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- CASE STUDY: The road to launching a new biological drug - a UCB logistics perspective
- Understanding the key considerations when creating a fit-for-purpose logistics department
- Identifying, training and organizing an effective global logistics team
- Assuring optimal management of shipping solution validation
- Exploring the UCB cold-chain logistical setup and lessons learned in the management of a global cold-chain system
- Examining the methods, procedures and solutions used in the transportation of -70° DS shipments and the rationale of the choices made
- Marc Mostinckx, Sr. Director, Global Logistics, UCB PHARMA SA
- Understanding the increasingly universal demand for ambient product stability data and controlled temperature conditions to better handle the implications of these demands on your controlled-temperature distribution practices
- Understanding the current regulatory requirements for implementing controlled room-temperature conditions
- Analyzing the degree to which these requirements will apply to your currently unmonitored or uncontrolled shipments
- Clarifying the measures that will need to be put in place for products which are not yet classified with stability data
- Exploring the best methods to avoid deviations in 2-25° and 15-25° categories without drastically increasing cost
- Evaluating the relevancy of mean kinetic temperatures and high and low excursions on newly controlled ambient temperature products
- Cornelia Nopitch-Mai, Scientist, Federal Institute for Drugs and Medical Devices, BFARM
- Exploring various solutions available for distributing controlled-room-temperature products whilst ensuring favourable outcomes in cost, compliance and quality
- Establishing the viability of a low-cost yet robust controlled room temperature packaging solution
- Outlining the possibilities in adapted road-freight for temperature controlled ambient shipments as an alternative to packaging solutions
- Clarifying what is possible when aiming to maintain a consistent 15° - 25° range in distribution through various external ranges
- Evaluating and validating these solutions to ensure you will meet compliance
- Assessing the suitability of these solutions to match your product stability data to ensure the correct choices are made
- Deriving the benefits vs. cost of implementing temperature controls on ambient products with long term regulatory trends in view
- Keren Winmill, CEO, Biotec Services International
- Panel Discussion: Exploring current trends in regulation and inspection requirements of controlled storage and distribution systems to best ensure preparedness for compliancy
- Identifying the next-round of stability concerns - humidity levels, physical challenges, ambient products
- Analysing the extent to which these issues will affect your particular product portfolio
- Establishing the implications for physical-impact stability assurance on testing and packaging needs
- Forecasting the timelines for tighter monitoring of ambient products to facilitate efficient preparation for their introduction
- Assessing the problem areas lacking sufficient solutions and defining the viability of finding these
- Optimising compliance with the help of innovative solutions whilst mitigating unreasonable cost increases
- Cornelia Nopitch-Mai, Scientist, Federal Institute for Drugs and Medical Devices, BFARM Marc Rechsteiner, Head of Supply Chain Management D-A-CH, NYCOMED PHARMA AG Henryk Junker, Quality Assurance Manager, ALLERGAN R&D EUROPE
- Establishing best practice in cold chain to avoid deviations when moving products between temperature controlled warehouses and transport
- Exploring the symptoms of “black-hole” gaps in cold-chain logistics to identify the causes and requirements of a solution
- Understanding the implications for regulatory compliance of such gaps in the chain
- Identifying and evaluating the solutions available to avoid deviations between temperature-controlled environments
- Building the essential stability data to support short-term deviations when handling products between two temperature controlled environments
- Marc Rechsteiner, Head of Supply Chain Management D-A-CH, NYCOMED PHARMA AG
- Ensuring premium qualification and verification of temperature controlled distribution solutions with practical and exhaustive qualification protocols
- Explaining the methods and options available when defining validation criteria
- Understand the implications of the validation results on your products in real terms
- Outlining the technical necessities for inclusion in a qualification protocol to ensure comprehensive attainment of these necessities
- Clarifying what data is needed to define the legitimate limitations of the validated solution
- Ensuring all bases are covered for compliance with inspector expectations
- Henryk Junker, Quality Assurance Manager, ALLERGAN R&D EUROPE
- Mitigating risks to temperature sensitive products late in the supply chain - avoiding delay and product wastage at customs clearance and ensuring compliance in storage by end-users
- Understanding the reasons behind the most common causes for avoidable delays
- Exploring how a comprehensive and exhaustive procedure for documentation preparation can reduce chances of complication
- Establishing methods to minimise the risks of deviations when unavoidable delays occur
- Implementing measures to protect the cold-chain through local affiliate action
- Outlining the current problem areas of temperature sensitive product-handling by pharmacies to grasp the extent of the issue
- Evaluating the possibilities and hurdles of implementing solutions to be used in the “last mile” to ensure efficacy to users
- Clarifying the practical considerations essential to any project which aims to improve control throughout the chain and with end-users
- Roula Wakim, Marketing Affiliate, Quality Assurance Associate, LILLY
- CASE STUDY: Ensuring optimal performance from subcontractors with effective management; production and distribution of temperature sensitive IMPs
- Assessing and selecting the most appropriate sub-contractors for packaging, labeling and clinical cold chain supply
- Ensuring end-to-end product protection with prepared unpackaging and distribution processes
- Examining the procedures from cell bank to IMP delivery
- Establishing best practice when packaging temperature sensitive IMPs for best possible outcomes in distribution
- Outlining the temperature monitoring and reporting procedures and the rationale for these processes
- Evaluating the handling of temperature deviations experienced in production and distribution
- Sam Corveleyn PhD, Director CMC, Qualified Person, ACTOGENIX
- CASE STUDY: Investigating the cold-chain transportation and qualification strategy in a small-size biotechnology company
- Examining the rationale behind multiple solutions for investigational, clinical and small-volume commercial transportation needs
- Exploring choices and designs in packaging to optimise the transport of cold chain products
- Outlining the Pharma Mar qualification strategy; “worst case” approach based on product stability and delivery time
- Monitoring of shipment temperature based on product and business risk
- José Luis Ortega, Director, Quality Unit, PHARMA MAR Santiago Naranjo, Head of Validation Department, PHARMA MAR
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Coldchain storage and distribution by Arena International
See all reports like this >> Synopsis The proceedings from VIB Pharma's 2010 ColdChain Storage and Distribution Conference Summary VIBpharma delivered cutting edge conference content for logistics and supply chain professionals in pharmaceutical companies. ...
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