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NETWORKING DRINKS
RECEPTION AND DINNER
Wednesday 13th December 2017:
End of Day One drinks reception
and dinner sponsored by Marken
BOOK BY 29TH SEPTEMBER AND SAVE £200 • BOOK BY 31ST OCTOBER AND SAVE £100
www.coldchain-distribution.com
Register online or contact the team on tel: +44 (0) 870 9090 711 or email: events@smi-online.co.uk
ACADEMIC & GROUP DISCOUNTS AVAILABLE
Sponsored by:
Copthorne Tara Hotel, London, UK
The race for the last mile - Maintaining GDP
compliance in an ever changing climate
SMi presents the 12th annual conference on...
Cold Chain
Distribution 2017
13th -14th
DEC
CHAIRS FOR 2017:
Tony Wright,
CEO,
Exelsius
INDUSTRY EXPERTS INCLUDE:
Glyn Stacey, UK Stem Cell Bank Director,
NIBSC (MHRA)
Andrea Gruber, Senior Manager, Special
Cargo, IATA
Chris Wallace, Senior Director - International
Supply Chain, Sanofi Genzyme
Gianpiero Lorusso, Director, Supply Operations
& General Services Global Manufacturing &
Supply, Merck Serono S.p.A.
Stephen Mitchell, Quality Lead, Logistics
Partnership, GSK
David Spillett, Key Account Director,
World Courier
Stephanie Fitt, Sales Manager UK &
Scandinavia, Emball’iso
Mark Edwards, Managing Director,
Modalis Ltd.
@SMIPHARM
#ColdChainSMI
Tim Saint, Senior Director
Business Development,
Marken
8 WAYS TO GAIN INDUSTRY LEVERAGE
1. Discover how to interpret and translate GDP
regulation into everyday practices
2. Measure competitive total cost of ownership to
re-examine current shipping and storing strategies
3. Why are we so afraid of the sea? – Listen to an
in-depth comparison of modes of transportation
4. Stay at the forefront of cutting edge progress
through developing pricing strategies to reduce
supply chain costs
5. Create competitive edge by identifying the
future trends to prevent risks
6. Learn how to establish a foundation to
successfully operate in emerging markets
7. Benefit from an agenda tailored towards
strengthening your understanding of mastering
global temperature control
8. Identify the appeal of supply chain social
responsibility
Lead Sponsor:
GALA DINNER
HOSTED BY
LEAD SPONSOR
ON 13TH DECEMBER
BY INVITATION ONLY
Register online at: www.coldchain-distribution.com
Supported byOfficial Associations
08.30 Registration & Coffee
09.00 Chair’s Opening Remarks
Tony Wright, CEO, Exelsius
GDP REQUIREMENTS ACROSS EUROPE
OPENING ADDRESS:
09.10 Managing current & future pharmaceutical supply chains across
a global air freight network
•Market growth drivers for air freighting time & temperature
sensitive products
•What are our customer expectations & concerns?
•What impact have the IATA TCR & EU GDP Guidelines
had upon airlines?
•How do airlines maximise product delivery service
performance across a global network?
Alan Dorling, Global Head - Pharmaceuticals & Life Sciences,
IAG Cargo
09.50 Industry update and how new trends are demanding smarter
solutions for cold chain management within the pharmaceutical
industry
•Latest developments and figures defining trends in the
pharmaceutical industry
•New therapies - new challenges for cold chain management
•Smart Packaging solutions and how they can support supply
chain automation and optimisation
Sascha Sonnenberg, VP Commercial
Operations Americas & EMEA, Marken
10.30 Morning Coffee & Networking Break
11.00 Direct-to-Patients: Translating thoughts into actions
•Why would last mile distribution be different and more
challenging?
•It’s not just about technology but ethics
•Developing a pioneering customer-centric distribution
strategy and supporting activities
David Spillett, Key Account Director,
World Courier
EXPLORING YOUR FREIGHT OPTIONS
11.40 Supply chain integrity: An approach to validating your cold chain
•An overview of global supply chain risk management strategies
•Case studies on a range of stability studies
•Ensuring compliance by performing your shipper qualification
Jeffrey LoPrete, Director - Global Supply Chain,
Amicus Therapeutics
12.20 Networking Lunch
13.20 Switching to sea freight
•Advantages of higher quality and lower costs
•Analysing all advantages and challenges
•Real life experiences of companies successfully using sea freight
Mark Edwards, Managing Director, Modalis Ltd.
14.00 Modes of transport: Air, road & sea
•A comparison of each freight option
•Challenges and opportunities of each method
•Choosing the best option for different, unique situations
•Why are we so afraid of the sea?
Amélie Ermel, Production Senior Specialist Associate, Eli Lilly
14.40 Afternoon Tea & Networking Break
MASTERING GLOBAL TEMPERATURE CONTROL
15.10 Active versus passive bulk shippers for cold chain distribution
•Active or Passive, what’s best for your shipping lane
•Risk versus cost, how to find the balance, what are the key
points to look for
•Re-use, single use or rental, what options are available and how
to make a considered choice
Paul Terry, Sales And Marketing Director,
Peli BioThermal
15.50 How to introduce warehouse automation technology into a
biopharma fill and finish environment
•The controlled temp inventory
•The material handling in a GMP CMC area
•The shipping cool chain
Gianpiero Lorusso, Director, Supply Operations & General Services
Global Manufacturing & Supply, Merck Serono S.p.A.
16.30 Preserving crucial stocks of stem cell lines for clinical use
•Maintaining a consistent ultralow temperature cold chain for
development and supply of stem cell based products is crucial
to the efficiency of manufacture and efficacy of cell therapies
•Careful monitoring, procedural controls and new equipment
are needed
•Lack of understanding of cryopreservation is still an issue in
cell-based research and development
•New cell types and formats required for therapy need new
technological and scientific developments
Glyn Stacey, UK Stem Cell Bank Director, NIBSC (MHRA)
17.10 PANEL DISCUSSION: What are the main challenges
in achieving GDP guideline compliance and where
can pharma focus investment to overcome them?
•How to interpret and translate GDP regulations into
everyday practice
•Quality assurance and validation - how to mitigate risks and
what measures should we take to enhance QA study?
•Due diligence and collaboration: Challenges with contractors
and sub-contractors
Moderator:
Tony Wright, CEO, Exelsius
Panelists:
Stephen Mitchell, Quality Lead Logistics Partnerships, GSK
Glyn Stacey, UK Stem Cell Bank Director, NIBSC (MHRA)
Mark Edwards, Managing Director, Modalis Ltd.
Sascha Sonnenberg, VP Commercial Operations
Americas & EMEA, Marken
17.50 Chair’s Closing Remarks and Close of Day One
18.00 - 19.00 Drinks Reception sponsored by
19.00 Depart for Dinner at the Bluebird Chelsea*
DAY ONE DRINKS RECEPTION AND DINNER
WEDNESDAY 13TH DECEMBER 2017
Marken would like to invite you to join the
drinks reception taking place between
6pm - 7pm on Wednesday 13th December 2017
at the Copthorne Tara Hotel, Kensington followed
by dinner at the Bluebired Chelsea*
Cold Chain Distribution
Day One | Wednesday 13th December 2017 www.coldchain-distribution.com
Sponsored by
* Strictly limited for pharmaceutical companies only
MARKETING OPPORTUNITIES
Want to know how you can get
involved? Interested in promoting
your services to this market?
Contact Kyra Williams,
SMi Marketing on
+44 (0) 207 827 6012 or
email: kwilliams@smi-online.co.uk
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
08.30 Registration & Coffee
09.00 Chair’s Opening Remarks
Tim Saint, Senior Director Business Development, Marken
KEYNOTE PRESENTATION:
09.10 Partnering with your air freight stakeholders to meet pharma
logistics excellence
•Complying with industry’s cold chain standards
•Consideration for optimal the industry’s facility capabilities
•Moving towards increased visibility and collaboration
•Serving a global market: Tapping into new markets while
bearing compliance in mind
Andrea Gruber, Senior Manager, Special Cargo, IATA
INVOLVING ALL STAKEHOLDERS
09.50 INTERACTIVE SESSION: Your hot topics in the cold chain!
•Interactive Q&A session to pose your logistical
supply chain questions
•Quick fire topic generation from the audience
•Conclusions and closing remarks
Nigel Cryer, Head of Compliance & Inspection Readiness, Sanofi
10.30 Morning Coffee & Networking Break
11.00 Reuse – Reduce – Recycle
•Single use vs. reusable packaging
•Challenges inherent to in-house reverse logistics
•One model doesn’t fit all. Commercial supply vs. CTS
•The management software
Stephanie Fitt, Sales Manager UK & Scandinavia,
Emball’iso
11.40 The impact of the Falsified Medicines Directive to the supply chain
•Falsified Medicines Directive & Delegated Regulation
•Development of European Medicines Verification Systems
•The cost implications for the operators
•Assess supply chain routes by road, air and sea
Martin Fitzgerald, Deputy Director, General for the European
Association of Pharmaceutical Full-line Wholesalers (GIRP)
12.20 Networking Lunch
13.20 PANEL DISCUSSION: Is faster better?
•Streamlining your cold chain operations while
adapting to the increasingly complex supply chain
requirements
•How to work with your suppliers and 3rd parties in a compliant
manner – defining liabilities and responsibilities
•If the pharma supply chain was faster, what is the implication
for logistics/cargo service providers?
Moderator:
Bob Hayes, Director, SeerPharma (UK)
Panelists:
Tim Wood, Manager, GSK
David Spillett, Key Account Director, World Courier
Yoram Eshel, Sr. Director Head of Global Transportation, Teva
14.00 Organisational culture: The new “hot topic”
•Introduced as a concept at the MHRA GDP Symposium in 2016,
the culture in a company will have a significant impact on
compliance
•The presentation will consider what “good” and “bad”
cultures look and feel like
•How to develop and encourage the right organisational
culture; how to recognise and measure organisational
culture and employee behaviours
Bob Hayes, Director, SeerPharma (UK)
14.40 Afternoon Tea & Networking Break
TACKLING LOGISTICAL AND SUPPLY CHAIN CHALLENGES
15.10 Supply chain challenges within emerging markets
•Best practices based on EU/GDP guidelines
•Challenges with suppliers and couriers
•Review of past experiences with sea/air transport
Chris Wallace, International Supply Chain Director, Sanofi Genzyme
15.50 Maintaining required temperature along the logistics chain:
Practical aspects
•Real time temperature surveillance and monitoring
•How to tackle temperature sensitive shipments?
•Maintaining the chill throughout the supply chain
Yoram Eshel, Sr. Director Head of Global Transportation, Teva
16.30 Chair’s Closing Remarks and Close of Day Two
Cold Chain Distribution
www.coldchain-distribution.com Day Two | Thursday 14th December 2017
www.coldchain-distribution.com
COLD CHAIN DISTRIBUTION ATTENDEES
2015 AND 2016 BY REGION
UK 59%
USA 1%
APAC 3%
EUROPE 37%
(EXCLUDING UK)
SUPPLIERS 23% REGULATORY 8%
ACADEMIA 5%
PHARMACEUTICAL 64%
COLD CHAIN DISTRIBUTION ATTENDEES
2015 AND 2016 BY INDUSTRY SECTOR
Lead Sponsor: Marken is a wholly owned subsidiary of UPS. Marken is the only patient-centric supply
chain organization 100% dedicated to the pharmaceutical and life sciences industries.
Marken maintains the leading position for Direct to Patient services and biological
sample shipments and offers a state-of-the-art GMP-compliant depot network and
logistic hubs in 45 locations worldwide for clinical trial material storage and distribution.
Marken’s more than 750 staff members manage 50,000 drug and biological shipments
every month at all temperature ranges in more than 150 countries. Additional services
such as biological kit production, ancillary material sourcing, storage and distribution,
shipment lane verification and qualifications, as well as GDP, regulatory and compliance
consultancy add to Marken’s unique position in the pharma and logistics industry.
www.marken.com
NETWORKING DINNER AT THE BLUEBIRD CHELSEA
WEDNESDAY 13TH DECEMBER 2017
SPONSORED BY MARKEN
Marken will be hosting a unique and exciting evening dinner at
the end of Day One. This event will be hosted at the Bluebird
Chelsea, leaving from the Copthorne Tara Hotel, Kensington at
7pm. It promises to be a fantastic networking opportunity. Places
are strictly limited for pharmaceutical companies only, visit our
website for further details.
www.coldchain-distribution.com
WHO SHOULD ATTEND THIS CONFERENCE:
You should attend this event if you work in the Pharmaceutical Industry with responsibilities in supply chain, cold chain,
logistics, distribution, packaging, operations, production, manufacturing, quality assurance and compliance.
Audience includes:
Directors, VPs, Chiefs, Heads, Principals, Managers of:
• Clinical Logistics
• Cold Chain
• Demand Planning
& Customer Operations
• Distribution
• GMP Compliance/ Inspection
• International Supplies
• Logistics
• Manufacturing
• Operations
• Packaging
• Quality Assurance & Compliance
Cold Chain Distribution
www.coldchain-distribution.com
PROUDLY SPONSORED BY:
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Cold Chain Distribution
www.coldchain-distribution.com
Berlinger & Co. AG
Swiss family run manufacturer of temperature monitoring devices, with over 30 years’ experience in the pharmaceutical
industry. Wide range of products ranging from temperature indicators, data loggers to wireless devices with automatic
upload of data. Berlinger’s temperature monitors can capture data in a passive mode or real time. SmartView is
Berlinger’s cloud based data management system, combining site monitoring and shipment monitoring under 1
platform.
Range of products:
• Temperature Indicators
• Temperature Monitors: Data loggers
• Wireless site Monitoring devices
(including Fridge Monitoring)
www.berlinger.com
Emball’iso
Since 1990, Emball’iso has been successfully assisting pharmaceutical companies in optimizing the global supply chain
with the design and manufacture of high performance temperature controlled packaging systems for the transport
of temperature sensitive biopharmaceutical products. Emball’iso is present across 4 continents with 8 production sites
(Brazil, China, France, Germany, India, Singapore, United Kingdom, United states with ISO 9001 certification) and 80
collection points. Our product range is extensive and can cover all aspects of thermal and capacity requirements:
from the single vial to pallets of products and for temperatures ranging from -80C to below +30C. Our services include
turnkey projects, integrated solutions, monitoring services, reverse logistic and rental program. Emball’iso deliver
quality, everywhere, just like you. www.emballiso.com
Peli BioThermal Limited offers the widest range of temperature controlled transport solutions in the world. Their products
ensure that delicate biological materials arrive intact and effective, despite exterior environments. Peli BioThermal is
dedicated to fulfilling the complex needs of the global healthcare industry. The company’s customers benefit from their
extensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. Peli BioThermal
also offers a complete range of services and software to support end-to-end temperature controlled packaging asset
management. Peli Products, S.L.U. is the European arm of Pelican Products, Inc. www.pelibiothermal.com
Sensitech
Sensitech is focused on delivering supply chain visibility solutions that track, monitor and protect products for global
leaders in the food, life sciences, consumer goods, and industrial markets. Our solutions are focused in three key areas:
quality and compliance, supply chain security, and logistics performance management. Quality and compliance
solutions address temperature-sensitive, complex supply chains focused on delivering the highest quality possible,
while our supply chain security solutions help to mitigate risks associated with theft, diversion and chain of custody.
Sensitech’s logistics performance solutions deliver origin-to-destination, real-time transparency to any in-transit journey.
www.sensitech.com
TP3 Global – SilverSkin Pallet Covers
Approved by an increasing number of global pharmaceutical companies, SilverSkin thermal pallet covers and
PalletQuilt reusable blankets are becoming the protection of choice for ambient and controlled room temperature
freight. With global manufacturing capability (USA, Europe, India, Australia & China), SilverSkin also comes with test
chamber and direct sunlight qualification data to support DGP QA risk based analysis.Temperature ranges of 2-40,
2-30, 15-25 and short spikes of 2-8C can be protected with a range of material grades to ensure capable temperature
risk management, whether requiring economical solutions for low risk routes, or thicker, more durable materials for
higher risk ambient. Ask us about various sizes, single, limited or multi use covers and blankets. www.tp3global.com
World Courier
World Courier is a global specialty logistics company that designs world-class logistics and supply chain programs in
complete alignment with our customers’ business goals. Pharmaceutical companies rely on us because they value
the peace of mind that comes with our unsurpassed knowledge, global reach and flawless supply chain execution.
Each trusted partnership we form with a customer is deeply rooted in our shared vision of improving global health. With
2,000+ associates in more than 140 offices across the globe, we offer solutions that instil confidence in the on-time,
on-temperature delivery of critical products. When trust is absolutely essential, there’s only one choice: World Courier.
www.worldcourier.com
Yourway Transport
Yourway Transport is a proven global industry leader in worldwide, pharma-specialist, premium transportation. We
are dedicated to providing our clients with best-in-class services and customer care in delivering the expertise and
level of attention that our customers demand. We look forward to continued collaboration with our many clients
contributing to the overall success of all clinical programs for which we provide shipping services. Yourway Transport
Biopharma Services is the division of YT that specializes in clinical supplies service solutions designed and delivered
to increase the quality and efficiency of the clinical trial process. Our solutions include GMP temperature controlled
depot storage, packaging and labelling, distribution to sites, samples to lab, global ambient cold chain temperature
controlled logistics, QP release, returns and reconciliation for destruction. www.yourwaytransport.co.uk
• Real Time tracking devices
• SmartView: Cloud based data management
system, combining facility and shipment
monitoring under 1 platform.
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of event require payment on booking. Access to the Document Portal will not be given until
payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send
a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferencesdocumentationviatheDocumentPortaltoanydelegatewhohaspaidbutisunable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able
to provide documentation in these circumstances. We cannot accept cancellations of orders
placed for Documentation or the Document Portal as these are reproduced specifically to order.
If we have to cancel the event for any reason, then we will make a full refund immediately, but
disclaim any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about
other products and services. Unless you tick here □ we may also share your data with third parties
offeringcomplementaryproductsorservices.Ifyouhaveanyqueriesorwanttoupdateanyofthe
data that we hold then please contact our Database Manager databasemanager@smi-online.
co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your
address on the attached letter.
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
on Document portal and literature distribution for all UK customers and for those EU
Customers not supplying a registration number for their own country here.
______________________________________________________________________________________
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
EARLY BIRD
DISCOUNT
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712
Unique Reference Number
Our Reference LVP-229
COLD CHAIN DISTRIBUTION
Conference: Wednesday 13th & Thursday 14th December 2017, Copthorne Tara Hotel, London, UK
4 WAYS TO REGISTER
www.coldchain-distribution.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd,
Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK
□ Book by 29th September 2017 to receive £200 off the conference price
□ Book by 31st October 2017 to receive £100 off the conference price
DELEGATE DETAILS
Terms and Conditions of Booking
VAT
VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SY
Payment must be made to SMi Group Ltd, and received before the event, by one of the
following methods quoting reference P-229 and the delegate’s name. Bookings made within
7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
Card Billing Address (If different from above):
PAYMENT
I cannot attend but would like to purchase access to the following
Document Portal/paper copy documentation Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
DOCUMENTATION
I would like to attend: (Please tick as appropriate) Fee Total
□ Conference only £1499.00 + VAT £1798.80
REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK)
□ End of Day One Evening Dinner at The Bluebird Chelsea
(Pharma only, subject to availability)
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.
CONFERENCE PRICES

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SMi Group's Pharmaceutical Cold Chain Distribution 2017 conference

  • 1. NETWORKING DRINKS RECEPTION AND DINNER Wednesday 13th December 2017: End of Day One drinks reception and dinner sponsored by Marken BOOK BY 29TH SEPTEMBER AND SAVE £200 • BOOK BY 31ST OCTOBER AND SAVE £100 www.coldchain-distribution.com Register online or contact the team on tel: +44 (0) 870 9090 711 or email: events@smi-online.co.uk ACADEMIC & GROUP DISCOUNTS AVAILABLE Sponsored by: Copthorne Tara Hotel, London, UK The race for the last mile - Maintaining GDP compliance in an ever changing climate SMi presents the 12th annual conference on... Cold Chain Distribution 2017 13th -14th DEC CHAIRS FOR 2017: Tony Wright, CEO, Exelsius INDUSTRY EXPERTS INCLUDE: Glyn Stacey, UK Stem Cell Bank Director, NIBSC (MHRA) Andrea Gruber, Senior Manager, Special Cargo, IATA Chris Wallace, Senior Director - International Supply Chain, Sanofi Genzyme Gianpiero Lorusso, Director, Supply Operations & General Services Global Manufacturing & Supply, Merck Serono S.p.A. Stephen Mitchell, Quality Lead, Logistics Partnership, GSK David Spillett, Key Account Director, World Courier Stephanie Fitt, Sales Manager UK & Scandinavia, Emball’iso Mark Edwards, Managing Director, Modalis Ltd. @SMIPHARM #ColdChainSMI Tim Saint, Senior Director Business Development, Marken 8 WAYS TO GAIN INDUSTRY LEVERAGE 1. Discover how to interpret and translate GDP regulation into everyday practices 2. Measure competitive total cost of ownership to re-examine current shipping and storing strategies 3. Why are we so afraid of the sea? – Listen to an in-depth comparison of modes of transportation 4. Stay at the forefront of cutting edge progress through developing pricing strategies to reduce supply chain costs 5. Create competitive edge by identifying the future trends to prevent risks 6. Learn how to establish a foundation to successfully operate in emerging markets 7. Benefit from an agenda tailored towards strengthening your understanding of mastering global temperature control 8. Identify the appeal of supply chain social responsibility Lead Sponsor: GALA DINNER HOSTED BY LEAD SPONSOR ON 13TH DECEMBER BY INVITATION ONLY
  • 2. Register online at: www.coldchain-distribution.com Supported byOfficial Associations 08.30 Registration & Coffee 09.00 Chair’s Opening Remarks Tony Wright, CEO, Exelsius GDP REQUIREMENTS ACROSS EUROPE OPENING ADDRESS: 09.10 Managing current & future pharmaceutical supply chains across a global air freight network •Market growth drivers for air freighting time & temperature sensitive products •What are our customer expectations & concerns? •What impact have the IATA TCR & EU GDP Guidelines had upon airlines? •How do airlines maximise product delivery service performance across a global network? Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo 09.50 Industry update and how new trends are demanding smarter solutions for cold chain management within the pharmaceutical industry •Latest developments and figures defining trends in the pharmaceutical industry •New therapies - new challenges for cold chain management •Smart Packaging solutions and how they can support supply chain automation and optimisation Sascha Sonnenberg, VP Commercial Operations Americas & EMEA, Marken 10.30 Morning Coffee & Networking Break 11.00 Direct-to-Patients: Translating thoughts into actions •Why would last mile distribution be different and more challenging? •It’s not just about technology but ethics •Developing a pioneering customer-centric distribution strategy and supporting activities David Spillett, Key Account Director, World Courier EXPLORING YOUR FREIGHT OPTIONS 11.40 Supply chain integrity: An approach to validating your cold chain •An overview of global supply chain risk management strategies •Case studies on a range of stability studies •Ensuring compliance by performing your shipper qualification Jeffrey LoPrete, Director - Global Supply Chain, Amicus Therapeutics 12.20 Networking Lunch 13.20 Switching to sea freight •Advantages of higher quality and lower costs •Analysing all advantages and challenges •Real life experiences of companies successfully using sea freight Mark Edwards, Managing Director, Modalis Ltd. 14.00 Modes of transport: Air, road & sea •A comparison of each freight option •Challenges and opportunities of each method •Choosing the best option for different, unique situations •Why are we so afraid of the sea? Amélie Ermel, Production Senior Specialist Associate, Eli Lilly 14.40 Afternoon Tea & Networking Break MASTERING GLOBAL TEMPERATURE CONTROL 15.10 Active versus passive bulk shippers for cold chain distribution •Active or Passive, what’s best for your shipping lane •Risk versus cost, how to find the balance, what are the key points to look for •Re-use, single use or rental, what options are available and how to make a considered choice Paul Terry, Sales And Marketing Director, Peli BioThermal 15.50 How to introduce warehouse automation technology into a biopharma fill and finish environment •The controlled temp inventory •The material handling in a GMP CMC area •The shipping cool chain Gianpiero Lorusso, Director, Supply Operations & General Services Global Manufacturing & Supply, Merck Serono S.p.A. 16.30 Preserving crucial stocks of stem cell lines for clinical use •Maintaining a consistent ultralow temperature cold chain for development and supply of stem cell based products is crucial to the efficiency of manufacture and efficacy of cell therapies •Careful monitoring, procedural controls and new equipment are needed •Lack of understanding of cryopreservation is still an issue in cell-based research and development •New cell types and formats required for therapy need new technological and scientific developments Glyn Stacey, UK Stem Cell Bank Director, NIBSC (MHRA) 17.10 PANEL DISCUSSION: What are the main challenges in achieving GDP guideline compliance and where can pharma focus investment to overcome them? •How to interpret and translate GDP regulations into everyday practice •Quality assurance and validation - how to mitigate risks and what measures should we take to enhance QA study? •Due diligence and collaboration: Challenges with contractors and sub-contractors Moderator: Tony Wright, CEO, Exelsius Panelists: Stephen Mitchell, Quality Lead Logistics Partnerships, GSK Glyn Stacey, UK Stem Cell Bank Director, NIBSC (MHRA) Mark Edwards, Managing Director, Modalis Ltd. Sascha Sonnenberg, VP Commercial Operations Americas & EMEA, Marken 17.50 Chair’s Closing Remarks and Close of Day One 18.00 - 19.00 Drinks Reception sponsored by 19.00 Depart for Dinner at the Bluebird Chelsea* DAY ONE DRINKS RECEPTION AND DINNER WEDNESDAY 13TH DECEMBER 2017 Marken would like to invite you to join the drinks reception taking place between 6pm - 7pm on Wednesday 13th December 2017 at the Copthorne Tara Hotel, Kensington followed by dinner at the Bluebired Chelsea* Cold Chain Distribution Day One | Wednesday 13th December 2017 www.coldchain-distribution.com Sponsored by * Strictly limited for pharmaceutical companies only
  • 3. MARKETING OPPORTUNITIES Want to know how you can get involved? Interested in promoting your services to this market? Contact Kyra Williams, SMi Marketing on +44 (0) 207 827 6012 or email: kwilliams@smi-online.co.uk Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 08.30 Registration & Coffee 09.00 Chair’s Opening Remarks Tim Saint, Senior Director Business Development, Marken KEYNOTE PRESENTATION: 09.10 Partnering with your air freight stakeholders to meet pharma logistics excellence •Complying with industry’s cold chain standards •Consideration for optimal the industry’s facility capabilities •Moving towards increased visibility and collaboration •Serving a global market: Tapping into new markets while bearing compliance in mind Andrea Gruber, Senior Manager, Special Cargo, IATA INVOLVING ALL STAKEHOLDERS 09.50 INTERACTIVE SESSION: Your hot topics in the cold chain! •Interactive Q&A session to pose your logistical supply chain questions •Quick fire topic generation from the audience •Conclusions and closing remarks Nigel Cryer, Head of Compliance & Inspection Readiness, Sanofi 10.30 Morning Coffee & Networking Break 11.00 Reuse – Reduce – Recycle •Single use vs. reusable packaging •Challenges inherent to in-house reverse logistics •One model doesn’t fit all. Commercial supply vs. CTS •The management software Stephanie Fitt, Sales Manager UK & Scandinavia, Emball’iso 11.40 The impact of the Falsified Medicines Directive to the supply chain •Falsified Medicines Directive & Delegated Regulation •Development of European Medicines Verification Systems •The cost implications for the operators •Assess supply chain routes by road, air and sea Martin Fitzgerald, Deputy Director, General for the European Association of Pharmaceutical Full-line Wholesalers (GIRP) 12.20 Networking Lunch 13.20 PANEL DISCUSSION: Is faster better? •Streamlining your cold chain operations while adapting to the increasingly complex supply chain requirements •How to work with your suppliers and 3rd parties in a compliant manner – defining liabilities and responsibilities •If the pharma supply chain was faster, what is the implication for logistics/cargo service providers? Moderator: Bob Hayes, Director, SeerPharma (UK) Panelists: Tim Wood, Manager, GSK David Spillett, Key Account Director, World Courier Yoram Eshel, Sr. Director Head of Global Transportation, Teva 14.00 Organisational culture: The new “hot topic” •Introduced as a concept at the MHRA GDP Symposium in 2016, the culture in a company will have a significant impact on compliance •The presentation will consider what “good” and “bad” cultures look and feel like •How to develop and encourage the right organisational culture; how to recognise and measure organisational culture and employee behaviours Bob Hayes, Director, SeerPharma (UK) 14.40 Afternoon Tea & Networking Break TACKLING LOGISTICAL AND SUPPLY CHAIN CHALLENGES 15.10 Supply chain challenges within emerging markets •Best practices based on EU/GDP guidelines •Challenges with suppliers and couriers •Review of past experiences with sea/air transport Chris Wallace, International Supply Chain Director, Sanofi Genzyme 15.50 Maintaining required temperature along the logistics chain: Practical aspects •Real time temperature surveillance and monitoring •How to tackle temperature sensitive shipments? •Maintaining the chill throughout the supply chain Yoram Eshel, Sr. Director Head of Global Transportation, Teva 16.30 Chair’s Closing Remarks and Close of Day Two Cold Chain Distribution www.coldchain-distribution.com Day Two | Thursday 14th December 2017
  • 4. www.coldchain-distribution.com COLD CHAIN DISTRIBUTION ATTENDEES 2015 AND 2016 BY REGION UK 59% USA 1% APAC 3% EUROPE 37% (EXCLUDING UK) SUPPLIERS 23% REGULATORY 8% ACADEMIA 5% PHARMACEUTICAL 64% COLD CHAIN DISTRIBUTION ATTENDEES 2015 AND 2016 BY INDUSTRY SECTOR Lead Sponsor: Marken is a wholly owned subsidiary of UPS. Marken is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient services and biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 45 locations worldwide for clinical trial material storage and distribution. Marken’s more than 750 staff members manage 50,000 drug and biological shipments every month at all temperature ranges in more than 150 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry. www.marken.com NETWORKING DINNER AT THE BLUEBIRD CHELSEA WEDNESDAY 13TH DECEMBER 2017 SPONSORED BY MARKEN Marken will be hosting a unique and exciting evening dinner at the end of Day One. This event will be hosted at the Bluebird Chelsea, leaving from the Copthorne Tara Hotel, Kensington at 7pm. It promises to be a fantastic networking opportunity. Places are strictly limited for pharmaceutical companies only, visit our website for further details. www.coldchain-distribution.com WHO SHOULD ATTEND THIS CONFERENCE: You should attend this event if you work in the Pharmaceutical Industry with responsibilities in supply chain, cold chain, logistics, distribution, packaging, operations, production, manufacturing, quality assurance and compliance. Audience includes: Directors, VPs, Chiefs, Heads, Principals, Managers of: • Clinical Logistics • Cold Chain • Demand Planning & Customer Operations • Distribution • GMP Compliance/ Inspection • International Supplies • Logistics • Manufacturing • Operations • Packaging • Quality Assurance & Compliance Cold Chain Distribution www.coldchain-distribution.com
  • 5. PROUDLY SPONSORED BY: SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Cold Chain Distribution www.coldchain-distribution.com Berlinger & Co. AG Swiss family run manufacturer of temperature monitoring devices, with over 30 years’ experience in the pharmaceutical industry. Wide range of products ranging from temperature indicators, data loggers to wireless devices with automatic upload of data. Berlinger’s temperature monitors can capture data in a passive mode or real time. SmartView is Berlinger’s cloud based data management system, combining site monitoring and shipment monitoring under 1 platform. Range of products: • Temperature Indicators • Temperature Monitors: Data loggers • Wireless site Monitoring devices (including Fridge Monitoring) www.berlinger.com Emball’iso Since 1990, Emball’iso has been successfully assisting pharmaceutical companies in optimizing the global supply chain with the design and manufacture of high performance temperature controlled packaging systems for the transport of temperature sensitive biopharmaceutical products. Emball’iso is present across 4 continents with 8 production sites (Brazil, China, France, Germany, India, Singapore, United Kingdom, United states with ISO 9001 certification) and 80 collection points. Our product range is extensive and can cover all aspects of thermal and capacity requirements: from the single vial to pallets of products and for temperatures ranging from -80C to below +30C. Our services include turnkey projects, integrated solutions, monitoring services, reverse logistic and rental program. Emball’iso deliver quality, everywhere, just like you. www.emballiso.com Peli BioThermal Limited offers the widest range of temperature controlled transport solutions in the world. Their products ensure that delicate biological materials arrive intact and effective, despite exterior environments. Peli BioThermal is dedicated to fulfilling the complex needs of the global healthcare industry. The company’s customers benefit from their extensive expertise in ensuring that temperature stability is maintained throughout the distribution chain. Peli BioThermal also offers a complete range of services and software to support end-to-end temperature controlled packaging asset management. Peli Products, S.L.U. is the European arm of Pelican Products, Inc. www.pelibiothermal.com Sensitech Sensitech is focused on delivering supply chain visibility solutions that track, monitor and protect products for global leaders in the food, life sciences, consumer goods, and industrial markets. Our solutions are focused in three key areas: quality and compliance, supply chain security, and logistics performance management. Quality and compliance solutions address temperature-sensitive, complex supply chains focused on delivering the highest quality possible, while our supply chain security solutions help to mitigate risks associated with theft, diversion and chain of custody. Sensitech’s logistics performance solutions deliver origin-to-destination, real-time transparency to any in-transit journey. www.sensitech.com TP3 Global – SilverSkin Pallet Covers Approved by an increasing number of global pharmaceutical companies, SilverSkin thermal pallet covers and PalletQuilt reusable blankets are becoming the protection of choice for ambient and controlled room temperature freight. With global manufacturing capability (USA, Europe, India, Australia & China), SilverSkin also comes with test chamber and direct sunlight qualification data to support DGP QA risk based analysis.Temperature ranges of 2-40, 2-30, 15-25 and short spikes of 2-8C can be protected with a range of material grades to ensure capable temperature risk management, whether requiring economical solutions for low risk routes, or thicker, more durable materials for higher risk ambient. Ask us about various sizes, single, limited or multi use covers and blankets. www.tp3global.com World Courier World Courier is a global specialty logistics company that designs world-class logistics and supply chain programs in complete alignment with our customers’ business goals. Pharmaceutical companies rely on us because they value the peace of mind that comes with our unsurpassed knowledge, global reach and flawless supply chain execution. Each trusted partnership we form with a customer is deeply rooted in our shared vision of improving global health. With 2,000+ associates in more than 140 offices across the globe, we offer solutions that instil confidence in the on-time, on-temperature delivery of critical products. When trust is absolutely essential, there’s only one choice: World Courier. www.worldcourier.com Yourway Transport Yourway Transport is a proven global industry leader in worldwide, pharma-specialist, premium transportation. We are dedicated to providing our clients with best-in-class services and customer care in delivering the expertise and level of attention that our customers demand. We look forward to continued collaboration with our many clients contributing to the overall success of all clinical programs for which we provide shipping services. Yourway Transport Biopharma Services is the division of YT that specializes in clinical supplies service solutions designed and delivered to increase the quality and efficiency of the clinical trial process. Our solutions include GMP temperature controlled depot storage, packaging and labelling, distribution to sites, samples to lab, global ambient cold chain temperature controlled logistics, QP release, returns and reconciliation for destruction. www.yourwaytransport.co.uk • Real Time tracking devices • SmartView: Cloud based data management system, combining facility and shipment monitoring under 1 platform.
  • 6. Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferencesdocumentationviatheDocumentPortaltoanydelegatewhohaspaidbutisunable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offeringcomplementaryproductsorservices.Ifyouhaveanyqueriesorwanttoupdateanyofthe data that we hold then please contact our Database Manager databasemanager@smi-online. co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. ______________________________________________________________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk EARLY BIRD DISCOUNT □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712 Unique Reference Number Our Reference LVP-229 COLD CHAIN DISTRIBUTION Conference: Wednesday 13th & Thursday 14th December 2017, Copthorne Tara Hotel, London, UK 4 WAYS TO REGISTER www.coldchain-distribution.com FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK □ Book by 29th September 2017 to receive £200 off the conference price □ Book by 31st October 2017 to receive £100 off the conference price DELEGATE DETAILS Terms and Conditions of Booking VAT VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SY Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-229 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment: □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. Card Billing Address (If different from above): PAYMENT I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) DOCUMENTATION I would like to attend: (Please tick as appropriate) Fee Total □ Conference only £1499.00 + VAT £1798.80 REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK) □ End of Day One Evening Dinner at The Bluebird Chelsea (Pharma only, subject to availability) PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference. CONFERENCE PRICES