SMi Group's 8th annual Pharmaceutical Cold Chain Distribution conference & exhibition returns in December

1. THE 8TH ANNUAL CONFERENCE ON...
COLD CHAIN
DISTRIBUTION
3RD - 4TH DECEMBER 2013 | MARRIOTT HOTEL REGENTS PARK, LONDON, UK
BOOK
30TH SEPT BY
EMBER
SAVE £100
FIRS
PHARMA C T 25
OMPANIES
ONLY £999
Key speakers include:
• The UK's only pharmaceutical cold chain distribution
conference returns for its 8th year
• Receive vital updates on regulation and GDP
guidelines and how they will affect your supply chain
• Hear experts discuss important case studies on
successful air and sea freighting and temperature
control strategies
• New topics for 2013 include: Transportation of
dangerous goods by air, Risk evaluation of sea
freighting, Comparisons of cold chain monitoring
devices, Effective collaboration with vendor companies
• End of day 1 drinks reception and dinner at Shaka Zulu
• Yoram Eshel, Senior Director, Teva
• Jason Cameron, Senior Director, European
Commercial Supply Chain, Genzyme
• Riekert Bruinink, Member of the GDP drafting
Group of the EMA, Dutch Health Care
Inspectorate
• Bev Nicol, Distribution Specialist, Pfizer
• Mark Edwards, Global Freight Manager, Actavis
• Stephen Mitchell, QA Manager, Quality &
Compliance, Logistics, GSK
• Alan Dorling, Global Head - Pharmaceuticals &
Life Sciences, IAG Cargo
• Andrea Gruber, Manager Cargo Business, IATA
• Sue Lee, Regional Quality Manager, World
Courier
PLUS AN INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOP
Monday 2nd December 2013 | Marriott Hotel Regents Park, London, UK
Transport Strategies for an Intemperate World
Hosted by World Courier
Workshop Leader: Sue Lee, Regional Quality Manager, World Courier
13.00 - 17.30
Lead Sponsor
Sponsored by
www.coldchain-distribution.com
Register online, call +44 (0) 20 7827 6156 or fax your registration form to +44 (0) 20 7827 6157
@SMIpharm
uk.linkedin.com/in/smipharma/
FREE TO
ATTEND FOR
PHARMA
COMPANIES

2. DAY ONE | 3RD DECEMBER 2013
08.30
Cold Chain Distribution
GLOBAL DISTRIBUTION STRATEGIES
REGISTRATION & COFFEE
EUROPEAN AND INTERNATIONAL REGULATION
09.00
09.10
09.50
CHAIRMAN'S OPENING REMARKS
Tony Wright, Managing Director, Exelsius Cold Chain Management
KEYNOTE ADDRESS
Global temperature-sensitive pharmaceutical logistics: Introduction
and overview
• How well has our industry managed the challenges so far?
• What challenges are on the horizon – how do we prepare for them?
• How do we improve quality within the healthcare logistics process?
• Is our industry facing 'over-regulation' or just lacking in global
harmonization?
Tony Wright, Managing Director, Exelsius Cold Chain Management
Temperature controlled transport - A risk mitigation approach
according to the EU GDP
• EU GDP and transport
• Risk management
• Transport strategies
• Qualification and monitoring
Luc Huybreghts, Senior Consultant, Pauwels Consulting
14.00
14. 40 Transporting dangerous goods by air
• Global overview of the dangerous goods regulations for air transport
• Responsibilities of the shipper
• Coolants (Dry Ice, Liquid Nitrogen, etc…)
• Battery-powered data logging devices
Brendan Sullivan, Manager, Dangerous Goods and Training Standards,
IATA
Recommendations concerning transportation of +2°C +8°C medicinal
products
• Regulation update since 2012 for the cold chain
• Recommendations 1 of French Pharmacist Council : Qualification and
measure of temperatures for trucks
• Recommendations 2 of French Pharmacist Council : Maintenance of
trucks
• Recommendations 3 of French Pharmacist Council : Limits of
responsibility
Marie Boned, Quality Assurance, Cemafroid
AFTERNOON TEA
15.40
IATA Standards: Air freight transportation of temperature sensitive
products
• Transforming the air cargo supply chain
• What are the challenges faced by the industry when transporting
temperature controlled products?
• How are the challenges addressed by IATA in a supply chain
collaborative approach?
• The way forward and future requirements
Andrea Gruber, Manager Business Process & Standards, IATA
16.20
Sea Freight – An evaluation of the opportunities and risks with
moving pharma shipments by sea instead of air
• Process differences between the two modes.
• Quality differences between the two modes.
• Cost differentials.
• Advantages and disadvantages of each mode
Mark Edwards, Global Freight Manager, Actavis
17.00
Panel Discussion: The impact of the revised EU GDP on the
management of temperature sensitive products in the supply chain
• Chair: Tony Wright, Managing Director, Exelsius Cold Chain
Management
• Stephen Mitchell, QA Manager, Quality & Compliance, Logistics, GSK
• Luc Huybreghts, Senior Consultant, Pauwels Consulting
• Yoram Eshel, Senior Director, Teva
17.40
Chairman’s closing remarks and close of day one
18.00
Drinks reception followed by Dinner at Shaka Zulu.
Transfer to hotel
MORNING COFFEE
10.50
15.20
21.30
10.30
11.30
12.10
12.50
Chemistry-based track and trace indicators
• Background to the TSB-funded research and development project
• A survey of various existing chemistry-based temperature monitoring
devices
• The importance of on-off switches in monitoring devices
• Novel chemistry-based device with on-off switches
Long Lin, Professor of Colour & Polymer Science, University of Leeds
An integrated view on Supply Chain Management
• What does Supply Chain Management (SCM) really mean?
• The role of SCM in Cool Chain Management?
• Demand management a first step to more reliable planning.
• Supply and demand balancing in your network.
• Important Supply Chain KPI´s.
Rüdiger Lohmann, Professor, Researcher, Lübeck University of
Applied Science
NETWORKING LUNCH
KEYNOTE ADDRESS
Temperature control management in the supply chain
• CRT Vs. Ambient – do they really define the required temperature
regime?
• The current paradigms about controlled temperature logistics.
• How CRT shipments look like in real life?
• How to practically manage your controlled temperature
transportation – the new language we have to speak.
Yoram Eshel, Senior Director, Teva
Register online at: www.coldchain-distribution.com • Alternatively fa
Lead Sponsor
Incorporated in 1969, World Courier is the leader in specialty logistics for global clinical trials delivering fully-integrated GxP-compliant temperaturecontrolled transport, storage and distribution solutions worldwide in over 10.000 clinical studies. World Courier has a network of over 150 company
offices operating in more than 50 countries plus a network of 13 x GMP compliant storage depots in strategic locations. Through its company-owned
network of offices World Courier provides door-to-door, customs-cleared service to more than 220 countries and territories and setc the benchmark
for temperature controlled, time sensitive transportation.
As Cold Chain shipments face increased scrutiny from internal bodies and international agencies alike, strict adherence to temperature control is
critical for compliance with international regulatory, manufacturing and safety standards. With our proven track record in Cold Chain Management,
World Courier is the only specialty logistics provider that offers comprehensive and customized temperature-controlled transportation services
24/7/365 worldwide. worldcourier.com
Sponsored by
ELPRO, founded in 1986, is a leading Swiss manufacturer of innovative solutions for monitoring environmental conditions throughout the perishable
goods supply chain. The monitoring process consists of measuring, recording and managing data. Then, based on the stability criteria, the data is
assessed for release or alarm. Our solutions result in the lowest total cost of ownership for our customers while ensuring compliance and maximum
efficiency. We partner with our clients to develop solutions that integrate our high-quality measurement components into their business processes.
The main industries we serve are in the pharmaceutical and healthcare sectors, but our products are also used in many other fields, such as the
environmental management, bio-banking & life sciences and the food industries. We provide solutions for laboratory, production, storage and
transportation through to the end user. Through our subsidiaries and a network of trained distributors ELPRO is active worldwide. www.elpro.com
Kuehne + Nagel is a world leader in providing integrated logistics services for the pharmaceutical and healthcare industries. We work with some of
the world's leading companies, and with other clients in related industries like medical equipment, animal drugs, personal care, and infant formula
categories. www.kuehne-nagel.com
Temperature Sensitive Solutions (TSS) offers Temperature Data loggers and a cutting edge Temperature Monitoring System (CCIS) that meets the
need for full visibility in order to improve shipments processes and lower costs. TSS and its key global customers have together taken the important
step to break old patterns and solve tomorrow’s challenges. CCIS provides outstanding added value by processing captured shipping data and translate
it into core business information. www.tss.se

3. Cold Chain Distribution
DAY TWO | 4TH DECEMBER 2013
08.30
REGISTRATION & COFFEE
09.00
CHAIRMAN’S OPENING REMARKS:
Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa,
World Courier
TEMPERATURE CONTROL MANAGEMENT AND SUPPLY CHAIN INTEGRITY
13.20
The global standard for supply chain resilience
• Introduction to TAPA Cargo Security Standards
• Case study of Truck Security Requirements
• Incident Information Service
• Training Programmes for TAPA members
Jason Breakwell, Director, TAPA EMEA
14.00
Challenges in air freighting of time and temperature sensitive freight
• Identifying and managing key risk points at the airport
• Quality & Compliance across a global network
• The need for supply chain collaboration - taking a tripartite approach
• Maximising service performance
Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG
Cargo
14.40
AFTERNOON TEA
15.00
Challenges of cold chain distribution within the pharmaceutical
industry
• How cold chain products are managed
• Utilisation of Validated shipping solutions
• Benefits and Constraints
• Working with Vendors for maximum effectiveness
Bev Nicol, Distribution Specialist, Pfizer
Christina Hilsden, Distribution Specialist, Pfizer
Sea Freight – +2C to +8C temperature control for biologics
• Advantages and Disadvantages of Sea Freight
• Sea Freight Container Study Approach
• Sea Freight Container Study - +2C to +8C Temperature Monitoring
• Sea Freight Temperature Data Analysis
Janusz Mielewczyk, Cold Chain Validation Specialist, Pfizer
TEMPERATURE CONTROL MANAGEMENT AND TECHNOLOGY
09.10
09.50
Temperature Issues within the context of clinical trials logistics.
Practical examples and solutions
• What are the common challenges facing shippers
• How temperature requirements can drive logistics options
• What can be done by shippers and 3PLs to improve the process and
to ensure operational conformity and optimum results
Sue Lee, Regional Quality Manager UK Ireland Middle East & Africa,
World Courier
KEYNOTE ADDRESS
New EU Good Distribution regulations
• The New EU GDP Guide in general
• What is new? Where more guidance ?
• Outlining the new items for temperature control during storage and
transportation
• Implementation issues
Riekert Bruinink, Member of GDP drafting Group, Dutch Health Care
Inspectorate
10.30
MORNING COFFEE
10.50
Creating efficiency by integrating stability data into your monitoring
solution
• What is stability data?
• Why is cold chain expensive?
• Technology to work with stability data
• Examples on how to use stability data
• Concerns about using stability data & solutions
Martin Peter, Head of Sales & Marketing, ELPRO-BUCHS AG
15.40
11.30
A practical approach to managing the temperature-sensitive supply
chain
• Why temperature sensitive-supply chains fail a GDP audit
• Common reasons for non-conformance
• Understanding packaging, temperature measurement and transport
• Taking a proactive approach to getting it right
Bob Hayes, Director, Cold Chain Consultants
16.20
12.10
NETWORKING LUNCH
17.00
KEYNOTE ADDRESS
Improving last mile distribution strategies
• Evaluating the physical distribution strategies
• How this affects the last mile
• Developing and implementing effective methods
• Impacts on patients and future distribution
Jason Cameron, Senior Director, European Commercial Supply Chain,
Genzyme
Chairman’s closing remarks and close of day two
ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Who should attend this conference?
This event is unnmissable for...
• Global Category Manager
• Logistics Manager CEE & Asia
• Operations Director
• Logistics Manager
• QA Manager
• Supply Chain Supervisor
• Cold Chain Specialist
• Cold Chain & Shipping Validation
Specialist
• Principle Supply Chain Analyst
• Clinical Supply Technician
• Logistics manager
• Consultant - Supply Chain
• And others...
New for 2013
Evening Dinner Day 1 at Shaka Zulu
There will be an Evening Dinner at the
end of day 1 taking place at London's
illustrious Shaka Zulu restaurant.
Transfer will be from and to the hotel
after the drinks reception. Places are
subject to availability.
www.shaka-zulu.com
Supported by

4. PRE-CONFERENCE WORKSHOP
Monday 2ND December 2013
13.00 – 17.30
Marriott Hotel Regents Park, London, UK
Transport Strategies
for an Intemperate World
Workshop Leader:
Sue Lee, Regional Quality Manager, World Courier
FREE TO ATTEND
for Pharma companies.
Overview:
Never have Clinical Trial Logistics been more challenging
than today. Consignors face shipping into emerging
markets with stricter temperatures ranges, increasing
regulatory requirements, budgetary restraints and
shrunken timescales and supplies. Getting drugs to
market quickly and successfully is what matters, wading
through these supply chain complexities, temperature
challenges into hostile environments, whilst keeping
stakeholders informed and satisfied can feel like juggling
elephants on a daily basis.
Aim:
This workshop will address common problems and
practical issues, identifying key factors, offering realistic
advice and sources of information. Delegates will get out
of the workshop a clear awareness of problems and
solutions, operational regulatory and quality solutions as
well as a greater understanding of critical industry issues.
Programme:
13.00 Registration and Coffee
13.30
Welcome and Introductions
13.40
Emerging Markets, what are the issues
• Considering multiple locations to establish
what challenges we all face
14.30
Regulatory Challenges
• What agencies matter and how do you keep up
to date?
• Understanding how the regulations affect
shipment
• Avoiding some common mistakes
15.15
Afternoon Tea
15.45
Packaging & Temperature control
• Passive or active?
• Single use or reusable, is it cost effective and
compliant to be green?
• A practical challenge
17.00
Discussion
17.30
End of Workshop
About the host:
Sue Lee, Regional Quality Manager UK Ireland Middle
East & Africa, World Courier
Sue trained in Microbiology, but then left hands on science
to pursue an alternate career in logistics. She has worked
for World Courier for more than 20 years. As the Regional
Quality Co-ordinator for UK, Eire, Middle East and Africa,
she is part of a global team working on development of
new and innovative quality systems and ensuring
compliance of offices and suppliers. She acknowledges
that few other people appreciate the joy and satisfaction
she has in creating user friendly work flow instructions
and SOPs, with lovingly hand crafted prose.

5. SMi PHARMACEUTICALS
FORWARD PLANNER 2013-2014
SEPTEMBER
Cancer Vaccines
18 – 19 September 2013, London
OCTOBER
Biosimilars & Biobetters
1 – 2 October 2013, London
Diabetes
1 – 2 October 2013, London
Orphan Drugs
14 – 15 October 2013, London
COPD: Novel Therapeutics and Management
Strategies
16 – 17 October 2013, London
European Pharmaceutical Pricing
& Reimbursement
21 – 22 October 2013, London
Point of Care Diagnostics - Market
Opportunities and Technology Trents
23 – 24 October 2013, London
NOVEMBER
Cell Based Assays
18 – 19 November 2013, London
Clinical Trials in CNS
18 – 19 November 2013, London
DECEMBER
Cold Chain Distribution
3 – 4 December 2013, London
JANUARY
Pharmaceutical Microbiology
20 – 21 January 2014, London
Social Media in the Pharmaceutical Industry
22 – 23 January 2014, London
Quality By Design
22 – 23 January 2014, London
Pre-Filled Syringes
27 – 28 January 2014, London
FEBRUARY
Parallel Trade
10 – 11 February 2014, London
Advances and Progress in Drug Design
17 – 18 February 2014, London
MARCH
Superbugs and Superdrugs
- A Focus on Antibacterials
5 – 6 March 2014, London
Imaging in Cancer Drug Development
12 – 13 March 2014, London
Controlled Release
12 – 13 March 2014, London
Paediatric Clinical Trials
24 – 25 March 2014, London
Adaptive Designs
24 – 25 March 2014, London
SPONSORSHIP AND EXHIBITION
OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising
and branding packages, uniquely tailored to
complement your company’s marketing
strategy. Prime networking opportunities exist
to entertain, enhance and expand your client
base within the context of an independent
discussion specific to your industry.
Should you wish to join the increasing number
of companies benefiting from sponsoring our
conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk

6. COLD CHAIN DISTRIBUTION
3RD - 4TH DECEMBER 2013 | MARRIOTT HOTEL REGENTS PARK, LONDON, UK
WORKSHOP: 2ND DECEMBER 2013 | LONDON, UK
4 WAYS TO REGISTER
ONLINE at www.coldchain-distribution.com
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,
FAX your booking form to +44 (0) 20 7827 6157
Harling House, 47-51 Great Suffolk Street, London, SE1 0BS
PHONE on +44 (0) 20 7827 6156
EARLY BIRD
DISCOUNT
□
Book by 30th September and save £100 off conference price
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee
Commercial Organisations
□ Conference only
£1499.00 +VAT
First 25 Pharma Companies
□ Conference LIMITED AVAILABILITY
£999.00
+VAT
REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK)
□ Pre-Conference workshop hosted by World Courier
□ End of day 1 Evening Dinner at Shaka Zulu restaurant
(For pharmaceutical companies only)
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