Programme Day One

Opening remarks from the Chair

Clarifying current and upcoming international cold chain regulations and how to implement them effectively in order to ensure full compliance

• Outlining national and GDP (Good Distribution Practice) regulations and guidelines relevant to cold chain equipment and processes
• Exploring European requirements regarding stability data of products requiring cold chain storage
• Highlighting the ongoing discussion on the European field regarding transport conditions
• Clarifying stability issues of pharmaceutical bulk products and assessing how to overcome them

Benefitting from advanced temperature monitoring across the clinical trial supply chain

• Outlining the challenges of temperature monitoring in clinical trials
• Assessing how the process for temperature monitor data review can be improved effectively
• Establishing what level of recording is feasible for in-specification results
• Discussing innovative solutions to the challenge of temperature monitoring in clinical trials

Debating the difficulty of making sure that your product arrives in the right condition and outlining the possibilities to ensure the cold chain until product administration

• Presenting a case study on the administration of a medicinal product by the doctor: how to ensure a successful standardised cold chain management from your warehouse to the administration of the product to the patient
• Comparing the regulatory requirements for manufacturers, distributors, wholesalers and pharmacists regarding storage and distribution: outlining guidelines on Good Distribution
  Practice (GDP) defined by WHO and national regulatory bodies such as the Irish Medicines Board
• Debating at what stage the responsibility for the cold chain management is transferred from the manufacturer to the customer and assessing the potential risk for a manufacturer if the cold chain is not respected by the customer
• Outlining the main actions a manufacturer can implement in order to mitigate the risk on his product

Overcoming cold chain challenges when distributing to emerging countries highlighting operational and regulatory solutions to be implemented

• Qualifying potential routes in countries with less established infrastructure: outlining potential alternatives that ensure safe cold chain distribution
• Assessing related risks and picturing scenarios to tackle them effectively
• Identifying best qualified 3rd parties for various types of shipments and understanding how to cooperate with them successfully
• Understanding local regulations and evaluating whether further safety measures need to be implemented to minimise risk
• Implementing an appropriate quality system to optimise the distribution process on a non-qualified route

Moving towards a global cold chain: entering new countries whilst finding reliable local service providers and complying with international regulations

• Assessing the infrastructure of the destination country in terms of routes, storage facilities and customers available as well as related risks
• Debating how to find the right couriers for small and large quantities and how to manage them successfully: executing audits and using reliable monitoring systems
• Uncovering how to manage the distribution process on a non-qualified route whilst minimising risk
• Understanding local regulations and practices in order to validate packaging and cooling systems and qualify 3rd parties accordingly
• Implementing a simple quality system that ensures process safety and control as well as integrity of the product

Identifying and managing risk in cold chain shipping by assessing clear actions to be taken in case of jeopardized process safety
Establishing and evaluating risk factors throughout all stages of cold chain and balancing risks while keeping processes aligned with determined safety margins

Overcoming challenges related to the control of frozen shipments
Identifying solutions to validate reliable freezers and qualify shippers successfully in order to ensure integrity of your products at all times

Assessing current regulatory trends with respect to monitoring ambient temperature shipments and how to implement a monitoring system cost-effectively
Clarifying upcoming guidelines to establish a strategy on how to monitor ambient temperature shipments effectively, in compliance with new standards and with minimal cost involved

Control and monitoring cold chain products from production to the patient as final customer

• Debating span of control, chain of custody and responsibilities of the different parties
• Assessing if individual unit monitoring will be a quality need in future
• Discussing quality oversight and qualification cold chain carriers