technology to enforce standards
• Utilizing software tools to track supply forecasts vs. site actuals

Managing the function: useful project management techniques

• Defining the different aspects involved in creating an effective strategy
• Increasing efficiency and handling more studies with limited resources
• Tracking and coordinating all projects
• Setting and meeting appropriate clinical supply metrics

Morning refreshments

Product pooling: creating efficiencies within your supply chain

• The real benefits of drug pooling
• Technologies that support this approach
• Supply labeling options 
• Difficulties in implementation - an assessment

Sascha Sonnenberg
Head of Sales and Marketing
Faubel & Co. Nachfolger

Cutting turnaround times for multilingual labels

• Generation processes for multilingual labels
  • who is involved
    
  • sources of errors and how to avoid them
  • Comparing scenarios
    
• Establishing an efficient process in order to achieve optimal timelines/results: a case study
  
• Design guide: a tool to define and specify a unique design
  

Lunch

Mariamo Abdallah-Bouno
Supply Chain Trial Manager
SANOFI AVENTIS

Part 1: Sanofi-Aventis’ model of managing import/export of IMP/CTM for global studies

• Overview of s-a functional structure
• Distribution strategy
• Requirements for import/export
• Model advantages
• Model limitations
  

Part 2: Overview of regulations governing import/export of
IMP/CTM

• Brief GM-GCP overview regarding IMP manufacture and certification
• US, EU Member States and other worldwide territories
• Manufacture and import considerations
• Labeling considerations
• Roles and responsibilities

Clinical supply challenges in Russia and Ukraine

• Geographical size
• Temperature control in extreme weather conditions
• Regulatory considerations
• Case study

Afternoon refreshments

Challenges to controlled drug distribution

• Exploring trial/molecule specific facility licenses to store and distribute narcotic clinical trial materials
  
• Moving clinical trial materials between countries: specific import and export licences needed and obstacles faced
  
• Controlled drug capacity at depots
  
• Analyzing different country requirements for different schedules of controlled drugs

Clinical trials: next generation forecasting and IWR technology

• A modern end-to-end clinical supply process
• The overlap between forecasting, simulation and IWR: beyond the boundaries of traditional systems and processes
• From scratch to sim to launch and back in several minutes
  

Improving forecasting abilities throughout the process

• Understanding the need for effective forecasting and simulation tools
• Assessing the variety of software available and choosing the best approach
• Using simulation tools to reduce overage
• Tailoring forecasting technologies and methodologies to specific studies

Closing remarks from the Chair  and close of Day One

Program Day Two Wednesday October 22 2008

Registration

Opening remarks from the Chair:

Lunch

 Key considerations when sourcing comparators

• Benefits of formulating a comparator supply strategy at an early stage
• Overview of available routes of supply for comparator products
• Validating your suppliers and supply chain: guarding against counterfeit products, assessing the risks of using PI products, assuring confidentiality and handling logistical considerations
• Identifying the key risks associated with comparator supply that could affect your trial           
• Choosing a single sourcing strategy: managing single trials involving both the US and EU and evaluating the pros and cons of adopting a single geographic source for your comparator

Sourcing comparators for clinical trials within India

• Clinical research and the pharmaceutical market in India, an overview
• ·Exploring the challenges of procuring comparator drugs
• Reviewing the necessary documentation needed for India
• Managing the logistics and security of supplying lines

Supporting adaptive trials effectively

• Outlining developments in the adaptive trial arena: current studies, popular designs and trends
• Examining the impact on the clinical supply department
• Creating an organizational structure to cope with increased demands, compressed timelines and changing study parameters

System integration in the ever evolving clinical supplies world

• What is integration and how can it work for you?
  
• How can you bring order to the proliferation of tools, ideas and issues?
  
• A case study that will work for years to come
  
• Why integration will bring long term value to your organization as it evolves
  
• How to make your organization process dependent, not people dependent

Case study: re-engineering Allergan’s clinical supply chain system through leading technology

• Creating operational excellence
• Reengineering our processes globally
• Implementing leading technology solutions

Case study: importing and exporting clinical materials in and out of the EU and US

• Ongoing communications with appropriate departments
  
• Timing to be included for planning shipping of supplies
  
• Sourcing issues for investigational drugs and comparator agents
  
• Maintaining flexibility of supplies
  
• Import and export process and agencies involved

Closing remarks from the Chair and champagne prize draw