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6th
Annual
Cold Chain &
Product Handling:
Temperature
Controlled Logistics
Conference Introduction
"Global demand for expensive structurally complex and temperature-sensitive biologics and specialty drugs
is up. In fact it is expected to fuel approximately 60% growth for temperature controlled logistics to $13.4
billion by 2020."
(MH&L June 2015, report by IMARC)
Conference
18 - 19 May 2016, Amsterdam, The Netherlands
+ Site Visit 17 May Afternoon
Crowne Plaza Hotel Schiphol
Site Visitto SchipholAirport
Rob Dekkers
GE Healthcare, the
Netherlands
Global Logistics and
Distribution Leader
Eugenio Filippi
Baxalta, Austria
Senior Manager, Plasma
Operations Europe/Logistics &
Dispositioning
Ruud van der Geer
MSD, the Netherlands
Assoc. Director, Supply Chain
Management CoE
EMEA Product Handling & Cold
Chain
Miguel Mercier
Sanofi Pasteur, Canada
Deputy Director, Quality
Operations
Eugenio Filippi
Baxalta, Austria
Senior Manager, Plasma
Operations Europe/
Logistics & Dispositioning
Ruud van der Geer
MSD, the Netherlands
Assoc. Director, Supply
Chain Management CoE
EMEA Product Handling &
Cold Chain
Yoram Eshel
Teva Pharmaceutical
Industries, Israel
Senior Director, Global
Transportation and
Logistics
Expert Advisors
Speakers
Thomas
Vestergaard
Pedersen
Danish Medicines
Agency, Denmark
Medicines Inspector
Rainer Wittenfeld
European Cold
Storage and
Logistics Association,
Germany
Chairman
Camillo Rossi
Eli Lilly, Belgium
Consultant Global
Logistics Clinical Trials
Roman Mijnhart
Sanofi Genzyme,
Netherlands
Director Global Supply
Chain Quality / RP
Gil Rochat
Merck Serono,
Switzerland
Logistics Director
Robert Potts
Vertex
Pharmaceuticals, UK
Director, International
Quality
Meirion Richards
Norgine, UK
Site Director
Sebastien Mauel
Ferring
Pharmaceuticals,
Switzerland
Head of Serialisation and
Product Security
Pedro Oliveira
KEDPLASMA,
Germany
Head of Purchasing,
Logistics & Projects
Monika Futschik
Roche, Germany
Head of Operations
Support and Finished
Goods
Matthias Seebens
Boehringer-
Ingelheim, Germany
Manager of Global
Logistics & Distribution
Luca Barboni
Car Fibreglass, Italy
CEO
Jeremy Laurens
Blulog
Co-founder, Sales and
Marketing Director
Gold Sponsor Bronze Sponsors Supporting Partner
Organized By
Why To Attend
	 Get tips from GDP authorities on the most common mistakes you should avoid during inspections and
audits
	 Be inspired by Teva's new approach to temperature control and implement it in your company
	 Receive practical recommendations for management of temperature excursions tested in practice by
Sanofi Genzyme
	 Gather tips on improving health and safety from Norgine, the ROSPA Gold Award winner
	 Discover effective tools to ensure a successful launch in new markets
Special Features
	 site visit to Schiphol Airport
	 2 award-winning case studies
	 roundtable discussions
	 practical demonstration of intelligent
monitoring solutions
	 insights and examples from Eli Lilly, Teva,
Sanofi Genzyme, Boehringer-Ingelheim,
Baxalta, Roche and Norgine
Who Will You Meet?
CEOs, SVPs, VPs, Global Heads, Heads,
Directors, Team Leaders, Specialists and
Managers of:
	 Cold Chain
	 Supply Chain
	Logistics
	Distribution
	Warehousing
	 Quality Assurance and Validation
	Transport
	Packaging
	Shipping
Last Annual’s Participants
Directors, Heads, Managers, Specialists
responsible for Supply Chain, Logistics,
Distribution, Warehousing, Inspections, Quality
Assurance from companies and regulatory
bodies such as Amgen, B.Braun, BluLog,
Bosnalijek, BMS, Chiesi, Dompe, FAGG, GSK,
Essers, Janssen, Mallinckrodt, Octapharma,
Peli Biothermal, F. Hoffmann-La Roche,
Sanquin, SFDA, Synthon, Teva, Zoetis and more
coming from various European and overseas
countries.
Get A Glimpse Of 2015
	 All Focused On Temperature: Real examples and success stories on challenging topics such as GDP
compliance End-to-End, Readiness of 3PL, Warehouse management, Real-life packaging and monitoring,
Managing deviations and Qualification topics
	 A balanced mix of delegates from industry, regulatory bodies and service and solution providers for
fruitful discussion and real-life results
	 The highest interactivity: Roundtables, a Meet and Greet with Business Cards and Building an Action
Plan
	 IATA Standard certified Brussels Airport site visit
Testimonials
“Really well-organized! A good mix of backgrounds and
experiences in the roundtables generated very interesting
discussions.”
Baxter
“The mix of speakers and cross-functional subject matter
knowledge in the audience combined with the scale and
format of the program resulted in a significant learning
experience.”
“Very good, learned a lot by listening to different opinions.
Extremely professional organizers run this event.”
Mallinckrodt
Media Partners:
Site visit:17 May 2016
14:45 	 Site visit to Schiphol Airport
15:00 	 Tour of Yusen Logistics' facilities
Yusen Logistics, with ocean and air freight forwarding
and contract logistics as its pillars, and by taking
advantage of a network spanning more than 470
locations in 40 countries around the world, is meeting
the increasingly diverse and sophisticated requests
of customers by developing logistics solutions across
land, sea, or air.
Over the past 25 years, Yusen Logistics has
invested significantly in specialised services,
facilities,personnel and knowledge to fully meet the
requirements of the Pharma & Healthcare industry.
16:10 	 Demonstration of a GDP certified truck by
Wallenborn
17:10 	 Tour of dnata's cargo handling operations at
Amsterdam Airport Schiphol including their
Pharma handling storage and Temperature
Control Centre
www.fleming.events
DAY 118 May 2016
8:30	 Morning coffee and registration
9:00	 Welcome note from Fleming.
9:05	 sli.do introduction
9:15	 Opening remarks from the chair
9:20 	 Keynote: A Trip to the Future: Cold Chain
in 2020
•	The explosive growth of cold chain
•	Serialisation
•	Changing market trends and related business
opportunities
Regulations
9:50 	 Serialisation and Traceability
•	A close look at the new GDP complement
•	The Delegated Act on Safety Features
•	The Impact of serialisation on warehousing
•	Implications for the industry and the cold chain
•	Steps for implementing the new requirements
Sebastien Mauel, Ferring Pharmaceuticals,
Switzerland, Head of Serialisation and Product
Security
10:20 	 Morning coffee & networking
11:00 	 Industry’s and GMP Requirements
Regarding Storage and Transport of
Plasma for Industrial Use to Suppliers
•	Legal framework: Important requirements for
storage and transportation
•	Best practices for storage
•	Important checks before loading (transfer of risk)
•	Best practices for transportation
Pedro Oliveira, KEDPLASMA, Germany, Head of
Purchasing, Logistics & Projects
11:30 	 Authorities Inspection of GDP with Focus
on Cold Chain Issues
Learn about and discuss inspections from the
viewpoint of the regulatory authorities
•	Authority focus during GDP/Cold chain inspection,
in relation to new GDP guidelines.
•	Examples of common authority observations from
GDP inspections.
Thomas Vestergaard Pedersen, Danish
Medicines Agency, Denmark Medicines
Inspector
12:10 	 Lunch
Quality & Validation
13:30	 Quality Considerations for International
Expansion
•	Ensuring Compliance in the global market place
•	Building effective tools to ensure successful
launch in new markets
Robert Potts, Vertex Pharmaceuticals, UK,
Director, International Quality
14:00 	 Case study: How to get a global governance
on cold chain distribution
•	Understanding the as-is situation
•	Develop a transport qualification approach
•	Establish a center of excellence for shipping
systems
Matthias Seebens, Boehringer-Ingelheim,
Germany, Manager of Global Logistics &
Distribution
14:30	 The Compliance to GDP in the Last Mile
•	The key benefit of Cover by Car Fibreglass
•	From Sweden to Spain, conversions for different
climatic zones;
Luca Barboni, Car Fibreglass, Italy, CEO
tel.: + 421 257 272 155	 email: lesly.solei@fleming.events
www.fleming.events
DAY 1
18 May 2016
15:00 	 Case study: Risk Assessment and
Mitigation Plan for Transportation of
Clinical Trial Room Temperature Products
Camillo Rossi, Eli Lilly, Belgium, Consultant
Global Logistics Clinical Trials
15:30 	 Coffee break & networking
16:00	 Brainstorm: End-to-end cold chain
management – How to respond to
increasing expectations from health
authorities ?
As the pressure increases it is harder and harder to
stay on top during inspections and audits. How can
you find your way in the maze of expectations, and
be ready to pass with flying colors?
Discussion leader:
Gil Rochat, Merck Serono, Switzerland,
Logistics Director
17:00	 Assuring Data Integrity
•	Assembling and retaining data
•	Integrity constraints
•	Steps to be taken to ensure the economic benefits
of resolving data issues
17:30 	 Feedback Session
17:40 	 Closing remarks from the chair
17:45 	 Evening Cocktail Reception
	 Speakers and delegates are cordially
invited to attend
a Networking Cocktail Reception
tel.: + 421 257 272 155	 email: lesly.solei@fleming.events
www.fleming.events
DAY 219 May 2016
8:30	 Morning coffee & networking
9:00	 Opening remarks from the chair
Product Handling & Operational
Excellence
9:05 	 Case study: Temperature Management
along the Supply Chain – Practical Aspects.
•	Temperature Management - where we are today -
paradigms Vs. reality
•	What are the latest news - the progress we made
in GDP during the last year
•	New approach - from Means to Processes
Yoram Eshel, Teva Pharmaceutical Industries,
Israel, Senior Director Global Transportation and
Logistics
9:35	 Case study: A Global, Practical Approach to
Dealing with Temperature Excursions
Roman Mijnhart, Sanofi Genzyme,
Netherlands, Director Global Supply Chain
Quality/RP
10:05 	 Coffee & Networking
10:35 	 A New MSD Shipping Strategy
Ruud Van Der Geer, MSD, the Netherlands,
Assoc. Director, Supply Chain Management CoE
EMEA Product Handling & Cold Chain
11:05	 Roundtable discussions including
practical demonstrations:
Table 1 The Connected isothermal box:
securing the transport of pharmaceutical
products
5 out of 10 of the most sold pharmaceutical
products need to be kept between 2 and 8°C
from the producer to the dispensary. Yet today,
isothermal packaging and temperature dataloggers
are sold separately. What if they could be
combined ?
Jeremy Laurens, Blulog, Co-founder, Sales and
Marketing Director
	 Table2 Protect your sensitive payload with
global passive packaging
Peli BioThermal
12:00 	 Luncheon
13:20 	 Case study: Pharma contract logistics:
Roche Pharma’s cold chain warehousing
•	Building an effective and regulatory compliant
cooperation with an external warehousing partner
•	Challenges for implementation
•	Key benefits of pharma contract logistics
Monika Futschik, Roche, Germany, Head of
Operations Support and Finished Goods
13:50 	 Case study: End-to-End Process Excellence
to Ensure Uninterrupted Delivery
•	Do you have the right skills? Outsourcing critical
activities
•	The searching and selecting of high-quality
shippers – the total cost of Quality
•	Small details that can't be overlooked
•	Temperature and damage protection, what to
consider?
Eugenio Filippi, Baxalta, Austria, Senior
Manager, Plasma Operations Europe/Logistics &
Dispositioning
tel.: + 421 257 272 155	 email: lesly.solei@fleming.events
www.fleming.events
DAY 2
19 May 2016
14:20	 Warehousing case study by the winner
of the ROSPA Gold Award presenting the
newest Norgine temperature controlled
warehouse and their improvements in
health and safety
•	The design and benefits of the build
•	Steps taken leading to attaining the ROSPA Gold
Award
•	Actions improving your processes and increasing
safety
Meirion Richards, Norgine, United Kingdom,
Site Director, Hengoed
14:50	 Out-of-the-box presentation on storage
and transportation of perishables
Rainer Wittenfeld, European Cold Storage and
Logistics Association, Germany, Chairman
15:20 	 Problem-solving roundtables: Suggest an
issue which you have encountered and
discuss possible solutions at a roundtable.
The best solutions win a prize.
16:25 	 Feedback session
16:30 	 Closing remarks from the chair
16:35 	 Farewell coffee & tea
I would like to thank everyone who has helped
with the research and organisation of this 	
event – especially the advisers and speakers – for
their support and commitment.
Stanislava Nichtova
Conference Producer
Fleming.
stanislava.nichtova@fleming.events
tel.: + 421 257 272 155	 email: lesly.solei@fleming.events

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6th-cold-chain-product-handling-temperature-controlled-logistics-

  • 1. www.fleming.events 6th Annual Cold Chain & Product Handling: Temperature Controlled Logistics Conference Introduction "Global demand for expensive structurally complex and temperature-sensitive biologics and specialty drugs is up. In fact it is expected to fuel approximately 60% growth for temperature controlled logistics to $13.4 billion by 2020." (MH&L June 2015, report by IMARC) Conference 18 - 19 May 2016, Amsterdam, The Netherlands + Site Visit 17 May Afternoon Crowne Plaza Hotel Schiphol Site Visitto SchipholAirport
  • 2. Rob Dekkers GE Healthcare, the Netherlands Global Logistics and Distribution Leader Eugenio Filippi Baxalta, Austria Senior Manager, Plasma Operations Europe/Logistics & Dispositioning Ruud van der Geer MSD, the Netherlands Assoc. Director, Supply Chain Management CoE EMEA Product Handling & Cold Chain Miguel Mercier Sanofi Pasteur, Canada Deputy Director, Quality Operations Eugenio Filippi Baxalta, Austria Senior Manager, Plasma Operations Europe/ Logistics & Dispositioning Ruud van der Geer MSD, the Netherlands Assoc. Director, Supply Chain Management CoE EMEA Product Handling & Cold Chain Yoram Eshel Teva Pharmaceutical Industries, Israel Senior Director, Global Transportation and Logistics Expert Advisors Speakers Thomas Vestergaard Pedersen Danish Medicines Agency, Denmark Medicines Inspector Rainer Wittenfeld European Cold Storage and Logistics Association, Germany Chairman Camillo Rossi Eli Lilly, Belgium Consultant Global Logistics Clinical Trials Roman Mijnhart Sanofi Genzyme, Netherlands Director Global Supply Chain Quality / RP Gil Rochat Merck Serono, Switzerland Logistics Director Robert Potts Vertex Pharmaceuticals, UK Director, International Quality Meirion Richards Norgine, UK Site Director Sebastien Mauel Ferring Pharmaceuticals, Switzerland Head of Serialisation and Product Security Pedro Oliveira KEDPLASMA, Germany Head of Purchasing, Logistics & Projects Monika Futschik Roche, Germany Head of Operations Support and Finished Goods Matthias Seebens Boehringer- Ingelheim, Germany Manager of Global Logistics & Distribution Luca Barboni Car Fibreglass, Italy CEO Jeremy Laurens Blulog Co-founder, Sales and Marketing Director
  • 3. Gold Sponsor Bronze Sponsors Supporting Partner Organized By Why To Attend  Get tips from GDP authorities on the most common mistakes you should avoid during inspections and audits  Be inspired by Teva's new approach to temperature control and implement it in your company  Receive practical recommendations for management of temperature excursions tested in practice by Sanofi Genzyme  Gather tips on improving health and safety from Norgine, the ROSPA Gold Award winner  Discover effective tools to ensure a successful launch in new markets Special Features  site visit to Schiphol Airport  2 award-winning case studies  roundtable discussions  practical demonstration of intelligent monitoring solutions  insights and examples from Eli Lilly, Teva, Sanofi Genzyme, Boehringer-Ingelheim, Baxalta, Roche and Norgine Who Will You Meet? CEOs, SVPs, VPs, Global Heads, Heads, Directors, Team Leaders, Specialists and Managers of:  Cold Chain  Supply Chain  Logistics  Distribution  Warehousing  Quality Assurance and Validation  Transport  Packaging  Shipping
  • 4. Last Annual’s Participants Directors, Heads, Managers, Specialists responsible for Supply Chain, Logistics, Distribution, Warehousing, Inspections, Quality Assurance from companies and regulatory bodies such as Amgen, B.Braun, BluLog, Bosnalijek, BMS, Chiesi, Dompe, FAGG, GSK, Essers, Janssen, Mallinckrodt, Octapharma, Peli Biothermal, F. Hoffmann-La Roche, Sanquin, SFDA, Synthon, Teva, Zoetis and more coming from various European and overseas countries. Get A Glimpse Of 2015  All Focused On Temperature: Real examples and success stories on challenging topics such as GDP compliance End-to-End, Readiness of 3PL, Warehouse management, Real-life packaging and monitoring, Managing deviations and Qualification topics  A balanced mix of delegates from industry, regulatory bodies and service and solution providers for fruitful discussion and real-life results  The highest interactivity: Roundtables, a Meet and Greet with Business Cards and Building an Action Plan  IATA Standard certified Brussels Airport site visit Testimonials “Really well-organized! A good mix of backgrounds and experiences in the roundtables generated very interesting discussions.” Baxter “The mix of speakers and cross-functional subject matter knowledge in the audience combined with the scale and format of the program resulted in a significant learning experience.” “Very good, learned a lot by listening to different opinions. Extremely professional organizers run this event.” Mallinckrodt Media Partners:
  • 5. Site visit:17 May 2016 14:45 Site visit to Schiphol Airport 15:00 Tour of Yusen Logistics' facilities Yusen Logistics, with ocean and air freight forwarding and contract logistics as its pillars, and by taking advantage of a network spanning more than 470 locations in 40 countries around the world, is meeting the increasingly diverse and sophisticated requests of customers by developing logistics solutions across land, sea, or air. Over the past 25 years, Yusen Logistics has invested significantly in specialised services, facilities,personnel and knowledge to fully meet the requirements of the Pharma & Healthcare industry. 16:10 Demonstration of a GDP certified truck by Wallenborn 17:10 Tour of dnata's cargo handling operations at Amsterdam Airport Schiphol including their Pharma handling storage and Temperature Control Centre
  • 6. www.fleming.events DAY 118 May 2016 8:30 Morning coffee and registration 9:00 Welcome note from Fleming. 9:05 sli.do introduction 9:15 Opening remarks from the chair 9:20 Keynote: A Trip to the Future: Cold Chain in 2020 • The explosive growth of cold chain • Serialisation • Changing market trends and related business opportunities Regulations 9:50 Serialisation and Traceability • A close look at the new GDP complement • The Delegated Act on Safety Features • The Impact of serialisation on warehousing • Implications for the industry and the cold chain • Steps for implementing the new requirements Sebastien Mauel, Ferring Pharmaceuticals, Switzerland, Head of Serialisation and Product Security 10:20 Morning coffee & networking 11:00 Industry’s and GMP Requirements Regarding Storage and Transport of Plasma for Industrial Use to Suppliers • Legal framework: Important requirements for storage and transportation • Best practices for storage • Important checks before loading (transfer of risk) • Best practices for transportation Pedro Oliveira, KEDPLASMA, Germany, Head of Purchasing, Logistics & Projects 11:30 Authorities Inspection of GDP with Focus on Cold Chain Issues Learn about and discuss inspections from the viewpoint of the regulatory authorities • Authority focus during GDP/Cold chain inspection, in relation to new GDP guidelines. • Examples of common authority observations from GDP inspections. Thomas Vestergaard Pedersen, Danish Medicines Agency, Denmark Medicines Inspector 12:10 Lunch Quality & Validation 13:30 Quality Considerations for International Expansion • Ensuring Compliance in the global market place • Building effective tools to ensure successful launch in new markets Robert Potts, Vertex Pharmaceuticals, UK, Director, International Quality 14:00 Case study: How to get a global governance on cold chain distribution • Understanding the as-is situation • Develop a transport qualification approach • Establish a center of excellence for shipping systems Matthias Seebens, Boehringer-Ingelheim, Germany, Manager of Global Logistics & Distribution 14:30 The Compliance to GDP in the Last Mile • The key benefit of Cover by Car Fibreglass • From Sweden to Spain, conversions for different climatic zones; Luca Barboni, Car Fibreglass, Italy, CEO tel.: + 421 257 272 155 email: lesly.solei@fleming.events
  • 7. www.fleming.events DAY 1 18 May 2016 15:00 Case study: Risk Assessment and Mitigation Plan for Transportation of Clinical Trial Room Temperature Products Camillo Rossi, Eli Lilly, Belgium, Consultant Global Logistics Clinical Trials 15:30 Coffee break & networking 16:00 Brainstorm: End-to-end cold chain management – How to respond to increasing expectations from health authorities ? As the pressure increases it is harder and harder to stay on top during inspections and audits. How can you find your way in the maze of expectations, and be ready to pass with flying colors? Discussion leader: Gil Rochat, Merck Serono, Switzerland, Logistics Director 17:00 Assuring Data Integrity • Assembling and retaining data • Integrity constraints • Steps to be taken to ensure the economic benefits of resolving data issues 17:30 Feedback Session 17:40 Closing remarks from the chair 17:45 Evening Cocktail Reception Speakers and delegates are cordially invited to attend a Networking Cocktail Reception tel.: + 421 257 272 155 email: lesly.solei@fleming.events
  • 8. www.fleming.events DAY 219 May 2016 8:30 Morning coffee & networking 9:00 Opening remarks from the chair Product Handling & Operational Excellence 9:05 Case study: Temperature Management along the Supply Chain – Practical Aspects. • Temperature Management - where we are today - paradigms Vs. reality • What are the latest news - the progress we made in GDP during the last year • New approach - from Means to Processes Yoram Eshel, Teva Pharmaceutical Industries, Israel, Senior Director Global Transportation and Logistics 9:35 Case study: A Global, Practical Approach to Dealing with Temperature Excursions Roman Mijnhart, Sanofi Genzyme, Netherlands, Director Global Supply Chain Quality/RP 10:05 Coffee & Networking 10:35 A New MSD Shipping Strategy Ruud Van Der Geer, MSD, the Netherlands, Assoc. Director, Supply Chain Management CoE EMEA Product Handling & Cold Chain 11:05 Roundtable discussions including practical demonstrations: Table 1 The Connected isothermal box: securing the transport of pharmaceutical products 5 out of 10 of the most sold pharmaceutical products need to be kept between 2 and 8°C from the producer to the dispensary. Yet today, isothermal packaging and temperature dataloggers are sold separately. What if they could be combined ? Jeremy Laurens, Blulog, Co-founder, Sales and Marketing Director Table2 Protect your sensitive payload with global passive packaging Peli BioThermal 12:00 Luncheon 13:20 Case study: Pharma contract logistics: Roche Pharma’s cold chain warehousing • Building an effective and regulatory compliant cooperation with an external warehousing partner • Challenges for implementation • Key benefits of pharma contract logistics Monika Futschik, Roche, Germany, Head of Operations Support and Finished Goods 13:50 Case study: End-to-End Process Excellence to Ensure Uninterrupted Delivery • Do you have the right skills? Outsourcing critical activities • The searching and selecting of high-quality shippers – the total cost of Quality • Small details that can't be overlooked • Temperature and damage protection, what to consider? Eugenio Filippi, Baxalta, Austria, Senior Manager, Plasma Operations Europe/Logistics & Dispositioning tel.: + 421 257 272 155 email: lesly.solei@fleming.events
  • 9. www.fleming.events DAY 2 19 May 2016 14:20 Warehousing case study by the winner of the ROSPA Gold Award presenting the newest Norgine temperature controlled warehouse and their improvements in health and safety • The design and benefits of the build • Steps taken leading to attaining the ROSPA Gold Award • Actions improving your processes and increasing safety Meirion Richards, Norgine, United Kingdom, Site Director, Hengoed 14:50 Out-of-the-box presentation on storage and transportation of perishables Rainer Wittenfeld, European Cold Storage and Logistics Association, Germany, Chairman 15:20 Problem-solving roundtables: Suggest an issue which you have encountered and discuss possible solutions at a roundtable. The best solutions win a prize. 16:25 Feedback session 16:30 Closing remarks from the chair 16:35 Farewell coffee & tea I would like to thank everyone who has helped with the research and organisation of this event – especially the advisers and speakers – for their support and commitment. Stanislava Nichtova Conference Producer Fleming. stanislava.nichtova@fleming.events tel.: + 421 257 272 155 email: lesly.solei@fleming.events