CHAIRMEN

Day 1: Luc Huybreghts, Senior QA Consultant, Pauwels Consulting

Day 2: Peter Scheyltjens, Managing Director, Advipro

PharmaDialogue Testimonial:

COLD SUPPLY SYSTEM AND SOLUTIONS 2014

Brussels Cold Chain Network presents the 3 annual CSS 2014 comprising of over 20 practical cases and in-depth discussions focused on the New GDP and Excursions during transport of controlled shipments.
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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

PharmaDialogue Testimonial:

ABSOLUT fundamental for 2014: GDP Inspection Readiness

Drs R.J. Bruinink, Healthcare Inspectorate The Netherlands, Senior GMP and GDP Inspector

DATE: 19 , 20

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AND 21 OF MARCH 2014

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LOCATION: BRUSSELS, BELGIUM

Ethel Mertens, Inspector, GMDP, Federal Agency for Medicines and Health Products, Belgium Inspector

VENUE: SHERATON BRUSSELS AIRPORT HOTEL

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

A PharmaDialogue Symposium Patient Safety matters Strategic Partners The Healthcare desk of Business Dialogue World Wide
Means of Registration:

Sponsors & Exhibitors

Telephone: 00 44 (0) 207 096 1152

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WWW.COLD-GDP.COM

My Confirmed Speaking Panel:

Who will I Meet There?
SPEAKER: Dr Umit Kartoglu, Scientist, World Health Organisation SPEAKER: Ethel Mertens, Inspector, GMDP, Federal Agency for Medicines and Health product, Belgium SPEAKER: Drs R.J. Bruinink, Healthcare Inspectorate the Netherlands, Senior GMP and GDP Inspector SPEAKER: Chris Wallace, International Supply Chain Lead, Genzyme SPEAKER: Nigel Cryer, Head of Quality Manufacturing and Supply Chain, Crucell SPEAKER: Lupo Marco, Director Operational Excellence, Takeda SPEAKER: Ing. Monique Aal, Quality Assurance Compliance Officer, Bilthoven Biologicals B.V SPEAKER: Luc Huybreghts, SR. QA Consultant Pharma Services SPEAKER: Andrea Gruber, Business and Process Manager, IATA International Air Transport Association SPEAKER: Ulrike Kreysa, VP, Healthcare GS1 Global Standards SPEAKER: Tim Mais, Project Manager, Vlaams Instituut voor de Logistiek SPEAKER: Bert Selis, Cargo Development Manager, Liege Airport SPEAKER: Peter Scheyltjens, Manage Director, Advipro SPEAKER: Fons S'Jegers, Managing Director, Supply Chain Consultant SPEAKER: Nathan De Valck, Cargo Manager, Brussels Airport SPEAKER: Bastian Eichler, Data Logger Product Manager, Testo SPEAKER: Maria D'Orazio, Head of Cold chain Logistics, Vaccines and Diagnosis, Novartis

My Auxiliary Sessions:
19 of March, Workshop A: GDP Inspection Readiness 19 of March, Workshop B: GDP Thermal Mapping PANEL Q&A SESSION: Standardisation and Harmonisation of Regulatory Requirements:
20th of March-Day 1: There are approximately 30 guidelines, standards and requirements applied internationally to manage time and temperature shipments; including GDP, WHO, IATA and FDA among others. The panel will assist in addressing your concerning in relation to finding alignment to international requirements.
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My Business Case For Attendance:

What Can I Expect To Learn:

COVERED GDP Inspection Readiness:

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30.
Best practice in handling Time and Temperature Controlled Products The importance of a 24/7 cold chain monitoring Assess novel and growing trends concerning Passive V Active Correct interpretation of the Good Distribution Guidelines A step by step approach to building a secure cold chain Risk assessments and mitigation involved in distribution Addressing fundamental points concerning transportation Vendor selection and choice of technology Address the question of cost effectiveness aligned to quality Meet European GDP Inspectorate Practical case studies shared from the field Plan and implement a secure and stable cold chain

Round Table and Panel on 20 of March 2013

20 of March-Day 1: Roundtable 1: Quality Management: CHAPTER 1 20 of March-Day 1: Roundtable 2: Premises and Equipment: CHAPTER 3
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Round Table and Panel on 21 of March:

21 of March-Day 2: Roundtable 1: Complaints, returns, suspected falsified medicinal products and medicinal product recalls: CHAPTER 6 21st of March-Day 2: Specific provisions for brokers: CHAPTER 10
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Contingency/back up plans if and so when delays occur

An A-to-Z of addressing challenges within the EU market A criterion based approach toward cost v quality The importance of addressing regulatory requirements Order, Monitor, Store and Distribute Interpretation of international standards concerning cold chain Simplified decision making criterion for solutions Regulatory expectations for cold chain the current changes Fundamental challenges concerning regulatory requirements

According to our recent GDP survey, the following are the Absolut Fundamentals for 2014:

A text interpretation of the current GDP: exploring the guidelines in relation to GDP-Inspection readiness
Practical insight on how to implement best practice in handling deviations based on the new GDP requirements Finding logistical and packaging solutions compliant to the current GDP requirement

Assess the question of cost in relation to packaging

Cold chain compliance and risk assessment Examine the possibilities and realistic options Developing best management for biological products Contingency planning for cold chain failure The cultural differences within the EU market Explore key f/actors concerning Passive/Active decisions Pre-plan and examine critical points of requirements Evaluate optimal outsourcing options

Master Class Workshop A; From 13:30 to 15:30, 19th of March 2014

Workshop A: GDP-Inspection Readiness: A recent survey by PharmaDialogue suggests a strong focus by many professionals and practitioners involved with Time and Temperature Controlled Shipments; to lack awareness and a detailed understanding on how to prepare for GDP inspections. Key areas such as Chapter 9 Transportation and Chapter 5 focused on Premises and Equipment Storage subject to isothermal packaging/containers or warehousing; have been identified to suggest lacking clarity and needing interpretation. As such the Brussels Cool Chain network with address the best practice based on direct assistance from EU Inspectors on how best prepare for EU GDP inspection. New EU guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Join us to learn and understand how to best prepare for Good Distribution Practice subject to inspection and industry best practice. Master Class Workshop A GDP Inspection Readiness: A summary of the current regulatory requirements and the purpose of inspection The inspection process What inspectors are looking for? Typical compliance issues Client and quality audits

Master Class Workshop B; From 15:30 to 17:30, 19th of March 2014

Workshop B: Performing compliant thermo mapping studies Pharmaceutical products are temperature-sensitive, requiring an environment with predefined parameters to preserve their quality and integrity. During transport, time and temperature sensitive pharmaceutical products move through the supply chain, which includes many stages and people from the manufacturer to the patient. As the product changes hands and passes through many different environments, it is critical for suppliers to be certain that the product has not been damaged or degraded by temperature excursions. Temperature monitoring is therefore a key element of supply chain integrity. New EU guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Solutions for monitoring your products within the supply chain are easily available, but are this monitoring system representative or in other words validated? An important key in answering this question is the execution of a thermo mapping. This workshop will showcase the key elements of temperature mapping from definition to interpreting the mapping result. Definitions The importance of thermo mapping How to assess the characteristics of the storage area Identifying risks spots Understanding the results of your mapping

Types of inspections: GDP/GMP audit of a Pharma company by the authority Pharma company performing supplier audit

Workshop Leader: Peter Scheyltjens, Managing Director, Advipro Peter has more than 20 years experience, last 10 years mainly within the area of validation. He is the Vice P resident of the BCW (Belgian Cleanroom Workgroup), member of several international associations (ISPE, EBSA, VCCN) and the Founder of Advipro, the independent and ISO certified Validation Company based in Zandhoven near Antwerp in Belgium. Advipro supports in the realization and validation of GxP processes, lab applications and controlled environments (cleanrooms, operating theatres, temperature controlled areas, safety labs)

The Workshop leaders: Luc Huybreghts, Senior QA Consultant, Pauwels Consulting Drs R J Bruinink, Senior GMP and GDP Inspector, Healthcare Inspectorate, Netherlands

Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: reg@cold-gdp.com

DAY ONE OF SYMPOSIUM

8:00 Registration 8:30 Welcome and Coffee 20th of March 2014 8:30 Chairmans opening

THE EU GOOD DISTRIBUTION PRACTICE GUIDELINES EXPLAINED BY GDP & GMP EU INSPECTORS

8:45 9:15: Opening Address: Challenges at the forefront of the healthcare sector in
Europe
Overview of the EU regulatory system and the revised guidance on GDP/GMP An update on harmonisation and co-ordination at an EU level The impact of the current new GDP in practice from an inspectors point of view Q&A

SPEAKER BACKGROUND: Drs R.J. Bruinink, Senior GMP and GDP Inspector, Netherlands:
Riekert Bruinink is working at the Dutch Healthcare Inspectorate and held various positions, including management positions. Now he is a Senior GMP/GDP Inspector and specialized in Good Distribution Practice. He is Member of the EMA GDP Drafting Group . This group was responsible for making a proposal for a new EU GDP Guide and procedures for harmonizing GDP inspections in the European Union. From 2008 until 2013 he was Chairman of the PIC/S GDP Working Group.

SPEAKER: Drs R.J. Bruinink, Senior GMP and GDP Inspector, Health Care Inspectorate, Netherlands

9:15 10:00: Keynote Address The New EU GDP - Chapter 9 Transportation

Additional requirements in the new guide to GDP New requirements about labelled conditions Reporting excursions Requirements for shipping temperature sensitive items Ambient transportation - and the requirements for documented risk assessment The use of dedicated vehicles Q&A
SPEAKER BACKGROUND: Ethel Mertens, Pharmacist - Inspector, GMDP, Federal Agency for Medicines and Health Products, Belgium Ethel Mertens has obtained a degree in Pharmacy at the university of Gent. She started her career by working in a pharmacy. After a few years she integrated the Belgian Federal Agency for medicines and health products for the department Hormones and Antibiotics and Borderline Products. In 2007 she changed her orientation to become a GMDP inspector, specialized in GDP. Since 2008 she is member of the GDP drafting Group at the EMA.

SPEAKER: Ethel Mertens, Pharmacist - Inspector, GMDP, Federal Agency for Medicines and Health Products, Belgium

10:00 10:30: NETWORKING BREAK & DIALOGUE IN MOTION: COFFEE AND TEA

STANDARDISATION AND THE CALL FOR HARMONISATION OF INTERNATIONAL REGULATORY REQUIREMENTS

10:30 11:15 World Health Organisation: Regulatory oversight: It is clear what needs to be done, but the question is how to do A summary of the technical supplements published in October 2013
The model guidance for storage and transport of time and temperature-sensitive pharmaceutical products was developed in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management, and was published as Annex 9 to the Technical Report Series 961 in 2011. The intention was that the guidance in this document should be directly applicable in less-developed countries as well as in industrialized world. To this end, as indicated in the document, supplementary technical materials were planned to be developed to show how the requirements can practicably be achieved, particularly in resource constrained settings. Experience with vaccine supply chain assessments in many less-developed countries demonstrates that the mandatory standards set out in this document can be achieved, and that some countries are also capable of meeting many of the optional requirements.

SPEAKER: Dr Umit Kartoglu, Scientist, World Health Organization

The WHO has been working with a group of distinguished experts in the following fields to develop the below listed technical supplements: 1. Port handling and customs clearance, 2. Estimating warehouse storage capacity, 3. Warehouse design, 4. Building security and fire protection, 5. Building maintenance, 6. Warehouse site selection, 7. Temperature monitoring of storage areas, 8. Temperature mapping of storage areas, 9. Qualification of temperature controlled storage areas, 10. Calibration of control and monitoring devices, 11. Cold chain equipment maintenance, 12. Materials handling, 13. Transport route profiling qualification, 14. Temperature and humidity control during transport, 15. Qualification of shipping containers, 16. Qualification of temperature-controlled road vehicles, 17. Packing shipping containers and refrigerated vehicles, 18. Environmental management of refrigeration equipment: Q&A

11:15 12:15: Panel Discussion Harmonising EU GDP guidelines and other global guidelines and regulations
International harmonisation efforts on a global scale Multi recognition agreements between different jurisdictions Global regulations and how GDP fits into that (WHO, UNICEF)

SPEAKER BACKGROUND: Umit KARTOGLU, Scientist, WHO Umit is a scientist at the World Health Organization, Department of Essential Medicines and Health Products, Quality, Safety and Standards team. He is responsible for learning programmes and coordinates the work of Global Learning Opportunities for Vaccine Quality (GLO/VQ. Prior to his WHO work, Dr Kartoglu worked with UNICEF as health officer in Central Asian Republics and Kazakhstan Area Office and as health coordinator for Operation Lifeline Sudan based in Kenya. Earlier he was Associate Professor in Public Health at the Institute of Pediatrics of Istanbul University and also held positions as permanent advisor in Public Health to the Ministry of Health in Turkey, and worked in different positions in rural health delivery system for 10 years. He is the founder of the Human Rights Branch of the Turkish Medical Association and WEBCOM (Communication Web for Health).

SPEAKER: Dr Umit Kartoglu, Scientist, World Health Organization SPEAKER: Drs R J Bruinink, Senior GMP and GDP Inspector, Healthcare Inspectorate, Netherlands SPEAKER: Ing. Monique Aal, Quality Assurance Compliance Officer, Bilthoven Biologicals B.V.

12:15 13:15: NETWORKING LAUNCH & DIALOGUE IN MOTION

Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: reg@cold-gdp.com

BUILDING A COMPLIANT SUPPLY CHAIN BASED ON MODES OF TRANSPORT AND PARTNERSHIPS

13:15 14:00: Shipping conditioned goods on rail over the Eurasian continent
Transporting conditioned goods between South-East Asia and Europe is traditionally performed via air or sea. However, Eurasian rail transport over long distances is faster than maritime shipping, more sustainable and less expensive than air freight transport but faster and safer than Eurasian road transport. Still, up till now it has not been considered as a serious alternative. The reason for this is that the knowledge concerning the transport of conditioned goods via rail, is not widely promoted nor is it consolidated. Based on a strong demand from Belgian perishable, chemical and pharmaceutical shippers, the Flanders Institute of Logistics initiated the TransPharma project to investigate the technical and economic feasibility of shipping conditioned goods on rail over long distances. Stepping away from the traditional approach, the project investigated new reefer and supervision technologies to offer a reliable means of transport. Administrative and process related burdens were unfolded to facilitate the setup of the trade lane. A shortened transit time can be achieved compared with maritime transport with more reliability and means to supervise and interact with the shipment during transport. Balancing east and west bound flow of goods will allow for the cost of transport to be more competitive. And thus a sustainable alternative corridor can be created: 1. Perishables, chemicals and pharmaceuticals, 2. Selecting the best reefer for the job, 3. Making sure the goods are supervised, 4. Working with different
stakeholders in several countries, 5. Making the best of customs and administration, 6. Showcasing the concept, 7. Q&A

SPEAKER: Tim Mais, Project Manager, Flanders Institute for Logistics 14:00 14:45: Case study Building a trustable supply chain for air transport:
Understanding the complete flow of pharmaceutical shipment The role of the airport/GDP certified warehouse The role of the airline The importance of collaborating with supply chain stake holder A practical insight into best practice Q&A
SPEAKER BACKGROUND: Tim Mais, Project Officer, FIL

SPEAKER: Bert Selis, Cargo Development Manager, Liege Airport

Tim is project officer at Flanders Institute for Logistics where he participated in several projects related to time & temperature shipments. He investigated administrative, operational, economic and technical feasibility of monitoring conditioned goods in multi-modal supply chains. He participated in: the set-up of a rail corridor for conditioned goods between Antwerp and China, monitoring of conditioned goods in air freight using GPRS enabled devices. He is the author of the report on GPRS monitoring of air freight.

14:45 15:15: NETWORKING BREAK & DIALOGUE IN MOTION: COFFEE AND TEA 15:15 - 16:00 Supply chain of petrochemicals, ensuring product quality is just the beginning
Many products contain petrochemical products which we use in our daily life. We can find them in markets such as food, cosmetics, and pharmaceuticals. To ensure the quality of these petrochemicals meets the high standards set by their customers, petrochemical producers need to design and implement supply chains to guarantee such quality assurance. That is however only a part of the job. Many other aspects need to be taken into account such as product safety (dangerous goods), environmental protection and of course state of the art supply chain requirements on product availability and optimized cost: 1. Translating product requirements and properties in handling requirements, 2. Designing international supply chains for petrochemical products, 3. Q&A

SPEAKER: Fons SJegers, Managing Director, Supply Chain Consultant

Roundtable Dialogue In Motion

16:15 - 17:00: Round Table 1: Chapter 1 of EU GDP Guidelines: Quality Management Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. Source: Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01).

16:15 - 17:00: Round Table 2: Chapter 3 of EU GDP Guidelines: Premises and Equipment Wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. Source: Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

Chairmans close: End of Day 1

Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: reg@cold-gdp.com

DAY TWO OF SYMPOSIUM

8:00 Registration 8:30 Welcome and Coffee 21st of March 2014 8:30 Chairmans opening

GLOBAL SUPPLY CHAIN AND DATA SYSTEMS AND TOOLS

9:00 9:45: Keynote Address: Traceability and the global supply chain
Global standards - why? Developments on traceability across the world Benefits of traceability in the vaccines supply chain Global regulatory developments Q&A
SPEAKER BACKGROUND: Ulrike Kreysa, VP of Healthcare, GS1
Ulrike is responsible for the Healthcare sector at the GS1 Global Office in Brussels and works with her local colleagues in 111 countries across the world to develop and implement GS1 standards in the healthcare industry. Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, group purchasing organizations, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations.

SPEAKER: Ulrike Kreysa, VP of Healthcare, GS1

9:45 10:30: Data systems and data recording solutions in accordance to GDP requirements:
Definition of Data systems and Data capturing tools Recording deviation and handling excursion based on the new GDP Understanding the impact of corrective data collection and data submission Recommendations and Q&A

COMPANY PROFILE: Testo AG, Data Systems & Data Logger Solutions Testo with its headquarters in Lenzkirch in the Black Forest, is a world market leader in the field of portable and stationary measurement technology. Worldwide, 2,450 staff are involved in research, production and marketing for the high-tech company, working to find innovative measurement solutions, e.g. in the fields of air conditioning and ventilation, food quality, building technology and emission control. With 30 subsidiary companies and over 80 distribution partners, Testo AG is represented on all five continents.

SPEAKER: Bastian Eichler, Data Logger Product Manager, Testo AG

10:00 10:30: NETWORKING BREAK & DIALOGUE IN MOTION: COFFEE AND TEA

PHARMA & BIOTECH QUALITY ASSURANCE AUDIT: AN INTERNAL INSPECTION READINESS

10:30 -11:15 A risk based QA auditing of pharmaceutical logistics - A risk based approach to auditing of logistics: Distribution warehouses
Cold Chain Couriers Road/Ocean and Air Freight Airlines
SPEAKER BACKGROUND: Nigel Cryer, Director of GMP, Crucell Nigel has worked for multinational companies throughout his career. Currently Director of Inspection Readiness at Crucell based in Bern. He has worked in all GxP environments and has developed many best practice systems. He has introduced the concepts of risk based approach in a pragmatic and added value manner to validation, investigations, distribution and vendor management. Working for Akzo, Astra Zeneca, Merck & Co, DHL Lifesciences, Roche, Norgine, Watson. He has managed successful MHRA, FDA, Swissmedic, Dutch, Brazillian and other audits. SPEAKER BACKGROUND: Monique Aal, QA Compliance Officer, Bilthoven Biologicals Immediately after graduating from my study Medical Biochemistry in 1995, I started working in the pharmaceutical industry as a research technician. I worked at a Veterinary Institute and conducted fundamental research on several disease like Swine Vesicular Disease Virus, Aujezsky disease and Streptococcus Suis. Since 1998 I started working for another vaccine company Fort Dodge Animal Health. The main task at Fort Dogde was to develop a multicomponent vaccine for chickens. In 2003, I made the transition to Solvay Pharmaceuticals, a human vaccine manufacturer. In the function as Bioprocess Developer I was responsible for troubleshooting and process optimization of Influenza vaccine. From 2007 till now I am working at Bilthoven Biologicals (formerly Dutch Vaccine Institute). I started as coordinator of MMR (Mumps, Measles and Rubella) By disposing of this task by the government, I was transferred to the Polio production plant. Since 2011, I work as a QA compliance employee at the QRD department. At BBIO I am responsible for the implementation of GDP in the organisation.

SPEAKER: Nigel Cryer, Director, GMP Readiness, Crucell

11:15 -12:00 Implementing GDP at Bilthoven Biologicals

By performing a gap analysis it was soon apparent where the weaknesses, with respect to GDP, were at Bilthoven Biologicals. The two main points that came to light were external transport and the lack of clear agreements with these parties. Existing SOPs were held against the light and rewritten or totally renewed. Parallel there was a team that dealt with design and qualification of new packaging for vaccines. The biggest challenge was to keep the customer satisfied and still meet GDP. GDP gap analysis GDP versus WHO requirements Design and qualification of insulated packaging Supplier auditing Contract and quality agreement Monitoring (storage and transport) Q&A

SPEAKER: Monique Aal, QA Compliance Officer, Bilthoven Biologicals

12:00 13:00: NETWORKING LAUNCH & DIALOGUE IN MOTION

Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: reg@cold-gdp.com

INTERNATIONAL AIR TRANSPORT ASSOCIATION AND THE CASE FOR GDP-AUDIT AIR TRANSPORT
13:00 13:45: IATA Standards and priorities for the coming year: labelling, setting standards in training and audit
The new IATA labelling requirements Developing standards in training and audits Collaborating with supply chain stake holders Q&A
COMPANY PROFILE: International Air Transport Association IATA was formed on 19 April 1945 in Havana, Cuba. It is the successor to the International Air Traffic Association, founded in The Hague in 1919, the year of the world's first international scheduled services. At its founding, IATA had 57 members from 31 nations, mostly in Europe and North America. Today it has about 243 members (as of April 2012) from more than 126 nations in every part of the world. IATA's stated mission is to "represent, lead and serve the airline industry." All the Airline rules and regulations are defined by IATA. The main aim of IATA is to provide safe and secure transportation to its passengers.

SPEAKER: Andrea Gruber, Business Process Manager, IATA

13:45 14:30: The role of the Airport in a GDP-Compliant environment:

The impact of the New Guidelines on Air Transport Standardisation of pharma cargo transport Implementing a GDP-Driven audit by an airport Examples of the New-GDP in practice at the Airport

COMPANY PROFILE: International Air Transport Association Brussels Airport currently consists of 54 contact gates, and a total of 109 gates. It is home to around 260 companies, together directly employing 20,000 people. In 2005, the airport was awarded Best Airport in Europe by Airports Council International/International Air Transport Association (ACI/IATA), based on a survey conducted with over 100,000 passengers worldwide. Brussels Airport continues to appear in top airports lists as of 2012.

SPEAKER: Nathan De Valck, Cargo Manager, Brussels Airport

14:30 15:00: NETWORKING BREAK & DIALOGUE IN MOTION: COFFEE AND TEA

END TO END SUPLLY CHAIN AND THE CASE FOR THE LAST MILE
15:00 15:45: The last mile Best Practices for ensuring product integrity is maintained to the end user and accountability is defined throughout the supply chain
Stability data & how it can be best used Channels to market Controls in supply chain before final mile and during final mile Different solutions for different markets Conclusions
SPEAKER BACKGROUND: Chris Wallace, Supply Chain, Genzyme Chris Wallace is International Supply Chain Director for Genzyme in the EMEA region. He is responsible for logistics development and operations, distribution compliance including third parties, new product introductions and the establishment of new routes to market. He has nearly 30 years supply chain and logistics experience across multiple sectors including automotive, fmcg, hi-tech, retail and third party service providers, but believes some of the most exciting supply chain developments are at present in the Pharmaceutical and Healthcare sector.

SPEAKER: Chris Wallace, International Supply Chain Director, Genzyme

15:45 16:30: Creating a lean supply chain in practice - A case study

Creating a lean supply chain is a challenge for most pharmaceutical companies. The operational excellence program at Takeda was launched five years ago and is now moving to the next level, from a production focus to tackling the lean supply chain challenges. The case study shows how operational excellence allowed a lean supply chain transformation at Takeda. Takeda company presentation Takeda operational excellence program overview The next level of operational excellence: tackling lean supply chain challenges A case study: how to start the lean supply chain transformation Q&A

SPEAKER BACKGROUND: Marco Lupo, Operational Excellence, Takeda Marco Lupo holds a Master Degree in Chemical Engineering, and is a certified Master Black Belt. Marco, in his over 10 years experience, has supported deployment of Lean Six Sigma programs in 3 different Big Pharma companies, in multiple countries, and in several areas of the business; his experience varies from drugs and medical devices manufacturing and packaging to sales and marketing operations, including significant experience with Research and Development, Supply Chain, and Healthcare world. Marco is based in Rome and is responsible for the Takeda Operational Excellence program in 5 different sites.

SPEAKER: Marco Lupo, Director, Operational Excellence, Takeda

Chairmans close: End of Day 2

Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: reg@cold-gdp.com

Pharma/Biopharma/Biotech attendance pricing structure:

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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

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

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

Means of Registration: Enquiry: 00 44 (0) 207 096 0597 Via Email: reg@cold-gdp.com