Temperature Controlled Logistics in Biopharmaceuticals Europe 2022

• From Covid-19 to oncology = how different indications and the level of urgency affects what kind of cold chain distribution vaccines should have
• Highlighting the latest challenges and innovations in the supply chain for temperature sensitive products
• Addressing key strategies for pharmaceutical companies to achieve development and operational success in temperature-controlled logistics
• Navigating global supply chain hurdles when shipping cold chain supplies overseas: dos and don’ts

• Factors influencing product safety in temperature-controlled logistic.
• Comparison of solutions: Active, standard passive and advance and high performance passive solutions.
• Qualified performance.
• Our contribution to avoid temperature deviations

• Debating the pandemic’s disruptive impact on global supply chains
• Exploring the impact of current trends on the future of temperature controlled supply chains
• The rise of patient-centricity – best practice in monitoring and controlling temperature for direct-to-patient shipments
• How the cold chain leads in innovation to gain increased visibility and boost consumer safety and trust
• The missing link to success – recognising the need for collaboration between various stakeholders to create an integrated value chain

• Exploring the benefits of a fully automated system for transportation
• Key milestones in a successful project launch – from conception to implementation in more than 100 warehouses worldwide
• Avoiding errors in programming and achieving almost real-time statistics when the goods arrive
• Collaborating with forwarders on future project improvements – remaining in the driver’s seat

• How full end-to-end temperature monitoring helps to improve patient safety and increase process efficiency
• How the various technological developments help to establish end-to-end temperature monitoring
• How the various systems are working together
• What to consider when implementing digitalized temperature monitoring

• Proven ways to reducing the risk of temperature excursions when shipping biologics
• Implementing technical data and effective stability budget to test product capability that is shipped around the world across a multitude of suppliers, regulations, and patients
• Exploring various model statistics around the analytical methods
• Discussing the global perspectives on stability budgets and impacts on supply chain products

• Adhering to standards enforced by regulatory bodies so that the products won’t negatively impact the quality, safety, or efficacy of the drugs
• The Quality by design approach – brief summary of the Quality Guidelines’ objectives
• The impact of new regulations on innovation and flexibility

• Speed, regulations and receiving sites are three variables that differ between the commercial and clinical trial context, giving rise to unique challenges
• Sharing how in order to solve these challenges, Controlant has run pilot programs with leading pharmaceutical companies during the distribution of products for clinical trials and we want to share our results
• Explaining why transporting pharmaceuticals around the world has become critical to our health and well-being
• The stakes are even higher when it comes to clinical trials, and only by tailoring cold chain services to their specific requirements can we ensure their robustness and reliability

• Developing a digital first mindset when adopting new technologies in pharmaceutical cold chains
• Obtaining transparency on transport partners and their capabilities and infrastructure
• Selecting the transport lanes with the lowest risk
• Achieving complete oversight on the status of IMPs in real-time and adjudication on excursions
• Making the best use of available data from the pharmaceutical cold chain – using data to achieve fully remote temperature monitoring during transport
• Responding to customer and patient expectations – the need for agility, performance and pace

The British Standards Institution (BSI) and Poseidon have come together to create a new GDP platform to champion:

• efficient quality management systems
• development of global GDP standards
• mutually-recognised assessment schemes
• supply chain best practice
• provision of professional guidance through the growing maze of GDP regulations

The Multi-Modal Compliance and Standards (MMCS) program is being developed as a consensus-based foundation on which can be built the common GDP standards and guidance needed for the safe, efficient and compliant transportation of vital pharmaceuticals in the virus age

• Overview: understanding the impact of temperature controlled packaging on the environment
• What is the current situation with sustainability/waste reduction and how may this change in the future?
• What can we do to reduce the impact of TCP on sustainability programmes and initiatives?
• Selecting your packaging supplier – single use or reusable shippers, how can rental or lease options assist to meet your sustainability goals

• Minimise lab testing but maximise test data with the use of Computational Modelling Software
• Using real-time temperature monitoring to complete Performance Qualification (PQ), where traditional methods are not possible
• Use of actual shipment data and simulation to complete risk assessment of new lanes, and to assess root-cause of temperature excursions to ensure the right CAPA is implemented

• Exploring novel shipping routes to reduce overall cost and ensure quality of product delivered is of the highest standard
• Lead times and temperature deviations – key considerations whilst shipping by train to China
• Navigating the changing international regulatory environment
• The border control challenge – how to avoid custom delays and their impact on potential temperature excursions

• How to minimize risk and ensure IMP’s integrity during transport?
• Discovering the benefits of live monitoring usage to improve the logistic quality and chain of custody
• Real life examples of recent implementation

• End-to-end logistics and last mile shipping – risk based approach
• What new innovations are available for shipping temperature sensitive products
• Best practice for temperature excursion management in last mile

• Learn how standards and certifications improve quality for airfreight shipments of pharmaceuticals
• Creating the highest level of visibility in the cold chain using technology
• Cooperating with forwarders and airlines in technology integration to  reduce potential risks and lead times

• Ensuring compliance in conflict-affected countries – lessons learned
• Working with limited budgets and overcoming the challenges posed by the ongoing pandemic – implications for temperature controlled logistics
• Exploring the trend of further growth of temperature-sensitive products from R&D to marketplace

Round table sessions offer delegates the possibility of delving into a topic and unpacking this in a thoughtful and constructive manner. Each speaker is a subject matter expert in their field and comes prepared with questions which will allow delegates the chance to debate and discuss in detail