Clinical Trial Supply

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VIBpharma’s Clinical Trial Supply conference brings together senior representatives from pharma and biotech manufacturers to discuss key issues through a series of high caliber presentations and interactive roundtable discussions led by industry experts. The topics being addressed will also include innovative drug mobility and labelling strategies, getting the most out of your IVRS, ensuring compliance across Europe, best practice approaches for temperature controlled transportation.

Join us in London in February to discover practical approaches for ensuring a cost-efficient clinical supply chain.

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Clinical Trial Supply

  1. 1. 11th Annual Conference Clinical Trial Supply Co-lo 23 – 24 february 2010, London uK www.clinicaltrialsevents.com/europe2010 with cate our o d annu u al Co r 7th Distr ld Chain ib confe ution rence 3 key event highlights: • Hear from Clinical Trials Supply leaders on the latest industry regulation • Learn how to optimise packaging and labelling to maximise supply chain efficiency • Discover the best strategies to forecast your requirements and become more efficient Distinguished Speakers include: Engage with industry leaders including: ● ASTRA zEnECA ● BAXTER ● Robert Smith, Qualified Person, Associate Director, Clinical Pharmacy Research Services, ● joHnSon & joHnSon ● BoEHRInGHER ● LunDBECK DEnMARK InGELHEIM GEnzYME uK ● SAnoFI-AVEnTIS ● Katie Mazuk, Associate Director, Global Clinical Supplies Unit, joHnSon & joHnSon Gold Sponsors: ● Birthe Brondum, Head of Clinical Supply Packaging, LunDBECK DEnMARK ● jon Chapman, Principal Scientist, Silver Sponsors: EMERGEnT BIo SoLuTIonS ● Sylvie Cotteux, Global Logistic Advisor, SAnoFI-AVEnTIS ● Dr Karoline Bechtold-Peters, Associate Director Clinical Trials Supply and Process Transfer, Boehringher Ingelheim ● Bernd Schaden, Clinical Supply Manager, BAXTER Organised by: VIBpharma
  2. 2. Agenda Day One Tuesday 23 February 2010 08:30 Registration and refreshments 10:30 Morning refreshments and networking 08:55 Chairman’s opening remarks optimising packaging and labelling to maxmise Ensuring compliance with the latest efficiency in the product supply chain and industry regulation to reduce bottlenecks simplify usage and prevent delays 11:15 Ensuring a high standard of product mobility through flexible automotive labelling techniques 09:00 Ensuring you adhere to the latest regulations ● The latest in amendable labelling and electronic labelling to optimise labelling and the pace of your for the value-added dual purpose of data storage reconciliation, and prevent delays in ● Creating on the spot label approval with the latest in compliance approval labelling technology ● Examining which propositions for the GMP annex 13 ● Successfully fitting all the text requirements on small legislation revision have been implemented and best labels so they are compliant practice interpretation of this new legislation ● Using an automotive system to generate useful data ● Acknowledging the outcome for the proposed removal during the labelling process of label expiry dates and the effect this will have on the ● Working with partners and drawing out expertise from future of prolonged short-term shelf life a collaborative approach ● Exploring how to best manage reconciliation according Birthe Brondum, Head of Clinical Supply Packaging, to annex 13 LunDBECK DEnMARK ● Increased communication for increased efficiency - enhanced strategies for ensuring compliance across 11:45 Assessing different packaging methods and the supply chain strategies, and the processes that prevailed for Robert Smith, Qualified Person, Associate Director, our operations Clinical Pharmacy Research Services, GEnzYME uK ● Looking at the most recent materials used for packaging supplies Forecasting techniques to amplify your ● The latest in packaging machinery to aid your performance predictions and minimise packaging deadlines resource wastage ● Assessing the difference between packaging and repackaging methods and how to align the two for 09:30 using short-term forecasting as a tool for better maximum efficiency with minimal excursion resource management ● Finding your ideal location for repackaging drugs - ● Estimating capacity requirements for trial numbers the sponsor site accurately so you can provide more precise product Reserved for PIRAMAL quantities ● Overcoming the inadequacies of the IVRS simulation 12:15 Achieving efficient in-house packaging processes model by using planning templates for a structured well – making the smooth transition for future managed approach resource savings ● Setting up contingency plans for re-supply or less demand ● Using in-house resources for maximum efficiency in so you save resources throughout dosage changes packaging your own products ● Unifying planning practices across divisions and country ● Optimizing quality control and assessing the quality borders to prevent confusion and maintaining company- control responsibility implications wide planning competencies ● Assessing the difference between packaging and Reserved for SCHREInER MEDIPHARM repackaging methods and how to move the two in house 10:00 How simulation is changing the CTS world with with minimal excursion Finding your ideal location for repackaging drugs: more accurate pre-operational understanding ● the sponsor site and supply prediction Evelyn Edwards, Clinical Supplies Manager, AnTISoMA ● Assessing the positive impact simulation and forecasting could have on your business in 2010 12:45 Lunch and networking ● Looking at the latest and most recent innovations in simulation and forecasting technology and methodology ● Realising the core value of simulations and positive side Organised by: effects of effective forecasting on your operations ● Understanding the business practicalities of robust prediction on your supply management ● Recognising the future possibilities of better managed supply delivery prediction and analysing the direction of the future of simulation Ed Tourtellotte, Vice President of Product Innovation, BIoCLInICA Katie C. Mazuk, Associate Director, Global Clinical Supplies unit, johnson & johnson, PHARMACEuTICAL RESEARCH AnD DEVELoPMEnT
  3. 3. Agenda Day One Tuesday 23 February 2010 Innovative resource saving approaches for 16:00 Speaker Hosted Roundtables maximum supply demand accuracy using your Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice ivrs system to enhance functions management and develop solutions to critical challenges facing the 14:15 Increasing operational efficiency to reduce supply industry as a whole. Hosted by industry experts and each wastage and make better use of valuable resources focused on a single issue, roundtables are an exciting, ● Observing the most beneficial areas for saving resources interactive way to build your personal network and learn and costs while improving operations across the clinical from the experience and expertise of others. trial supply process Delegates can attend up to 3 round tables and may ● Implementing positive reductions of manufactured select from: amounts for more precise product supply and an ongoing proactive reduction in wastage Roundtable 1 ● Looking at ways to reduce manufacturing time to increase ● Overcoming European regulatory requirements and using competitive advantage and revenue them for your advantage in simplifying your clinical trial ● Facilitating communication and reducing human error supply labelling through structured, regulated meetings and mandatory ● Looking at similar regulatory requirements in European IVRS change updates for dramatically improved re- countries and how these can simplify your labelling supply accuracy processes for superior efficiency jon Chapman, Principal Scientist, EMERGEnT BIo Hansjoerg nortmeyer, Clinical Investigational Product SoLuTIonS Project Manager Leader, SAnoFI-AVEnTIS GERMAnY 14:45 optimal integrated IVRS usage to facilitate Roundtable 2 increased operational speed and communication ● Looking at the most efficient ways of preparing large ● Ensuring medical and production departments input quantities of packaged drugs and the most successful changes into your IVRS for optimum data management packaging methods for all trial phases and bullwhip effect avoidance ● Observing the difference in manual and automated ● What are the alternatives to IVRS and what benefits do packaging methods, assessing which most impedes on they have to offer? lead time and the qualification and validation necessities ● How best to use your IVRS for saving code, track supply for automation, where there are real time and cost R.O.I’s and controlling label expiry dates Bernd Schaden, Clinical Supply Manager, BAXTER ● Looking at the best usage of IVRS for supply chain management to positively impact your timelines Roundtable 3 Celia Belline, Director, Global Supply Chain ● Using your IVRS for controlling and managing your supply Management, SAnoFI-AVEnTIS FRAnCE chain centrally and assessing it’s suitability for smaller Sylvie Cotteux, Global Logistic Advisor, SAnoFI-AVEnTIS organisations ● Learning how to fully utilise your IVRS for greater supply 15:15 Afternoon refreshments and networking chain control through monitoring - is the system more of a hindrance than a benefit in smaller organisations? Celia Belline, Director, Global Supply Chain Management, Sanofi-Aventis France Sylvie Cotteux, Global Logistic Advisor, SAnoFI-AVEnTIS Roundtable 4 ● Effectively determining when outsourcing within trials can add value to your business and when you reap greater rewards performing the operations internally ● Hearing the impact of outsourcing whole, partial, small or large scale portions of trials and managing when and where this can add value to your business Roundtable 5 ● Analysing the latest supply methods for adaptive trials for malleable innovative trial performance ● Examining the complexity of supplying adaptive trials and overcoming the logistics and lack of forecasting for a measurable positive impact in eliminating delays Roundtable 6 Looking at the commonly used label translation methods and VIBpharma ● observing the success rate of these different approaches ● Looking at ways in which labels are translated and whether country or company-wide strategies are most effective VIBevents provides high-quality commercially focused conferences, based on our own research and our close links with leading practitioners and business advisors. VIBevents is a trading name of 18:15 Chairman’s summation and close of day one SPG Media Ltd., a wholly owned subsidiary of SPG Media Group Ltd. © VIBevents 2009
  4. 4. Agenda Day Two Wednesday 24 February 2010 08:30 Registration and refreshments Innovative outsourcing strategies: working with 08:55 Chairman’s opening remarks your suppliers in order to achieve the greatest return on investment Sourcing comparator drugs to fully examine 11:45 Working with suppliers for accelerated timelines and provide viable market data for commercial and mutual accomplishment of your targets product production and revenue ● Successful supplier selection through thorough auditing 09:00 Proactively preparing for strategic and research: gaining a full interpretation of your comparator sourcing supplier’s capabilities ● Working with IMP and non IMP’s in trials and obtaining ● Overcoming your supplier’s internal procedures the most accurate comparator product ● Observing new ways of amending signed contracts and ● Analysing the definitions in the new EU treatment improving release times guidelines: an overview ● Assisting the improvement of your supplier practices ● Where to go to obtain the most sufficient and reliable through a ‘partnership’ approach and targets comparator drugs in order to obtain viable commercial ● Achieving performance-related returns from your trial outcomes supplier selection ● Ensuring the efficient delivery and distribution 12:15 Lunch and networking of comparator products Lekishia White, Vice President, MuLTIPHARMA Achiving an optimal supply chain set up through obtaining accurate licenses for products in-house and outsourced distribution solutions and the most robust product delivery and 13:45 Good storage and distribution practices - closing monitoring systems for phase one trials the gap between IMP manufacture and use ● Reviewing the latest regulations on GSP and GDP and the 09:30 Finalising faultless licenses and fast trial implications these have for your distribution practices preparation for phase one trial commencement ● Audit findings – Reality vs. Theory ● Preparing for a phase 1 clinical trial and assessing the ● Analysing the depot/courier interface and how this can accurate recognition of what is making ready for use and be improved for smoother distribution what is preparation ● Best practice in IMP distribution and GxP compliance ● Ensuring preparation units get accurate licenses that ● A detailed overview on global management of time and reflect their intentions so trial conditions can be met and temperature sensitive time has not been jeopardised Sue Manager, Biopharm Systems, ● Managing the small dosages required for phase one WoRLD CouRIER (uK) LTD trials and generating a robust system to monitor and communicate dosage changes for minimal errors 14:15 Creating an in-house global distribution network Steve Day, Director Clinical Trial Supply Chain, for cheaper faster trial supply GLAXo SMITH KLEIn ● Developing an internal distribution network: finding the unseen resources Maximising trial potential in emerging european ● Setting up and detailing your distribution on the IVRS markets and conducting this transition with ● Sharing the lessons in how to best conduct this operation minimal challenges ● Analysing the short and long term benefits of moving this 10:00 Adapting quickly to a shift in study location for in-house - immediate expenditure vs. long term savings Taking responsibility for your distribution: the the most advantageous new ventures ● implications of ownership ● Understanding the purpose and benefits of conducting Alexandra Henges, Manager Clinical Supply, jAnSSEn trials in emerging markets: the definitive selection process ● Overcoming the challenges of these new regions for the 14:45 Managing cold chain and ambient storage facilities best possible trial conduction to actively preserve valuable supplies ● Finding suppliers in new regions and using their expertise ● Electronic vs. mechanical temperature monitors to overcome local customs challenges ● Implementing temperature monitoring in a study site Dr Karoline Bechtold Peters, Associate Director ● Best practice temperature control methods - ambient and Clinical Trials Supply and Process Transfer, temperature specific product distribution BoEHRInGHER InGELHEIM ● Managing deviation and guaranteeing your product 10:30 Morning refreshments and networking stability through comprehensive temperature control and monitoring strategies Exploiting contract manufacturing expertise Reserved for PEnn PHARMACEuTICALS for enhanced flexibility and cost efficiency 15.15 Afternoon refreshments and networking in clinical trials 16.00 Session reserved for sponsor 11:15 Reserved for Penn Pharmaceuticals 16.30 Session reserved for sponsor 17:00 Chairman’s summation 17:15 Close of conference
  5. 5. Gold Sponsor: Multi Pharma offer worldwide comparator drug sourcing for clinical trials. With facilities in Switzerland, Germany World Courier handles approximately 80% of the and New Jersey we fulfill needs of single lot, long expiration clinical trials market worldwide requiring a premium date, Certificate of Analysis, Material Safety Data Sheet, courier service. Specialists in packaging and airfreight GMP Certificate, samples, etc. We have the capacity and experience to qualification, compliance and dangerous goods, operating Best Practice in supply large amounts fast directly from the manufacturer. temperature sensitive pharmaceuticals 24x7x365 service; all shipments leave on www.multipharma.ch next-flight-out; all packing materials to UN specifications; real-time web tracking and email alerts; ISO 9001 certification worldwide www.worldcourier.com Phase Forward is a leading provider of integrated data management solutions for PAREXEL International is a leading global bio/ clinical trials and drug safety. The company offers proven solutions pharmaceutical services organization offering for electronic data capture (InFormTM), phase I clinic automation significant expertise from drug development and regulatory consulting to (LabPasTM), clinical data management (ClintrialTM), clinical trials clinical pharmacology, clinical trials management, medical education and signal detection (CTSDTM), strategic pharmacovigilance (Empirica reimbursement. This expertise is enhanced by industry-leading technology SignalTM) and Signal Management, adverse event reporting (Empirica solutions from its Perceptive Informatics division through medical imaging, TraceTM), applied data standards (WebSDMTM) and Web-integrated CTMS, IVRS/IWRS and integration services. www.parexel.com interactive response technology (Clarix™). In addition, the company provides services in the areas of application implementation, hosting Silver Sponsors: and validation, data integration, business process optimization, safety data management and industry standards. Additional information about Almac offers an integrated supply chain management Phase Forward is available at www.phaseforward.com. solution that draws on the expertise of its best in class clinical trial supplies and IVR/web based services. Its integrated solution does more than just combine IMP Logistics’ core business is investigational related services under one roof; it incorporates supply planning, technology medical products and clinical materials implementation, and project oversight into a unified study start-up and warehousing, distribution, import licensing and customs clearance. IMP management approach that optimises the supply chain at each level. Almac and Logistics is focused on clinical trials and because of this specialization its affiliated companies provide a broad range of services across drug discovery, its reputation and business has grown rapidly in recent years. IMP diagnostics, pharmaceutical research and development, API manufacturing, Logistics is now established as the leading facility of its type in Russia clinical trials and drug manufacturing. US operations are based in Pennsylvania, and Ukraine. www.imp-log.com North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh. Schreiner MediPharm is a leader in the development www.almacgroup.com and manufacture of innovative specialty labels with value-added benefits. These products simplify Penn Pharma is a leading provider of integrated product dispensing and administering of pharmaceuticals, enhance drug safety development and custom manufacturing services to the and clearly reduce process costs. As a long-standing expert partner of international healthcare industry including formulation the pharmaceutical industry, Schreiner MediPharm offers a range of and analytical development, clinical trial supply, custom manufacture, customized products and services specifically addressing the complexity high containment processing, CMC consultancy and QP release services. of clinical trials. www.schreiner-medipharm.com Penn manufactures to GMP and is MHRA licensed and FDA inspected. www.pennpharm.co.uk Durbin text - Durbin is a specialist provider of comparator drugs for clinical trials. In addition Piramal Healthcare is at the forefront of custom to comparator drugs, Durbin also provides manufacturing for the Pharmaceutical Industry. Our ancillary supplies and placebos. Durbin brings global sourcing capabilities extend across the high quality development expertise,transparent pricing and global custom distribution to the and manufacture of API, Formulations and Clinical Trial Materials. Our global supply of comparators and ancillaries for clinical trials. network of services integrated across the drug life cycle, offers a unique blend www.durbin.co.uk of flexibility and efficiency as your CMO partner of choice. www.piramalpharmasolutions.com Clintrak Clinical Labeling Services, LLC. Is the industry leader in providing innovative clinical labeling MWV Healthcare Packaging is working solutions. Clintrak manufactures single panel labels, with you to turn your objectives for quality, multi-panel labels, multi-language booklet labels, performance and visual impact into one-of-a-kind packaging that really stands case report forms and blinding/code break cards. Our in-house printing out for patients. Their packaging promotes adherence and health literacy, while capability, exclusive translation/regulatory approval system and making products childproof and tamper resistant, senior-friendly, traceable and expertise in clinical label design will streamline the label segment of compliant for the clinical trial, OTC and ethical drug markets. www.MWV.com yourtrials. Last year alone, Clintrak produced over 20 million labels for clinical trials use! Clintrak is a member of Fisher BioPharma Services Division and Thermo Fisher Scientific. www.clintrak.com Biotec is a UK based Clinical Trials Supply company focusing on the import, Qualified Person certification, labelling, assembly, storage and world-wide distribution of clinical trial supplies for Phase I to IV trials, through to commercial supplies. We specialise in handling temperature sensitive biopharmaceuticals from controlled ambient conditions to 2-8°C, -20°C and -80°C. www.biotec-uk.com Yourway Transport has set the standard for quickness, dependability and personalized service within the transportation industry. Today speed of delivery is no longer the only consideration. Temperature control, specialized packaging, multicentre coordination, just-in-time logistical supply chain solutions, enhanced computer and information requirements are also of vital importance. Our ongoing commitment is to earn the trust and confidence of our customers by providing consistent, reliable service and communication. Combine our years of operational experience with some of the best information systems in the industry and it’s easy to see why Yourway Transport continues to be the market leader. www.yourwaytransport.com Tourtellotte Solutions produces leading applications for the pharmaceutical industry – tcVisualize for clinical supply simulation - Fusion for document processes - Trident for next generation IWR, - and builds custom enterprise solutions for Fortune 500 companies worldwide. www.tourtellottesolutions.com
  6. 6. Exhibitors: GE Sensing & Inspection Technologies Media Partners: World Pharmaceutical Frontiers www.worldpharmaceuticals.net
  7. 7. Booking Form 11th Annual Clinical Trial Supply Tuesday 23 and Wednesday 24 February 2010, London, UK Prices & Payment Information (please tick option) Four Easy Ways To Book: Yes, I would like to register for the event: BEFoRE BEFoRE BEFoRE AFTER ■ Register online at 25.11.2009 23.12.2009 20.01.2010 20.01.2010 ■ Email us at events@arena-international.com Pharma manufacturers and Biotechs I would like the VIP attendees package to include €2450 €2590 €2730 €2940 ■ Tel +44 (0)20 7753 4268 the two day conference + interactive CD-ROM (VAT where (VAT where (VAT where (VAT where (saving €70) applicable) applicable) applicable) applicable) ■ Fax +44 (0)20 7915 9773 I would like to attend the two day conference only €1820+VAT@ €1960+VAT@ €2100+VAT@ €2310+VAT@ Venue Details 17.5% = €2138.50 17.5% =€2303.00 17.5% =€2467.50 17.5% =€2714.25 The two day conference will take place on Tuesday Academic/Government representatives 23 and Wednesday 24 February 2010. The venue I would like the VIP attendees package to €1540 €1680 €1820 €2030 will be a centrally located hotel in London, UK. For include the two day conference + interactive (VAT where (VAT where (VAT where (VAT where further information contact our Operations CD-ROM (saving €70) applicable) applicable) applicable) applicable) department on +44 (o) 207 753 4201. I would like to attend the two day conference only €910+VAT@ €1050+VAT@ €1190+VAT@ €1400+VAT@ 17.5% =€1069.25 17.5% =€1233.75 17.5% =€1398.25 17.5% =€1645.00 Are you registered? You will always receive an acknowledgement of Fee for other participants (Non Pharma Manufacturers/Biotechs) your booking. If you do not receive anything, I would like the VIP attendees package to include €3450 €3590 €3730 €3940 please call us on +44 (0) 20 7753 4268 to make the two day conference + interactive CD-ROM (VAT where (VAT where (VAT where (VAT where sure we have received your booking. (saving €70) applicable) applicable) applicable) applicable) ALL ToTAL FEES ARE SuBjECT To A 2.5% SERVICE CHARGE I would like to attend the two day conference only €2820+VAT@ €2960+VAT@ €3100+VAT@ €3310+VAT@ 17.5% =€3313.50 17.5% =€3478.00 17.5% =€3642.50 17.5% =€3889.25 All participants I cannot attend the conference but would like to €700 (VAT where €700 (VAT where €700 (VAT where €900 (VAT receive the interactive CD ROM applicable) applicable) applicable) where applicable) Total Discount code if applicable _________________________________ Discounts are at the discretion of VIBpharma and are not cumulative Vibpharma Conference Delegate terms and conditions 4. General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations 1. Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and of this Agreement (in whole or part) without our prior consent. 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