of supply chain operations sa opportunity to network with

COLD SUPPLY SYSTEM AND SOLUTIONS 2013

Brussels Cold Chain Network presents the 2nd annual CSS 2013 comprising of over 20 practical cases dedicated to safe

transport of ‘time and temperature sensitive’ medicine.

PharmaDialogue Testimonial:

“We are very pleased to be part of

this event; I describe it as a fantastic

opportunity to network with a list of

who is who in the market.” Senior

GDP Manager, Germany

CHAIRMAN

NAME: LAURENT FOETISCH

CURRENT: MANAGING DIRECTOR AND FOUNDER

OF SUPPLY CHAIN OPERATIONS SA

EXPERIENCE: 21 YEARS AS VP OF GLOBAL SUPPLY CHAIN AT

SERONO

Sponsors & Exhibitors


“Thank you the platform as promised was end user driven and I really appreciate that only two other competitors were accepted on site. We do not see the need to for any further marketing investment. I thank you again and will see again next year.” Cold Chain Manager, AZ Pharma

Strategic Partners

DATE: 6TH

, 7TH

AND 8TH

OF MARCH 2013

LOCATION: BRUSSELS, BELGIUM

VENUE: SHERATON BRUSSELS AIRPORT HOTEL

A PharmaDialogue Symposium Patient Safety matters…

The Healthcare desk of Business Dialogue World Wide

Means of Registration:

Telephone: 00 44 (0) 207 096 0597

Free Toll: 0 800 8101495

Via Email: [email protected]

Via Email: [email protected]

Via Fax: 00 44 (0) 207 096 8975

ABSOLUT fundamental for 2013: GDP Text Interpretation Drs R.J. Bruinink, Healthcare Inspectorate The Netherlands, Senior GMP and GDP Inspector

Patrick Pichler, The Austrian Health Agency, AGES, GMP

Inspector

WWW.COLD-GDP.COM

http://www.cold-gdp.com





My Confirmed Speaking Panel:

Who will I Meet There?

Laurent Foetisch, Managing Director, Supply Chain

Operations SA

Edith Penxton – EMEA Clinical Supply, BMS

Drs. R.J. Bruinink, Senior GMP and GDP Inspector, Health

Care Inspectorate The Netherlands

Patrick Pitchler, Austrian Health Agency (Ages), GMP

Inspectorate

Maurizio Caschera, Sanofi Pasture – Quality Assurance

PD Dr. Judith Kreyenschmidt, Cold-Chain Management

Group, ITW, Universität Bonn,

Debby Mattyes, MSD, EMEA Logistics Director

Verena Brenner, Research Associate, Jacobs University

Andrea Grober, IATA – QA – (chapter 17)

Jurgen DeHenau, Transport & Cold Chain compliance

manager, Pfizer

Luc Huybreghts, SR. QA Consultant, Pauwels Consulting

Frank Peters, Managing Director, QP, Tobeas

Jens Lamberth, Category Department, AstraZeneca

Nathan De Valck, Cargo Director, Brussels Airport

Ulrike Kreysa, GS1 Global Office, Vice-President

Healthcare.

My Auxiliary Sessions:

6th

of March, Workshop A: Cold Chain Challenges

6th

of March, Workshop B: Thermal Mapping & Validation and

transportation: CHAPTER 3 & 9

Round Table and Panel on 7th of March 2013

7th of March-Day 1: Complaints and Return: suspected falsified

Medicinal Products and Medicinal Product Recalls: CHAPTER 6

7th of March-Day 1: Product Traceability: based on suppliers and

customers qualification, marketing authorisation and exchange of

medicinal goods: CHAPTER 5

How would you tackle the current GDP requirements concerning

Ambient Packaging?

Round Table and Panel on 8th of March:

8th of March, Panel: GDP Text Interpretation?

8th of March-Day 2: Quality Management: Quality System,

Management Review and Monitoring, Quality Risk Management:

CHAPTER 1

8th of March-Day 2: Contract Operations: Supplier Selection, Contract

Giver, Contract Acceptor and Contract: CHAPTER 7

According to our survey, the following are the Absolut

Fundamentals for 2013:

A text interpretation of the current GDP: explore

the guidelines

Practical insight on how to implement best practice

in handling deviations: Preventative measures

Mapping & Validation and Transportation: Chapter

3 (premises and equipment) - Chapter 9

(transportation)

Engage in solution driven discussions covering all

range of temperature product specifications

My Business Case For Attendance:

What Can I Expect To Learn:

COVERED GDP CHAPTERS: 1, 3, 5, 6, 7 & 9

1. Best practice in handling Time and Temperature Controlled

Products

2. The importance of a 24/7 cold chain monitoring

3. Assess novel and growing trends concerning Passive V Active

4. Correct interpretation of the Good Distribution Guidelines

5. A step by step approach to building a secure cold chain

6. Risk assessments and mitigation involved in distribution

7. Addressing fundamental points concerning transportation

8. Vendor selection and choice of technology

9. Address the question of cost effectiveness aligned to quality

10. Meet European GDP Inspectorate

11. Practical case studies shared from the field

12. Plan and implement a secure and stable cold chain

13. Contingency/back up plans if and so when delays occur

14. An A-to-Z of addressing challenges within the EU market

15. A criterion based approach toward cost v quality

16. The importance of addressing regulatory requirements

17. Order, Monitor, Store and Distribute

18. Interpretation of international standards concerning cold chain

19. Simplified decision making criterion for solutions

20. Regulatory expectations for cold chain the current changes

21. Fundamental challenges concerning regulatory requirements

22. Assess the question of cost in relation to packaging

23. Cold chain compliance and risk assessment

24. Examine the possibilities and realistic options

25. Developing best management for biological products

26. Contingency planning for cold chain failure

27. The cultural differences within the EU market

28. Explore key f/actors concerning Passive/Active decisions

29. Pre-plan and examine critical points of requirements

30. Evaluate optimal outsourcing options




Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: [email protected]

Sample List of Attendees in 2012

Company Job Title Location

AFMPS Belgium Health Agency Head of Inspection GDP/GMP Belgium

German Health Agency Senior GDP/GMP Inspectorate Germany

Statens Serum Institute Qualified Person Quality Assurance Denmark

Statens Serum Institute Shipping Manager Denmark

Boehringer Ingelheim Head of Supply & Quality Management Germany

Logistics Consulting e2e Managing Director USA

MSD-Ireland Validation Engineer Ireland

Merck Global Logistics - EMEA Belgium

Amgen Senior Transport Manager Netherlands

Merck - France Logistic Manager - Shipping / Export / Internal flow France

Almirall S.A. Corporate QA &Supplier Selection Spain

Almirall S.A. Corporate QA & Manager Logistics Spain

Brussels Airport Head of Development Belgium

Janssen Pharmaceutica nv Senior Manager - Qualified Person QA Belgium

Janssen Pharmaceutica nv Head of Global Division - Qualified Person - QA Belgium

Envirotainer Head of Compliance and Partner Selection USA

Baxter Director Transport EMEA Belgium

Sanofi Quality Assurance India

Penske Logistics Cold Chain Specialist Netherlands

BTGIL - (Vaccine company Israel) Head of Logistics Israel

BTGIL - (Vaccine company Israel) Quality and Logistics Israel

Aviapartner Cargo Director Belgium

Aviapartner Site Manager Belgium

Bayer Healthcare Clinical Distribution Germany

Cardio3 BioSciences S.A. Supply Chain Manager Belgium

Alcon Labs Supply Chain Manager Belgium

Baxter Supply Chain Director India

Merck India Director of Distribution India

UPS Senior Director of QA Netherlands

Distribution Wholesalers Association Corporate Advisor Belgium

Perrigo Pharmaceuticals Logistics Director UK

Tabriz Consulting Managing Director UK

CSS2013 symposium in a nutshell? All presentations,

Workshops, Roundtable Dialogues at CSS2013 are ‘practical’

from the field and ‘new’ discussed for the first time;

concerning Time and Temperature Controlled Healthcare

products.

Strategic Focus? The speaking panel comprises of Senior GDP

inspectorates, pharmaceutical cold chain champions and

professionals and practitioners. At strategic level the focus is

firstly: to implement best practice in optimal ‘standardisation’

of processes. Secondly; correct ‘interpretation’ of the current

Good Distribution Practices Guidelines’ text, hence to address

‘regulatory harmonisation’.

Number of Attendees? For 2013 we are expecting 70 or more

registrations from practitioners; in excess of 45 registrations

were submitted for 2012 event. The majority of colleagues

joining come from EU based Pharmaceutical companies. They

are all concerned with challenges within the EU market and

overcoming them; in relation to the Global cold chain market.

This event is a platform for ‘END USERS / Decision Makers from

the Pharmaceutical Industry’; but also welcomes a limited

number of suppliers.

Why Belgium, Brussels? Belgium is the most strategically

located country in Europe – for anyone attempting to reach

the European Union customer base. A market of 500 million

people with Brussels as its Capital is the most ideal place of

business.

Brussels is the capital of the European Union (EU) hosting

principle EU institutions and home to numerous international

organisations. Brussels in on the boundary between the Latin

cultures of southern Europe and Germanic cultures of

Northern Europe. It is in fact both perfect as ‘test transport

location’ and a permanent hub in EU. Further global access

given its Air, See and Land transport systems.

mailto:[email protected]


Master Workshop A; From 13:00 to 14:30, 6th

of March 2012

Master Workshop A; From 13:00 to 14:30, 6h of March 2012

Workshop A: End to End Temperature Controlled Chain Management - Associated

Challenges and Risks Mitigation Headache:

Explore the impact of early planning and identification of risk exposure within the

Temperature Controlled chain and listen about suggested solutions/recommendations. Here

the entire time will be dedicated to temperature sensitive chain and will be opened for

discussion and interaction. Assess how the role of technology or mode of transport can impact

your ability to achieve control over excursions. Deep dive on "too many" product handovers

within the temperature chain, from manufacturing to patient use, where the product change

hands and how critical those transmission points are to mitigate risk of deviation. The

workshop is interactive and builds momentum through an in-depth group sharing:

Understand the Temperature controlled chain with its basic set-up and functionality

Explore a detailed approach how best to identify weakness and challenges within

the temperature controlled chain

De-risking your temperature controlled chain and build-in processes to mitigate risk

of excursion and enhance compliance.

1. Review the organization and structure dedicated to temperature controlled chain

2. Understand the impact of the upcoming tightened GDP regulations

3. Assess the role of technology

4. Identify alternative mode of transportation

Practical insight on how to implement best practice in handling deviations

Strengthen the chain through better relationship and communication with

‘partners/CMOs/suppliers, and/or governmental agencies involved’.

Engage in solution driven discussions covering all range of temperature product

specifications.

The last mile: how critical it can be?

About your workshop leader: Laurent Foetisch has been working for 21 years as VP Global

Supply Chain at Serono and then Merck Serono. In 2011, Laurent founded Supply Chain

Operations SA with the objective to provide support to Pharma, Biotech and Medtech

companies in their day-to-day supply chain operational challenges. Laurent is also a member

of the Marken Advisory Board and professor at EHL, Lausanne.

Master Workshop B; From 15:00 to 16:30, 6th

of March 2012

Master Workshop B; From 15:00 to 16:30, 6th of March 2012 Workshop B: Validation of warehousing and transportation systems to comply with current GDP – a risk based approach: Good Distribution Practices and the impact on Temperature Regulated and Temperature Controlled Medicine for Human Consumption. The current Guidelines on GDP was published in 1994 and is no longer adequate, it does not take into account advancements of products in EU. With the publication of the Directive 2011/62/EU on the Community Code relating on Medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products, additional pressure was generated for revision and updating of the GDP guidelines. European Commission Health Files: vol-4/2011-07 GDP Guideline Public Consultation One of the key areas highlighted as high priority is ‘Mapping & Validation and Transportation’ covered respectively in:

Chapter 3 (premises and equipment)

Chapter 9 (transportation) The workshop will assist delegates with: The extent of initial Thermal Mapping in relation to GDP requirements prior to commencement of use of us Warehouse and transportation system: warehousing and transport risk management for cold, ambient, cool and so on.

1. Risk management challenges to assure GDP compliance 2. Assess the impact of modifications made to the facility or temperature controlling

equipment 3. Address qualification and validation related to change control and CAPA’s 4. Discuss transportation as per requirement of storage conditions for medicinal products

Workshop leader: Frank Peters, PhD, QP, Managing Director, Tobeas, expert in qualification and validation of warehouses, transport controls and warehouse management systems for pharmaceutical products with; more than 10 years’ experience in the field.


“The overall symposium was clear and concise in identifying

emerging trends and addressing them.” Logistics Manager, Belgium





DAY ONE OF SYMPOSIUM

8:00 Registration, 8:30 Welcome and Coffee 7th of March 8:45 Chairman’s opening

9:00 – 9:45: GS1’s approach to traceability:

GS1‟s focus on developing and implementing standards concerning

traceability

Assessing GS1 standard for healthcare patients, products, places

and transport

Further discussing logistics and supply chain – both locally and

globally

Practical examples of „authentication‟ e-pedigree

Emerging trends across the globe

SPEAKER: ULRIKE KREYSA, GS1 GLOBAL OFFICE,

VICE-PRESIDENT HEALTHCARE

9:45 – 10:30: In this presentation a best practice will be shared on how security review is set up within the MSD EMEA entity:

When talking about GDP and pharma, people think mostly of quality related protection of the product, such as temperature and environmental control, qualifications, change control, quality risk management, training, complaints. But how first rate and effective those may be, it is crucial that those products are continuously stored and transported in a well secured and protected way. In this presentation a best practice will be shared on how security review is set up within the MSD EMEA entity. Topics that will be handled are internal questionnaire, site security review and lane-assessments.

SPEAKER: DEBBY MATTYS, MSD GLOBAL LOGISTICS

OPERATIONS EMEA DIRECTOR

New Case Study: GS1 Standards and Authentication

Global Standards One – GS1 is a non-profit organisation dedicated to

improving the efficiency & visibility of supply & demand chains globally

Its member organisations are in over 100 countries

Over 30 years of experiences and coverage of Healthcare, Transport and

Logistics, Retail among others

Intra-Accepted: FDA: US Food & Drug Administration, UN, CEFACT,

WHO, WCO, Ministry of Health UK, Ministry of Health Japan,

CIP/ACL (France) is a partial list of organisations/Governmental bodies

supporting GS1

ARE YOU setting up a „traceability‟ system subject to the GDP

requirements, addressing Grey areas? Do you have a question? Email us:

[email protected]

New Case Study: The best approach to

address security and protection

Assess the effectiveness of your continuous monitoring

system for your time and temperature sensitive products

Key examination of qualifications, quality risk

management and complaints

Lane assessments and environmental control of the

products

Best Practice approach of how „security reviews‟ are set up

within MSD EMEA.


10:30 – 11:00 Morning Tea and Coffee: Networking and Dialogue in Motion

11:00 – 11:45: Comply with provisions a proper qualification/validation of monitoring equipment, containers, vehicles, and measuring equipment should be performed:

The transport conditions should maintain the quality of the product, protect against breakage, adulteration and theft, and ensure appropriate environmental conditions are maintained during transport. Medicinal products should be transported in accordance with the storage conditions indicated on the packaging information. To comply with these provisions a proper qualification/validation of monitoring equipment, containers, vehicles, and measuring equipment should be performed. The validation should consider different seasons of the year, transport durations (hubs), and types of vehicles used for the transport. The validation costs are dependent on the extent and depth of the validation.

SPEAKER: Patrick Pichler, GMP Inspector, The Austrian Health

Agency, AGES

New & Exclusive TO CSS 2013: Address

the key focus on validation/qualification in relation the GDP requirement

Qualification as defined in „Eudralex Volume 4 Glossay to

the GMP Guidelines‟ is: “Action of proving that any

equipment works correctly and actually leads to the expected

results”.

Validation is also a „word‟ used sometimes to widened to

incorporate the concept of Qualification

As a wholesale distributor you “should identify what qualification and or validation work is necessary to demonstrate control of key aspects of their activates”. SOURCE: http://ec.europa.eu/health/files/eudralex/vol-4/2011-

07_gdpguidline_publicconsultation.pdf

To what extent are you ready to address the ABSOLUTE FUNDAMENTALS for 2013?

11:45 – 12:30: A risk mitigation approach in identifying and classifying modes of transport:

Definition of ‘Risk Mitigation’ in Cold/Cool chain concerning the mode of transport?

Identifying weak lanes and the choice of mode: Sea, Air or Land

Thermal route qualification and in relation to associated risks

Choice/Setting the route and seeking collaborations and clarity from all stakeholders: such as airliners through quality agreements

SPEAKER: Luc Huybreghts, SR. QA Consultant Pharma,

Pauwels Consulting

New & Unique presentation to CSS 2013: an

assessment and identification of weak lanes of transport.

Risk based decision making process based on thermal qualification

Vital to risk mitigation is „weak lanes‟ identification

Assessing the role of all stakeholders based on quality agreements

Luc Huybreghts, is a Senior Consultant, Pauwels Consulting, a key

note Speaker, industry Expert and Contributor to the global cold chain

community.

If you wish to submit a question prior to participation, concerning „risk

mitigation‟ to Luc please email: [email protected] and we‟ll redirect

it to Mr Huybreghts



12:30 – 13:30 Launch: Networking and Dialogue in Motion

13:30 – 14:15: Lessons learned and the key to Green Packaging:

Definition of Green Packaging? Identifying critical points within the chain subject to excursion USA v EU packaging similarities and differences Addressing wastage and associated challenges Understanding the solution required and identifying the solution provider Balancing cost V quality in relation to internal requirements A question for the Audience: Given the current changing nature of time and

temperature supply chain landscape: How would you tackle the current GDP requirements concerning Ambient Packaging?

SPEAKER: Edith Penxten, Director EMEA, BMS

New Case Study: the question of long

term investment into cold chain Green Packaging is explored by BMS for the First Time:

Use the definition of Green Packaging for pharma cold

chain as the bases of your decision What are the longer terms benefits of Green Packaging?

And can such benefits be used to influence the ‘internal organisational’ decision making process?

Examine the impact on wastage

Are you considering a Green Packaging initiative? Would you be interested in explore the influence of the current GDP might be on ambient packaging?

Email us your thoughts on ‘GDP V Ambient’ packaging at [email protected]

14:15 – 15:00: Container validation a case for collaboration with suppliers:

The difference between passive and active

Seasonal and weather changes in relation to container modification

Addressing and overcoming challenges via ‘transparent partner relationship’

SPEAKER: Jurgen DeHenau, Pfizer, Transport & Cold

Chain compliance manager

New Case Study: based on Pfizer’s experience in assessing

and implementing the best container system

How can the transparency of your partners help in overcoming your

cold chain management complications

What specifications would you look to request when requesting

container modification?

PharmaDialogue Testimonial: “I wanted to thank you, the symposium was in fact excellent, it

has been a very long time since I have attended a presentation and felt I was learning

something new. Also thanks for the free presentations from last year.” QP, France



15:00 – 15:30 Afternoon Tea and Coffee: Networking and Dialogue in Motion

16:15 – 17:00: Round Table Dialogue A & B:

15:30 – 16:15: Academic Spotlight: Cold Chain Optimisation and Predictive Tools and

Technology:

Starting point of the presentation are problems of temperature monitoring within the supply chain of food and summarized results of some chosen investigations in food chains. Suggestions, how to optimize the temperature monitoring in international pharmaceutical chains will be shown, that bases on the investigations in food chains. The use of time-temperature indicators will be discussed, especially to control the temperature history of a product. Examples will be given, how such a technology can be used within the pharmaceutical industry. It also will be introduced, how to develop models to deliver information about the real quality of a product and how such models can be combined with time-temperature indicators to predict the remaining shelf life of a product. The presented results are from the Cold Chain.

SPEAKER: Ed PhD, Dr Judith Kreyenschmidt, Cold-Chain Management Group,

ITW, Management Group of the University of Bonn – Universität Bonn

New Case Study;

Academic Spotlight: Can the food industry help in presenting new and novel ideas to improve pharma cold chain management?

Assess the how examples of

applied technology from the Food

Industry can be harmonised into

the „pharma‟ cold chain and

address challenges

Direct recommendations based

on „study of the food industry‟

and how it can be expended to

help the pharma industry

A. Complaints and Return: suspected falsified Medicinal Products

and Medicinal Product Recalls

“All complaints and other information concerning potentially defective medicinal products must be collected and reviewed carefully according to written procedures.” AND “Standard Operating Procedures for handling product recalls and other similar situations should be prepared, maintained, and implemented.” Chapter 6 GDP Draft, SOURCE: http://ec.europa.eu/health/files/eudralex/vol-

4/2011-07_gdpguidline_publicconsultation.pdf

B. Product Traceability: based on suppliers and customers

qualification, marketing authorisation and exchange of medicinal goods:

“All actions taken by the distributor should ensure that the identity of the medicinal product is not lost and that wholesale distribution of medicinal products is handled according to the specifications given on the packaging information.” Chapter 5 GDP Draft, SOURCE: http://ec.europa.eu/health/files/eudralex/vol-


Chairman’s close: End of Day 1



DAY TWO OF SYMPOSIUM

8:00 Registration, 8:30 Welcome and Coffee 8th of March 8:45 Chairman’s opening

9:00 – 9:45: A best practice approach to quality agreements

What are the regular expectation of a Quality Agreement within the GDP

framework?

Identifying key stockholders and agreeing on terms of agreement

Assessing and mitigating potential risks; business Vs compliance or business &

compliance?

Regulatory and operative company requirements

Best possible approach and further recommendation

SPEAKER: Maurizio Caschera, Quality Assurance, Sanofi Pasture-MSD

9:45 – 10:30: Assessing the impact of harmonised procedures in handling time and temperature excursion:

Defining Harmonisation or Standardisation?

What is the procedure, the definition of an excursion

Identifying key stakeholders

Challenges in establishing common producers in handling excursions

The role of external partners – such as vendors or logistics providers?

Suggestions, Benefits and recommendations for establishing a harmonised approach

SPEAKER: Jens Lamberth, Global Category, AstraZeneca

New and exclusive to CSS

2013:

A practical and methodological assessment of quality

agreements and key consideration within the GDP

structure

Classifying the stakeholders in relation to terms of

agreement

Examine how to balance the regulatory requirements

against the operative procedures

New Case Study:

Evaluate and prepare for key obstacle arising while

implementing standardised and common procedures

Key consideration in defining excursion in relation to

both time & temperature

How to unify and coordinate efforts with solution

providers on pre-established grounds when tackling

excursions?

PharmaDialogue Testimonial: “This is how you run a symposium; trends,

details presentations, great speakers and an operational team on site that was

exceptionally proactive in help me with networking. Thank you

PharmaDialogue.” Shipment Department, Denmark


10:30 – 11:00 Morning Tea and Coffee: Networking and Dialogue in Motion

11:00 – 11:45: An strategic overview of the impact of the GDP especially on transportation of Time and Temperature sensitive products:

A perspective based on the EMA GDP drafting group‘s attention

Assess and examine the key changes and requirements in general

Examine the impact on time and temperature sensitive products

What can be the expectation on for Ambient Products?

SPEAKER: Drs R.J. Bruinink, Healthcare Inspectorate, The

Netherlands, Senior GMP and GDP Inspector

New perspective on GDP

requirements: a key fundamental to 2013

preparations and preventative measures is ‘Ambient’

How can you position the transportation, and safe delivery of products based on EMA GDP drafting consideration

Gain a clear focus on the overall impact of the GDP on your entire chain

Address the key requirements and expectation in relation to Ambient

11:45 – 12:30: A text interpretation of the current GDP: explore the Good Distribution practice guideline

Pose direct question from the GDP experts

Accurate understanding of the 'text' in relation to cold/cool/ambient products

Examine, Discuss and Engage so to erase grey areas of the GDP text

Panel of Experts:

1. Drs R.J. Bruinink, Healthcare Inspectorate The Netherlands, Senior GMP

and GDP Inspector 2. Patrick Pichler, GMP Inspector, The Austrian Health Agency, AGES

Panel of experts: address and

question the GDP draft and prepare for potential outcomes

To what extent are you prepared for the new

GDP guidelines?

Have you considered how the draft may impact

cold chain management as whole?

Are you repositioning your cold chain

management systems – would you have an

interest in meeting GDP and GMP inspectors

from EU to and answer your questions?

Submit your questions ahead of symposium and

we‟ll redirect them for you: [email protected]



12:30 – 13:30 Launch: Networking and Dialogue in Motion

13:30 – 14:15: IATA standards: Air freight transportation of temperature senstive products

IATA Standards: Air Freight Transportation of Temperature Sensitive Products; The presentation is aimed at sharing with the industry how the current challenges in transporting healthcare products by air are addressed by IATA together with the supply chain stakeholders in a collaborative approach. The IATA Perishable Cargo Regulations (PCR) Chapter 17 “Air Transport Logistics for Time and Temperature Sensitive Healthcare Products” specifically addresses the temperature control management issues identified by the industry and sets out standards such as the mandatory use of the IATA Time and Temperature Sensitive label effective July 1st, 2012. A shipment label, specific to the healthcare industry that must be affixed by shippers to healthcare products transported as temperature controlled cargo. These requirements enhance the transport and handling of such specific healthcare commodities with the aim to ensure patients safety through effective cold chain distribution. The feedback of the industry on the implementation of the label is key for IATA to enable to enhance the regulation and address industry’s need. As next steps, IATA will be looking at the development of standards setting in areas such as training and audits.

SPEAKER: Andrea Gruber, Business and Standards, IATA, International Air Transport Association

14:15 – 15:00: The role of Brussels Airport Authority in promoting and creating transparency in cold/cool supply chain:

The GPRS project, securing the BruCargo zone and building new infrastructure

Identification of blind spots in lanes of transport and applied solutions

Push toward technological innovation and Standard Operating Procedures

Evaluating why Brussels Airport can be the preferred choice for all cold/cool chain stakeholders

SPEAKER: Nathan De Valck, Cargo Account Manager - Cold

Chain - Brussels Airport Company

New Case Study: Brussels Airport championing

the cold/cool supply chain as a key Hub for EU air transports system

Explore the extent of the Extent of Brussels Airport Cold

Chain capabilities

Question Brussels Airport‟s study in relation to weak lane

identification

Assess how the new infrastructure can assist you in

increasing security and safe delivery of products based on

the Airport‟s capabilities

PharmaDialogue Testimonial: “Brilliant service tailored to our budget and the

needs of our continuous improvement logistics project. I was very sceptical that we

could join the symposium; and we remain obliged to share our experience; given

the level of service we received from you.” Logistics Manager, Ireland


15:00 – 15:30 Afternoon Tea and Coffee: Networking and Dialogue in Motion

16:15 – 17:00: Round Table Dialogue A & B:

15:30 – 16:15: Preventative measures concerning cold/cool chain disruption:

360 Degree Cockpit Disruption Tool: a complete supply chain monitoring tool

Identify, classify and priorities information

Locate cold/cool chain weak points and recommend counter measures

Analysis of the different distribution partners based on Empirical Data

Industry colleagues are invited to discuss potential collaboration concerning this tool

SPEAKER: Verena Brenner, Research Associate, Cold-Chain

Management, Jacobs University

New Case Study: Jacobs University is

developing a predicative tool for cold chain management

Can you assess information and implement preventive

measures prior to „excursions‟?

Can you prepare or anticipate a disruption?

In absence of harmonised-standardised procedures – what

course will you take?

Jacobs University is now developing a predictive tool that

can assist you with recommended counter measures in

handling counter measures

A. Quality Management: Quality System, Management of Outsourced

Activities, Management Review and Monitoring, Quality Risk Management

“Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.” AND “The quality system should incorporate quality risk management principles.” Chapter 1 GDP Draft, SOURCE: http://ec.europa.eu/health/files/eudralex/vol-4/2011-07_gdpguidline_publicconsultation.pdf

Contract Operations: Supplier Selection, Contract Giver, Contract Acceptor

and Contract

“Both the contract giver and the contract acceptor must hold a distribution authorisation.” AND “Contract should cover all wholesale distribution activities and clearly establish the duties and responsibilities of each party” – AND - contracts should be established for any activity likely to impact on GDP related activities. Chapter 7 GDP Draft, SOURCE: http://ec.europa.eu/health/files/eudralex/vol-


Chairman’s close: End of Day 2



Pharma/Biopharma/Biotech attendance pricing structure:

Cost of registration for End Users Register and pay by 21st

of Dec 2012 Register and pay by 25th

of January 2013 Register and pay by 15th

of February 2013 Standard Price

Conference Save: €350 Pay Only: €1149 Save: €250 Pay Only: €1249 Save: €150 Pay Only: €1349 Only €1499

Conference + Workshop Save: €400 Pay Only: €1698 Save: €300 Pay Only: €1798 Save: €200 Pay Only: €1898 Only €1998

Conference + Recordings Save: €350 Pay Only: €1648 Save: €250 Pay Only: €1748 Save: €150 Pay Only: €1848 Only €2098

Conference + 2 Workshop Save: €510 Pay Only: €2187 Save: €410 Pay Only: €2287 Save: €310 Pay Only: €2387 Only €2497

Conference + 1 Workshop + Recordings Save: €500 Pay Only: €2097 Save: €400 Pay Only: €2197 Save: €300 Pay Only: €2297 Only €2547


Above Pricing Structure applies to colleague joining form Pharmaceutical, Biopharmaceutical, Biotechnology and Clinical Trial Management Companies. . If you are uncertain if this price applies to you and your company we advise you; PRIOR to registration to contact us directly: 00 44 (0) 207 096 0597. Or you may require a ‘budget tailored’ package: specific workshop, day or a package according your budget. We strongly advise you to contact us directly: [email protected]

Vendors/Suppliers/Service Providers attendance pricing structure:

Cost of registration for End Users Register and pay before 21st

of Dec 2012 Register and pay before 25th

of January 2013 Register and pay before 15th of February 2013 Standard Price

Conference Save: €350 Pay Only: €1649 Save: €250 Pay Only: €1749 Save: €150 Pay Only: €1849 Only €1999

Conference + Workshop Save: €400 Pay Only: €2098 Save: €300 Pay Only: €2198 Save: €200 Pay Only: €2298 Only €2498

Conference + Recordings Save: €350 Pay Only: €2248 Save: €250 Pay Only: €2348 Save: €150 Pay Only: €2448 Only €2598

Conference + 2 Workshop Save: €510 Pay Only: €2487 Save: €410 Pay Only: €2587 Save: €310 Pay Only: €2687 Only €2997



Above Pricing Structure applies to colleague joining from vendor/solution/service providing companies. If you are uncertain if this price applies to you and your company we advise you; PRIOR to

registration to contact us directly: 00 44 (0) 207 096 0597. Or you may require a ‘budget tailored’ package: specific workshop, day or a package according your budget. We strongly advise you to contact us directly: [email protected]

Exhibition/Sponsorship: 00 44 (0) 207 096 1152

You may also place an order for: Workshop A or B: €499, CD-ROM, Conference Recording: €599. Team Discounts* We are able to coordinate team and/or group discounted passes usually for a team of

three or more; please take a moment request a quote from our customer service team [email protected] All early bird discounts require payment at the actual time of registration and the

discount will not be available subsequent to the deadline date. Please ensure to assess our standard delegate policy prior to submitting your registration [email protected] or Free Call: +44 800 8101495


Sofrigam, european leader in refrigerated

packaging

Rely on Sofrigam expertise to ensure the

security of your cold chain logistics

Sofrigam designs and qualifies isothermal

and refrigerated packaging enabling the

transport of heat sensitive products (fresh

or frozen) in non-refrigerated vehicles.

The materials used associated with the

expertise of our engineers and our

partnership with Ater Métrologie

laboratory, means our products are

suitable for sectors that are VERY

demanding with regard to quality and

safety, such as the pharmaceutical,

chemical, biotechnology industries.

We offer our clients a range of standard or

made-to-measure products and services

enabling them to establish secure,

economic and ecological cold chain

logistics. www.sofrigam.com

Exam Packaging provides reliable and

tailor made isothermal packaging

systems: Our solutions apply mainly to

the pharmaceutical and biotechnological

sectors and Clinical Research

Organizations.

All our packagings are developed and

tested for their insulating and mechanical

qualities in our own laboratories,

produced in our own production facilities

and controlled at various stages of the

production process, in accordance with

our ISO certification.

Our range of products includes

Polyurethane in mould injected boxes in a

wide range from 2,5 liters up to 1200 liters

(Palletshipper up to 120 h). Other

products include Isotainers, robust

polypropylene boxes with interchangeable

in mould injected polyurethane insulating

walls, Dangerous goods UN packaging for

toxic or infectious products and diagnostic

samples. All our boxes can be used with

coolpacks or dry ice and can be

customised.

Brussels Airport is one of the largest

airports in Europe:

handling 750,000 tonnes of airfreight

annually in the dedicated cargo area

BRUcargo. Brussels Airport links the

European capital with 231 destinations

worldwide that are served by 88 different

airlines: 74 passenger airlines and 14 full-

freighter airlines. With its ideal location as

a European Gateway combined with our

customer intimacy and partnership we

offer logistical solutions to today’s

challenges for our cargo customers. It is

for this reason that our motto at Brussels

Airport is “Welcome to Europe”. Preferred

pharma gateway in Western Europe The

temperature controlled segment is a

strategic priority for Brussels Airport, in

order to further develop BRUcargo as the

preferred pharma gateway in Western

Europe. The Brussels Airport Authority

takes a leading role in promoting and

creating transparency in the cold/cool

supply chain.

Our mission is to provide value-added

consulting, training and validation services

in regulated industries of all sizes across

the world. We are a multi-disciplinary

consultancy company offering a wide

range of advisory, project management

and validation services to life sciences

companies. Our goal is to improve your

compliance towards the applicable

regulations and guidelines. Tobeas bvba

was founded by Frank Peeters, a

consultant with more than 20 years

experience in the field. Our team of

qualified professionals assist our

customers and provides services that are

specific to the regulated industries: -

Pharmaceutical Production (GxP) o Life

Cycle Management / Qualification &

Validation o Quality Assurance, Training &

Coaching, Auditing, Qualified Persons o

Risk Management and Control o Business

Continuity / Disaster Recovery Planning o

Strategic Consulting / Business Process

Modelling.





Universal Freight Organisation (UFO) was established in January 2000 so that privately

owned freight forwarding companies could form partnerships on an international scale, whilst working in accordance with our strict

Code of Conduct. Today, the UFO is an ISO 9001:2008 certified network of 120+ freight forwarders located in 105+ countries. With

over 95,000 shipments handled every month, we offer clients the personal local service and flexibility that only privately-owned

forwarders can, whilst benefiting from being electronically connected to a network covering over 840 air and sea ports. Please visit

www.universalfreightorg.com for more details.

Freightbook is a fast growing online searchable database containing the details of 600+ freight

forwarders in over 125 countries. Most Freightbook advertisers are privately-owned independent companies who focus on providing a

personal service that is tailored to client’s needs. Each company can provide comprehensive logistics solutions through their

experienced staff who have an in-depth understanding of their local market. To obtain rates and advice on a shipment, please

complete our Quote Request form. Our simple but effective system enables you to obtain advice and pricing from all registered freight

agents in the country of origin, thus providing a variety of options. Alternatively, please search our database and contact companies

directly. www.freightbook.net

Project Cargo Network (PCN) is an ISO 9001:2008 certified organisation established to

provide a networking platform for the world’s top project cargo specialists. Our Members handle the transportation of oversized and

heavy items or shipments that consist of complex components that must be disassembled, shipped and then re-assembled. They offer

project cargo management for engineering, procurement and construction companies servicing energy, mining, chemical,

petrochemical, pipeline, infrastructure and other sectors. Our fast-growing organisation currently comprises of 130+ heavy lift

specialists in 70+ countries. Visit www.projectcargonetwork.com.

Medical News Today is the largest independent medical

and health news site on the web - with over 2,500,000

unique monthly users it is ranked number one for

medical news on Google and Yahoo!. Medical News

Today is used by Blue Chip pharmaceutical and health

organizations, advertising agencies, PR companies and

vertical ad networks to deliver targeted

disease/condition and general health campaigns. For

more information contact

[email protected] or visit

www.medicalnewstoday.com.


Delegate Details:

Mr/Mrs/Ms/Dr/Other

First name:

Family Name:

Job Title:

Tel No.

Email:

Company:

Address:

Postcode:

Package:

Signature:

I agree to BUSD’s cancelation, substitution and payment terms (if

you do not receive confirmation within 2 hours of submission

please contact us directly).

Payment Method: Please tick what is relevant to you:

Debt: OR Credit Card:

AMEX MC VISA

Card Number:

Exp. Date: Security Code:

Name On the Card: Signature:

Billing Address (if different from Delegate Registration Details)

City/Country/Postcode:

Cheque enclosed for (€):

Made payable to: Business Dialogue World Wide Limited (BUSD)

Please quote: 20012.1 with remittance advice

Business Dialogue World Wide Limited (BUSD) Bank Details: HSBC

SORT CODE: 40 03 11 Account No: 91607529 IBAN: GB52MIDL40031191607529

SWIFT: MIDLGB22 Account Name: Business Dialogue World Wide Limited

How to register:

Call us:

Direct Line: 00 44 (0) 207 096 1152

Free Phone: 0800 8101 495

Fax Line: 00 44 (0) 207 096 89 75

Email:

A) [email protected]

Post: Your Registration Details to:

Business Dialogue World Wide Limited

145-157 St John Street, London, EC1V 4PW

Online: http://www.cold-gdp.com

Registration is restricted to the first 30

participants owing to limited space at the

venue and the contract held with Sheraton

Brussels Airport Hotel.

Registration will be closed once the 70

colleagues are confirmed.

Terms and Conditions, Registration for attendees: Once we receive your complete your registration form, full payment must be complete either by credit card immediately or within 7

working/business days from the actual date of invoice. All payments without credit card are subject to a £49 + VAT (£49 plus VAT) per registration processing fee. Furthermore, we reserve the

right of refusal admission if payment is not complete prior to the conference, as such payment must be complete before the event taking place. Discounts for attendees: You may receive a discount

only once and this discount is not to be combined with any other discount. All discounted registration must conduct payment prior to the cut-off date of the discount deadline. Furthermore, all

discounted offered by Business Dialogue this includes all team discounts must make payment at the time of the registration. Event and Registration Cancellation, Event Rescheduling and Registered

Attendee Replacement Policy. Registered attendees can exchange their place with another colleague within their organisation; you may provide reasonable notice to Business Dialogue of the

substitution up to 7 working/business days prior to the event. If an event is rescheduled or cancelled by Business Dialogue for any reason and the attendee cannot or will not attend the rescheduled

date, you may receive a 100% credit for the contract fee paid. You may use this credit for another event organised by Business Dialogue provided there is mutual agreement within one year of the

credit date. All cancellations must be submitted with 7 working/business days prior to the event; the attendee will receive a 85% credit to be used at another Business Dialogue event occurring

within a year from the issuance date of this credit. A 15% is retained by Business Dialogue to cover both initial registration and current cancellation costs and for permission of cancellations.

Furthermore; all cancellations occurring after the 7 working/business days will not receive a credit. Business Dialogue is not held responsible for any loss or damage as a result of a cancellation,

rescheduling, date or alteration of an event. Furthermore, while speakers, sessions and topics are confirmed at the time of producing an event, circumstances beyond the control of the Business

Dialogue may require alterations, cancellations and further exchange speakers/topics. Therefore Business Dialogue holds the right to alter or modify the advertised speakers and/or subjects of

necessary without any liability to you of any kind. All changes are made known on the product web page. Business Dialogue assumes no liability of any kind if the event is cancelled, rescheduled or

postponed due to a unexpected event and or situation; unforeseen occurrence; God and/or Gods' intervention and or any other situations; or events that may render performance of the actual event

taking place; making it impracticable, illegal or impossible. Furthermore, this also includes extreme weather, labour strike, earthquakes, tsunami, war, fire, and act of terrorism, anarchy and/or

other emergencies


of supply chain operations sa opportunity to network with

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