The 11th annual conference on clinical trial supply held in London on February 23-24, 2010, featured key discussions on optimizing packaging, labelling, and forecasting strategies to enhance supply chain efficiency. Notable speakers included industry leaders from AstraZeneca, Johnson & Johnson, and Sanofi-Aventis, who shared insights on regulatory compliance and innovative practices. The event included interactive roundtable sessions and focused on collaborative approaches to managing clinical trial supplies effectively.

1. 11th Annual Conference
Clinical Trial Supply
Co-lo
23 – 24 february 2010, London uK www.clinicaltrialsevents.com/europe2010 with cate
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annu u
al Co r 7th
Distr ld Chain
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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. 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. 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. 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. 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. Exhibitors:
GE
Sensing & Inspection Technologies
Media Partners:
World Pharmaceutical Frontiers www.worldpharmaceuticals.net

7. Booking Form 11th Annual Clinical Trial Supply
Tuesday 23 and Wednesday 24 February 2010, London, UK
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