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Cool Chain Brochure 2013.pdf - Sofrigam

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Presents the 12th Annual<br />

Pre-Conference Workshop Day: 28th January 2013<br />

www.coolchaineurope.com<br />

Two Day Conference: 29th–30th January 2013<br />

Congress Centre Basel, Switzerland<br />

Europe’s LargEst gathering of the <strong>Cool</strong> <strong>Chain</strong> and temperature<br />

Controlled Logistics Community: delivering the right quality vs. cost<br />

balance for your cold and ambient supply chains<br />

What’s new at Europe’s leading temperature<br />

control meeting?<br />

• Full day stream focused on supply chain integrity and<br />

security: how to ensure complete visibility throughout<br />

your supply chain and critical updates on the latest<br />

developments in live tracking technologies<br />

• Dedicated sessions to address the issues specific to small<br />

and mid-sized companies – most importantly, cost effective<br />

shipping for small batches!<br />

• Spotlight on emerging markets: Latin America with Humberto<br />

Laserna, Pfizer, Peru and India with Dr Ravi Prakash Mathur,<br />

Director Supply <strong>Chain</strong> Management, Dr. Reddy’s Laboratories<br />

• Debate and discuss case studies focused on improving<br />

relationships and communication with 3rd party<br />

collaborators to ensure a controlled yet agile supply chain<br />

• Learn how to protect your manufacturing materials in the<br />

cool chain from API manufacturing to intermediates<br />

storage and beyond<br />

Unrivalled networking opportunities with:<br />

, 450+ attendees<br />

, 40+ speakers<br />

, 60+ sponsors<br />

, 25+ countries in attendance<br />

, 106 attendees were brand<br />

new to <strong>Cool</strong> <strong>Chain</strong> Europe 2012<br />

, 5 streams in 2 days<br />

, 2 training days<br />

, 70+ VPs/Heads/Global<br />

Directors/Directors from<br />

pharma/bio in attendance<br />

, 39% of our pharma/bio<br />

audience are senior-level<br />

decision-makers<br />

Bringing you the largest,<br />

most highly attended cool<br />

chain and temperature<br />

control event in Europe<br />

Keynote speakers:<br />

Dr Ravi Prakash Mathur, Director Supply<br />

<strong>Chain</strong> Management, Dr. Reddy’s Laboratories<br />

Shirley-Ann Feld, Global Quality Supply <strong>Chain</strong><br />

Deputy Director, Sanofi-Aventis<br />

get exclusive first hand insight from<br />

industry experts…<br />

Frederic Zwahlen, Vice President Supply <strong>Chain</strong>,<br />

Vifor Pharma<br />

Dr Ravi Prakash Mathur, Director Supply<br />

<strong>Chain</strong> Management, Dr. Reddy’s Laboratories<br />

Simon White, Director Quality Operations,<br />

Global Logistics & Supply, EMEA Region, Pfizer<br />

Steef van Amersfoort, Global Transportation &<br />

Warehousing Professional and Chairman Dutch<br />

Airfreight Shippers Council, Abbott<br />

Gudrun Schaefer, Head of Supply <strong>Chain</strong><br />

Management, Medinova AG<br />

…and leading gDP regulators;<br />

registration<br />

inCLuDEs entrance to<br />

the 2013 awards ceremony!<br />

Dr. Mary Foster, Chair, Packaging and<br />

Storage Expert Committee, US Pharmacopeia<br />

Riekert Bruinink, Group Chairman of the PIC/S<br />

GDP Working Group, Member of the EMEA<br />

GDP Drafting, Dutch Health Care Inspectorate<br />

Ian Holloway, Senior Pharmaceutical Assessor,<br />

MHRA<br />

RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


12th annual <strong>Cool</strong> <strong>Chain</strong> logistics europe<br />

monday 28th January – wednesday 30th January 2013<br />

Dear colleague,<br />

With anticipation of the new EMA GPD updates building, the emphasis<br />

is well and truly on the requirements for all 15-25 o C products to have a<br />

temperature monitored supply chain. Over the coming year, the face of<br />

logistics across the industry is set to change entirely.<br />

A recent community wide survey revealed that 81% of biopharma<br />

companies are outsourcing their ambient logistics<br />

…with 94% saying that finding costs effective services and solutions is the<br />

biggest challenge relating to the storage and transportation of controlled<br />

room temperature and ambient products – I’ll send you a copy of the full<br />

report soon.<br />

Having said this, the visibility of finished goods flowing through the supply<br />

chain still remains a critical issue. As well the alarming abundance of<br />

counterfeit pharmaceutical products within both industrialised and emerging<br />

markets has grown tremendously in the past 10 years. Couple this with the<br />

emergence of new technologies and we see live tracking and tracing methods<br />

being assessed and implemented at a higher rate than ever before.<br />

The 12th annual <strong>Cool</strong> <strong>Chain</strong> Logistics Europe meeting is back in Basel<br />

where you can address these challenges to help guide you through the new<br />

regulatory landscape and plan your temperature controlled, secure supply<br />

chain strategy!<br />

Other CCLE 2013 programme themes include;<br />

• Embedding quality and flexibility in your supply chain<br />

• New label requirements from IATA<br />

• Using stability data effectively to develop label claim<br />

• Regional spotlight on developing a logistics plan in india and latin<br />

america<br />

• Supply chain and distribution considerations for small batches<br />

• Perfecting the last mile<br />

• Getting to grips with reverse logistics<br />

• Collaborations with 3rd parties, 4PL set-ups and improving relationship<br />

management<br />

Aside from the latest case studies and presentations, there will also be<br />

hours of networking, interactive sessions and discussions to cement what<br />

you’ve learned, forge new contacts and strengthen your temperature<br />

controlled logistics strategy.<br />

The speakers, sponsors and advisory board look forward to seeing you in<br />

Basel,<br />

Nicola Ambler<br />

event Director – <strong>Cool</strong> <strong>Chain</strong> logistics europe 2013<br />

www.coolchaineurope.com<br />

www.coldchainiq.com<br />

2013 industry advisory<br />

Board<br />

Lisa Mazzoni, Operational<br />

Excellence Specialist, Global<br />

Packaging Development, roche<br />

sadaam Huq, QA Senior<br />

Manager, Global Logistics & Cold<br />

<strong>Chain</strong>, gsK Biologicals<br />

al Davis, Supply <strong>Chain</strong><br />

Temperature Control Leader,<br />

Johnson and Johnson<br />

graham Martin, Supply <strong>Chain</strong><br />

Excellence Manager, Pfizer<br />

Maria D’Orazio, Head of Cold<br />

<strong>Chain</strong> Logistics, novartis<br />

Paul glossop, Head of Logistics,<br />

teva<br />

2013 Partner advisory Board<br />

Martin Peter,<br />

Head of Sales, Elpro<br />

Henry ames,<br />

Vice President Strategy and<br />

Business Development,<br />

sensitech<br />

sascha sonnenberg,<br />

Vice President, Commercial<br />

Operations, Marken<br />

David Walsh,<br />

CEO, intelsius<br />

Peter Lockett,<br />

Director, tc2 global<br />

Who will attend?<br />

VPs, Heads, Directors and<br />

managers of;<br />

• Supply <strong>Chain</strong><br />

• Logistics<br />

• Quality<br />

• Temperature Control<br />

• <strong>Cool</strong> <strong>Chain</strong><br />

•Transportation<br />

• Distribution<br />

•Warehousing and Storage


interact and discuss the latest temperature control and<br />

supply chain strategies with your expert speaker panel;<br />

Dr Ravi Prakash Mathur,<br />

Director Supply <strong>Chain</strong> Management,<br />

Dr. Reddy’s Laboratories<br />

Frederic Zwahlen, Vice President Supply<br />

<strong>Chain</strong>, Vifor Pharma<br />

Gudrun Schaefer, Head Of Supply <strong>Chain</strong><br />

Management, Medinova AG<br />

Shirley-Ann Feld, Global Quality Supply <strong>Chain</strong><br />

Deputy Director, Sanofi-Aventis<br />

Alfred Hunt, GDP and Controlled Drugs<br />

Inspector with the Irish Medicines Board /<br />

Member of the EMA GDP Drafting Group<br />

Dr. Mary Foster, Chair, Packaging and<br />

Storage Expert Committee, US Pharmacopeia<br />

Riekert Bruinink, Group Chairman of the<br />

PIC/S GDP Working Group, Member of the<br />

EMEA GDP Drafting, Dutch Health Care<br />

Inspectorate<br />

Stephen Todd, Senior GDP Medicines<br />

Inspector, MHRA<br />

Ian Holloway, Senior Pharmaceutical<br />

Assessor, MHRA<br />

Simon White, Director Quality Operations,<br />

Global Logistics & Supply, EMEA Region, Pfizer<br />

Steef van Amersfoort, Global Transportation<br />

& Warehousing Professional and Chairman<br />

Dutch Airfreight Shippers Council, Abbott<br />

Ronald Van Zitteren, Global Warehousing and<br />

Logistics Director, UCB<br />

Humberto Laserna, Quality Coordinator,<br />

Pfizer, Peru<br />

Peter Schuele, VP Supply <strong>Chain</strong> EMEA, Sigma<br />

Aldrich and committee member, Rx360<br />

Over 400 people from 191 different companies attended <strong>Cool</strong> <strong>Chain</strong> Logistics Europe in 2012<br />

A+P Grupo<br />

AAC Capital Partners<br />

Abbott Gmbh and Co KG<br />

Abbott Logistics B.V<br />

Actelion Pharmaceuticals Ltd<br />

Agilent Technologies<br />

Manufacturing GmbH & Co. KG<br />

Air Canada Cargo<br />

Air France – KLM Cargo<br />

Airbridge Cargo Airlines<br />

AirBridgeCargo Airlines, LLC<br />

Aircontainer Package System<br />

Sweden AB<br />

Alcon Couvreur NV<br />

Alexion International<br />

Allergan<br />

Ambient Systems<br />

American Airlines Cargo<br />

Amgen Europe BV<br />

AmSafe Bridport<br />

Antaris Solutions<br />

ApotheekZorg B.V.<br />

Arvato Logistics, Competence<br />

Center Logistics & Real Estate<br />

| CC-LR<br />

Astellas Pharma Europe<br />

Astra Zeneca<br />

Bachem AG<br />

Baxter SA<br />

Bayer Healthcare<br />

Bech-Hansen & Studsgaard A/S<br />

Beckman Coulter Eurocenter SA<br />

Berlinger & Co AG<br />

Biotest AG<br />

Boehringer Ingelheim Pharma<br />

GmbH<br />

Bristol Myers Squibb<br />

Brussels Airport<br />

Built Tech GmbH<br />

CAPPI<br />

Cargolux Airlines International SA<br />

Celgene<br />

Cilag AG<br />

Claude Ammann Consulting<br />

Coldway<br />

Controlant ehf<br />

<strong>Cool</strong> Containers, LLC<br />

Cryo Store<br />

Cryopak<br />

Cryoport Inc.<br />

CSafe LLC<br />

Daiichi Sankyo Europe GmbH<br />

Delta T GmbH<br />

DHL<br />

DHL Logistics (Switzerland) Ltd<br />

DHL Solutions & Innovations<br />

DHLFreight Glbal Management<br />

DoKaSch GmbH Switzerland<br />

Dometic<br />

Dryce Italia Srl<br />

Dubai FDI<br />

Dutch Health Care Inspectorate<br />

DVV Media<br />

Dyzle Services BV<br />

Eisai Manufacturing Ltd<br />

Eli Lilly and Co<br />

ELPRO -Buchs AG<br />

Elpro-Buchs AG<br />

Benjamin E. Blumer, Supply <strong>Chain</strong><br />

Manager, Horizon Pharma AG<br />

Alan J. Davis, Supply <strong>Chain</strong> Temperature<br />

Control Leader, Johnson & Johnson<br />

Bertrand Jacquet, Supply <strong>Chain</strong> Specialist,<br />

Health Technology Centre, UNICEF<br />

Laurent Foetisch, Managing BIOGRAPHICAL Director, NOTES<br />

Supply <strong>Chain</strong> Operations SA<br />

Daniel Liebermann<br />

Daniel Liebermann, Director, Luxembourg<br />

Director Ministry of the Economy and Foreign Trade<br />

Directorate Logistics<br />

Ministry of the Economy and Foreign Trade<br />

Zvonimir Majic, Senior Manager<br />

Transportation and International Freight,<br />

Pliva Croatia Ltd<br />

Johannes Schoen, Senior Manager,<br />

Anti-Counterfeiting, Boehringer Ingelheim<br />

Robert Bronstein, Director - Clinical Supply<br />

Operations, MacroGenics<br />

Saddam Huq, QA Senior Manager, Global<br />

Logistics & Cold <strong>Chain</strong>, GSK Biologicals<br />

Lisa Mazzoni, Operational Excellence<br />

Specialist, Global Packaging Development,<br />

Roche<br />

Maria D’Orazio, Head of Cold <strong>Chain</strong><br />

Management, Novartis<br />

Chris Wallace, Distribution Director,<br />

Genzyme Ltd<br />

Jaap Visser, Head Warehousing & Distribution<br />

Logistics, Sanquin Plasma Products<br />

Ralph Ambagtsheer, Process Engineer,<br />

Sanquin Plasma Products<br />

Andrea Graf-Gruber, Manager Business<br />

Process & Standards, IATA<br />

Emballiso<br />

Envirotainer<br />

Escortcoldchain<br />

Eusa Pharma<br />

eutecma gmbh<br />

EXAM Packaging SPRL/BVBA<br />

Exelsius<br />

EX-LAB<br />

F HoffmanLa Roche<br />

Farmamondo<br />

FedEx<br />

Fiege Logistics (Switzerland) Ltd.<br />

Forest Laboratories<br />

Frigo-Trans<br />

Genzyme Ltd<br />

GEODIS Wilson<br />

Geodis Wilson Sweden AB<br />

GlaxoSmithKline<br />

GlaxoSmithKline Biologicals<br />

Globex Couriers GmbH<br />

Green Harbour Advisory<br />

Hellmann Worldwide Logistics<br />

GmbH & Co KG<br />

Henry Schein Services GmbH<br />

Hirslanden Bern<br />

Hoffmann la Roche<br />

IATA<br />

IJS Global<br />

Institut Straumann AG<br />

Intelligent Thermal Solutions<br />

Intelsius<br />

InterMune International AG<br />

Ipsen Pharma<br />

Janssen Pharmaceutica<br />

Johnson & Johnson<br />

Johnson and Johnson Medical<br />

Device and Diagnostics<br />

JRI Maxant<br />

Kalibox<br />

Kern Frio S.A.<br />

Knauf Industries<br />

Kohlpharma GmbH<br />

Kühne + Nagel Aktiengesellschaft<br />

Kwizda Pharmadistribution GmbH<br />

Laminar Medica Limited<br />

LifeConEx<br />

Lufthansa Cargo<br />

Luxembourg Ministry of the<br />

Economy and Foreign Trade<br />

MacroGenics, Inc<br />

Marken<br />

Maxim Integrated Products<br />

Mediline Isothermal Solutions<br />

Medimmune<br />

Medinova AG<br />

Merck<br />

Merck Serono SA<br />

Merck Sharp and Dohme BV<br />

MeshWorks WIreless Oy<br />

MHRA<br />

Minnesota Thermal Science<br />

Movianto GmbH<br />

Mylan Ireland Ltd<br />

Nanopore Insulation Limited<br />

NC Advisory<br />

Novartis Pharma AG<br />

Novartis Vaccines & Diagnostics<br />

Novo Nordisk AS<br />

Prof. Dr. Rüdiger Lohmann, Professor at,<br />

Lübeck University of Applied Science and<br />

Management Consultant<br />

Graham Martin, Supply <strong>Chain</strong> Excellence<br />

Manager, Pfizer<br />

C YRILL C ARL B AETSCHER<br />

Cyrill Bätscher,<br />

Schlossgasse 6, Postfach 15<br />

CH-4456 Tenniken<br />

Head of Logistic Services, Synthes<br />

Claude Amman, Education Director,<br />

Claude Amman Consulting<br />

Work Experience<br />

Joern Leewe,<br />

Managing Partner, Novumed<br />

Christelle Laot, Technical Fellow - Cold <strong>Chain</strong><br />

Management & Quality Assurance, FedEx Express<br />

Barry Conlon, CEO,<br />

FreightWatch<br />

Sascha Sonnenberg, Vice President,<br />

Commercial Operations, Marken<br />

Liam Holmes, Senior Project Engineer,<br />

ThermoSafe<br />

Patrick Tobler, <strong>Cool</strong> <strong>Chain</strong> Specialist,<br />

Page 1 of 1<br />

Built Tech GmbH<br />

Fabian Eschenbach, Business<br />

Unit Manager Thermal Packaging, Va-Q-Tec<br />

Richard Peck,<br />

Senior Programme Manager, Sensitech<br />

Paul Gibbons, Security Director EMEAA,<br />

Amgen Europe B.V. and member of TAPA EMEA<br />

Gilles Labranque,<br />

CEO, <strong>Sofrigam</strong><br />

Thomas Grubb, Manager, Cold <strong>Chain</strong> Strategy,<br />

Cargo Sales, AmericanAirlinesCargo<br />

Cathy O’Brien,<br />

Corporate Sector Manager Clinical, TNT<br />

Doetsch Grether AG, Basel (220 Employees)<br />

07/08 - 04/09 Member of the Board, Head of Finance and Services; Head of Pension fund<br />

04/08 - 04/09 Member of the Board, Head of Finance and Controlling<br />

Daniel Liebermann is Director at the Luxembourg Ministry of the Economy & Ringele AG, Pratteln (200 Employees)<br />

Foreign Trade.<br />

01/06 – 03/08 Function: Head of Finance & Controlling, Purchasing and ERP Project<br />

07/02 – 06/07 Function: Head of Finance & Controlling and Purchasing<br />

11/01 – 06/07<br />

He joined the Ministry of the Economy in 2004. Initially, he was participating in the<br />

Function: Head of Finance & Controlling<br />

assessment of the country’s competitiveness. In this capacity, he became closely Stratec Medical AG resp. Synthes / Stratec Inc., Oberdorf (> 1’000 Employees)<br />

involved with the economic development policy, including foreign direct 07/00 – 10/01 Function: Business Unit Manager Sales, Joint Replacement<br />

10/99 – 06/00<br />

investment (especially from Asia). Today, he is responsible for the development of<br />

Function: Group Product Manager<br />

10/97 – 09/99<br />

the logistics industry in Luxembourg which one of the key sectors of Luxembourg’s 06/96 – 09/97<br />

Function: Product Manager<br />

Function: Junior Product Manager<br />

economic development policy.<br />

02/95 – 05/96 Function: Product Developer Maxillofacial/Hand<br />

Mr. Liebermann is a member of the board of directors of S.O.L.E.I.L SA (a public<br />

private joint venture responsible for developing warehousing facilities), of the<br />

Société de Promotion et de Développement de l’Aéroport de Luxembourg (a<br />

company responsible for promoting Luxembourg airport platform) and of CTI<br />

Systems SA (a company specialized in the design and manufacture of automated<br />

systems for the lifting and handling of heavy goods).<br />

After graduating from the Université Libre de Bruxelles (Belgium) with a Bachelor's<br />

degree in economics, Mr. Liebermann obtained a Master of Science in Finance from<br />

the University of Durham (United Kingdom) and a Master of Arts in European<br />

Interdisciplinary Studies from the College of Europe (Poland).<br />

Daniel Liebermann was born on April 30 1977. He is married with two children.<br />

10/03 MBA, State University of New York / GSBA 1 Dual Degree<br />

03/01 Bachelor of Business Administration, GSBA<br />

11/94 Bachelor of Mechanical Engineering Ingenieur HTL, IBB 2<br />

Synthes Inc., West Chester (> 11’000 Employees)<br />

10/10 - Head of Logistic Services<br />

05/09 – 10/10 Project Manager Enterprise Projects (Efficiency Gains)<br />

1<br />

Graduate School for Business Administration<br />

2<br />

Ingenieurschule beider Basel – State Institute for Technology<br />

Nuriya<br />

NV Log S.A.<br />

Nycomed Christaens<br />

OCI Company Ltd.<br />

Omrix Biopharmaceuticals Ltd.<br />

PakSense, Inc.<br />

Pauwels Consulting/Genzyme<br />

Peli Products, S.L.U.<br />

Pfizer<br />

Pharmafreight Ltd<br />

PHSE S.r.l.<br />

Pliva Croatia Ltd.<br />

RHB<br />

Roche Products Pty Limited<br />

Rubitherm Technologies GmbH<br />

Sanofi Pasteur<br />

Sanofi Pasteur MSD<br />

Sanofi Winthrop Industries<br />

Sanquin Plasma Products<br />

Savsu<br />

SCA <strong>Cool</strong> Logistics<br />

Seattle Genetics Inc.<br />

SEB<br />

Sensitech<br />

Sentipharm AG<br />

Shire Pharmaceuticals Ireland<br />

Ltd.<br />

Siemens Healthcare Diagnostics<br />

<strong>Sofrigam</strong><br />

Softbox Systems Ltd.<br />

Spedition Kautetzky GmbH &<br />

Co. KG<br />

SpePharm Holding BV<br />

Supply <strong>Chain</strong> Operations SA<br />

Swiss Medicines Inspectorate<br />

Swiss World Cargo<br />

Synthes, Inc.<br />

Taracell<br />

TAS Trust Advisory Services<br />

S.à r.l.<br />

TCP RELIABLE<br />

Teva Runcorn<br />

Thermo Fisher Scientific<br />

Thermo King<br />

Thermosafe Brands<br />

Thrombogenics Ltd<br />

TNT<br />

Topa Verpakking BV<br />

TOWER Cold <strong>Chain</strong> Solutions<br />

Transposafe Systems<br />

Tri-Vizor<br />

TSS<br />

Turkish Airlines<br />

UCB<br />

UK NEQAS<br />

United Cargo<br />

United States Pharmacopeia<br />

UPS<br />

Vaisala Oyj<br />

va-Q-tec AG<br />

VTS H.Verdijk Int. Transport b.v.<br />

Warehouse Alfa Omega SA<br />

Wockhardt UK Holdings Ltd<br />

World Courier Logistics Ltd<br />

World Health Organization<br />

RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


pRe-CONfeReNCe WORkshOp Day<br />

mondAy 28tH JAnuAry 2013<br />

Workshop A<br />

Dr. Mary Foster,<br />

Chair, Packaging and<br />

Storage Expert<br />

Committee,<br />

US Pharmacopeia<br />

Workshop B<br />

Andrea Graf-Gruber,<br />

Manager, Cargo Business<br />

Process and Standards,<br />

International Air<br />

Transport Association<br />

(IATA)<br />

Workshop C<br />

Richard Peck,<br />

Senior Program Manager<br />

Life Sciences, EMEA<br />

Professional Services,<br />

Sensitech EMEA B.V.<br />

Paul DellaVilla,<br />

Project Manager Life<br />

Sciences, Professional<br />

Services,<br />

Sensitech EMEA B.V.<br />

Workshop D<br />

Simon White,<br />

Director Quality<br />

Operations, Global<br />

Logistics & Supply,<br />

EMEA Region, Pfizer<br />

9.00 –<br />

12.00<br />

an update of usP general Chapter good Distribution Practices—supply<br />

<strong>Chain</strong> integrity and industry Comments<br />

A new general USP Chapter Good Distribution Practices - Supply <strong>Chain</strong> Integrity has been presented in the new issue of the USP<br />

Pharmacopeia Forum (volume 38, edition 2).<br />

Attend this workshop to talk through the important chapters of regulations, with a specific focus on supply chain integrity. The objective of the new<br />

chapter is to ensure product identity, strength, quality, purity, and safety remains intact throughout the supply chain.<br />

The main issue of the new chapter focuses on counterfeited medicines. Here are the topics which are dealt with in detail:<br />

Legal definition of counterfeit medicines (laid down in an EU Directive for Europe, in FDCA, 21 USC 321 § 201 for the USA, inexistent in some countries),<br />

• Types of counterfeit medicines<br />

• Medical consequences of counterfeit medicines<br />

• Distribution (e.g. also via internet)<br />

• How to prepare your organisation for changes to chapter <br />

A paragraph entitled “Best Practices to combat Counterfeit Drugs and Medical Devices” presents a range of measures and possibilities to combat<br />

counterfeit medicines – this workshop will give you an overview of these strategies and how you can implement them.<br />

Some of these measures include;<br />

• Packaging technologies (secured packaging, authentication and serialisation technologies, etc.)<br />

• Establishment of Pedigrees / e-Pedigrees<br />

• Use of 2D bar codes (ECC 200) or RFID tags<br />

9.00 –<br />

12.00<br />

Practical approaches for implementing iata regulations for time & temperature<br />

sensitive air Freight shipments<br />

IATA has been collaborating with supply chain stakeholders to understand and define high-standard requirements for time and temperature<br />

sensitive air freight shipments.<br />

This workshop will examine practical approaches to sensitive healthcare products transport and how to comply with the Perishable Cargo<br />

Regulations (PCR) Chapter 17, including IATA labels. The workshop will assess the current challenges in perishable air freight and discuss how<br />

these challenges are addressed in the regulation to ensure communication, processes and standards are in place to maintain the integrity and<br />

quality of the time and temperature sensitive products along the PCR supply chain.<br />

The workshop will discuss:<br />

• What is the feedback of the industry on the implementation of the IATA Time and Temperature label?<br />

• Is the industry ready to implement end to end standard processes?<br />

• The IATA’s Road Map for 2013<br />

12.30 –<br />

15.30<br />

the use of time and temperature generated Data to Create Meaningful KPis,<br />

Enabling a greater understanding of the supply <strong>Chain</strong>, Helping to safeguard<br />

Product integrity<br />

Time and temperature data related to the distribution of temperature-sensitive medicinal products is an important element of a company’s quality<br />

initiatives. Throughout the supply chain, there are many unforeseen and uncontrollable factors that can cause products to be exposed to temperatures<br />

outside of their acceptable range for storage and distribution. These variations, if not managed carefully, may result in expensive and time-consuming<br />

quarantine processes, product loss, or at worst, harm to the end user.<br />

Utilising a comprehensive data storage management tool capable of generating reports linked to Key Performance Indicators (KPIs), enables<br />

managers to review the current state of the supply chain, assessing various risks, whilst delivering critical notifications to managers in quality,<br />

logistics, distribution, warehousing, etc… These reports allow for the implementation of fast and effective preventative measures thus minimizing<br />

risks in the supply chain.<br />

The workshop will focus on two objectives:<br />

1) Look at industry best practices and the pitfalls of data collection and report generation, then;<br />

2) Outline the methods used to set up appropriate data collection processes enabling the development of meaningful KPIs, demonstrating how<br />

certain KPIs can be used to support continuous process improvement.<br />

12.30 –<br />

15.30<br />

Keeping up with the EMa: Controlled room temperature requirements<br />

This session will lead you through the top 3 anticipated challenges relating to the GDP updates. Simon is actively involved in tracking feedback for<br />

the GDP developments and will address each individually before assigning a crisis case study to you in groups. The challenges;<br />

1.Distribution under controlled room temperature<br />

Controlled room temperature implies a certain degree of control over the temperature of the storage conditions and a continuous temperature<br />

monitoring system is required for the storage of medicinal products.<br />

2.Segregation of product<br />

Many Distribution Centres export globally, what is the purpose and benefit of segregating EU product from non-EU product? What is considered<br />

a definition of ‘segregation’ (physical, electronic, both...)? All finished product batches can be considered segregated since they are – as A GMP<br />

requirement - packaged, identified and managed in such as a way to avoid cross-contamination with other product, whether for use in humans or<br />

animals and irrespective of the indication for use.<br />

3.Intermediaries<br />

What is the industry’s oversight protocol for Intermediaries in the distribution process, carriers, freight forwarders etc.? What is the most effective<br />

quality oversight method for service providers, expectations, who should be responsible...?<br />

Your Task;<br />

You will be presented with a real life case study and must work through possible solutions in your group. Each group will then feedback to the whole<br />

workshop and you will walk away with brand new strategies!<br />

RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


CONfeReNCe Day ONe:<br />

tuesdAy 29 JAnuAry 2013<br />

7.30 Registration & Networking Coffee<br />

8.15 Cold <strong>Chain</strong> IQ welcome<br />

8:20 Chairman’s Opening Remarks - Laurent Foetisch, Managing Director, Supply <strong>Chain</strong> Operations SA<br />

8.30 KEYNOTE: Building an Efficient Supply <strong>Chain</strong> and Logistics<br />

Strategy<br />

• Striking the balance of quality vs. cost in an ever changing industry<br />

• Embedding flexibility into the supply chain without compromising<br />

control or quality<br />

• Evaluating the impact of regulatory changes on a global supply<br />

chain<br />

• Integrating your supply chain and the temperature control<br />

distribution community through horizontal pooling LTL distribution<br />

strategies<br />

• What can we learn from other industries?<br />

Dr Ravi Prakash Mathur, Director Supply <strong>Chain</strong> Management,<br />

Dr. Reddy’s Laboratories<br />

SEEKING HARMONISATION OF THE EVER EVOLVING<br />

REGULATORY LANDSCAPE<br />

9.00 REGULATORY SESSION:<br />

New EU GDP Regulations, a step forwards<br />

• The new GDP Guideline in general<br />

• New items and items with more guidance<br />

• Outlining specific temperature requirements for storage and<br />

transportation<br />

• Implementation issues<br />

Riekert Bruinink, Group Chairman of the PIC/S GDP Working<br />

Group, Member of the EMEA GDP Drafting, Dutch Health Care<br />

Inspectorate<br />

11.10 Breakout Roundtable Sessions<br />

Simply choose the roundtable topic of most interest to you and join in the discussion! These sessions are open, informal and a<br />

great opportunity to really gauge what your peers are planning and to share ideas and lessons learned. You will walk away with<br />

tangible ideas on how to solve your biggest challenges.<br />

You will get a choice of 2 roundtables, as after 30 minutes you will be able to switch and join another group<br />

12.10<br />

A. Stationary Warehouse<br />

Monitoring<br />

Warehousing & Distribution<br />

Logistics<br />

Ralph Ambagtsheer, Process<br />

Engineer<br />

Sanquin Plasma Products<br />

E. Cold <strong>Chain</strong> Distribution<br />

Strategies and Geographical<br />

Zoning<br />

Graham Martin, Supply <strong>Chain</strong><br />

Excellence Manager, Pfizer<br />

B. Anti-Counterfeiting: Falsified<br />

Medicine Directive and beyond<br />

Johannes Schoen,<br />

Senior Manager,<br />

Anti-counterfeiting,<br />

Boehringer Ingelheim<br />

F. Sustainable and Reusable<br />

Packaging Solutions<br />

if you’re interested in leading<br />

this session please contact<br />

nicola.ambler@iqpc.co.uk<br />

9.30 REGULATORY SESSION: MHRA Update on the Requirements<br />

of Licensed Facilities for Handling 2-8C Products<br />

• Updates on new license requirements for 2-8°C handling<br />

• Expectations for handling and storage facilities<br />

• The impact of these updates for CRT products<br />

Ian Holloway, Senior Pharmaceutical Assessor, MHRA<br />

10.00 Following a Cold <strong>Chain</strong> Shipment through an Integrator<br />

Network<br />

• Custodial control and visibility into shipments<br />

• Technical support and expertise prior to shipping temperature-<br />

sensitive products is critical<br />

• Adjusting desired environmental parameters and contingency<br />

plans<br />

• Risk management leading to preventive and corrective actions<br />

Christelle Laot, Technical Fellow - Cold <strong>Chain</strong> Management &<br />

Quality Assurance, Fedex Express<br />

10.30 Networking Coffee Break<br />

C. Understanding Inspection<br />

Criteria and Expectations from a<br />

UK Perspective<br />

Stephen Todd,<br />

Senior GDP Medicines Inspector,<br />

MHRA<br />

G. Evaluating LTL Processes and<br />

Potential<br />

Cyrill Baetscher,<br />

Head of Logistic Services,<br />

Synthes<br />

D. Is a 4PL Approach<br />

the Future?<br />

Joern Leewe,<br />

Managing Partner,<br />

Novumed<br />

INTERACTIVE<br />

H. Optimising Data and<br />

Information Flow through the<br />

Supply <strong>Chain</strong><br />

Prof. Dr. Rüdiger Lohmann,<br />

Professor at, Lübeck University<br />

of Applied Science and<br />

Management Consultant


CONfeReNCe Day ONe:<br />

tuesday 29 JAnuAry 2013<br />

STREAM A: IMPLEMENTING STABILITY<br />

DATA AND LABEL CLAIM REQUIREMENTS<br />

TO PROTECT PATIENT SAFETY<br />

12.10 Handling Temperature Excursions and<br />

the Role of Stability Data<br />

• What does the regulator say about<br />

temperature excursions?<br />

• Reviewing the standard tests that facilitate<br />

decision making<br />

• How to increase stability knowledge to add<br />

value to our products<br />

Claude Amman, Director, Claude Amman<br />

Consulting<br />

12.40 5 minute change over<br />

12.45 PANEL<br />

Painting the Regulatory<br />

Picture<br />

• Expectations and boundaries for use of<br />

stability data<br />

• What will change in the GDP updates?<br />

• Achieving the ultimate goal of patient safety<br />

Mary Foster, Chair, Packaging and<br />

Storage Expert Committee, United States<br />

Pharmacopeia<br />

Riekert Bruinink, Group Chairman of the<br />

PIC/S GDP Working Group, Member of the<br />

EMEA GDP Drafting, Dutch Health Care<br />

Inspectorate<br />

13.15 Networking Lunch Break<br />

14.30 Sponsor Spotlight Session<br />

This session is reserved for a leading supplier,<br />

if you think your product would be of interest<br />

to the delegation, get in touch on +44 207<br />

368 9300 or email sponsorship@iqpc.co.uk<br />

TAILOR YOUR AGENDA<br />

STREAM B: ACHIEVING SUPPLY CHAIN<br />

INTEGRITY AND ENSURING TOTAL DATA<br />

VISIBILITY TO MINIMISE RISK<br />

USP Chapter Good Distribution<br />

Practices—Supply <strong>Chain</strong> Integrity<br />

• An update of USP General Chapter <br />

Good Distribution Practices—Supply <strong>Chain</strong><br />

Integrity and industry comments<br />

• Implementing supply chain integrity<br />

measures to minimise risks that arise<br />

anywhere along the supply chain<br />

• Using GDP to develop sound business practices<br />

that help deter unauthorised access to and<br />

manipulation of pharmaceutical materials<br />

• Devising effective means for detecting<br />

adulterated drug components and drug products<br />

so that they do not enter the supply chain<br />

Mary Foster, Chair, Packaging and<br />

Storage Expert Committee, United States<br />

Pharmacopeia<br />

Minimising supply <strong>Chain</strong> Risk<br />

Deployment of Solutions for End to End<br />

Data Visibility and Integrity<br />

• Identifying supply chain risks in managing<br />

cold chain distribution<br />

• Evaluating solutions to reduce temperature<br />

excursions<br />

• Using end to end services to ensure<br />

visibility and integrity of your temperature<br />

data<br />

Cathy O’Brien, Corporate Sector Manager<br />

Clinical, TNT<br />

Best Practice for End to End Visibility<br />

on your international Cold Supply <strong>Chain</strong><br />

using RFID Technology<br />

• Embedding monitoring and visibility<br />

strategies from the outset<br />

• Thoroughly qualification and briefing<br />

of suppliers to ensure full transparency<br />

throughout distribution<br />

• Effectively designing and setting up your<br />

supply chain<br />

• Successfully qualifying the whole supply<br />

chain to ensure it is robust<br />

• Reporting and Documentation, merges<br />

Event- and Temperature data<br />

• Always keeping in mind GDP guidelines<br />

Benjamin E. Blumer, Supply <strong>Chain</strong><br />

Manager, Horizon Pharma AG<br />

STREAM C: PACKAGING AND<br />

QUALIFICATION METHODOLOGIES<br />

Enhancing Profitability of your Cold <strong>Chain</strong><br />

Management by Improving Relationships<br />

with Your Partners<br />

• Achieving transparent communication: the<br />

importance of defining your constraints<br />

from the outset<br />

• Developing an adapted logistic and<br />

packaging programme<br />

• Test, evaluate and adopt<br />

Gilles Labranque, CEO, <strong>Sofrigam</strong><br />

The Role of Industrial Design in<br />

Temperature Assured Packaging<br />

• Understanding industrial design and its role<br />

in the industry<br />

• Examples of industrial design in industry<br />

• Temperature Assured Packaging and the<br />

challenges faced by the TAP Industry<br />

• Analysing success factors for design<br />

management<br />

• Implementation of the latest approaches<br />

and ideas for TAP<br />

Liam Holmes, Senior Project Engineer,<br />

ThermoSafe<br />

Multi-use, Single-use or Both? Economic<br />

and Ecologic Considerations of a New<br />

Packaging Provider<br />

• Assessing alternative, cost effective<br />

packaging solutions<br />

• Designing a sustainable supply chain and<br />

reducing your CO2 footprint<br />

• Recycling possibilities by technology<br />

• A practical guide to calculating sustainability<br />

Patrick Tobler, <strong>Cool</strong> <strong>Chain</strong> Specialist, Built<br />

Tech GmbH<br />

Live Shipment Performance Data within a<br />

Global Rental Network<br />

• An overview of ambient temperature<br />

profiles in real shipments<br />

• The impact of temperature profiles on<br />

container performance<br />

• Real life case studies<br />

Fabian Eschenbach, Business Unit<br />

Manager Thermal Packaging, Va-Q-Tec


CONfeReNCe Day ONe:<br />

tuesdAy 29 JAnuAry 2013<br />

15.00 5 minute change over<br />

15.05 IATA Insight on New Label Claim<br />

Requirements – Updates to Chapter 17<br />

Effective July 1st, 2012 the IATA Time and<br />

Temperature Sensitive label will become<br />

mandatory for the transportation of healthcare<br />

cargo shipments – hear directly from IATA on<br />

these changes and join the post presentation<br />

discussion to assess current implementation;<br />

• Guaranteeing the appropriate handling and<br />

operational processes associated to<br />

healthcare transport and/or logistics<br />

through correct labelling<br />

• Working towards international standards<br />

• Ensuring all stakeholders are familiar both<br />

with the regulations and the appearance of<br />

the label<br />

Andrea Graf-Gruber, Manager Business<br />

Process & Standards, IATA<br />

15.35 5 minute change over<br />

STREAM D: COST EFFECTIVE LOGISTICS<br />

STRATEGIES FOR SMALL BATCHES<br />

15.40 Designing a Supply <strong>Chain</strong> for Small Batches<br />

• Raising awareness of controlled room<br />

temperature requirements across the<br />

supplier network<br />

• Does horizontal pooling work for us?<br />

• Assessing realistic cost saving strategies<br />

Cyrill Baetscher, Head of Logistic Services,<br />

Synthes<br />

16.10 Coffee Break<br />

Achieving a Global Serialisation and<br />

Aggregation Strategy<br />

• Ensuring product safety and security<br />

globally<br />

• Addressing the challenges for a global<br />

company to adhere to non-global<br />

regulations<br />

• Anticipating the US federal law changes<br />

and what this means for our supply chains<br />

and security strategy<br />

• An overview of updates from Asia and<br />

South America<br />

Johannes Schoen, Senior Manager,<br />

Anti-counterfeiting, Boehringer Ingelheim<br />

STREAM B: ACHIEVING SUPPLY CHAIN<br />

INTEGRITY AND MINIMISING RISK CONT…<br />

PANEL<br />

Supply <strong>Chain</strong> Integrity and<br />

Security Strategies Securing the<br />

Pharmaceutical Supply <strong>Chain</strong><br />

Since the original publication of USP <br />

Good Storage and Shipping Practices, a host of<br />

subsequent yet equally important regulatory and<br />

standards-based guidance documents have been<br />

published and revised. In support of the market’s<br />

evolving focus, the USP published a PF version<br />

of USP “Good Distribution Practices –<br />

Supply <strong>Chain</strong> Integrity” in late 2011 and other<br />

groups including the Transported Asset Protection<br />

Association (TAPA) and Rx360 have published<br />

equally important industry best practices.<br />

This panel session will include an overview of<br />

freight security best practices needed to achieve<br />

end-to-end supply chain integrity. The panel<br />

participants will review case studies and tools<br />

for providing greater supply chain visibility and<br />

control across the pharmaceutical supply chain.<br />

Moderator:<br />

Rafik Bishara, Pharmaceutical Cold <strong>Chain</strong><br />

Interest Group Leader, PDA<br />

Panellists:<br />

Barry Conlon, CEO, FreightWatch<br />

Paul Gibbons, Security Director EMEAA,<br />

Amgen Europe B.V. and member of TAPA<br />

EMEA<br />

SURVEY SESSION:<br />

INTERACTIVE<br />

You will have the option to take part in our<br />

pre-conference survey focusing on what the<br />

industry’s packaging needs and strategies are.<br />

What are your qualification processes? How<br />

are you assessing packaging for controlled<br />

room temperature products?<br />

The results will be collected and made into a<br />

report that will be presented at the event – you’ll<br />

also be given a copy to take back to the office!<br />

Here’s a sample of the survey questions;<br />

• What are your biggest challenges in<br />

temperature control today?<br />

• How are your peers addressing these challenges?<br />

• What will be the focus of regulators in the<br />

years to come?<br />

Participate in this lively survey session to see<br />

the answers and learn how you can use them<br />

to improve your processes.<br />

Lisa Mazzoni, Operational Excellence Specialist,<br />

Global Packaging Development, Roche<br />

STREAM E: REGIONAL SPOTLIGHT<br />

SESSION<br />

Actual Trends in the Global Healthcare<br />

Market – Insights and Outlook<br />

• The most attractive market segments and<br />

shipping products for healthcare logistics<br />

companies<br />

• What are crucial markets and regions?<br />

• How important will the Indian pharma<br />

market be in the future?<br />

• Novumed’s vision for healthcare in 2030<br />

Joern Leewe, Managing Partner, Novumed<br />

RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


CONfeReNCe Day ONe:<br />

tuesdAy 29 JAnuAry 2013<br />

16.45 Planning A Global Temperature Sensitive<br />

Clinical Supply <strong>Chain</strong><br />

Planning a strategy for global distribution of<br />

temperature sensitive clinical supplies poses<br />

many challenges that effect availability and<br />

success of a clinical program.<br />

This presentation will address;<br />

• Considerations for cold chain shipment<br />

• Identifying opportunities to streamline<br />

temperature sensitive supply pathways<br />

• Strategies to improve time-to-site<br />

• Assessing the importance of supply<br />

chain partnerships and developing effective<br />

communication throughout your network<br />

Robert Bronstein, Director - Clinical Supply<br />

Operations, MacroGenics<br />

17.15 5 minute change over<br />

17.20 Designing the Optimum<br />

Outsourcing and Collaboration<br />

Strategy: The SME Perspective<br />

• The impact of company size on the ability to<br />

fully manage your supply chain<br />

• Successfully outsourcing transportation and<br />

logistics services – sourcing, selection and<br />

relationship management<br />

• Effective approaches to transportation<br />

qualification<br />

• Considerations when designing a supply<br />

chain with a mix of cool and ambient elements<br />

• Cost optimisation strategies for a<br />

combination supply chain<br />

Gudrun Schaefer, Head Of Supply <strong>Chain</strong><br />

Management, Medinova AG<br />

Tracking Technology Updates and<br />

Achieving Supply <strong>Chain</strong> Visibility<br />

• Exploring the recent studies of radio<br />

frequency impact on biologicals<br />

• Understanding the impact of the falsified<br />

medicines act on temperature controlled<br />

distribution chains<br />

• Using RFID systems to fulfil supply chain<br />

integrity and prevent counterfeiting<br />

• Overcoming the current limitations with<br />

respect to RFID readers<br />

Jean Pierre Emond, Director Cold <strong>Chain</strong><br />

Research, Georgia Institute of Technology<br />

Rx360 and Supply <strong>Chain</strong> Security<br />

• Background on rx360<br />

• Supply chain security workgroup<br />

• Overview of supply chain security<br />

whitepapers<br />

• Industry success factors going forward<br />

Peter Schuele, VP Supply <strong>Chain</strong> EMEA,<br />

Sigma Aldrich and committee member,<br />

Rx360<br />

17.50 5 minute change over<br />

17.55 Manoeuvring Successfully in a Temperature Controlled Environment<br />

• Determine the financial risks from temperature excursions<br />

• Considerations for the global logistics supply chain<br />

• Identify and overcome specific regulatory challenges in emerging markets<br />

• Utilise new packaging and temperature monitoring technologies to streamline global drug distribution<br />

Sascha Sonnenberg, Vice President, Commercial Operations, Marken<br />

18.25 End of day 1, Chair’s closing remark<br />

18.30<br />

<strong>Cool</strong> <strong>Chain</strong> Excellence<br />

Award Ceremony<br />

19.00 Networking Drinks Reception sponsored by Marken and<br />

<strong>Cool</strong> <strong>Chain</strong> Excellence Awards Casino Night<br />

Welcome to India!<br />

INTERACTIVE<br />

Following the 2012 community wide survey,<br />

India was identified as one of the biggest<br />

opportunities in terms of emerging markets…<br />

We are pleased to bring you this feature<br />

length, interactive session, which will allow<br />

you to really dive into the realities and<br />

solutions of temperature controlled strategies<br />

in India. Discuss your experiences and those<br />

of your peers and come away with innovative<br />

ideas for a robust logistics strategy.<br />

Dr Ravi Prakash Mathur, Director Supply<br />

<strong>Chain</strong> Management, Dr. Reddy’s Laboratories<br />

Designing a Quality Strategy for<br />

Cold <strong>Chain</strong> Supply in Latin<br />

America<br />

• Understanding the risk of international<br />

and national cold chain distribution in Latin<br />

America<br />

• Developing training and planning strategies<br />

for all stakeholders<br />

• An overview of facilities and qualification<br />

Humberto Laserna, Quality Coordinator,<br />

Pfizer, Peru<br />

Nominations are now open! For all of the<br />

criteria and submission materials please<br />

visit www.choolchaineurope.com/awards<br />

or call +44 (0)207 368 9300<br />

RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


CONfeReNCe Day tWO:<br />

wednesdAy 30 JAnuAry 2013<br />

8.00 Registration & Networking Coffee<br />

8.40 Chairman’s Recap<br />

ACCLIMATISING TO CONTROLLED ROOM TEMPERATURE AND<br />

AMBIENT LOGISTICS REQUIREMENTS<br />

9.00 CRT Supply <strong>Chain</strong>: Optimising the Risk vs. Budget Balance<br />

• Evaluating the right temperature control strategy for CRT products<br />

• Lowering the financial impact of packaging and storage<br />

• Case study: evaluating the results of a thermal cover evaluation<br />

study<br />

• What are the options and potential risks?<br />

Shirley-Ann Feld, Global Quality Supply <strong>Chain</strong> Deputy Director,<br />

Sanofi-Aventis<br />

9.30 How to Handle Temperature Deviations from Approved<br />

Storage Requirements: the regulatory perspective<br />

• Understanding the expectations for temperature excursions<br />

• Managing calibration failures<br />

• Deviations from procedures<br />

• Equipment failures<br />

• Setting alarm limits<br />

• Improving the application of temperature mapping results to<br />

prevent excursions<br />

Alfred Hunt, GDP and Controlled Drugs Inspector with the<br />

Irish Medicines Board / Member of the EMA GDP Drafting<br />

Group<br />

STREAM D: Evaluating and Validating<br />

Temperature Control Transportation<br />

11.50 Quick Win Networking<br />

An opportunity to exchange<br />

business cards with colleagues<br />

ocusing on transportation<br />

11.55 Developing an Airfreight<br />

CASE<br />

STUDY<br />

Programme Directly with the<br />

Airlines<br />

• Addressing the increasing CRT shipping<br />

requests<br />

• New GDP guidelines compliance challenges<br />

• Increasing extreme temperatures ranges at<br />

origin, destination and in-transit<br />

• Overcoming the complexity of airfreight<br />

services with many stakeholders<br />

• Developing an airline assessment<br />

programme specific for Time and<br />

Temperature sensitive services<br />

• Implementing airfreight lane and airport risk<br />

assessment as part of this programme<br />

Steef van Amersfoort, Global Transportation<br />

& Warehousing Professional and Chairman<br />

Dutch Airfreight Shippers Council, Abbott<br />

TAILOR YOUR AGENDA<br />

10.00 PANEL The Practicalities and Top Priorities<br />

of Controlled Room Temperature Logistics<br />

This interactive panel session will bring together the regulatory, end<br />

user and supplier perspective on the forthcoming CRT requirements,<br />

how this will impact business and how to plan for the changes that<br />

lie ahead.<br />

Here’s an overview of the discussion points;<br />

• Ocean refer qualification for CRT<br />

• Air freight route qualification for CRT<br />

• Supplier selection processes and criteria<br />

• Air vs. sea transportation solutions for CRT, comparison, pros and cons<br />

• Temperature monitoring - data logger friend or foe.<br />

This is the perfect opportunity to discuss your challenges and<br />

questions with our expert line up and the wider community and gain<br />

some tangible solutions – just come armed with your questions!<br />

Chair:<br />

Frederic Zwahlen, Vice President Supply <strong>Chain</strong>, Vifor Pharma<br />

Panellists; Riekert Bruinink, Group Chairman of the PIC/S GDP<br />

Working Group, Member of the EMEA GDP Drafting, Dutch<br />

Health Care Inspectorate<br />

Zvonimir Majic, Senior Manager Transportation and<br />

International Freight, Pliva Croatia Ltd<br />

Shirley-Ann Feld, Global Quality Supply <strong>Chain</strong> Deputy Director,<br />

Sanofi-Aventis<br />

Lisa Mazzoni, Operational Excellence Specialist, Global<br />

Packaging Development, Roche<br />

10.30 Networking Coffee Break<br />

11.15 Sponsor Spotlight Session<br />

This session is reserved for a leading supplier, if you think<br />

your product would be of interest to the delegation, get in<br />

touch on +44 207 368 9300 or email sponsorship@iqpc.co.uk<br />

STREAM B: Addressing the Inbound<br />

Supply <strong>Chain</strong>: APIs and Intermediates<br />

Quick Win Networking<br />

An opportunity to exchange<br />

business cards with colleagues<br />

focusing on the inbound supply<br />

chain<br />

Designing API Storage and Shipping<br />

Strategies<br />

If you’re interested in leading this session<br />

please contact nicola.ambler@iqpc.co.uk<br />

STREAM E: Blue Sky Boardroom for<br />

Supply <strong>Chain</strong> Executives<br />

Quick Win Networking<br />

An opportunity to exchange<br />

business cards with senior level<br />

colleagues<br />

This year sees the<br />

return of the BLUE<br />

SKY INNOVATION<br />

BOARDROOM to tackle<br />

challenges unique to the most senior<br />

executives.<br />

With changing times presenting new<br />

challenges for pharma and bio supply chain<br />

and temperature control logistics, we are<br />

bringing the senior community together to<br />

openly discuss the challenges and strategic<br />

solutions.<br />

So what’s new?<br />

No vendors, press or consultancies will be<br />

permitted entrance and the meeting will not<br />

be recorded – this is a closed discussion for<br />

you to freely evaluate and develop the next<br />

step in your supply chain plans


CONfeReNCe Day tWO:<br />

wednesdAy 30 JAnuAry 2013<br />

STREAM D: Evaluating and Validating<br />

Temperature Control Transportation<br />

12.25 Networking Lunch Break<br />

13.40 Understanding the<br />

CASE<br />

STUDY<br />

Practicalities of Ocean Freight;<br />

The Port Authority’s View of the<br />

Handling Process<br />

This case study from a port authority<br />

perspective will take you through the handling,<br />

storage and temperature control measures<br />

and contingency plans put in place and how<br />

the ocean freight industry is working to cater<br />

for your needs.<br />

14.10 5 minute change over<br />

13.40 The Development of Global<br />

Pharmaceutical Logistics: Luxembourg’s<br />

positioning<br />

• An overview of the developing logistics<br />

hubs in Luxembourg<br />

• Combining the assets of Luxembourg<br />

with current trends to develop an efficient<br />

pharmaceutical logistics hub<br />

• Investigating the transportation<br />

infrastructure in Luxembourg<br />

Daniel Liebermann, Director, Luxembourg<br />

Ministry of the Economy and Foreign Trade<br />

TAILOR YOUR AGENDA<br />

STREAM B: Addressing the Inbound<br />

Supply <strong>Chain</strong>: APIs and Intermediates<br />

INTERACTIVE SESSION: Managing and<br />

Monitoring the Cold <strong>Chain</strong> during<br />

Manufacturing<br />

Join this open discussion forum to take a<br />

step back and review the early supply chain<br />

challenges surrounding manufacturing and APIs.<br />

• What are the temperature control<br />

requirements?<br />

• Does your manufacturer understand and<br />

adhere to these requirements?<br />

• How can we implement robust strategies<br />

to prevent excursions throughout the whole<br />

supply chain, not just at finished product level.<br />

Find out how your colleagues and fellow<br />

temperature control specialists are managing this<br />

and be part of the discussion!<br />

Saddam Huq, QA Senior Manager, Global<br />

Logistics & Cold <strong>Chain</strong>, GSK Biologicals<br />

Storage and Monitoring for Intermediates<br />

• An overview of the storage process for<br />

human blood plasma and intermediates<br />

• Validation of our new storage facility<br />

for plasma and intermediates including<br />

temperature monitoring system<br />

• Validation conform V-Model<br />

Jaap Visser, Head Warehousing &<br />

Distribution Logistics, Sanquin Plasma<br />

Products<br />

Ralph Ambagtsheer, Process Engineer,<br />

Sanquin Plasma Products<br />

What last year’s attendees thought about the record<br />

breaking cool chain event:<br />

“A great event! I’m glad to discuss many<br />

interesting topics and industry movements with<br />

experts”<br />

Logistics & Fleet Management, Boehringer Ingelheim<br />

“Very good to have the opportunity to really discuss<br />

current issues with industry peers”<br />

Senior Manager, Quality Assurance, Amgen Europe BV.<br />

STREAM E: Blue Sky Boardroom for<br />

Supply <strong>Chain</strong> Executives<br />

How do I get involved?<br />

Due to the exclusive nature of the Blue Sky<br />

Boardroom, there are a limited number of seats<br />

available, issued on a first come, first-served<br />

basis after meeting the admission criteria.<br />

When registering, please indicate that you<br />

would like to be considered.<br />

Contact nicola.ambler@iqpc.co.uk for more<br />

information and eligibility criteria.<br />

What Will Be Discussed?<br />

Whatever you like! This is an open forum for you<br />

to discuss the issues that matter most to you.<br />

There is an outline but you can shape the<br />

boardroom;<br />

• Forecasting and planning<br />

• API manufacturing and shipping<br />

• Creating an adaptive, flexible supply chain<br />

• New product launches<br />

• Horizontal collaboration<br />

• Agile supply chains; how to create flexibility<br />

in pan-EU operations<br />

Moderator: Laurent Foetisch, Managing<br />

Director, Supply <strong>Chain</strong> Operations SA<br />

RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


CONfeReNCe Day tWO:<br />

wednesdAy 30 JAnuAry 2013<br />

CLOsing KEYnOtE sEssiOns On COLLaBOratiOns anD 3rd PartY ManagEMEnt stratEgiEs<br />

Don’t miss these closing keynotes form leading supply chain, logistics and temperature control professionals<br />

14.45 UNICEF Experience - Last Miles in<br />

Distribution of Needed Vaccines<br />

• Cold chain equipment required for longer distances<br />

• Challenges of “In-country’’ logistics to destination<br />

• Logistics and local healthcare partnerships required to ensure<br />

safe delivery of vaccines<br />

• Areas of concerns and perspectives for future improvement<br />

Bertrand Jacquet, Supply <strong>Chain</strong> Specialist, Health Technology<br />

Centre, UNICEF<br />

15.15 Developing a Centralized Transportation and Logistics<br />

Model - European Case Study<br />

• Comparison between decentralized and centralized management<br />

model<br />

• What kind of support can logistics market over in case of<br />

centralized approach<br />

• 4PL role and responsibilities<br />

• How much is transportation and logistics industry ready for new<br />

EU and WHO GDP guidelines<br />

• Two highly regulated industries, airlines and pharmaceutical<br />

manufacturers working together and goods are still left on a<br />

tarmac (why, what to do to prevent)<br />

Zvonimir Majic, Senior Manager Transportation and<br />

International Freight, Pliva Croatia Ltd<br />

15.45 Five Imperatives for Controlling Quality in the Cold-<strong>Chain</strong><br />

• Learn how to develop programs which provide enhanced<br />

transparency and communication among logistics partners.<br />

• Discover which practices are key in mitigating environmental<br />

impact in the cold-chain.<br />

• Understand how to work with your partners to effectively<br />

integrate GDP Guidelines into your quality program<br />

Thomas Grubb, Manager, Cold <strong>Chain</strong> Strategy, Cargo Sales,<br />

American Airlines Cargo<br />

16.15 AIR CARGO DEBATE! How Can Two Highly<br />

Regulated Industries (Aviation And Pharma<br />

Manufacturing) Keep Goods Away From Tarmac?<br />

Air freight is a complex environment with considerable number of<br />

stakeholders involved in handling TTSP shipments. Understanding<br />

it means communication - communication means written<br />

agreements. This debate will bring together both sides to discuss<br />

how the industry will evolve and how they can work in tandem to<br />

improve product handling and efficiency.<br />

Some points for discussion;<br />

• Commercial airline capacities vs. Freighters, capacity<br />

availabilities, seasonality, fuel prices and special products for TTSP<br />

• Role of LSP<br />

• Regulatory approach - strength of GMP / GDP vs. IATA PCR<br />

• What about the TTSP label now?<br />

• Why is air freight turning to ocean freight (is this about to<br />

become a KPI for large volumes in years to come? What will be<br />

the airlines answer to these phenomena?<br />

• CO2 emissions and night flight bans - what is to be expected<br />

from airlines?<br />

Pharma representatives;<br />

Zvonimir Majic, Senior Manager Transportation and<br />

International Freight, Pliva Croatia Ltd<br />

Steef van Amersfoort, Global Transportation & Warehousing<br />

Professional and Chairman Dutch Airfreight Shippers Council, Abbott<br />

Airline representatives;<br />

If you are interested in being part of the debate or want more<br />

information, please do get in touch on +44 207 368 9300 or email<br />

sponsorship@iqpc.co.uk<br />

16.40 Networking Coffee Break<br />

17.10 The Increase of Partnerships and Logistics<br />

CASE<br />

STUDY<br />

About The Organisers<br />

Cold <strong>Chain</strong> IQ: An international resource center<br />

for the temp control life science professional, Cold<br />

<strong>Chain</strong> IQ delivers insightful, unbiased information<br />

about today’s ‘hot topics’. Members (free to join)<br />

benefit by reading expert interviews, trend-setting articles and watching podcasts,<br />

videos and top-rated presentations from IQPC’s global event series.<br />

Cold <strong>Chain</strong> IQ, part of IQPC, has the largest cold chain pharmaceutical international<br />

database, offering strategic partners, members and contributors an unparalleled<br />

opportunity to network, share ideas and disseminate best practice information<br />

across the globe with peers. Join today! www.coldchainiq.com<br />

Media Partners<br />

Collaborations and Improving Supplier<br />

Relationships<br />

• Driving use of 3rd party supply chain logistics to focus on core<br />

competencies<br />

• Investigating the potential and effectiveness of strategic partnerships<br />

• Building relationships and strengthening communications: key<br />

factors to successful partnerships<br />

• Managing subcontractors and maintaining quality and SOP<br />

adherence across your supplier network<br />

Alan J. Davis, Supply <strong>Chain</strong> Temperature Control Leader,<br />

Johnson & Johnson<br />

17.40 Collaboration Matters! Case study: Implementation of a Cold<br />

<strong>Chain</strong> Data Management System at UCB Pharma<br />

This case study will discuss;<br />

• Identification of the need and setting the project development<br />

timeline<br />

• Understanding the role of the partner/vendor in the end-to-end<br />

process<br />

• An overview of our implemented solution and current status<br />

Enhancements<br />

• Our lessons learned<br />

Ronald Van Zitteren, Global Warehousing and Logistics<br />

Director, UCB<br />

Richard Peck, Senior Programme Manager, SensiTech<br />

18.10 Chair’s closing remarks and end of conference


spONsORs<br />

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healthcarelogistics<br />

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IQPC’s 12th annual <strong>Cool</strong> <strong>Chain</strong> Logistics Europe is the largest gathering of the temperature control logistics community in<br />

Europe<br />

The conference is attended by senior decision-makers, bringing together representatives from the whole supply chain<br />

spectrum in one location. Focused and high-level, this is an excellent platform to initiate new business relationships.<br />

Packages can be tailor-made to suit your company’s needs and can include complimentary entry passes, targeted<br />

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RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


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RegisteR NOW<br />

phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com


6th AnnuAl <strong>Cool</strong> ChAin<br />

ExCEllEnCE AwArds<br />

29th JAnuAry 2013<br />

<strong>Cool</strong> <strong>Chain</strong> Logistics Basel is the largest gathering of temperature<br />

control supply chain professionals in Europe and as such, we want<br />

to celebrate the community’s greatest achievements over the past<br />

year. Everyone is faced with budget constraints and resource cuts<br />

and these are bringing creativity and innovation to the supply chain.<br />

The balance between cost and quality is more important than ever!<br />

DO YOU KNOW SOMEONE, A TEAM OR ORGANISATION THAT<br />

HAS WORKED HARD TO ACHIEVE OUTSTANDING RESULTS IN<br />

LOGISTICS OR QA?<br />

gO tO www.coolchaineurope.com/invite tO<br />

nOMinatE tHEM tODaY!<br />

Why attend Clinical trial supply 2013?<br />

For details on cross event ticket discounts contact us on enquire@iqpc.co.uk<br />

or call +44 (0)207 368 9300<br />

Nomination<br />

Deadline:<br />

December<br />

14th 2012<br />

1. The most interactive, discussion focused clinical supply programme – really get to grips with the<br />

possible solutions and what the rest of the community is doing<br />

2. Hear the latest regulations form United States Pharmacopeia and ensure complete supply chain<br />

integrity<br />

3. Lessons in forecasting and planning – how to use your IVR data to improve future forecasting<br />

registration<br />

inCLuDEs entrance to<br />

the 2013 awards ceremony!<br />

2013 awards Categories:<br />

Best Quality and Risk Management Project<br />

Best Temperature Control Logistics Project<br />

Supply <strong>Chain</strong> Integrity Innovator of the Year<br />

Cold <strong>Chain</strong> IQ Lifetime Achievement Award<br />

How does it work?<br />

• The winners will be chosen by our public voting system and expert<br />

judging panel<br />

• Nominations close on 14th December 2012<br />

• Online voting then starts on 7th January 2013<br />

• Winners are announced at <strong>Cool</strong> <strong>Chain</strong> Logistics Europe in Basel<br />

For all the information on nomination criteria, guidelines and judging process go to www.coolchaineurope.com/awards<br />

Clinical Trial Supply Europe follows on from <strong>Cool</strong> <strong>Chain</strong> in<br />

Basel and is Europe’s most senior attended clinical supply<br />

meeting and addresses the latest approaches to improve<br />

the flexibility and reactivity of clinical supply chains.<br />

Feedback from previous attendees:<br />

“Fruitful and motivating!”<br />

Clinical Trial Manager, Transgene<br />

“Very good networking<br />

possibilities”<br />

Theorem Clinical Research


CONfeReNCe CODe: 11399.006<br />

*To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not valid in conjunction with any other offer.<br />

** Please select your choice of workshops: Workshop A OR Workshop B Workshop C OR Workshop D<br />

UK Companies will be charged UK VAT at 20%> VAT Registration #: GB 799 2259 67<br />

Please note: • All ‘Early Bird’ discounts require payment at time of registration and before the cut-off date in order to receive any discount.<br />

• Any discounts offered (including team discounts) must also require payment at the time of registration.<br />

• All discount offers cannot be combined with any other offer.<br />

DELEGATE DETAILS - SIMPLY COMPLETE THIS FORM AND CLICK SUBMIT<br />

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Please indicate if you have already registered by: Phone Fax Email Web<br />

Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking.<br />

PAYMENT METHOD<br />

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Card Number: VISA M/C AMEX<br />

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Pre-Conference Workshop Day: 28th January 2013<br />

Two Day Conference: 29th–30th January 2013<br />

Congress Centre Basel, Switzerland<br />

to speed registration, please provide the priority code located on the mailing label or in the box below.<br />

my registration code pDfW<br />

please contact our database manager on +44(0) 207 368 9300 or database@iqpc.co.uk quoting the registration code above to<br />

inform us of any changes or to remove your details.<br />

gOLD<br />

siLVEr<br />

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OCTOBER 2012<br />

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DECEMBER<br />

2012<br />

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END USER<br />

END USER<br />

63,289 63,398 63,498<br />

61,799 61,999 62,199<br />

VENDOR<br />

VENDOR<br />

63,798 63,898 63,998<br />

62,699 62,799 62,999<br />

• 2 Day Conference<br />

• 2 TRAINING DAY<br />

• Unlimited time in the Exhibition Hall<br />

• Lunch<br />

• Evening Networking Drinks Reception<br />

• Cold <strong>Chain</strong> IQ Membership and access to 100’s of Articles, Podcasts<br />

and Webinars<br />

• Post Event Presentations Access<br />

• Access to the Cold <strong>Chain</strong> IQ Member Lounge<br />

** Limited Packages to 25 (capacity of training)<br />

• 2 Day Conference & Workshops<br />

• Selection of up to 2 Workshops<br />

• Unlimited time in the Exhibition Hall<br />

• Lunch<br />

• Evening Networking Drinks Reception<br />

• Cold <strong>Chain</strong> IQ Membership and access to 100’s of Articles, Podcasts<br />

and Webinars<br />

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City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.)<br />

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5 Ways tO RegisteR<br />

phONe: +44 (0) 20 7368 9300<br />

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pOst: your booking form to iqpc, 129<br />

wiLton roAd,VictoriA, London, sw1V 1JZ<br />

email:enquire@iqpc.co.uk<br />

WeB: www.cooLcHAineurope.com<br />

FIRST 25<br />

TICKETS<br />

REGISTER &<br />

PAY BY 30TH<br />

OCTOBER<br />

2012<br />

BrOnZE<br />

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NOVEMBER<br />

2012<br />

END USER<br />

IQPC recognises the value of learning in teams. Groups<br />

of 3 or more booking at the same time from the same<br />

company receive a 10% discount, 5 or more receive<br />

a 15% discount, 7 receive a 20% discount. Only one<br />

discount available per person.<br />

VENUE & ACCOMMODATION<br />

Venue: Congress Centre, Basel, Switzerland<br />

Accommodation: Accommodation: to be released<br />

shortly. Please check www.coolchaineurope.com for<br />

further information<br />

FREE ONLINE RESOURCES<br />

To claim a variety of articles, podcasts and other free<br />

resources please visit www.coolchaineurope.com<br />

DIGITAL CONFERENCE ON CD-ROM<br />

A digital version of the conference proceedings,<br />

including all presentations, is available to buy.<br />

Recent digital conferences available £599+Vat each<br />

Pharmaceutical Distribution 2012<br />

Nordic Pharmaceutical Distribution 2012<br />

Clinical Trial Supply 2012<br />

Serialisation and Traceability 2012<br />

for further information please call: 0207 368 9300<br />

or email: knowledgebank@iqpc.co.uk<br />

To search IQPC’s archived conference documentation<br />

visit: www.iqpcknowledgebank.com<br />

TERMS AND CONDITIONS<br />

Please read the information listed below as each booking is subject to IQPC Ltd<br />

standard terms and conditions. Payment Terms: Upon completion and return of<br />

the registration form, full payment is required no later than 5 business days from the<br />

date of invoice. Payment of invoices by means other than by credit card, or purchase<br />

order (UK Plc and UK government bodies only) will be subject to a €65 (plus VAT)<br />

per delegate processing fee. Payment must be received prior to the conference date.<br />

We reserve the right to refuse admission to the conference if payment has not been<br />

received. IQPC Cancellation, Postponement and Substitution Policy: You may<br />

substitute delegates at any time by providing reasonable advance notice to IQPC. For<br />

any cancellations received in writing not less than eight (8) days prior to the conference,<br />

you will receive a 90% credit to be used at another IQPC conference which must occur<br />

within one year from the date of issuance of such credit. An administration fee of 10%<br />

of the contract fee will be retained by IQPC for all permitted cancellations. No credit<br />

will be issued for any cancellations occurring within seven (7) days (inclusive) of the<br />

conference. In the event that IQPC cancels an event for any reason, you will receive<br />

a credit for 100% of the contract fee paid. You may use this credit for another IQPC<br />

event to be mutually agreed with IQPC, which must occur within one year from the<br />

date of cancellation. In the event that IQPC postpones an event for any reason and the<br />

delegate is unable or unwilling to attend in on the rescheduled date, you will receive a<br />

credit for 100% of the contract fee paid. You may use this credit for another IQPC event<br />

to be mutually agreed with IQPC, which must occur within one year from the date of<br />

postponement. Except as specified above, no credits will be issued for cancellations.<br />

There are no refunds given under any circumstances. IQPC is not responsible for any<br />

loss or damage as a result of a substitution, alteration or cancellation/postponement<br />

of an event. IQPC shall assume no liability whatsoever in the event this conference<br />

is cancelled, rescheduled or postponed due to a fortuitous event, Act of God,<br />

unforeseen occurrence or any other event that renders performance of this conference<br />

impracticable, illegal or impossible. For purposes of this clause, a fortuitous event<br />

shall include, but not be limited to: war, fire, labour strike, extreme weather or other<br />

emergency. Please note that while speakers and topics were confirmed at the time<br />

of publishing, circumstances beyond the control of the organizers may necessitate<br />

substitutions, alterations or cancellations of the speakers and/or topics. As such,<br />

IQPC reserves the right to alter or modify the advertised speakers and/or topics if<br />

necessary without any liability to you whatsoever. Any substitutions or alterations<br />

will be updated on our web page as soon as possible. Discounts: All ‘Early Bird’<br />

Discounts require payment at time of registration and before the cut-off date in order<br />

to receive any discount. Any discounts offered by IQPC (including team discounts)<br />

also require payment at the time of registration. Discount offers cannot be combined<br />

with any other offer.<br />

PAYMENT MUST BE RECEIVED<br />

PRIOR TO THE CONFERENCE<br />

REGISTER &<br />

PAY BY 18TH<br />

DECEMBER<br />

2012<br />

6699 61,399 61,499 61,599<br />

VENDOR<br />

62,199 62,299 62,349<br />

• 2 Day Main Conference<br />

• Unlimited time in the Exhibition Hall<br />

• Lunch<br />

• Evening Networking Drinks Reception<br />

• Cold <strong>Chain</strong> IQ Membership and access to 100’s of Articles, Podcasts<br />

and Webinars<br />

• Post Event Presentations Access<br />

*** Heads, VPs and Directors can apply for a limited number of ViP tickets to the event at just €299 – it’s first come, first served! ***

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