TEMPERATURE CONTROLLED EUROPE 2011 - imec Messtechnik ...

“Very good lectures, interesting people, chance 

for interactive exchanges of information.” 

Alexandra Marx , Specialist QA, 

Boehringer Ingelheim Animal Health GmbH 

4 

Cool Chain 

TemperaTure ConTrolled europe 2011 

th International Symposium 

Regulatory Requirements • Selection & Validation of Transport Partners 

Effective Monitoring & • Communication • Identifying & Managing Risks 

29 – 31 August 2011 | Steigenberger Hotel Berlin, Germany 

Hear leading international case 

studies from leading companies 

and institutes: 

• Roche Diagnostics 

• Novartis Vaccines and 

Diagnostics 

• F. Hoffmann-La Roche Ltd. 

• Kohlpharma GmbH 

• Bayer Healthcare AG 

• Fraunhofer Institut für 

Materialfluss und Logistik (IML) 

• Lübeck University of Applied 

Sciences 

• Pharmaceutical Cold Chain 

Interest Group (PCCIG) 

• Saxon State Ministry of Social 

Affairs and Consumer Protection 

• Topotarget Switzerland SA 

• World Courier (Deutschland) 

GmbH 

• CPL Pharma Lager- und 

Vertrieb GmbH 

• University of Bonn 

• Sanofi-Aventis 

• Berlinger & Co. AG 

Sponsors 

SAVe 

up to € 290,- with our 

Early Birds if you book by 

the 17 June 2011! 

visit our download center for free white papers, articles and much more! www.cool-chain-conference.com/MM 

feel safe 

Effectively manage cool chain challenges and shape ideas for the future by 

discussing how to: 

• Improve your selection and validation of transport partners through supplier 

assessment process 

• Establish effective controlling and monitoring of transportation from 

production to the final consumer by using RFID and TTI labels 

• Identify and manage risks along the cool chain like the weak spot airport 

and last mile 

• Implement current and upcoming EU regulations and industry standards 

• Use technical solutions such as temperature data logger and multiuse 

thermo container systems for optimised control of the cool chain 

Interactive Workshop Day | Wednesday, 31 August 2011 

A: Qualification of Refrigerated Trucks and Rooms 

B: Manage the Whole Transportation Process to Prevent Loss and 

Minimize Risks 

C: Mitigating Supply Chain Risks in the Cold Chain 

D: Shipping Temperature Sensitive Clinical Supplies 

Highlight Speaker 

Jochen Heinzel 

Supply Chain quality Manager 

F. Hoffmann La-Roche Ltd. 

Klaus Kauer 

Manager qualitätssicherung 

Roche Diagnostics 

Rico Schulze, GMP Inspectorate, 

Saxon State Ministry of Social 

Affairs and Consumer Protection 

Media Partners 

Claude Ammann, 

Managing Director, 

former Site Manager and 

Director of quality 

Assurance / quality Control 

Topotarget Switzerland SA 

Shirley Feld 

Deputy Director, Corporate 

Supply Chain quality & 

Compliance 

Sanofi-Aventis 

Researched and 

developed by 

To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 32 10 | E info@iqpc.de | www.cool-chain-conference.com/MM 

INTERNATIONAL PHARMACEUTICAL INDUSTRY 

INTERNATIONAL PHARMACEUTICAL INDUSTRY INTERNATIONAL PHARMACEUTICAL INDUSTRY 

International Pharmaceutical Industry 

Supporting the industry through communication 


Supporting the industry through communication

4 

Cool Chain 




Dear Colleagues, 

Temperature controlled transportation or cool chain is still one of the most challenging issues within the 

pharmaceutical supply chain. With regulatory requirements currently under review and expected to change, 

the need for up-to-date cold chain logistic solutions is obvious. Furthermore industry standards are converging. 

The difficulty lies in the balance of both quality and cost. 

One of the key challenges in cool chain management contains the selection and validation of reliable 

transport partners. After finding an adequate partner, effective processes of communication and monitoring 

need to be established, so that temperature control and security can be assured. 

Interfaces between different partners and means of transportation are still problematic. Furthermore the last 

mile transportation can be difficult, especially in emerging economies. 

A challenge that is getting more and more into focus is the ambient transportation from 15°C to 25°C. 

Save the date and book now! I look forward to meeting you personally in Berlin. 

Best regards, 

Julian Kerber 

Pharma IQ Team 

Media Partners 

INTERNATIONAL PHARMACEUTICAL INDUSTRY 

INTERNATIONAL PHARMACEUTICAL INDUSTRY INTERNATIONAL PHARMACEUTICAL INDUSTRY 





Sponsorship 

Register for our email updates! 

Get the latest news on our events, additional 

download possibilities, early bird deadlines and 

much more! Register now at 

www.cool-chain-conference.com/MM. 

Sponsor 

World Courier (Deutschland) GmbH 

Seesener Strasse 10-13 

10709 Berlin, Germany 

Tel: +49 211 942 27 27 

Fax: +49 211 942 48 22 

Email: nfoucart@worldcourier.be 

www.worldcourier.com 

CPL Pharma Lager und Vertrieb GmbH 

Solmsstraße 25 

60486 Frankfurt am Main, Germany 

Tel.: 069/79203-0 

Fax: 069/79203-390 

Email: info@cplpharma.de 

www.cplpharma.de 

feel safe 

Berlinger & Co. AG 

We have a variety of packages available to 

Mitteldorfstr. 2 

suit your requirements. For all Sponsorship 

CH-9608 Ganterschwil, Switzerland 

Tel.: +49 (71) 982 88 11 

and Exhibition opportunities call Matthias 

Fax: +49 (71) 982 88 39 

Richter: +49 (0)30 20 91 32 75 or email 

Email: info@berlinger.ch 

COOLCHAIN 

matthias.richter@iqpc.de. 

www.berlinger.com 

ubigrate GmbH 

Since 72 years, pharmind® has been the periodical to be read by decision-makers and multipliers of the pharma scene. Schnorrstraße 

2010 

76 

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PackReport is the large language trade journal for industrial packaging. PackReport readers are the decision-makers from Email: info@ubigrate.com 

the food, beverage, pharmaceutical, cosmetic and consumer goods industries. PackReport reports on newest develop- www.ubigrate.com 

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neue verpackung, the multisectoral decision-maker’s magazine for packaging processes, is one of Europe’s leading 

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Email: info@thermoking-sued.de 

Pharmaceutical Manufacturing and Packing Sourcer (PMPS) is a specialist journal providing coverage of topics relating to www.thermoking-sued.de 

the pharmaceutical manufacturing and packaging sectors. The quarterly journal provides a platform of information-sharing 

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LOGISTIK HEUTE is a professional logistics magazine aiming at decision makers from industry, retail and service provid- IWL AG 

ers. It is an essential source of information which presents new concepts and products as well as current trends along 

Mühlsteige 4 

the whole supply chain. On www.logistik-heute.de the readers will find news, a market place for logistics & IT and a 

comprehensive career portal including a job market. Subscribers are offered a large articles data base, an encyclopae- 89075 Ulm, Germany 

dia explaining technical terms from logistics as well as current studies and presentations by famous logistics experts. Tel.: +49 (0) 731140500 

LOGISTIK HEUTE weekly presents the most important news and events from the field of logistics week by week. For Fax: +49 (0) 73114050 50 

free registration or a trial subscription see www.logistik-heute.de 

Email: info@iwl.de 

Journal for Clinical Studies - Published bi-monthly, JCS is a unique journal, dedicated to providing information to the global www.iwl.de 

pharmaceutical, biotechnology, medical devices and CROs, practical and theoretical operational procedures, challenges, 

validatory and regulatory guidelines when conducting trials on a multisite basis and particularly within the emerging markets, 

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Industriestrasse 13 

International Pharmaceutical Industry (IPI) "Supporting the Industry through Communication" IPI was established to fill in 35463 Fernwald, Germany 

the void for effective marketing and communication between all stakeholders in the life sciences sector globally. Clients Tel.: +49(0)641/795462-0 

use us due to the extensive knowledge and reach we have built up over the years with our Editor, Editorial Advisory 

Fax: +49(0)641/795462-20 

board and market research. We give you links into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. In addition 

to our extensive reach in the Americas & Europe, we have established a strong presence in the Middle East, Latin Email: info@deltaT.de 

America, Eastern Europe, Asia and Africa which are becoming increasingly important to the way the industry is moving www.deltat.de 

forwards in areas of Research and Development, Trials, manufacturing and Technology Transfer. www.ipimedia.com 

www.worldpharmatoday.com is one of the leading online service providers to the Pharma Community. It’s a complete 

Pharma business to business platform which facilitates to bridge the gap between the manufacturer and suppliers in 

improving their business relationships. http://www.worldpharmatoday.com/target-audience Worldpharmatoday.com IMEC Messtechnik GmbH 

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promotional services assists our clients in reaching the top CEO's and key decision makers in the industry. 

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To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 32 10 | E info@iqpc.de | www.cool-chain-conference.com/MM

4 

Cool Chain 



Conference Day One | Monday, 29 August 2011 

09:00 Reception & coffee 

09:30 Chairman’s opening of the first congress day 

Selecting and Collaborating with Transportation Partners 

09:45 Efficient Selection of Transportation Partners 

Case 

Study 

• Efficient systems and parameters to systematically 

scan and select possible partners 

• Selection of partners in new and difficult markets 

• Qualification of partners before go-live 

• Ongoing performance monitoring 

Jochen Heinzel, Supply Chain quality Manager, 

F. Hoffmann La-Roche Ltd 

10:30 How to Valuate and Control your Transportation 

Case 

Study 

Partners? 

• Global-bid including (RFI, RFP, RFQ) 

• Supplier assessment process 

• Scoring / Performance monitoring 

• Core carrier concept 

• From general meetings to quality circles 

Klaus Kauer, quality Manager Global Supply Chain, 

Roche Diagnostics 

12:30 Expert-Panel: 

• Are the revised EU Good Distribution Practices 

� applicable to the realities of cool chain management? 

13:15 Networking luncheon 

14:45 EU Good Distribution Practices: Current Legislation 

Revisions and their Impact on Temperature Controlled 

Storage and Distribution 

• Presentation and discussion of the revised EU GDP 

Guidelines 

• What is the impact on cold chain management? 

Rico Schulze, GMP Inspectorate, 

Saxon State Ministry of Social Affairs and Consumer 

Protection 

Highlight 

Highlight 

15:30 Cool Chain as a Global Challenge 

• Pharmaceutical sensitivity of cool chain products 

• Overview of regulations and guidelines in the US / EU: 

cool and ambient 

• Maintenance of the cool chain as a possible global 

challenge 

• First example: Requirements for the truck carrier 

• Second example: Wholesaler - Active versus passive 

transport (micro distribution) 

• Third Example: Next steps regarding public pharmacy 

(last-mile challenges) 

• Outlook: Possibility of a chain validation? 

Dr. Christoph Frick, Head of quality Assurance and 

Pharmaceutical Development, qualified Person, 

Kohlpharma GmbH 

16:15 Refreshment break & networking 

Technical Solutions for Control of the Cold Chain 

16:45 Key Aspects of Managing the Supply Chain with Multi- 

Use Thermo Container Systems 

• Active and passive systems (pros and cons) 

• Customs (procedures/problems/solutions) 

11:15 

11:45 COOLCHAIN 

• Cleaning/desinfection procedures 

Refreshment break & networking 

• Maintenance 

• Performance control/requalification 

A Reliable Temperature Controlled Supply Chain in 

Claudia Pierenz, Training and Development Executive, 

Emerging Economies 

World Courier (Deutschland) GmbH 

• Risk assessment approach 

• Determine strategies for risk mitigation and securing 

end-to-end cold chain control 

• Recent developments of regulatory details 

Robert Müller, Head of Supply Logistic & 

Warehouse Global, 

Novartis Vaccines and Diagnostics 

17:30 

2010 

Creating a Cost Effective Cool Chain Transporting System 

• The benefits of passive cooling systems 

• Development of a holistically validated system chain for 

the shipment of thermo-labile medicines 

• Ensuring the perfect condition of all products that get to 

the pharmacy through a specially designed thermocontainer 

for normal and special shipment sizes 

• Integrated micrologistics system 

Regulatory Background and Industry Standards 

Jürgen Spindler, Managing Director, 

CPL Pharma Lager und Vertrieb GmbH 

Case 

Study 

Team Discounts 

Highlight 

18:15 Temperature Control of Food Products: Visions and Limits 

• Face the facts - Temperature monitoring in food chains 

• Temperature monitoring devices 

• Modelling the quality status of food as a function of the 

temperature 

• Linking shelf life models and temperature data to calcu- 

late the remaining shelf life 

• Challenges - The implementation of shelf life models 

within food chains 

PD Dr. Judith Kreyenschmidt, 

Head Working Group Cold Chain Management, 

University of Bonn 

19:00 Closing remarks of the chairman and 

end of the first congress day 

To Register | T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 32 10 | E info@iqpc.de | www.cool-chain-conference.com/MM 

Case 

Study 

We are offering attractive Team Discounts, please contact Hannah Schädler on +49 (0)30 20 91 32 74 or email eq@iqpc.de. 

“Very interesting and good package to increase knowledge 

and understanding of the cool chain management.” 

Luc de Visscher, Distribution and Customer 

Service Manager, Sanofi Pasteur MSD

4 

Cool Chain 



Conference Day Two | Tuesday, 30 August 2011 

08:45 Reception & coffee 

09:10 Chairman’s opening of the second congress day 

Dealing with Risks in the Cool Chain 

09:15 Risk Management: Identifying and Handling Risks to 

Case 

Study 

Maintaining Specified Temperatures 

• Identification of potential risks 

• Risk mitigation 

• Case examples 

Shirley Feld, Head of Global quality Transport, 

Sanofi-Aventis 

10:00 How to Deal with Problematic Interfaces between 

Case 

Study 

Different Partners and Means of Transportation 

• Strategies for a smooth handing over 

• Weak spot airport 

• Ways to handle the special challenges of ambient 

temperature transport 

Ingo Ocklenburg, Global Sourcing Manager 

Distribution & Logistics, 

Bayer Healthcare AG 


11:15 Long Term Temperature Monitoring for Last Mile 

• Interruption during storage, loading and shipping 

• Life time monitoring – from manufacturer to end-user 

• Challenges in a cost-efficient and reliable documentation 

Andreas Giger, Sales Director, 

Berlinger & Co. AG 

Transparency from Production to the Final Consumer 

12:00 Managing Temperature Excursions and Implemen- 

Case 

Study 

ting a Stability Program for the Cold Chain Distribution 

• What is already available in the stability data? 

• Using these data to assess temperature excursions? 

• How to add more value to stability data? 

• Practical examples on how these studies can be used to 

decide on temperature excursions 

Claude Ammann, Managing Director, former Site 

manager and Director of quality Assurance/ 

quality Control, 

Topotarget Switzerland SA 

12:45 Networking luncheon 

What’s in your download center? 

Highlight 

Highlight 

The purpose of the download center is to provide you with relevant content 

to enhance your knowledge of current trends and industry news. All content 

is 100% complimentary, easy to download, and current. Featuring live podcast 

interviews which you can stream on your computer or portable device, 

up-to-date news from local and 

international sources, industry whitepapers, and other relevant content – the 

download center is your online portal to expand your knowledge and add 

value to your business. We encourage your feedback and participation, for all 

comments or enquiries please 

contact Hannah on +49 (0)30 20 91 32 74 or eq@iqpc.de. 

Get free white papers, articles and much more! 

www.cool-chain-conference.com/MM 

14:15 Supply Chain Management – a Tool to Optimize your 

Cool Chain 

• Some fundamentals of Supply Chain Management (SCM) 

• Why is SCM important for your cool chain? 

• Demand forecasting – the first step to better information 

• Supply & demand balancing your network 

• Important performance indicators for the chain 

Prof. Dr. Rüdiger Lohmann, Department of Mechanical 

Engineering and Business, 

Lübeck University of Applied Sciences 

Packaging Systems 

15:00 Pharma Standard for Re-Usable Passive Shipping Systems: 

• With an ever increasing number of passive shipping systems 

being distributed and increasing variety of passive 

systems being supplied worldwide: 

There is limited availability of programs for re-using 

passive systems; 

And there are no standards for returning passive 

systems with no clear guidance on re-usable passive 

shipping systems 

• The aim of the task team is to : 

Create a guidance document on the re-use, return and 

recycling processes for passive shipping systems 

• The overall objective being: 

The development of sustainable solutions for returning 

or re-using passive shipping systems 

Reduction of landfill and becoming more “green” 

Meeting existing and future regulations on re-using 

and recycling requirements 

2010 

for packaging materials 

Richard Peck, European Steering Committee Member of 

PDA’s Pharmaceutical Cold Chain Interest Group 

(PCCIG), and Sub-team leader for the Re-usable Passive 

Systems Task Team 

COOLCHAIN 


16:15 Passive Isolated Packaging Systems as the Connecting 

Link in the Supply Chain 

Approaches to put environmentally-friendly initiatives into 

practice 

• Comparison of isolated packaging 

• Freight room temperatures as subject to season 

• Weak spot handling: showcase measurements 

• Technological progress via monitoring 

Gerrit Hasselmann, Project Lead packaging test laboratory, 

Fraunhofer Institut für Materialfluss und Logistik (IML) 

17:00 Closing remarks of the chairman and 

end of the second congress day 

Who will you meet? 

The congress is targeting executives of 

the pharmaceutical industry and pharmaceutical 

logistic provider: 

• Head of quality distribution 

• Head of quality assurance 

• Head of logistics 

• Head of supply chain 

• Head of distribution (and warehousing) 

• Director of operational quality 

• Head of transportation 


4 

Cool Chain 



Interactive Workshop Day | Wednesday, 31 August 2011 

Workshop A 

09:00 – 12:00 

Workshop B 

09:00 – 12:00 

Workshop C 

13:00 – 16:00 

Workshop D 

13:00 – 16:00 

Qualification of Refrigerated Trucks and Rooms 

• Masterplan 

• Risk analysis 

• User requirements specification (URS) 

• Functional specification 

• DQ, IQ, OQ, PQ 

• Plans and reports 

Dr. Christoph Frick, Head of quality Assurance and Pharmaceutical Development, qualified Person, 

Kohlpharma GmbH 

Manage the Whole Transportation Process to Prevent Loss and Minimize Risks 

How do you control your cold chain? “Control” means, to check, monitor and verify by evidence. It should eliminate, prevent, 

minimise the risk of, and adjust to a requirement. Learn how active intervention management can prevent loss and 

find out how you can answer vital questions such as, ‘What is happening? Where it’s happening? When it’s happening? 

What is the resolution?’ 

For further information please visit our website: www.cool-chain-conference.com/MM 

COOLCHAIN 

Mitigating Supply Chain Risks in the Cold Chain 

Minimizing supply chain risk is paramount within the temperature controlled supply chain of pharmaceutical products 

2010 

• Define cold chain risks 

• Examine the tradeoff of lean vs. redundant inventory 

• Identify risks and measure value-at-risk 

• Explore collaborative planning as a way of de-risking 


Shipping Temperature Sensitive Clinical Supplies 

The clinical trial supply chain is unique with a huge number of destinations, smaller packaging and added pressure to mitigate 

risks that could have a severe impact on expensive clinical trials. This workshop will focus on the operating challenges 

related to clinical trial supply of temperature sensitive IMPs and materials and how companies can establish achievable 

goals, select the proper tools and leverage crossfunctional supply chain capabilities. 


IQPC provides business executives around the world with tailored practical congresses, large scale events, topical 

seminars and in-house training programs, keeping them up-to-date with industry trends, technological developments and 

the regulatory landscape. IQPC’s large scale congresses are market leading “must attend” events for their respective 

industries. IQPC produces more than 1,500 events annually around the world, and continues to grow. Founded in 1973, 

IQPC now has offices in major cities across 5 continents including: Berlin, Dubai, London, New york, São Paulo, Singapore, 

Stockholm, Sydney and Toronto. IQPC leverages a global research base of best practices to produce an unrivalled portfolio 

of congresses. www.iqpc.de 


Congress code DE12234.004 

4 

Cool Chain 




If undeliverable, please return to: 

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yOUR DETAILS: PLEASE CONTACT OUR DATABASE MANAGER (vERTEILER@IQPC.DE) AND INFORM THEM OF ANy INCORRECT 

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2 day congress plus 1 workshop 

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4 Ways to Register 

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Post: IQPC Gesellschaft für 

BOOKINGCODE 

Management Konferenzen mbH 

Friedrichstraße 94 


Online: www.cool-chain-conference.com/MM 

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Phone: +49 (0)30 20 91 33 30 

Venue and Accommodation 

Steigenberger Hotel Berlin 

Los-Angeles-Platz 1 


Tel.: +49 (0)30 2127 0 

Fax: +49 (0)30 2127 117 

Email: berlin@steigenberger.de 

www.berlin.steigenberger.de 

COOLCHAIN 

Please indicate choice of workshop on Wednesday, 31 August 2011 

Only one discount applicable per person. 

CAN'T MAKE IT TO THE CONGRESS? PURCHASE THE 2-DAy CONGRESS DOCUMENTATION FOR € 595,- +vAT. 

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A: qualification of Refrigerated Trucks and Rooms 

B: Manage the Whole Transportation Process to Prevent Loss and Minimize Risks 

C: Mitigating Supply Chain Risks in the Cold Chain 

D: Shipping Temperature Sensitive Clinical Supplies 

IMEC 

Accommodation: A limited number of reduced rate rooms 

are available at the conference hotel. Accommodation can 

be booked by calling the central reservation number. 

Please always quote the booking reference IQPC-Berlin. 

Hotel accommodation and travel costs are not included 

in the registration fee. 

For further information 

2010 

please visit our website www.cool-chain-conference.com/MM 

or contact Hannah on +49 (0)30 20 91 32 74 or email 

eq@iqpc.de. 

Team Discounts 

We are offering attractive Team Discounts, please contact us! 

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