clinical trial supply

11th Annual Conference

Clinical Trial Supply

Engage with industry leaders including: ● ASTRA zEnECA● joHnSon & joHnSon● LunDBECK DEnMARK● SAnoFI-AVEnTIS

● BAXTER● BoEHRInGHER

InGELHEIM

23 – 24 february 2010, London uK www.clinicaltrialsevents.com/europe2010

Organised by:

VIBpharma

Engage with industry leaders including: ASTRA zEnECA

www.clinicaltrialsevents.com/europe2010Co-located with our our 7th

annual Cold Chain Distribution conference

Silver Sponsors:

Gold Sponsors:

● Robert Smith, Qualifi ed Person, Associate Director, Clinical Pharmacy Research Services, GEnzYME uK

● Katie Mazuk, Associate Director, Global Clinical Supplies Unit, joHnSon & joHnSon

● Birthe Brondum, Head of Clinical Supply Packaging, LunDBECK DEnMARK

● jon Chapman, Principal Scientist, 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

Distinguished Speakers include:

3 key event highlights:

Hear from Clinical Trials Supply • leaders on the latest industry regulationLearn how to optimise packaging • and labelling to maximise supply chain effi ciencyDiscover the best strategies to • forecast your requirements and become more effi cient

Agenda Day One Tuesday 23 February 2010

08:30 Registration and refreshments

08:55 Chairman’s opening remarks

Ensuring compliance with the latest industry regulation to reduce bottlenecks and prevent delays 09:00 Ensuring you adhere to the latest regulations

to optimise labelling and the pace of your reconciliation, and prevent delays in compliance approval Examining which propositions for the GMP annex 13 ●

legislation revision have been implemented and best practice interpretation of this new legislationAcknowledging the outcome for the proposed removal ●

of label expiry dates and the effect this will have on the future of prolonged short-term shelf life Exploring how to best manage reconciliation according ●

to annex 13 Increased communication for increased efficiency - ●

enhanced strategies for ensuring compliance across the supply chainRobert Smith, Qualified Person, Associate Director, Clinical Pharmacy Research Services, GEnzYME uK

Forecasting techniques to amplify your performance predictions and minimise resource wastage09:30 using short-term forecasting as a tool for better

resource management Estimating capacity requirements for trial numbers ●

accurately so you can provide more precise product quantitiesOvercoming the inadequacies of the IVRS simulation ●

model by using planning templates for a structured well managed approachSetting up contingency plans for re-supply or less demand ●

so you save resources throughout dosage changesUnifying planning practices across divisions and country ●

borders to prevent confusion and maintaining company-wide planning competenciesReserved for SCHREInER MEDIPHARM

10:00 How simulation is changing the CTS world with more accurate pre-operational understanding and supply predictionAssessing the positive impact simulation and forecasting ●

could have on your business in 2010 Looking at the latest and most recent innovations in ●

simulation and forecasting technology and methodologyRealising the core value of simulations and positive side ●

effects of effective forecasting on your operationsUnderstanding the business practicalities of robust ●

prediction on your supply managementRecognising the future possibilities of better managed ●

supply delivery prediction and analysing the direction of the future of simulationEd Tourtellotte, Vice President of Product Innovation, BIoCLInICAKatie C. Mazuk, Associate Director, Global Clinical Supplies unit, johnson & johnson, PHARMACEuTICAL RESEARCH AnD DEVELoPMEnT

10:30 Morning refreshments and networking

optimising packaging and labelling to maxmise efficiency in the product supply chain and simplify usage11:15 Ensuring a high standard of product mobility

through flexible automotive labelling techniquesThe latest in amendable labelling and electronic labelling ●

for the value-added dual purpose of data storage Creating on the spot label approval with the latest in ●

labelling technology Successfully fitting all the text requirements on small ●

labels so they are compliant Using an automotive system to generate useful data ●

during the labelling process Working with partners and drawing out expertise from ●

a collaborative approach Birthe Brondum, Head of Clinical Supply Packaging, LunDBECK DEnMARK

11:45 Assessing different packaging methods and strategies, and the processes that prevailed for our operationsLooking at the most recent materials used for ●

packaging suppliesThe latest in packaging machinery to aid your ●

packaging deadlinesAssessing the difference between packaging and ●

repackaging methods and how to align the two for maximum efficiency with minimal excursion Finding your ideal location for repackaging drugs - ●

the sponsor siteReserved for PIRAMAL

12:15 Achieving efficient in-house packaging processes – making the smooth transition for future resource savingsUsing in-house resources for maximum efficiency in ●

packaging your own products Optimizing quality control and assessing the quality ●

control responsibility implications Assessing the difference between packaging and ●

repackaging methods and how to move the two in house with minimal excursion Finding your ideal location for repackaging drugs: ●

the sponsor site Evelyn Edwards, Clinical Supplies Manager, AnTISoMA

12:45 Lunch and networking

Organised by:

Innovative resource saving approaches for maximum supply demand accuracy using your ivrs system to enhance functions management14:15 Increasing operational efficiency to reduce supply

wastage and make better use of valuable resourcesObserving the most beneficial areas for saving resources ●

and costs while improving operations across the clinical trial supply process Implementing positive reductions of manufactured ●

amounts for more precise product supply and an ongoing proactive reduction in wastageLooking at ways to reduce manufacturing time to increase ●

competitive advantage and revenueFacilitating communication and reducing human error ●

through structured, regulated meetings and mandatory IVRS change updates for dramatically improved re-supply accuracy jon Chapman, Principal Scientist, EMERGEnT BIo SoLuTIonS

14:45 optimal integrated IVRS usage to facilitate increased operational speed and communicationEnsuring medical and production departments input ●

changes into your IVRS for optimum data management and bullwhip effect avoidanceWhat are the alternatives to IVRS and what benefits do ●

they have to offer?How best to use your IVRS for saving code, track supply ●

and controlling label expiry datesLooking at the best usage of IVRS for supply chain ●

management to positively impact your timelinesCelia Belline, Director, Global Supply Chain Management, SAnoFI-AVEnTIS FRAnCE Sylvie Cotteux, Global Logistic Advisor, SAnoFI-AVEnTIS

15:15 Afternoon refreshments and networking

16:00 Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity

to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Delegates can attend up to 3 round tables and may select from:

Roundtable 1Overcoming European regulatory requirements and using ●

them for your advantage in simplifying your clinical trial supply labellingLooking at similar regulatory requirements in European ●

countries and how these can simplify your labelling processes for superior efficiency Hansjoerg nortmeyer, Clinical Investigational Product Project Manager Leader, SAnoFI-AVEnTIS GERMAnY

Roundtable 2Looking at the most efficient ways of preparing large ●

quantities of packaged drugs and the most successful packaging methods for all trial phasesObserving the difference in manual and automated ●

packaging methods, assessing which most impedes on lead time and the qualification and validation necessities for automation, where there are real time and cost R.O.I’sBernd Schaden, Clinical Supply Manager, BAXTER

Roundtable 3 Using your IVRS for controlling and managing your supply ●

chain centrally and assessing it’s suitability for smaller organisationsLearning how to fully utilise your IVRS for greater supply ●

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 4Effectively 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 5Analysing the latest supply methods for adaptive trials ●

for malleable innovative trial performanceExamining the complexity of supplying adaptive trials ●

and overcoming the logistics and lack of forecasting for a measurable positive impact in eliminating delays

Roundtable 6Looking at the commonly used label translation methods and ●

observing the success rate of these different approachesLooking at ways in which labels are translated and whether ●

country or company-wide strategies are most effective

18:15 Chairman’s summation and close of day one

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 SPG Media Ltd., a wholly owned subsidiary of SPG Media Group Ltd. © VIBevents 2009

VIBpharma

Agenda Day One Tuesday 23 February 2010

Innovative outsourcing strategies: working with your suppliers in order to achieve the greatest return on investment11:45 Working with suppliers for accelerated timelines

and mutual accomplishment of your targets Successful supplier selection through thorough auditing ●

and research: gaining a full interpretation of your supplier’s capabilitiesOvercoming your supplier’s internal procedures ●

Observing new ways of amending signed contracts and ●

improving release timesAssisting the improvement of your supplier practices ●

through a ‘partnership’ approach and targetsAchieving performance-related returns from your ●

supplier selection

12:15 Lunch and networking

Achiving an optimal supply chain set up through in-house and outsourced distribution solutions13:45 Good storage and distribution practices - closing

the gap between IMP manufacture and useReviewing the latest regulations on GSP and GDP and the ●

implications these have for your distribution practices Audit findings – Reality vs. Theory ●

Analysing the depot/courier interface and how this can ●

be improved for smoother distribution Best practice in IMP distribution and GxP compliance ●

A detailed overview on global management of time and ●

temperature sensitive Sue Manager, Biopharm Systems, WoRLD CouRIER (uK) LTD

14:15 Creating an in-house global distribution network for cheaper faster trial supply Developing an internal distribution network: finding the ●

unseen resourcesSetting up and detailing your distribution on the IVRS ●

Sharing the lessons in how to best conduct this operation ●

Analysing the short and long term benefits of moving this ●

in-house - immediate expenditure vs. long term savingsTaking responsibility for your distribution: the ●

implications of ownershipAlexandra Henges, Manager Clinical Supply, jAnSSEn

14:45 Managing cold chain and ambient storage facilities to actively preserve valuable suppliesElectronic vs. mechanical temperature monitors ●

Implementing temperature monitoring in a study site ●

Best practice temperature control methods - ambient and ●

temperature specific product distribution Managing deviation and guaranteeing your product ●

stability through comprehensive temperature control and monitoring strategies Reserved for PEnn PHARMACEuTICALS

15.15 Afternoon refreshments and networking

16.00 Session reserved for sponsor

16.30 Session reserved for sponsor

17:00 Chairman’s summation

17:15 Close of conference

08:30 Registration and refreshments

08:55 Chairman’s opening remarks

Sourcing comparator drugs to fully examine and provide viable market data for commercial product production and revenue09:00 Proactively preparing for strategic

comparator sourcingWorking with IMP and non IMP’s in trials and obtaining ●

the most accurate comparator productAnalysing the definitions in the new EU treatment ●

guidelines: an overviewWhere to go to obtain the most sufficient and reliable ●

comparator drugs in order to obtain viable commercial trial outcomes Ensuring the efficient delivery and distribution ●

of comparator products Lekishia White, Vice President, MuLTIPHARMA

obtaining accurate licenses for products and the most robust product delivery and monitoring systems for phase one trials09:30 Finalising faultless licenses and fast trial

preparation for phase one trial commencementPreparing for a phase 1 clinical trial and assessing the ●

accurate recognition of what is making ready for use and what is preparation Ensuring preparation units get accurate licenses that ●

reflect their intentions so trial conditions can be met and time has not been jeopardised Managing the small dosages required for phase one ●

trials and generating a robust system to monitor and communicate dosage changes for minimal errors Steve Day, Director Clinical Trial Supply Chain, GLAXo SMITH KLEIn

Maximising trial potential in emerging european markets and conducting this transition with minimal challenges10:00 Adapting quickly to a shift in study location for

the most advantageous new venturesUnderstanding the purpose and benefits of conducting ●

trials in emerging markets: the definitive selection process Overcoming the challenges of these new regions for the ●

best possible trial conduction Finding suppliers in new regions and using their expertise ●

to overcome local customs challenges Dr Karoline Bechtold Peters, Associate Director Clinical Trials Supply and Process Transfer, BoEHRInGHER InGELHEIM

10:30 Morning refreshments and networking

Exploiting contract manufacturing expertise for enhanced flexibility and cost efficiency in clinical trials11:15 Reserved for Penn Pharmaceuticals

Agenda Day Two Wednesday 24 February 2010

Gold Sponsor:

World Courier handles approximately 80% of the clinical trials market worldwide requiring a premium courier service. Specialists in packaging and airfreight

qualification, compliance and dangerous goods, operating Best Practice in temperature sensitive pharmaceuticals 24x7x365 service; all shipments leave on next-flight-out; all packing materials to UN specifications; real-time web tracking and email alerts; ISO 9001 certification worldwide www.worldcourier.com

PAREXEL International is a leading global bio/pharmaceutical services organization offering

significant expertise from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. This expertise is enhanced by industry-leading technology solutions from its Perceptive Informatics division through medical imaging, CTMS, IVRS/IWRS and integration services. www.parexel.com

Silver Sponsors:Almac offers an integrated supply chain management 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

related services under one roof; it incorporates supply planning, technology implementation, and project oversight into a unified study start-up and management approach that optimises the supply chain at each level. Almac and its affiliated companies provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, API manufacturing, clinical trials and drug manufacturing. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh. www.almacgroup.com

Penn Pharma is a leading provider of integrated product development and custom manufacturing services to the international healthcare industry including formulation

and analytical development, clinical trial supply, custom manufacture, high containment processing, CMC consultancy and QP release services. Penn manufactures to GMP and is MHRA licensed and FDA inspected. www.pennpharm.co.uk

Piramal Healthcare is at the forefront of custom manufacturing for the Pharmaceutical Industry. Our capabilities extend across the high quality development

and manufacture of API, Formulations and Clinical Trial Materials. Our global network of services integrated across the drug life cycle, offers a unique blend of flexibility and efficiency as your CMO partner of choice. www.piramalpharmasolutions.com

MWV Healthcare Packaging is working with you to turn your objectives for quality,

performance and visual impact into one-of-a-kind packaging that really stands out for patients. Their packaging promotes adherence and health literacy, while making products childproof and tamper resistant, senior-friendly, traceable and compliant for the clinical trial, OTC and ethical drug markets. www.MWV.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

Multi Pharma offer worldwide comparator drug sourcing for clinical trials. With facilities in Switzerland, Germany and New Jersey we fulfill needs of single lot, long expiration date, Certificate of Analysis, Material Safety Data Sheet,

GMP Certificate, samples, etc. We have the capacity and experience to supply large amounts fast directly from the manufacturer. www.multipharma.ch

Phase Forward is a leading provider of integrated data management solutions for

clinical trials and drug safety. The company offers proven solutions for electronic data capture (InFormTM), phase I clinic automation (LabPasTM), clinical data management (ClintrialTM), clinical trials signal detection (CTSDTM), strategic pharmacovigilance (Empirica SignalTM) and Signal Management, adverse event reporting (Empirica TraceTM), applied data standards (WebSDMTM) and Web-integrated interactive response technology (Clarix™). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Additional information about Phase Forward is available at www.phaseforward.com.

IMP Logistics’ core business is investigational medical products and clinical materials

warehousing, distribution, import licensing and customs clearance. IMP Logistics is focused on clinical trials and because of this specialization its reputation and business has grown rapidly in recent years. IMP Logistics is now established as the leading facility of its type in Russia and Ukraine. www.imp-log.com

Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits. These products simplify

dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. As a long-standing expert partner of the pharmaceutical industry, Schreiner MediPharm offers a range of customized products and services specifically addressing the complexity of clinical trials. www.schreiner-medipharm.com

Durbin text - Durbin is a specialist provider of comparator drugs for clinical trials. In addition to comparator drugs, Durbin also provides

ancillary supplies and placebos. Durbin brings global sourcing expertise,transparent pricing and global custom distribution to the supply of comparators and ancillaries for clinical trials. www.durbin.co.uk

Clintrak Clinical Labeling Services, LLC. Is the industry leader in providing innovative clinical labeling solutions. Clintrak manufactures single panel labels, multi-panel labels, multi-language booklet labels,

case report forms and blinding/code break cards. Our in-house printing capability, exclusive translation/regulatory approval system and expertise in clinical label design will streamline the label segment of 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

Exhibitors:

GE Sensing & Inspection Technologies

Media Partners:

World Pharmaceutical Frontiers www.worldpharmaceuticals.net

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clinical trial supply

Health & Medicine

clinical supply manager

clinical trials supply

supply chain efficiency

latest efficiency

product supply chain

remarksoptimising packaging

amendable labelling

packaging machinery