08:50 Opening Remark from Chairperson

09:00 Exploring the Latest Methods to Forecast Demand Accurately and the Potential To Free Up Resource

• Investigating new technology offerings being used to optimise forecasting accuracy
• Determining how the use of technology as opposed to traditional means of forecasting can result in extra resource availability
• Debating the validity of forecasting tools in an effort to understand trends in universal acceptance
• Assessing the impact of trial simulations on supply chain efficiency
• Ensuring that your forecasts incorporate all stages of the supply chain including trial length, sample size and product evolution
• Optimising communication with clinical teams to prevent overage and promote accuracy

Linc Chen
Clinical Supply Manager
Bayer

09:40 Meeting the Challenges of Clinical Supply Manufacturing in a Dynamic Environment

• Identifying the differences in manufacturing requirements at different stages of drug development
• Recognising the new technology available to simplify and ensure continuous improvement in clinical trials manufacturing
• Establishing how flexibility in clinical trial manufacturing is truly defined and exploited
• Ensuring compliance and quality in clinical trial manufacturing

Jennifer Yu
Head of Quality Management for Trial Material
Shanghai Roche Pharmaceutical

10:50 Recognising Best Practices When Sourcing Comparators for Your Trial to Minimise the Likelihood of Unforeseen Challenges

• Uncovering solutions to manufacturer reluctance when providing product documentation such as certificate of analysis and compliance documentation to prevent preliminary delays
• Avoiding risk through ensuring the supply of your comparator is secure
• Choosing a supplier with an expedient sourcing strategy which operates successfully
• Forecasting comparator demand to expose any potential limitations or delay to your trial
• Outlining requirements when distributing comparator drugs to global trial locations

Li Ding
Director, Trial Operations Asia Pacific Coordinator, Trial Operations China Group Leader
sanofi aventis China

11:30 Analysing the Logistical and Financial Factors Involved When Redesigning Your Label Design Process

• Outlining the steps needed to design and implement processes which significantly reduce lead times on label creation
• Considering regulatory requirements to ensure that your new process meets all governed expectations and ensures approval is given speedily
• Ensuring the quality of input is optimal so that volume of rework is minimised and resources are spared
• Investigating the challenges associated with accomplishing a total change in labelling processes
• Weighing the cost vs benefits of redesigning the process and detailing the benefits of a new efficient system

Christopher Huang
Founder & General Manager
Pharmacons Tech

13:10 Streamlining Logistics for Clinical Trials in China

• Detailing considerations and challenges with supplying trials in China
• Exploring insight when supplying trials in China and sharing experiences with regards to common hurdles
• Investigating and drawing trends from industry experience in China and Asia Pacific countries
• Exploring the services and facilities availabled to support distribution of products to these regions

Jessica Liu
Senior Director of Clinical Operations, Head of Asia Pacific
INC Research

13:50 Ensuring Compliance in Cold Chain and Temperature Controlled Shipment throughout the Supply Chain

• Outlining the current regulatory demands for clinical cold chain shipping
• Forecasting the potential for an increased regulatory focus on temperature control in clinical supply
• Determining the validation criteria for compliant cold chain shipping
• Defining what data is needed to handle temperature deviations in transit or storage
• Delivering an overview of the latest technologies to evaluate their suitability for your clinical supplies

Charlie Chen
Vice President
GCP Clinplus

15:00 Panel Discussion: Focusing on Vendor Management in a Cost-Containment World: Optimising Real-Term ROI. Value for Money, Risk and Results

• Assessing the real-term returns on strategic outsourcing decisions
• Evaluating the implications of outsourcing to single or many vendors on trial and supply management
• Establishing the key differences when outsourcing from a small company vs large pharma – pricing, priorities and risks
• Examining alternative evaluations of vendor performance in relation to your priorities
  • Quality of project management
  • Human resources
  • Standard of technologies used
  • Proven reliability
  • Typical timelines
  • Global coverage
  • Cost implications
• Reviewing the cost/benefit rationales in prioritizing vendor choices pre-selection
• Understanding your vendor‟s internal processes to foresee potential obstacles to effective partnerships

Panellists:

15:40 Ensuring Compliance in Cold Chain and Temperature Controlled Shipment throughout the Supply Chain

• Outlining the current regulatory demands for clinical cold chain shipping
• Forecasting the potential for an increased regulatory focus on temperature control in clinical supply
• Determining the validation criteria for compliant cold chain shipping
• Defining what data is needed to handle temperature deviations in transit or storage
• Delivering an overview of the latest technologies to evaluate their suitability for your clinical supplies

Panellists:

16:20 Interactive Roundtable Discussion

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables

Roundtable 1:

Investigating Creative Solutions to “Do More With Less”; Optimising The Supply Function With Limited Resources

Roundtable 2:

Defining and Evaluating Best Practice and “Acceptable” Practice in Exercising Final Drug Accountability

Roundtable 3:

Optimising Selection, Sourcing and Management of Comparator Drugs – Thoroughly Examining Opportunities, Benefits and Drawbacks of Different Approaches

Roundtable 4:

Sharing Realistic, Practical Guidance on Supplying Trials in China

Roundtable 5:

Enhancing Communication with Vendors After Interface Deployment to Handle Logistics With A Large Number of Vendors Effectively

Roundtable 6:

Investigating Cost Effective Storage and Distribution Solutions for Ambient and Controlled Room-Temperature Products

Roundtable 7:

Identifying Best Practice Approaches When Supplying Early Phase Trials

*Roundtable leader to be announced

17:20 Closing Remarks from Chairperson and End of Conference