SMi proudly presents its 6th annual Cold Chain Distribution conference to be held in London on Monday 5th & Tuesday 6th of December 2011. This conference follows on from SMi’s previous highly successful Cold Chain Distribution events and offers the opportunity to keep up-to-date with the latest regulations, challenges and solutions that you need to know about for successful and cost-effective cold chain distribution
1. REGISTER BY 30TH SEPTEMBER 2011 AND RECEIVE A £100 DISCOUNT
EUROPE’S LEADING COLD CHAIN CONFERENCE
SMi present their 6th annual conference on…
Cold Chain Distribution
& New For 2011: Temperature Control Management
Monday 5th & Tuesday 6th December 2011
Marriott Regents Park, London
KEY SPEAKERS SO FAR INCLUDE:
Ray Goff Nigel Cryer
Director Head Quality Operations
Pfizer Arrow Pharrm
Marc Mostinckx Gerald Cavalier
Senior Director, Global Logistics Lead Executive Director
UCB Cemafroid
Elvia Quiroz Loriega Andrea Graf-Gruber
Cold Chain & Shipping Validation Specialist Manager, Cargo Business Process and
Pfizer Standards
International Air Transport Association
Stephen Mitchell
QA Manager, Quality & Compliance, Sue Lee
Logistics Regional Quality Manager, UK & Ireland
GSK World Courier
WHY ATTEND THIS EVENT:
• Analyse the environmental impact and responsibilities within the cold chain. Reusable
and recyclable packaging will play an ever more important role to maintain green
credentials, but are they cost effective?
• Develop your understanding of data management within your cold chain
• Understand new regulations - learn how to adapt to new CRT regulations. Gain
advantage and avoid costly & time consuming auditing
• Explore the possibility of an uninterrupted cold chain - with supply delays causing massive
disruption as well as coming at a heavy cost it is more important than ever to effectively
contingency plan. Minimising and avoiding delay is critical within the cold chain
• Improve your monitoring of wholesaler security. Passing trust and liability on comes
with risk but also reward for both parties. Effective management of the relationship is
therefore critical
• Evolve your understanding of temperature control management. New temperature
management regulations effect not just the cold chain, but also room temperature
storage, as 'room temperature' can fluctuate wildly and needs to be controlled and
supervised correctly
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 7th December 2011, London Marriott Hotel Regents Park
Workshop A: Practical Management of Risk Workshop B: A Measured Approach Towards
in the Pharmaceutical Cold Chain Temperature Controlled Shipments
Workshop Leader: Workshop leader: Jane Seeley, Managing Director, GeoStasis Ltd
Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd 1.30pm - 5.30pm
8.30am - 12.30pm
Gold Sponsor Sponsored by
www.coldchain-distribution.com
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Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
2. Cold Chain Distribution
Day One | Monday 5th December 2011 www.coldchain-d
8.30 Registration and Coffee Cold Chain Planning
9.00 Chairman's opening remarks 2.10 Putting a global organization in place to deal with Distribution, Cold
Sue Lee, Regional Quality Manager, UK & Ireland, World Courier Chain Management and Shipping Qualification for new products
• Understanding the key considerations when creating a fit-for-
9.10 Offsetting fuel costs in clinical distribution purpose logistics department
• Outline of current systems used • Identifying, training and organizing an effective global logistics team
• 7-8 new ways to offset fuel price increases • Assuring optimal management of shipping solution validation
• Modelling your response to price increases • Exploring the UCB cold-chain logistical setup and lessons learned in
Ray Goff, Director Vaccine Research, Pfizer the management of a global cold-chain system
• Examining the methods, procedures and solutions used in the
9.50 When to and why use a specialist courier? transportation of temperature sensitive shipments and the
rationale of the choices made
A conversation between Finance and Quality to make the best
Marc Mostinckx, Senior Director, Global Logistics Lead, UCB
decisions about using a clinical trials transport budget
This will consider what to take into account for: 2.50 Data Management in Cold Chain
• Difficult and Emerging Markets • Why is it important to collect and manage the temperature data
• Temperature Controlled Shipments coming from cold chain monitoring?
• Controlled Drugs • What are the challenges with data management in Cold Chain?
• Biologics and Biomarkers • What are the solution approaches and what are the advantages and
Sue Lee, Regional Quality Manager, UK & Ireland, World Courier disadvantages of the different approaches?
• "Big Pharma best practice example": Monitoring and data
10.30 Morning Coffee management process in a complex supply chain
Martin Peter, Director, Elpro-Buchs AG
Temperature Control Analysis
3.30 Afternoon Tea
11.00 Pharmaceuticals cold chain guidelines update
• International transport under controlled temperature for 4.00 Panel Discussion: Emerging regulatory temperature monitoring
pharmaceuticals requirements for non cold chain products
• Last km of pharmaceuticals cold chain • Discussion on regulatory expectations
• Certification initiatives and frames for pharmaceuticals cold chain - Which regulators are active in this area?
• Sustainability of pharmaceuticals cold chain - What is in / out of scope?
• Approaches to managing the requirements
Gérald Cavalier, Executive Director, Cemafroid
• What to do with data that has not been collected before & dealing
with ‘excursions’
11.40 Predictive risk-based supply modelling in clinical trials
Panel Chair: Stephen Mitchell, QA Manager, Quality & Compliance,
• Main uncertainties and risks in CT supply chain process
Logistics, GlaxoSmithKline
• Predictive patient recruitment modelling tool
• Risk-based supply predictive modelling 5.00 Chairman's Closing Remarks
• Software tools for supply modelling
Prof. Dr. Vladimir Anisimov, Senior Director, Quantitative Sciences, 5.10 Drinks Reception
GlaxoSmithKline - UK - Hosted by
12.20 Networking Lunch Please join us for a drinks reception immediately after
the panel discussion which closes the first day. This
1.30 Cold Chain Distribution in Clinical Home Care will be a relaxed and social setting for you to network
• Overview of clinical home care with delegates and sponsors and to follow up any
• The scale of the cold chain distribution challenge questions you may have with speakers
• Benefits to Pharma, patients & healthcare providers
Kerry Hinton, General Manager, Healthcare At Home Ltd 6.40 Close of Day One
Register online at www.coldchain-distribution.com • Alternatively f
Who should attend?
• Global Category Manager • Logistics Manager • Senior Transportation Manager • Principle Supply Chain Analyst
• Logistics Manager CEE & Asia • QA Manager • Regulatory Affairs Manager • Clinical Supply Technician
• GDP Inspector • Head of Service • Supply Chain Supervisor • Senior Director
• Operations Director • MD • Cold Chain Specialist • Logistics manager
• Business Development • Product Specialist • Shipping Specialist • Consultant - Supply Chain
Manager • Pharmaceutical Warehouse • Cold Chain & Shipping • International Logistics Manager
• Sr. Pharmaceutical Scientist Supervisor Validation Specialist
Official Platinum Media Partners Supported by
3. Cold Chain Distribution
distribution.com Day Two | Tuesday 6th December 2011
8.30 Re-registration and Coffee Cold Chain Management
9.00 Chairman's opening remarks
1.50 Truck carrier selection and their qualification
Tony Wright, Managing Director, Exelsius Cold Chain Management
• Why is it so urgent?
Transportation Planning • Making the right choice
• Pharma requirements
9.10 Management of transportation of temperature sensitive goods
• From Guidance to Regulation – how has this been achieved? • Current regulations
• Importance of Standards – IATA development of a standard label Christoph Frick, PhD Head of Quality Assurance and Pharmaceutical
• What are the challenges and how are these addressed? Development Qualified Person, Kohlpharma GmbH
• The way forward and future requirements
Andrea Graf-Gruber, Manager Business Process & Standards, IATA
2.30 Auditing Cold chain and temperature-sensitive supply chains
9.50 Passive Shipper Qualification – A bracketing Approach - A presentation on case studies from around the world.
• Grouping similar lanes over a summer/winter period • Why temperature sensitive-supply chains fail a GDP audit
• Bracketing multiple lanes for a single set of qualification data
• Where they go wrong
• Adding lanes without performing additional qualification
• What to do when things go wrong (off-loads/delays) • Validating your supply chain
• Quick, visual, determination of shipper performance within a lane • Challenges for the industry
Royce Heap, Cold Chain Manager, Pfizer • A proactive approach
Andrew Meyers, Managing Director, Cold Chain Consultants
10.30 Morning Coffee
11.00 When are transportation studies required and when not: 3.10 Afternoon Tea
A Risk based approach
• Is transportation the same as storeage?
• Which products need are at risk and protection? 3.40 Maintaining data security throughout the distribution network
• Which trade lanes, modes of transport are at risk? • Role of Standards
• When do we need to do transportation studies? • Traceability in Healthcare
Nigel Cryer, Head Quality Operations, Arrow Pharrma – Watson
• Coding in Traceability
Pharmaceutical Group
• Implementing Traceability
11.40 Utilizing In-transit Temperature Monitoring to Improve the Quality and Roger Lamb, Healthcare Manager, GS1 UK
Efficacy of Biopharmaceuticals: A Case Study
• Why decreasing revenue streams and the growth of
4.20 Shipping container 'validation' or 'qualification'; semantics or is there
biopharmaceuticals are driving optimized supply chains
• How changes in healthcare delivery will affect the supply chain: a difference?
chain-of-custody, the last mile and ensuring 100% efficacy • What is shipping container validation?
• Temperature monitoring options for the supply chain: advantages and • What is shipping container qualification?
disadvantages
• Improving the supply chain: benefits for manufacturers, distributors, • Differences and similarities
providers and the patient • Conclusion
• Case study: Real-world use cases utilizing in-transit temperature Elvia Quiroz Loriega, Cold Chain & Shipping Validation Specialist, Pfizer
monitoring
SA de CV
Peter Mehring, CEO, Intelleflex
12.20 Networking Lunch 5.00 Chairman’s Closing Remarks and Close of Day Two
fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
PHARMACEUTICAL FORWARD PLANNER
SEPTEMBER Pharmaceutical mHealth European Pharmaceutical JANUARY Advances and Progress APRIL JULY
Biomarkers in Clinical 10-11 October 2011 Pricing and Reimbursement Biomarkers Summit in Drug Design Asthma & COPD KOL Management and MSL
Trials 31 October-1 November 16-17 January 2012 20-21 February 2012 16-17 April 2012 Best Practice in Europe
19-20 September 2011 GP Commissioning 2011 (Switzerland) 2-3 July 2012,
12-13 October 2011 Pre-Filled Syringes MARCH MAY (Switzerland)
Biosimilars and Biobetters NOVEMBER 18-19 January 2012 Imaging in Cancer Drug “Generics, Supergenerics
26-27 September 2011 COPD: Novel Cell Based Assays Development and Patent Strategies” ADMET
Therapeutics and 21-22 November 2011 Social media in the 5-6 March 2012 14-15 May 2012 9-10 July 2012
KOL Management Technology Trends pharma industry
and MSL Best Practice 19-20 October 2011 Clinical Trials in CNS 23-24 January 2012 Superbugs & Superdrugs Clinical Trial Logistics Social Media in the
28-29 September 2011 23-24 November 2011 - A Focus on Antibacterials 16-17 May 2012 Pharmaceutical Industry
Point of Care Diagnositcs - FEBRUARY 14-15 March 2012 Pain Therapeutics 9-10 July 2012
OCTOBER Market Opportunities and DECEMBER Parallel Trade 21-22 May 2012
Partnerships with CROs Technology Trends Cold Chain Distribution 6-7 February 2012 Controlled Release BioBanking
3-4 October 2011 24-25 October 2011 5-6 December 2011 28-29 March 2012 ADC Summit 2012 11-12 July 2012
23-24 May 2012
All conferences take place in central London, UK – unless indicated otherwise in brackets
4. HALF-DAY POST-CONFERENCE AM WORKSHOP
8.30am – 12.30pm Wednesday 7th December 2011
Workshop A: Practical Management of In association with
Risk in the Pharmaceutical Cold Chain
Workshop Leader: Robert J Hayes, Director, Cold Chain Consultants (UK) Ltd
Overview of workshop
The workshop will review current and future regulatory trends in the application of risk-management
Programme methodologies to the temperature-controlled pharmaceutical supply chain. It will take a practical
8.30 Registration & Coffee look at the tools and techniques for risk assessment and delegates will have the opportunity to work
through real examples using an established industry model. Delegates will be helped to identify and
9.00 Welcome & Introductions develop solutions to common problems found in the pharmaceutical supply chain.
9.10 History of risk-based approach in the Why you should attend:
pharmaceutical industry • Analyse future risk trends • Enjoy practical study of risk assessment
• Share insight with experienced Cold Chain • Develop solutions to problems in the supply
9.50 Current and future trends specialists chain that your business faces
• Regulator
• Industry About the workshop host
The workshop will be led by Eur Ing Robert J Hayes BSc, CEng, FIMechE, FIET
10.30 Morning Coffee Bob has worked in the Pharmaceutical Industry for thirty years. A Chartered Mechanical Engineer,
his experience includes Production and Engineering Management, New Product Development,
11.00 Tools and techniques Factory Design, Supply Chain Management, Validation and a variety of support functions. Bob is Vice
Chair of the Pharmaceuticals Technical Activity Committee of the Institution of Mechanical Engineers
and a Fellow of the Institution.
11.30 Extended workshop – using FMEA
Practical solutions to common
problems About Cold Chain Consultants (UK) Ltd
Cold Chain Consultants offers unique and specialist services focusing on the operational requirements
12.30 Close of Workshop of temperature sensitive supply chain. Cold Chain Consultants combine skills and experience in
logistics, temperature measurement, qualification, mapping, cold chain packaging, refrigeration and
GDP to provide invaluable cold chain knowledge. Cold Chain Consultants are specialists in cold chain
and temperature sensitive logistics for the pharmaceutical, life sciences and blood product industries.
HALF-DAY POST-CONFERENCE PM WORKSHOP
1.30pm – 5.30pm Wednesday 7th December 2011
Workshop B: A Measured Approach Towards In association with
Temperature Controlled Shipments
Workshop Leader: Jane Seeley, Managing Director, GeoStasis Ltd
Overview of workshop
Programme The workshop will provide a high-impact, in-room business simulation to accelerate your awareness
1.30 Registration & Coffee and understanding of the Cold Chain. This interactive workshop reviews the challenges that exist as we
explore the journey, the products and services that are on offer and benefits of a ’Service Management’
2.00 Welcome & Introductions approach to temperature controlled shipments. Following this workshop you will have an appreciation
of how to benchmark your supply chain in order to drive a continuous improvement culture.
2.10 Short overview and simulation ‘warm-up’
Why you should attend:
2.30 Facilitated simulation that will: • Learn more about service management in • Analyse your own solutions and findings and
• Experience the supply chain in action the Cold Chain how they can be used in your business
• Reflect on observations • Experience the Cold Chain in action in an • Increase your awareness and understanding
• Draw upon conclusions & learning’s interactive business simulation of the Cold Chain
• Put these learning’s into practice
About the workshop host
3.30 Afternoon Coffee Jane Seeley has over 28 years’ experience of delivering international best practice and Innovative
solutions in support of supply chain excellence. Having worked for one of the world’s largest logistics
4.00 Simulation session completion companies, responsible for strategic direction, development and delivery of innovative solutions, Jane
has a comprehensive understanding of the international challenges that exist, the components required
4.30 Workshop conclusions on how to make and the alignment of multiple service partners that is critical to prove a true end to end service. This
a step change towards a measured understanding along with the vision and passion to mature the management of perishable cargo drove
approach to temperature controlled Jane to co-found GeoStasis Ltd.
shipments.
About GeoStasis Ltd
5.30 Close of Workshop GeoStasis Ltd brings together best of breed products and services to focus on the provision of quality
logistics solutions with special attention to performance based operating processes.
5. Gold Sponsor
As cold chain shipments excursions face increased scrutiny from regulators
around the world, it is more important than ever before to get it right the first time.
World Courier is the sole truly global premium logistics provider to offer a cold
chain transport service. We lend intangible regulatory insight, unmatched
experience and value-added support worldwide, including emerging markets such as Brazil, India, Argentina and Russia.
Service Features
• Comprehensive Guidance with Country Specific Import Requirements
• Global SOP’s for All Temperature Ranges
• Consultation on Specialty Packaging Solutions
• Refrigerated Trucking Services
• GMP Compliant Depot Storage Facilities in Argentina, Australia, Brazil, Chile, China, Colombia, India, Mexico, Peru,
Russia and South Africa.
• Expedited Customs Brokerage
• More than 149 Company Owned Offices Spanning the Globe
www.worldcourier.com
Sponsored by
ELPRO provide high quality and innovative solutions for Cold Chain Temperature Monitoring which
are easy to use and help reduce cost in the Cold Chain. Our products include the market leading
Libero PDF datalogger and our services include installation, calibration and qualification. With over
20 years experience ELPRO is dedicated to supporting the Pharmaceutical and Biopharmaceutical
industries. www.elpro.com
The Intelleflex® Pharmaceutical Cold Chain Solution provides you with on-demand visibility for
tracking and monitoring the temperature of biologics and other pharmaceuticals throughout the
cold chain. With Intelleflex XC3 Technology™, you can easily and cost-effectively monitor the
temperature and condition of the product every step of the way while it's in-transit – without
unpacking – to ensure efficacy and product quality. For more information, visit www.intelleflex.com
Movianto UK is a subsidiary of the Europe-wide Movianto Group, a leading logistics and distribution
service provider for the pharmaceutical and healthcare industry. With a pallet storage capacity of
over 50,000 spaces as well as seven strategically located warehouses and depots throughout the
country, Movianto UK is able to deliver to every UK hospital and pharmaceutical wholesaler on a
daily basis with its own fleet. The company also delivers cold chain and ambient medicines and
healthcare products to supermarkets, pharmacies, GPs, nursing homes and direct to patients’
homes on a next day basis. The Movianto Group operates in 13 European countries offering a total
storage capacity of 225,000 pallet spaces. Movianto is a business unit of Celesio AG. More
information on www.movianto.com
For over 30 years, QuickSTAT has played a critical role in managing clinical trial logistics for all
phases of research and drug development. We specialise in global shipping of time and
temperature-sensitive clinical research samples, investigational drugs, clinical trial supplies,
vaccines and dangerous goods. www.qicstat.com
Yourway Transport has set the standard for quickness, dependability and personalized service
within the global pharmaceutical logistics industry. Our expertise includes ambient and cold chain
premium courier services, consultation on global transport requirements, customs clearance,
sourcing and provision of shipping supplies and logistical project management. Yourway also
provides an established network of strategically positioned, cGMP Depots, in regions such as Latin
America, Europe, Eastern Europe, India, South Africa, Australia and Asia. The depot network is
supported via a proprietary management system that provides immediate visibility to all
transactions related to their product and studies. Please visit our website at
www.yourwaytransport.com
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
Want to know how you can get involved?
Interested in promoting your pharmaceutical services to this market?
Contact Margaret Mugema, SMi Marketing on +44 (0)20 7827 6072, or email: mmugema@smi-online.co.uk
6. COLD CHAIN DISTRIBUTION
Conference: Monday 5th & Tuesday 6th December 2011, Marriott Regents Park, London, UK
4 WAYS TO REGISTER
www.coldchain-distribution.com
FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great Guildford
PHONE on +44 (0) 870 9090 711 Business Square, 30 Great Guildford Street London, SE1 0HS, UK
EARLY BIRD □ Book by 30th September to receive a £100 off the conference price
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