The document is an agenda for the 6th Annual Cold Chain & Product Handling: Temperature Controlled Logistics Conference taking place from May 18-19, 2016 in Amsterdam. The conference will focus on key issues in temperature controlled logistics for pharmaceuticals and biologics, which is expected to grow to a $13.4 billion industry by 2020. Speakers will address topics like serialisation, regulations, quality assurance, and operational best practices. There will also be case studies, roundtable discussions, and a site visit to logistics facilities at Schiphol Airport. The event aims to provide industry professionals insights and solutions for ensuring compliance in global cold chain distribution.
Experienced Warehouse Manager with a demonstrated history of working in logistics. Skilled in Customer Service, Coaching, Medical Devices, Sales, and Business Development.
Experienced Warehouse Manager with a demonstrated history of working in logistics. Skilled in Customer Service, Coaching, Medical Devices, Sales, and Business Development.
IQPC’s Cold Chain MENA summit will combine Supply Chain, Logistics and Quality leaders from Multi-national biopharma companies from the region and around the world as well as government and regulatory figures to discuss issues and proposed solutions that may occur across the supply chain.
For more information, visit www.coldchainmena.com
Pharma IQ brings you Clinical Trial Supply Europe Conference Profit. Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials.
SMi Group announces the return of its 11th annual Pharmaceutical Logistics conference to London on the 18th- 19th May 2017. Outsourcing logistics tasks to third parties has been observed as an emerging trend in the global market and it is only expected to gain momentum in the coming years
Pharma IQ’s Cold Chain & Temperature Management Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain. All new discussions will include: review of Health Canada’s revised <0069>, Canadian importation strategies, specialty logistics, stability data and risk mitigation.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
Meet the most senior supply chain decision makers of top global pharma companies like Abbott, AstraZenca, Baxter, Bayer Healthcare, Boehringer Ingelheim, GSK, Lilly, MSD, Merck, Novo Nordisk, Pfizer, Queisser Pharma, Sandoz, Teva, UCB, and many more…
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
IQPC’s Cold Chain MENA summit will combine Supply Chain, Logistics and Quality leaders from Multi-national biopharma companies from the region and around the world as well as government and regulatory figures to discuss issues and proposed solutions that may occur across the supply chain.
For more information, visit www.coldchainmena.com
Pharma IQ brings you Clinical Trial Supply Europe Conference Profit. Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials.
SMi Group announces the return of its 11th annual Pharmaceutical Logistics conference to London on the 18th- 19th May 2017. Outsourcing logistics tasks to third parties has been observed as an emerging trend in the global market and it is only expected to gain momentum in the coming years
Pharma IQ’s Cold Chain & Temperature Management Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain. All new discussions will include: review of Health Canada’s revised <0069>, Canadian importation strategies, specialty logistics, stability data and risk mitigation.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
Meet the most senior supply chain decision makers of top global pharma companies like Abbott, AstraZenca, Baxter, Bayer Healthcare, Boehringer Ingelheim, GSK, Lilly, MSD, Merck, Novo Nordisk, Pfizer, Queisser Pharma, Sandoz, Teva, UCB, and many more…
IDMP Implementation - Impact on Data, Systems and Processes. How to cover gap...Torben Haagh
ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead!
Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information:
# Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site!
# Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma
# Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies
# Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals!
For more information visit our website: http://bit.ly/EventWebsite
If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event
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