VIBevents’ 7th Annual Cold Chain Storage and Distribution conference will bring together key manufacturers and industry experts to discuss these amongst other core issues. From understanding key transport, packaging, validation and qualification methods to optimising strategies for storing biotech and pharma products, this event will provide a platform to debate best practice approaches. Once again, this event will be co-located with our established Clinical Trial Supply event in order to provide you with more opportunities to interact and exchange ideas with peers from both backgrounds.

1. Organised by:
VIBpharma
7th Annual
Cold Chain Storage
and Distribution
Tuesday 23 and Wednesday 24 February 2010, London, UK • www.coldchain-events.com
Co-lo
with cated
Achieve control throughout your cold chain o
Annu ur 11th
al Cli
processes and ensure full compliance with Trial nic
Supp al
confe ly
current and upcoming regulations rence
DISTINGuISHED SPEAKERS INCLuDE: BRAND NEW CASE STuDIES THIS
Viliam Kovac, Vice President Quality and Divisional Export YEAR WILL uNCoVER:
Control, RoCHE DIAGNoSTICS • How to overcome the challenge of keeping the
Fabio Mioli, Senior Manager, Commercial Office and temperature stable for 2-8°C and frozen shipments
Distribution, WYETH PHARMACEuTICALS/PFIZER
• Techniques for making the right cold chain decisions
Bert janssen, Manager QA Supply Chain, Quality
Assurance Pharmaceutical, Operations Beerse, Janssen early to optimise your supply chain processes
Pharmaceutica, joHNSoN & joHNSoN • Why conducting a risk assessment is a crucial part
Maria Dorazio, EMEA Distribution Manager, of your validation in guaranteeing a safe cold chain
BRISToL-MYERS SQuIBB
process from start to finish
Angelique Keijzer, Clinical Support Manager,
SANoFI-AVENTIS • Current regulatory trends in ambient temperature
Eric Delestre, Marketing Affiliates Quality Assurance control and how to implement auditing systems
Associate, ELI LILLY cost-effectively
Maurizio Caschera, GDP Responsible & Regulatory Affairs
Executive, SANoFI PASTEuR MSD
Ilona Zwernemann, Manager ADM and GMP Logistics, ENGAGE WITH INDuSTRY LEADERS INCLuDING:
BAYER HEALTHCARE • MHRA • BRISToL-MYERS SQuIBB
Michael Krahe, Manager Cold Chain Operations/Logistics, • joHNSoN & joHNSoN • RoCHE DIAGNoSTICS
BAYER HEALTHCARE
• ELI LILLY • WYETH/PFIZER
Saddam Huq, Cold Chain Technology Lead,
WYETH PHARMACEuTICALS/PFIZER • SANoFI-AVENTIS • BFARM
Cornelia Nopitsch-Mai, Scientist, Federal Institute for
Drugs and Medical Devices Germany, BfArM
Ian Holloway, Manager, Defective Medicines Reporting
A choice of interactive roundtable discussions
Centre, MHRA on all the most challenging issues!
REGISTER NoW:
■ online: www.coldchain-events.com ■ Email: book@vibevents.com
■ Tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773
Gold Sponsor: Silver Sponsors:

2. Programme Day One Tuesday 23 February 2010
08:30 Registration and coffee chain management is transferred from the manufacturer
to the customer and assessing the potential risk for a
08:55 opening remarks from the Chair manufacturer if the cold chain is not respected by the
customer
Qualifying cold chain shipments while ● Outlining the main actions a manufacturer can implement
validating components and performance in order to mitigate the risk on his product
through continuous monitoring Maurizio Caschera, GDP Responsible &
09:00 Conducting qualification studies of ambient Regulatory Affairs Executive, SANoFI PASTEuR MSD
temperature shipping packages and systems in
order to comply with global standards and giving a 10:30 Morning refreshments
regulatory update
● Clarifying the key regulatory requirements on ambient 11:15 overcoming cold chain challenges when distributing
temperature control to emerging countries highlighting operational and
● Advising pharma and biotech companies for developing an regulatory solutions to be implemented
effective global ambient temperature strategy ● Qualifying potential routes in countries with less
• Setting up a thermal mapping on ambient and trailer established infrastructure: outlining potential alternatives
conditions to identify which temperature extremes the that ensure safe cold chain distribution
shipping is exposed to ● Assessing related risks and picturing scenarios to tackle
• Utilising temperature profiles typical for the type them effectively
of packaging used to assess the period of time the ● Identifying best qualified 3rd parties for various types of
temperature is kept on constant shipments and understanding how to cooperate with them
• Establishing if passive and/or active cooling systems are successfully
needed based on the ambient temperature the shipping ● Understanding local regulations and evaluating whether
will be facing further safety measures need to be implemented to
● Ensuring appropriate handling of the product through logistics minimise risk
solutions providers by clarifying responsibilities in order to ● Implementing an appropriate quality system to optimise
guarantee the product quality is kept on a high standard the distribution process on a non-qualified route
● Establishing appropriate quality check and auditing systems Roger Price, Director Business Development, ClinStar,
for your own cold chain structure IMP LoGISTICS
Ian Holloway, Manager, Defective Medicines Reporting
Centre, MHRA 11:45 Moving towards a global cold chain: entering new
countries whilst finding reliable local service providers
09:30 Carrying out a risk assessment as a crucial part of
and complying with international regulations
the validation process and driving factor of costs to ● Assessing the infrastructure of the destination country in
guarantee a safe cold chain terms of routes, storage facilities and customers available
● Executing stability studies and evaluating stability data of as well as related risks
products to be shipped and stored ● Debating how to find the right couriers for small and large
● Establishing risk factors in connection with all components quantities and how to manage them successfully: executing
involved such as packaging, shipping trailers and storage audits and using reliable monitoring systems
facilities ● Uncovering how to manage the distribution process on a
● Assessing the risk to be considered with regards to non-qualified route whilst minimising risk
operations and handling of products such as number and ● Understanding local regulations and practices in order to
duration of stop-overs validate packaging and cooling systems and qualify 3rd
● Rating all factors and identifying how to handle the risks parties accordingly
that need to be faced effectively ● Implementing a simple quality system that ensures process
● Balancing risk and cost based on the determination of safety and control as well as integrity of the product
safety margins in order to ensure a smooth cold chain Robert Arendal, Chairman, CooL CHAIN ASSoCIATIoN
process within budget
Viliam Kovac, Vice President Global Quality and Divisional 12:15 Clarifying current and upcoming international cold
Export Control, RoCHE DIAGNoSTICS chain regulations and how to implement them
Going global: how to enter new markets, effectively in order to ensure full compliance
Outlining national and GDP (Good Distribution Practice)
comply with regulations and overcome ●
regulations and guidelines relevant to cold chain equipment
operational challenges and processes
10:00 Debating the difficulty of making sure that your ● Exploring European requirements regarding stability data of
product arrives in the right condition and outlining products requiring cold chain storage
the possibilities to ensure the cold chain until ● Highlighting the ongoing discussion on the European field
product administration regarding transport conditions
● Presenting a case study on the administration of a ● Clarifying stability issues of pharmaceutical bulk products
medicinal product by the doctor: how to ensure a successful and assessing how to overcome them
standardised cold chain management from your warehouse Cornelia Nopitsch-Mai, Scientist, Federal Institute for Drugs
to the administration of the product to the patient and Medical Devices Germany, BFARM
● Comparing the regulatory requirements for manufacturers,
distributors, wholesalers and pharmacists regarding storage 12:45 Lunch
and distribution: outlining guidelines on Good Distribution
Organised by: (GDP) defined by WHO and national regulatory
Practice
bodies such as the Irish Medicines Board
● Debating at what stage the responsibility for the cold

3. Programme Day One Programme Day Two
08:30 Registration and coffee
14:15 RouNDTABLE AFTERNooN SESSIoNS
08:55 Opening remarks from the Chair
Delegates will be able to attend three one-hour
roundtable discussion groups from a selection of key Controlling cold chain processes effectively to
topics. Each session will be chaired by an industry expert ensure product safety and integrity
who will facilitate an exchange of opinions, essential
experiences and learning related to a current aspect 09:00 Case study: outlining the key elements of temperature
of cold chain storage and distribution. A 45 minute and quality management and how these contribute
afternoon refreshment break will take place after the successfully to your overall distribution strategy
first roundtable session. ● Identifying what a pharmaceutical company aims for in terms
of successful temperature management in accordance to
Roundtable 1: Identifying and managing risk in cold current regulations
chain shipping by assessing clear actions to be taken ● Highlighting which solutions are in place by temperature
control solution providers and exploring future trends to
in case of jeopardized process safety
optimise the outcome
Establishing and evaluating risk factors throughout all
● Learning how to ensure effective quality management by
stages of cold chain and balancing risks while keeping
• Developing internal cold chain guidelines and updating
processes aligned with determined safety margins
quality agreements
Sue Lee, Manager, BioPharm Systems, Research and
• Establishing detailed cold chain documentation according
Development, WoRLD CouRIER
to regulatory requirements
• Auditing cold chain capabilities and qualifying shipping
Roundtable 2: Assessing current regulatory trends lanes and road and air transportation equipment
with respect to monitoring ambient temperature ● Uncovering how to implement these successfully in your
shipments and how to implement a monitoring system overall distribution process map and distribution strategy
cost-effectively Maria Dorazio, EMEA Distribution Manager,
Clarifying upcoming guidelines to establish a strategy BRISToL-MYERS SQuIBB
on how to monitor ambient temperature shipments 09:30 overcoming challenges related to the control of frozen
effectively, in compliance with new standards and with shipments and uncovering solutions to validate
minimal cost involved
reliable freezers and qualify shippers
Wim van Bon, President, European Cold Storage and
● Presenting regulatory developments and trends with respect to
Logistics Association, ECSLA
frozen shipments in Europe
● Finding the right technology or solution provider who is able to
Roundtable 3: Debating the difficulty of making sure develop a freezer system that matches your needs
that your product arrives in the right condition when ● Establishing ways to validate your packaging and freezing
administered to the patient devices successfully in order to ensure integrity of your
Discussing at what stage the responsibility for cold chain products at all times
management is transferred from the manufacturer to the ● Qualifying shippers that are able to guarantee safe handling
customer and assessing the potential risk for a manufacturer and delivery
if the cold chain is not respected by the customer ● Analysing defrost cycles of the products in order to establish
Maurizio Caschera, GDP Responsible & Regulatory Affairs when the product quality is jeopardized in case of failure of the
Executive, SANoFI PASTEuR MSD cooling system
● Identifying approaches to remedy the breakdown of a
freezing system to ensure the temperature is kept within the
Roundtable 4: Identifying alternative means and required limit
ways of cold chain distribution while keeping the Marc Weinzweig, QP (Qualified Person) and Founder, BIoTEC
required quality standards
Evaluating alternative solutions including new distribution
10:00 Case study: Dealing with temperature excursion
channels while keeping your distribution processes flexible successfully in a challenging environment
and efficient ● Addressing the Italian logistics system to explore and
Ilona Zwernemann, Manager ADM and GMP Logistics, understand characteristics and challenges
BAYER HEALTHCARE ● Outlining temperature excursion risks and potential issues for
biotech drugs and vaccines
Michael Krahe, Manager Cold Chain operations/Logistics, ● Explaining selected systems and solutions to ensure the
BAYER HEALTHCARE maximum safety level
● Debating the trends of cold chain logistics and exploring new
solutions of some of the main players
18:00 Closing remarks from the Chair and end of day one Fabio Mioli, Senior Manager Commercial office and
Distribution, WYETH PHARMACEuTICALS/PFIZER
10:30 Morning refreshments
11:15 Implementing cold chain controls from manufacturing
to distribution for cold chain pharma products
● Understanding national and international regulations on
temperature requirements in terms of ambient, 2-8°C or dry
ice shipments
● Evaluating acceptable excursions based on stability data
● Assessing distribution and production scenarios from the
manufacturing site to the last mile

4. Programme Day Two Wednesday 24 February 2010
● Identifying the risks and challenges on each distribution level 14:45 Reviewing airfreight shipment of cold chain products
and establishing strategies to overcome them cost-effectively using PAG shippers
● Implementing lean documentation practices to support the ● Identifying the system design and temperature
quality of the product specification of the product
● Checking that all shippers are well informed about product ● Assessing shipping lanes and routes to be considered
handling requirements and implementing a monitoring system and how to qualify them
to ensure product safety ● Exploring the challenges to keep the temperature stable
Bert janssen, Manager QA Supply Chain, Quality Assurance within the specification of 2-8°C and how to overcome them
Pharmaceutical, operations Beerse, janssen Pharmaceutica, ● Outlining the options of green credentials for cold chain
joHNSoN & joHNSoN products and how to secure them
Saddam Huq, Cold Chain Technology Lead,
uncovering techniques for making the right cold WYETH PHARMACEuTICALS/PFIZER
chain decisions early to optimise the process
11:45 Managing cold chain and ambient storage facilities to 15:15 Closing remarks from the Chair and close of the
actively preserve valuable supplies conference
● Electronic vs. mechanical temperature monitors: which
perform best?
● Assessing how to implement adequate temperature
monitoring in a study site
● Outlining 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
Angelique Keijzer, Clinical Support Manager, SANoFI-AVENTIS
12:15 Lunch
13:45 outlining the cold chain distribution of medical
samples: what are options, challenges and how to
overcome them
● Presenting the different existing options for the distribution
of medical samples
● Clarifying the regulatory requirements and how to
ensure compliance
● Describing options of storage and assessing the pros and cons
● Exploring current ways of transportation and addressing
issues faced
● Explaining the equipment used
● Clarifying which parts of the process can be qualified and
how to achieve full qualification
● Identifying how to optimise the process by quality
issues management
Eric Delestre, Marketing Affiliates Quality Assurance
Associate, ELI LILLY
14:15 Presenting strategies to plan cold chain storage
effectively and establishing approaches to make
storage activities cost-efficient
● Evaluating storage in centralised vs. decentralised supply chain
systems in order to find the best solution for your cold chain
distribution
● Planning the storage process: using a reduced number of
distribution centres as a result of consolidation activities
● Keeping your storage planning flexible to avoid shortage of
space
● Assessing the number, service range and quality of local
contractors to establish whether all product handling
requirements can be met cost-effectively
● Developing approaches to make the entire storage process more
cost-efficient
● Managing internal and external warehouses and staff effectively:
actions to be taken and checklists to be used
Wim van Bon, President, European Cold Storage and Logistics
Association, ECSLA

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
IMP Logistics’ core business is investigational
integrated solution does more than just combine related services under one
medical products and clinical materials
roof; it incorporates supply planning, technology implementation, and project
warehousing, distribution, import licensing and customs clearance. IMP
oversight into a unified study start-up and management approach that optimises
Logistics is focused on clinical trials and because of this specialization
the supply chain at each level. Almac and its affiliated companies provide a broad
its reputation and business has grown rapidly in recent years. IMP
range of services across drug discovery, diagnostics, pharmaceutical research
Logistics is now established as the leading facility of its type in Russia
and development, API manufacturing, clinical trials and drug manufacturing. US
and Ukraine. www.imp-log.com
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 Schreiner MediPharm is a leader in the development
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
Biotec is a UK based Clinical Trials Supply company Division and Thermo Fisher Scientific. www.clintrak.com
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 7th Annual Cold Chain Storage and Distribution
Tuesday 23 and Wednesday 24 February 2010, London, UK
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25.11.2009 23.12.2009 20.01.2010 20.01.2010
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