The Program

Dick Winokur
Vice President, Clinical Investigational Products, Clinical Supply Chain
SANOFI-AVENTIS

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

• How to work with your clinical team to minimize drug loss
• Developing flexible randomization and labeling schemes
• Using an IVRS/IWRS keep tight control of your clinical supplies

• Reviewing the current EU regulatory landscape
• Current status and recent changes to the EU clinical trial directive
• Implementing best practice methodologies for smooth distribution through European borders
• Ensuring compliance throughout the distribution process

• Following regional GMP guidelines and regulations
• Managing expiry dates and manufacturing demands
• Understanding the role of the QP and ensuring timely product release
• The interface between GMP and GCP

• Setting up a distribution process – focusing on overcoming cold chain challenges
• Complying with global regulations
• Depot selection and management in emerging markets
• Managing supply volumes and overage for individual sites
• Reducing costs and maximising ROI

• Managing carriers and monitoring the progress
• Dealing with cold chain distribution
• Depots versus direct to site
• Implementing effective returns processing strategies

Clinical Supply Simulation with Live IVRS Data

• Pre-trial simulation and forecasting
• In-trial monitoring, simulation and re-forecasting
• Important data elements from IVRS
• Implementation process and costs

• Selecting the right CMO and setting up clear manufacturing agreements
• Defining the responsibilities and successfully managing the distribution of work
• Managing relationships and ensuring a timely process
• Implementing last minute protocol changes

• Defining vendor selection criteria - capacity, capability, technology, experience
• Qualifying your vendor selections
• Audit scope - facilities, SOPs, systems, quote process
• Establishing agreements  - Quality/Technical, Master Service
• What is the "right number" of vendors you should have for your company

Automating clinical trials labeling for improved efficiency and accuracy

• Discovering the most common pitfalls of clinical trials labeling management and how to avoid them
• Hearing real life examples of best practice
• Learning what key features all FDA compliant systems share
• Find out what technical advances are aiding labeling management
• Knowing the vital questions you should ask to weed out unsuitable solution providers

Program Day Two Thursday June 4 2009

Registration

Opening remarks from the Chair

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of clinical trial supply.

Lunch

Roundtable leaders will discuss the key findings and highlight future challenges that were uncovered during the morning session

OPTIMISING CLINICAL SUPPLY FORECASTING

Accurately forecasting clinical trial supply demands to reduce cost

• Understanding the importance of demand forecasting
• Effective forecasting tools and techniques
• Best practices in forecasting CTS requirements

TRANSITIONING TO ADAPTIVE TRIAL SUPPLY

Understanding CTS requirements for adaptive trials

• Pinpointing the challenges of flexible dosing and mid-trial modifications on the CTS department
• Resolving difficulties in forecasting clinical products for an adaptive trial
• Complying with regulations and guidelines for packaging and labeling products for adaptive trials
• Implementing technologies such as IVRS to manage adaptive trial supply
• Ensuring cross-department compliance to ensure timelines are kept

Afternoon refreshments

LABELING AND PACKAGING SOLUTIONS FOR LOCAL AND GLOBAL TRIALS

Increasing efficiency in the supply chain for multilingual labels

• Multilingual label a crucial step in the whole clinical supply chain
• View on the supply chain for multilingual labels – challenges to overcome
• A case study
• Tools to optimize the supply chain for multilingual labels
• The future of clinical labeling – an outlook on technical possibilities

Electronic document management systems and clinical label approval

• Switching from a manual process of reviewing and approving labels text to an electronic process
• Monitoring approvals and version control
• Using approved labels as a resource

Closing remarks from the Chair and close of conference