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- Keynote Presentation: Developing a robust global distribution strategy to efficiently supply clinical trials
- Analysing the importance of having a strong distribution process as a key link in the clinical supply chain
- Aligning distribution planning and execution to streamline the process
- Developing and merging into an efficient and effective global distribution network
- Outlining considerations to develop a temperature control and monitoring strategy
- Developing and maintaining successful and safe vendor relationships to realise the potential of outsourcing
- Alexander Debets, Head of Global Clinical Supplies, Merck, Sharp and Dohme
- Exploring the dos and don’ts of supplying clinical trials in Japan; a case study example of regulatory and cultural variation in the region and the considerations to take when setting up trials in this market
- Uncovering the unwritten rules; outlining some key cultural factors relevant to your packaging process to ensure acceptance from the public
- Clarifying the situation with direct distribution to determine whether sites are accepting of the 2008 regulation
- Completing the groundwork in terms of data and documentation necessary to supply trials in Japan
- Outlining region-specific differences in regulation and considerations which must be made
- Julian Schulz, Associate Director, Clinical Supply, Takeda Pharmaceuticals
- Case Study - Operating effectively in Russia and Ukraine
- Anticipating the challenges associated with meeting requirements at customs to effectively prepare for your shipment
- Tackling the issue of rising values at customs and assessing the financial impact on ROI
- Outlining the challenges which are still being experienced when supplying trials in Russia to identify solutions for future processes
- Determining the differences between supplying trials in these two regions and the considerations necessary for each
- Kamila Schmirlerova, Clinical Supply Chain Manager, Amgen
- Panel Session: Counteracting the challenges associated with product distribution to new and emerging markets
- Tackling customs: understanding the documentation requirements and regulations in place in various new markets to prevent your trial from being subject to delay
- Clarifying the acceptance of nominal values at customs - does the industry now have to provide actual values?
- Ensuring your product remains at the required temperature when distributing to hotter countries such as the Middle East and India
- Identifying the local distribution capabilities and processes to ensure efficiency is maintained throughout
- Exploiting the best sources to offer information on local regulation and cultural considerations and prevent delay and the risk of non-acceptance
- Generating a training programme for local staff which is not resource or cost intensive
- Panel members include: Chioma Nwoko, Director Clinical Supply Operations, Daiichi Sankyo Justin Doel, Global Head Clinical Supplies, Novartis
- Alexander Debets, Head of Global Clinical Supplies, Merck, Sharp and Dohme
- Simplifying the labelling process through clarification on expiry date regulation and innovative approaches to translation
- Keynote Presentation: Establishing regional requirements in product expiry dates and forecasting future trends in acceptance
- Exposing levels of acceptance of expiry date removal when using IVRS and whether this limits global trials
- Gaining acceptance at site level for removal of dates and combating the inconsistencies between regulation and the site
- Predicting the likelihood of an EU ruling to eliminate industry uncertainties concerning regional acceptance
- Deciding whether to change your process - is it worth a country by- country application?
- Validating the appropriateness of IVRS as a system to prevent the dispensing of expired products
- Graham Briscoe, Regional Lead Quality Assurance, Clinical Supply Team, Genzyme
- Case Study: 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
- Jan Pieter Kappelle, Director, Clinical Supply Chain Management, Amgen
- Identifying and countering the packaging and labelling challenges associated with vaccine studies
- Distinguishing vaccine studies from other trials to establish the key supply chain differences which should be considered
- Clarifying the challenges in terms of packaging and labeling vaccines and the impact these challenges have on strategic decisions
- Learning best practice approaches to management of the expiry dates on labels of vaccines
- Demonstrating how strict regulation on temperature maintenance of vaccines can cause issues during cold chain distribution and identifying strategies to manage distribution effectively
- Establishing methods to efficiently source concomitants for your vaccine trial
- Lesley George, Associate Director, Supply Chain Management, Pfizer
- Analysing the impact of IVR /IWR on the operational efficiency of clinical supply allowing you to make crucial strategic decisions about your supply processes
- Analysing the extent to which IVR/IWR can be used to control enrolment and accurately forecast demand for your trial
- Exploring the role of IVR/IWR in adaptive trials to enable flexibility in design to be met with flexibility in supply
- Investigating how IVR/IWR can assist with the optimisation of drug supplies at a programme level
- Establishing the role which IVR/IWR can play in the packaging and labelling of products, particularly when removing product expiry dates
- Gayle Flynn, Worldwide Director RAMOS and IVR S, GlaxoSmithKline
- Designing logistics tracking/planning systems that effectively uses IXRS capabilities for drug pooling and inventory management
- Learn how you can manage the global clinical trial supply chain using IXRS
- Understand how to leverage IXRS to maximise efficiencies in the clinical supply chain
- Using predictive supply strategies to provide for more efficient delivery
- Analyse the benefits and complexities of drug pooling
- Senior Representative from United Bio Source Corporation
- Extended usage of IVRS for non investigational drugs and ancillary supplies
- Identifying when to use IVRS to manage non investigational drugs and ancillary supplies
- Uncovering the challenges of tracking non-uniquely labeled supplies in IVRS, including expiry management
- Defining regulatory needs and requirements and how they harmonize with the use of IVR Systems
- Exploring the disadvantages of not using IVRS for non-IMPs including examples
- Andrea Zobel, Director, Clinical Logistics, EME A, PAREXEL International
- Sarah Waters, Analyst, Randomization and Trial Supply Management, Perceptive Informatics
- Networking Lunch
- Our networking lunch offers a structured but informal way to find and connect with delegates who share your CTS focus. Luncheon tables are signed to indicate areas of interest - simply choose your table and enjoy lunch in the company of peers sharing the same area of interest and expertise
- Streamlining your supply chain through accurate, innovative forecasting
- Exploring the very latest methods being used to forecast demand accurately and the potential this has to free up resource elsewhere
- Investigating new technology offerings being used to optimise forecasting accuracy
- Determining how the use of technology can result in extra resource availability
- 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
- Joint presentation
- Dirk De Naeyer, Global Head, Clinical Supply Management, JOHNSON & JOHNSON
- Katien Meeus, Manager, Clinical Supplies Design, JOHNSON & JOHNSON
- Optimising your manufacturing process to ensure a streamlined supply chain
- Meeting the challenges of clinical supply manufacturing in a dynamic environment
- Identifying variation in manufacturing requirements at different stages of the drug development process
- 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
- Ross MacRae, Head Clinical Supply Manufacturing, Global Supply Chain, Pfizer
- Optimising distribution strategies to prevent excess resource allocation whilst meeting regulatory requirements
- Identifying the best depot management practices for materials to ensure the smooth running supply of your clinical trials
- Completing initiation and execution of a warehouse audit including a review of checklist content, audit frequency, common findings and proposed solutions
- Reviewing depot policies and procedures to ensure they match your expectations:
- Inventorying and cycle counting policies
- Pick/pack/ship procedures
- Disaster recovery and storage contingency plans
- Storage conditions and equipment back-up systems
- Establishing the import and export requirements to prevent any delay to shipments
- Ensuring the appropriate regulatory and customs documentations are prepared to streamline operations for distribution
- Developing and maintaining reliable partnerships to ensure distribution and shipping are carried out optimally
- Lekishia Moffett White, Managing Director, Multipharma
- Clarifying whether it is necessary to log temperature during ambient shipments and uncovering the most cost effective method that can be applied
- Defining the regulation with regards to temperature logging, and how this varies across different regions
- Establishing the optimal method of resourcing for the logging requirement to prevent the process from becoming too resource intensive
- Assessing the cost impact of temperature logging on strategic business decisions
- Uncovering the latest software solutions being used to minimize resource and cost inefficiencies
- Predicting future trends in temperature logging in the industry and on a global scale
- Session reserved
- Improving and maintaining quality throughout the supply chain whilst avoiding compromises in efficiency
- Keynote Presentation: Optimising clinical supply processes and organisation in order to make robust, effective strategic decisions
- Session details to be confirmed
- Andre Goerke, Global Head Supply Management, Novartis
- Balancing the drive for greater efficiency in logistical operations whilst maintaining quality in the clinical supply chain
- Determining the strategies your competitors are using to reduce cost in the tough economic environment
- Replacing out of date processes to streamline and modernise your supply chain
- Highlighting stages in the process which are resource intensive and establishing potential technology offerings to mitigate this
- Promoting economical processes by adapting lean principles to prepare for larger and more complex trials
- Implementing the appropriate metrics to measure improvements in efficiency
- Sue Lee, Manager Biopharm Systems, R&D, World Courier
- Unearthing strategies to minimise wastage and prevent associated implications on cost
- Determining the key steps to take to make lean principles a reality in your organisation
- Identifying the best strategies to minimise waste and prevent overage and overspend
- Uncovering a practical and pragmatic method to measure the effectiveness of waste prevention techniques
- Establishing how innovative drug pooling can benefit the financial efficiency of your supply chain
- Communicating with clinical teams to identify gaps in the trial process before dosing, which could allow for low wastage supply
- Helen Treece, Global Supply Chain Manager, Astrazeneca
- Alleviating challenges with comparat or sourcing and identifying novel strategies for distribution
- 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
- Jonah Randria, Head of Clinical Supply Chain Management, Pfizer
- Identifying practices to effectively and efficiently source for a comparator study
- Determining the sourcing complexity during the trial design process to reduce the likelihood of delays
- Compiling a sourcing strategy, or identifying a sourcing vendor to create a robust supply chain
- Implementing cost savings to dramatically reduce eventual expenditure
- Understanding the unique sourcing criteria of comparators, the challenges likely to be presented and how to overcome them
- Acquiring specific information on applicable regulations and how they will apply in practice
- Senior Representative from Durbin PLC
- Choosing your vendor: a comparison and evaluation of the opt ions available to sponsors and an insight into the key drivers for supplier choice to guarantee value for money
- Panel Session: Comparing the advantages of outsourcing to one as opposed to many suppliers and answering the questions such as who to use, what to outsource and how to measure performance
- Identifying a vendor with a strategy that fits your business model and defining expectations and timelines
- Deciding when and what to outsource to optimise efficiency and allow you to allocate resource effectively
- Considering individual strengths and factors such as cost to determine the number of suppliers to use
- Exploring best practice approaches when managing the relationship with your supplier(s) and building a partnership to promote investment, commitment and trust
- Uncovering the capabilities of your suppliers with respect to resource and technological offering and how these match up to the market leaders
- Panel Session Members include:
- Jonah Randria, Director, Clinical Supply Management, Pfizer Didier Basseras, Vice President, SCP Clinical Supplies, Sanofi-Aventis Bernd Schaden, Clinical Supply Chain, Ba xter Catherine Michielsens, Head of Clinical Supply Design, Johnson & Johnson
- Panel Session: Assessing the benefits and most efficient methods of outsourcing the QP for your trial to ensure you are meeting the required standards
- Defining the expectations of your QP to determine roles and responsibilities and the extent of involvement you require
- Weighing up the pros and cons of outsourcing the QP to determine the advantages an external QP can offer above an internal allocation
- Outlining a detailed and appropriate contract to ensure expectations are met and liability is agreed
- Determining where to outsource from, the types of companies which can offer these services, and the best option to take
- Foreseeing the possibilities when outsourcing QP, and identifying where impossibilities lie, to avoid making the wrong decisions
- Panel session members include:
- Henk Mollee, Director, CTM Supply and Operations, Ast ellas Pharma Europe B.V
- Graham Briscoe, Regional Lead Quality Assurance, Genzyme Didier Basseras, Vice President, SCP Clinical Supplies, Sanofi-Aventis
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