SMi Group's Prefilled Syringes East Coast 2018 conference is back next April in Boston

1. plus tWo iNteRaCtive half-DaY pRe-CoNfeReNCe WoRkshops
TUESDAY 10TH APRIL 2018, SHERATON BOSTON HOTEL, BOSTON, USA
B: human factors for Connected Drug Delivery systems
Workshop Leaders: melanie turieo, Director, Human Factors and
Industrial Design, Cambridge Consultants and karen unterman,
Group Leader, Human Factors Engineering, Cambridge Consultants
13.30 - 17.00
ChaiRs foR 2018:
• Dhairya mehta, Associate Director of Device
and Combination Products, shire
• stephen Barat, Head of Pre-Clinical
and Early Clinical Development, scynexis
featuReD top phaRma speakeRs:
• Justin Wright, Vice President, Drug Delivery
Innovation, DDR&D Technology, eli lilly
• tieming Ruan, Associate Director of Device
Development, takeda
• molly story, Head, Global Usability Engineering
and Risk Management, Sanofi
• gary henniger, R&D Director, Discovery and
Product Development R&D, teva pharmaceuticals
• michael song, Pharmaceutical Device and
Digital Health, medimmune
• steve Bowman, Device Program Lead, shire
• gary mills, Associate Director, Drug Product
Development, tesaRo
• kashappa goud Desai, Investigator,
Biopharmaceutical Product Sciences,
glaxosmithkline
• susan Neadle, Head, Combination Products
Center of Excellence, Janssen
www.pfsamericas.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
aCaDemiC & gRoup DisCouNts availaBle @smiphaRm
#smipfsusa
RegisteR BY 15th DeCemBeR aND save $400
RegisteR BY 31st JaNuaRY aND save $200
RegisteR BY 28th feBRuaRY aND save $100
a: Design Considerations for the World outside the Clinic
Workshop Leaders: Debbie mcConnell, Human Factors Technical Lead,
Human Centric Design, Battelle and annie Diorio-Blum,
Principal Industrial Designer, Human Centric Design, Battelle
08.30 - 12.30
spoNsoReD BY
SMi presents the East Coast’s Leading, 5th Annual Conference and Exhibition…
Sheraton Boston Hotel, Boston, USA
WORKSHOPS: 10TH
CONFERENCE:
11TH - 12TH
APRIL
2018
Pre-Filled Syringes
East Coast
enabling the next generation of pre-filled syringes from design to manufacture
NeW foR 2018:
• Understand end-use interaction with delivery systems and
Human Factor engineering methods
• Guidance in overcoming challenges of delivering high-
concentration formulations and challenges for biologics
• Explore how to integrate Quality-by-Design principles for best
practice solutions in developing your combination products
• Benchmark against updates on new technologies, including
digital monitoring biomarkers from Eli Lilly; electronic-
enabled drug delivery devices from MedImmune; and PFS
tech transfer of in-line products from Merck
• Engage with the latest results from recent studies in
chemical compatibility; comparison of COP vs glass; and
container integrity
• Participate in our two interactive panel discussions and gain
from over 5 hours of dedicated networking time

2. engage with top pharma scientists
and engineers in our
pfs focused conference
hear the very latest plans
about drug-device development
in the injectables industry
Network with industry
and pharma leadership
in the exhibition area
letteR fRom the ChaiRs:
Dear participants,
We are absolutely delighted to welcome each of you to SMi’s Pre-Filled
Syringes East Coast conference.
Over the past decade, pre-fi lled syringe venues have grown signifi cantly
in terms of content and attendance and much of this can be attributed
to the interest and need to share information, as the development of
pre-fi lled syringe drug products are a prime example of complex, multi-
disciplinary efforts. Pre-fi lled syringes have undoubtedly improved the lives
of the patients who rely on these drug products. As such, as an industry,
we share a responsibility to continue to develop and evolve these drug
products as new technologies in delivery, formulation and manufacturing
emerge – also considering the impact that global regulatory and
geopolitical landscapes may have – in order to meet the needs of our
patients and improve upon therapeutic options.
The meeting will therefore allow for the face-to-face assembly of subject
matter experts in all areas related to the development of pre-fi lled syringe
and other related combination drug products, and thereby provide a
tremendous opportunity for meaningful discourse.
We look forward to seeing you there!
Dhairya mehta,
Associate Director of Device and Combination Products,
shire
stephen Barat,
Head of Pre-Clinical and Early Clinical Development,
scynexis
08.30 RegistRatioN & Coffee
09.00 Co-ChaiRs’ opeNiNg RemaRks
Dhairya mehta, Associate Director of Device and Combination
Products, shire
stephen Barat, Head of Pre-Clinical and Early Clinical
Development, scynexis
RegulatoRY upDates foR the pfs iNDustRY
keYNote aDDRess
09.10 NavigatiNg RegulatoRY CoNsiDeRatioNs iN the pfs
maRket eNviRoNmeNt
• Regulatory considerations for industry relating to USP <1207>
• Applicable regulatory schemes and potential regulatory
strategies
• Latest updates and changes for FDA requirements
session Reserved for fDa Representative
pfs maNufaCtuRiNg aND pRoCess:
ChalleNges aND solutioNs
09.50 sYRiNge filliNg of high-CoNCeNtRatioN moNoColoNal
aNtiBoDY foRmulatioN: ChalleNges aND solutioNs
• There has been a steady increase in the number of high-
concentration mAb formulations in ready-to-use pre-fi lled
syringes for subcutaneous administration
• Challenges of successful syringe fi lling of high-concentration
mAb formulations by an automated fi lling machine
• Outlining challenges associated with syringe fi lling of high-
concentration formulations
• This presentation summarizes the key challenges and
mitigation strategies
kashappa-goud Desai, Associate Fellow, gsk
10.30 moRNiNg Coffee spoNsoReD BY
11.00 Cop - teChNiCal Data upDate
• Key properties of COP - update
• Case Study: Study on Protein adsorption/aggregation with
actual protein drug - COP vs. glass
• Case Study: Study on delamination with glass syringe vs. COP
syringe
• Leachable data on COP syringe with various chemicals
toshiro katayama, Product Manager, zeon
11.40 DRug-DeviCe ComBiNatioN pRoDuCts DevelopmeNt
ChalleNges
• Combination Products: Application of drugs with medical
devices minimizes adverse events, while maximising
treatment response and positive user experiences
• Compare and contrast the drug and device development
processes and integration of the two
• Combination products risk management
• Dynamic combination products regulatory environment
susan Neadle, Head, Combination Products Center of
Excellence, Janssen
12.20 NetWoRkiNg luNCh spoNsoReD BY
iNteRgRateD QualitY BY DesigN (QbD)
pRiNCiples iNto DevelopmeNt
13.20 sessioN ReseRveD foR NemeRa
adrien tisserand, Category Manager - Parenteral,
Nemera
14.00 safetY evaluatioN of leaChaBles WheN DevelopiNg
a pRe-filleD sYRiNge DRug pRoDuCt
• Background on leachables from pre-fi lled syringe drug devices
• Why is safety assessment of leachables required?
• How leachable issues related to drug product quality can
impact safety and effi cacy
• Best practice recommendations during development
stephen Barat, Head of Pre-Clinical and Early Clinical
Development, scynexis
14.40 pRe-filleD sYRiNge seCoND souRCe iNitiative:
a Dual souRCe iDeNtifiCatioN to ReDuCe supplY usiNg
QualitY-BY-DesigN (QBD) pRiNCiples
• Understanding Quality by Design (QbD)
• A global regulatory initiative with the goal of enhancing the
quality of combination products
• Summary of the application of QbD principles for
combination product development
• Evaluation of syringe second source by applying QbD principles
kashappa-goud Desai, Associate Fellow, gsk
Nathan heacock, Associate Scientist, gsk
15.20 afteRNooN tea spoNsoReD BY
15.50 the Best plastiC sYRiNge foR BiologiCs
• OXYCAPT Multilayer Plastic Syringe having Glass-like
Oxygen Barrier
• Excellent Oxygen Barrier contributes to Stability of Biologics
• Very Low Extractables contribute to Stability of Biologics
• Good UV Barrier contributes to Stability of Biologics
shota arakawa, Researcher, mitsubishi gas Chemical
16.30 iNtegRatiNg DRug-DeviCe ComBiNatioN pRoDuCt
DevelopmeNt
• Integrating the design process with methodical
pharmaceutical development
• QbD and design controls as a paradigm for aligning
combination development
• Comparison with regulatory guidance on Combination
Products and the current state of development of drug
device development
Justin lacombe, Senior Manager Process Development,
teva pharmaceuticals usa
gary henniger, Director Engineering,
teva pharmaceuticals usa
tReNDs toWaRDs a Rise iN BiologiCs
aND the impliCatioNs foR pfs
17.10 paNel DisCussioN: DeBatiNg the ChalleNges
aND solutioNs foR pfs DevelopmeNt aND
the iNCReasiNg tReNDs toWaRDs BiologiCs
• What are the biggest challenges for biologic
drug products at the interface of formulation,
primary packaging and applications?
• How should we bridge the gaps in drug-delivery innovations
to address the challenges of delivering complex biologics?
• How should we maintain patient centricity to our
development processes?
Dhairya mehta, Associate Director of Device and Combination
Products, shire
steve Bowman, Device Program Lead, shire
Justin Wright, Vice President, Drug Delivery Innovation, DDR&D
Technology, eli lilly
17.50 Co-ChaiRs’ ClosiNg RemaRks aND Close of DaY oNe
pre-filled syringes east Coast www.pfsamericas.com
DaY oNe | WeDNesDaY 11th apRil 2018
Register online at www.pfsamericas.com

3. 08.30 Registration & Coffee
09.00 Co-Chairs’ Opening Remarks
Dhairya Mehta, Associate Director of Device and Combination
Products, Shire
Stephen Barat, Head of Pre-Clinical and Early Clinical
Development, Scynexis
human factors and the end-user consideration
in the design feedback loop
KEYNOTE ADDRESS
09.10 The critical importance of recognizing the considerations,
decisions and trade-offs inherent in all combination
product development
• Your product has multiple customers beyond patients - do
you know all of them? How well? Are you sure? Prove it!
• The saying “a chain is a s strong as its weakest link” applies to
combination product development too. What’s yours (likely
there are many)? What are you doing to address them?
• The future of combination products is bright - but are we
confident we know what it will look like?
Steve Bowman, Device Program Lead, Shire
09.50 The Challenges of Platformization
• From a human factors perspective, what would it take to
create a device that is a true platform which can be utilized
for multiple molecules and a variety of user groups?
• What effects might the choice of molecule have on design
of the device?
• What effects might the choice of molecule have on the
user’s interactions with the device?
• For which users should the device be designed?
Molly Story, Head, Global Usability Engineering and
Risk Management, Sanofi Pharmaceuticals
10.30 Morning Coffee Sponsored by
11.00 Leveraging Preformative Research to Inform Lifecycle
Management of Combination Products for Complex
Disease States
• Empathizing with total disease burden for complex
disease states
• Challenges of managing drug delivery (use steps)
from patient perspective
• How to identify opportunities to reduce complexity
for patients
• Two case studies (Hemophilia Primary
Immunodeficiency Disease)
Joke Maes, Product Manager,
Terumo Pharmaceutical Solutions
Chris Franzese, Lead Clinical Analyst, Matchstick
11.40 Panel Discussion: What is missing from the
Human Factors studies and why is this still
a prevalent issue?
• Are we misunderstanding patient compliance?
• Real world case-studies and considering end-user group
needs - are we using the bigger picture?
• How is IoT assisting in Human Factors studies and is this
actually a hinderance to device interaction?
Gary Mills, Associate Director, Drug Product Development,
TESARO
Stephen Barat, Head of Pre-Clinical and Early Clinical
Development, Scynexis
Molly Story, Head, Global Usability Engineering and Risk
Management, Sanofi Pharmaceuticals
12.20 Networking Lunch Sponsored by
13.20 Smart Labeling Solutions for Pre-filled Syringes:
Patient Centricity Enhanced
• Innovative RFID/NFC solutions to improve user experience
and patient safety through connectivity
• Customizing injection devices with multi-functional labels
• User-friendly, label-integrated needlestick prevention
• Low migration labels and challenges of COC/COP materials
• Ensuring container integrity through novel technologies
Eric Caro, Key Account Manager, Schreiner MediPharm
14.00 Lessons learned from Human Factor studies of
pre-filled syringes
• Formative study versus Summative study
• Number of arms (IFU only versus IFU + QRG)
• Formative study versus Summative study: Are both formative
and summative studies required if an off-shelf product is used
with certain modification?
• Number of arms: How many arms need to be included in the
human factor studies? IFU only, IFU + QRG or QRG only
• Use Errors: How to deal with Use Errors found from Human
Factor studies and what if these Use Errors can’t be mitigated?
Tieming Ruan, Associate Director of Device Development, Takeda
the future of parenteral drug delivery
14.40 New developments in low temperature VHP terminal surface
sterilization and PFS material compatibility
• New applications and technology developments on VHP
(Vaporized Hydrogen Peroxide)
• Low temperature terminal surface sterilization
• PFS material compatibility
Juha Mattila, Senior Product Manager, STERIS
15.20 Composite Digital Monitoring Biomarkers Come of Age:
The Framework for Utilization
• Activity and investments in connected injection systems and
platforms continues to increase
• The opportunity exists to combine connected systems with
composite digital monitoring biomarkers to create hybrid
closed loop systems for all diseases.
• The incorporation of digital monitoring biomarkers into
health, wellness and disease management will be reviewed
on the context of next generation drug delivery systems
Justin Wright, Vice President, Drug Delivery Innovation, DDRD
Technology, Eli Lilly
16.00 Afternoon Tea Sponsored by
16.30 PFS tech transfer of in-line products not originally
developed as combination prodcuts
• Defining Design User Requirements
• Dealing with suppliers providing device constituent components
• Systems engineering needs
• Retrospective design documentation
Maria Linzmayer, Associate Director, Drug Delivery Devices, Merck
17.10 Future of digitially connected device and changing
paradigm in disease management
• Digitalization: Benefits of electronic-enabled drug delivery
devices in patient disease management beyond adherence
• Tackling hurdles of connectivity for combination products:
cost, technology, regulatory and time-to-market
considerations
• Evaluating add-on platforms as a step towards integrated
device ecosystem
• Exploring opportunities for pharma, patient and HCP
engagement through connected drug delivery devices
Michael Song, Sr. Manager, Drug Delivery and Device
Development, MedImmune Inc
17.50 Co-Chairs’ Closing Remarks and Close of Day Two
Pre-Filled Syringes East Coast www.pfsamericas.com
Day Two | Thursday 12th APRIL 2018
•Abbott Laboratories
•AbbVie
•Alexion
•American Regent
•Amgen
•Aptar Pharma
•Aurobindo Pharma
USA Inc.
•Baumann Springs
Usa Inc
•BCM Group LLC
•BD
•Bemis Healthcare
Packaging
•Biocorp
•Biogen Incorporated
•Bristol-Myers Squibb
•Centurion Medical
Products
•Connecticut Spring
Stamping
•Cook Pharmica LLC
•Daicel Corporation
•Datwyler Schweiz AG
•Eastman Chemical
Company
•Eli Lilly
•Ermo
•FDA
•Fluid Imaging
Technologies
•GSK
•Janssen
Pharmaceutical
Incorporated
•Kashiv Pharma
•Key Tech
•McArdle
Associates, LLC
•Merck Company
•Mitsubishi Gas
Chemical Company
•Momenta
Pharmaceuticals Inc
•Mw Industries
•Nemera
•Nipro Pharma
Packaging
•NN Inc
•Noble
•Nye Lubricants
•Nypro
•Overlook Industries,
Inc.
•Owen Mumford Ltd
•Pfizer
•Philips - Medisize
•Plastibell DTP Holding
•rap. ID, Inc.
•Regeneron
Pharmaceuticals
•Robert Bosch
Packaging
Technology Inc
•Sagentia Ltd
•Sanofi
•SCA Pharmaceuticals
•Schott AG
•SCHOTT
Pharmaceutical
Packaging
•Schreiner Medipharm
•Shire
•Siegfried Irvine
•Smithers Rapra
•Suttons Creek Inc
•Takeda
Pharmaceuticals
•Teleflex
•Terumo
Pharmaceutical
Solutions
•TESARO
•Topas Advanced
Polymers
•Trinseo
•W.L. Gore
Associates, Inc.
•Weidmann Medical
Technology AG
•West Pharmaceutical
Services, Inc.
•Zeon Chemicals L.P.
Pre-Filled Syringes East Coast 2017 Attendee List
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
SMi’s Upcoming
Events in
the Pre-Filled
Syringe Series:
Pre-Filled Syringes
Europe
Copthorne Tara Hotel,
London, UK
17th - 18th January 2018
Pre-Filled Syringes
West Coast
Crowne Plaza,
San Diego, CA, USA
4th - 5th June 2018

4. Workshop Leaders:
melanie turieo, Director, Human Factors
and Industrial Design, Cambridge Consultants and karen unterman,
Group Leader, Human Factors Engineering, Cambridge Consultants
half-DaY pRe-CoNfeReNCe WoRkshop B
tuesDaY 10th apRil 2018 | 13.30 - 17.00
sheRatoN BostoN hotel, BostoN, usa
humaN faCtoRs foR CoNNeCteD DRug DeliveRY sYstems
Workshop overview
This workshop will cover how to successfully incorporate Human Factors into the development process for
connected drug delivery systems to achieve both commercial goals and meet regulatory requirements. The
Human Factors engineering process and regulatory requirements for traditional medical device development
are fairly well established and will be reviewed to ensure there is a common understanding of the current
landscape. We will then explore how to adapt this process to meet the needs and requirements for a system
which includes digital as well as physical elements.
Why you should attend
For anyone thinking about bringing digital health solutions to market, this workshop will identify the
considerations that need to be addressed when designing a comprehensive Human Factors engineering
process for a system which contains both physical and digital elements, and how to leverage the tools,
methodologies and best practices across device development, User Interface (UI), and User Experience (UX)
development.
about the workshop leaders
melanie is a Director in Cambridge Consultants Global MedTech division and head of Human
Centred Design. She has over 20 years’ experience providing human factors expertise to the design
and development of regulated and safety-critical items, including medical, military and consumer
products. She has extensive experience in the development of drug delivery systems from early
stage needs assessment and product defi nition through concept generation, detailed development, and
HF validation. Melanie has a Bachelor of Science in Human Factors Engineering from Tufts University’s School
of Engineering.
karen is the Human Factors Group Leader at Cambridge Consultants in Boston MA. Her experience is
in performing human factors activities throughout the development process, including: ethnographic
research, translating stakeholder needs into measurable, technical requirements, facilitating
creative workshops, assessing product risk, and designing, conducting and analyzing Formative and
Validation usability studies. Karen graduated from Northwestern University’s McCormick School of Engineering
and Applied Sciences with a Bachelor of Science in Biomedical Engineering.
about the organisation
Cambridge Consultants develops breakthrough products and technology for clients worldwide. For more
than 50 years, the company has been helping its clients turn business opportunities into commercial successes,
whether they are launching fi rst-to-market products, entering new markets, or expanding existing markets
through the introduction of new technologies. with a team of over 700 staff and offi ces in Cambridge, UK,
Boston, MA and Singapore, Cambridge Consultants offers solutions across a diverse range of industries around
the world.
programme
13.30 Workshop Registration and
afternoon Coffee
14.00 Workshop leaders’ introduction
14.15 overview of human factors for
medical development
• Human Factors Engineering process
• Regulatory requirements
• Commercial goals
14.45 overview of the regulatory landscape
for digital health
• Is it a medical system or not?
• Consumer digital systems
• Medical digital systems
15.30 afternoon tea and Networking Break
16.00 Bringing digital into the hf process
• How does it impact the process?
• What is UX and how is it interpreted
for hybrid systems?
• Tools, methodologies and best
practices
16.30 validation of the digital system
17.00 Closing Remarks from Workshop leaders
and end of Workshop
Workshop overview
This workshop will provide a practical approach to ensuring that your prefi lled syringe design fi ts the needs
of laypersons and supports use outside the clinic. You’ll learn how to characterize the intended users and
use environments, discover and fi ll gaps in your understanding of the users, explore possible risks, convert
user needs into user interface requirements, and provide a complete support system when your product is in
commercial use. Gathering these usability design inputs creates a solid foundation for your product design
that will result in user satisfaction and ensure safe use.
Why you should attend
• Understand diverse users, from parents caring for children to aging adults caring for their spouses
• Explore environments ranging from the home and workplace to worldwide travel destinations
• Plan for fi eld research
• Map user needs to demonstrable user interface requirements
• Provide a complete support system, including effective instructions for home use
• Capitalize on early research to reduce the number of design iterations
about the workshop leaders
ms. mcConnell has more than 25 years of experience working with product development teams in
private industry, public service, and government agencies. She has worked exclusively in the Medical
Device industry for the past 12 years. As a Human Factors Technical Lead, Ms. McConnell’s focus is on
identifying and delivering medical device design solutions that exceed customers’ expectations and
ensure safe use. Ms. McConnell has experience in all phases of the product development lifecycle, including
research-based design inputs, use error analysis, prototyping, usability testing, summative validation studies,
regulatory submissions, and product launch support. Her recent work ranges from large scale robotic systems
used by surgeons during procedure in an operating room to handheld devices used by patients to deliver
therapy at home.
ms. Diorio-Blum has 10+ years’ experience in the medical device design and product development
fi eld. She has experience working in multi-disciplinary teams consisting of industrial designers,
engineers and human factors engineers. She has spent the majority of her career primarily focused
on design and ethnographic research in the healthcare space. Her research efforts have taken her
to many hospitals, clinical care, and home health care settings throughout the United States and Europe. She
has extensive experience in data analysis, synthesis, and translating research fi ndings into user requirements
for design and engineering teams. She conducts conducting focus groups, contextual research, and in-depth
interviews from the RIVA training institute, and has conducted over 500 interviews in her career.
about the organisation
Our mission at Battelle is to translate scientifi c discoveries and technology advances into societal benefi ts.
Battelle was formed in 1925, as a charitable trust, from the will of industrialist Gordon Battelle. Today, Battelle
is the largest private, independent research and development organization in the world. Battelle has about
22,000 employees. Our headquarters is in Columbus, OH and we have over 130 locations worldwide.
programme
8.30 Workshop Registration and
morning Coffee
9.00 Workshop leaders’ opening Remarks
and introduction
9.10 exploring diverse users and use
environments
• Breakout groups: How to draft profi les
for users and environments with design
inputs in mind
10.10 getting the most out of early user
research
• Case Studies: How user and
environment profi les inform plans for
early user research
10.30 morning Coffee
11.00 mapping user needs to user interface
requirements
• Case Studies: How to trace user
research fi ndings to user needs and user
interface requirements
11.30 providing a complete support system
• Discussion: use outside the clinic
requires multiple forms of support
• Discussion: Instructions for use are part
of the user interface and should be
created using a Human Centric Design
approach
12.30 Closing Remarks from Workshop leaders
and end of Workshop
DesigN CoNsiDeRatioNs foR the WoRlD outsiDe the CliNiC
half-DaY pRe-CoNfeReNCe WoRkshop a
tuesDaY 10th apRil 2018 | 08.30 - 12.30
sheRatoN BostoN hotel, BostoN, usa
Workshop Leaders:
Debbie mcConnell, Human Factors Technical Lead,
Human Centric Design, Battelle and annie Diorio-Blum,
Principal Industrial Designer, Human Centric Design, Battelle
Register online at www.pfsamericas.com

5. pRouDlY spoNsoReD BY:
suppoRteD BY
spoNsoRship aND exhiBitioN oppoRtuNities
smi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you 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 conference please call:
alia malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
maRketiNg oppoRtuNities
Want to know how you can get involved? interested in promoting your services to this market?
Contact lyudmyla Durneva, smi marketing on +44 (0) 207 827 6088 or email: lDurneva@smi-online.co.uk
pre-filled syringes east Coast
www.pfsamericas.com
mitsubishi gas Chemical
Mitsubishi Gas Chemical is a leading company in the fi eld of oxygen barrier and absorbing technologies. Based on these
technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen
and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs. www.mgc.co.jp
Nemera
NEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical,
biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal,
Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in the parenteral
device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed:
Safe’n’Sound®, a fully passive safety device for prefi lled syringes to avoid accidental needle-sticks. Safelia®, a new generation
of 2-steps auto-injector for fl uid and viscous formulations. www.nemera.net
NN, inc precision engineered products
NN, Inc Precision Engineered Products Group is an engineered solutions company, focusing on medical and drug delivery
devices. We provide components, complex assemblies and clean room packaging, specializing in metal stamping, injection
molding and ISO Class VIII clean room assembly. Learn more at www.pep-corp.com
owen mumford
Owen Mumford offer an integrated design and build service from a broad base of proven self-injection and blood-sampling
platform devices and intellectual property. Find out more at omdevicesolutions.com or contact us at devicesolutions@
owenmumford.co.uk www.omdevicesolutions.com
sChott
SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical,
diagnostic, analytical, dental ophthalmic markets. Products include glass and polymer prefi llable syringes (bulk and sterile),
cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new
fi ll fi nish equipment. www.us.schott.com/pharma
schreiner medipharm
Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added
benefi ts for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts
and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering
and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of
pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized
know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality
supplier to leading pharmaceutical companies. www.schreiner-medipharm.com
steRis Corporation
For over 100 years STERIS Corporation has been known as a global leader, trusted partner and solutions provider in the fi eld of
sterilization and contamination control. From Formulated Chemistries, to Capital Equipment to Parts and Services, STERIS Life
Sciences is Science and Solutions for Life. www.sterislifesciences.com
terumo pharmaceutical solutions
Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical technology.
In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed
to meet your specifi c requirements. www.terumo-ps.com
zeon Corporation
ZEON’s Zeonex® and Zeonor® cyclo olefi n polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization
containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-
like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph
shift concerns. www.zeonex.com
offiCial meDia paRtNeRs

6. pRe-filleD sYRiNges east Coast
Conference: Wednesday 11th Thursday 12th April 2018, Sheraton Boston Hotel, Boston, USA
Workshops: Tuesday 10th April 2018, Sheraton Boston Hotel, Boston, USA
4 WaYs to RegisteR
www.pfsamericas.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
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
conferences documentation via the Document Portal to any delegate who has paid but is unable
to attend for any reason. Due to the interactive nature of the Briefi ngs 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 specifi cally 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
Act1998andwemayusethistocontactyoubytelephone,fax,postoremailtotellyouaboutother
products and services. Unless you tick here □ we may also share your data with third parties offering
complementary products or services. If you have any queries or want to update any of the 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.
Payment must be made to smi group ltd, and received before the event, by one of
the following methods quoting reference p-243 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
□ uk BaCs Account Name: SMi (Group) Ltd
□ Wire transfer Sort Code: 30-00-09, Account: 11775391
Lloyds TSB Bank Plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): loYDgB21013, Account 11775391
IBAN gB75 loYD 3000 0911 7753 91
□ Cheque We can only accept US Dollar Cheques drawn on a US 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):
VAT at 20% is 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
□ 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
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)
unique Reference Number
our Reference lvp-243
eaRlY BiRD
DisCouNt
□ Book by 15th December to receive $400 off the conference price
□ Book by 31st January to receive $200 off the conference price
□ Book by 28th february to receive $100 off the conference price
Delegate Details
terms and Conditions of Booking
paYmeNt
vat
DoCumeNtatioN
veNue sheraton Boston hotel, Boston, usa
CoNfeReNCe pRiCes
i would like to attend: (Please tick as appropriate) fee
□ Conference 2 Workshops $2997.00
□ Conference 1 Workshop A □ B □ $2498.00
□ Conference only $1999.00
□ 2 Workshops $998.00
□ 1 Workshop only A □ B □ $499.00
pRomotioNal liteRatuRe DistRiButioN
□ Distribution of your company’s promotional
literature to all conference attendees $1598 + vat $1917.60
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.