plus tWo iNteRaCtive half-DaY pRe-CoNfeReNCe WoRkshopsTUESDAY 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 ClinicWorkshop 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: 10THCONFERENCE:

11TH - 12TH

APRIL 2018

Pre-Filled Syringes East Coastenabling 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

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.

Overthepastdecade,pre-filledsyringevenueshavegrownsignificantlyin 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-filledsyringedrugproductsareaprimeexampleofcomplex,multi-disciplinaryefforts.Pre-filledsyringeshaveundoubtedlyimprovedthelivesof 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 matterexpertsinallareasrelatedtothedevelopmentofpre-filledsyringeand 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 aDDRess09.10 NavigatiNg RegulatoRY CoNsiDeRatioNs iN the pfs

maRket eNviRoNmeNt • RegulatoryconsiderationsforindustryrelatingtoUSP<1207> •Applicableregulatoryschemesandpotentialregulatory

strategies •LatestupdatesandchangesforFDArequirements 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

•Therehasbeenasteadyincreaseinthenumberofhigh-concentrationmAbformulationsinready-to-usepre-filledsyringes for subcutaneous administration

• Challengesofsuccessfulsyringefillingofhigh-concentrationmAbformulationsbyanautomatedfillingmachine

•Outliningchallengesassociatedwithsyringefillingofhigh-concentration formulations

•Thispresentationsummarizesthekeychallengesandmitigation strategies

kashappa-goud Desai, Associate Fellow, gsk

10.30 moRNiNg Coffee spoNsoReD BY

11.00 Cop - teChNiCal Data upDate •KeypropertiesofCOP-update •CaseStudy:StudyonProteinadsorption/aggregationwith

actual protein drug - COP vs. glass •CaseStudy:Studyondelaminationwithglasssyringevs.COP

syringe •LeachabledataonCOPsyringewithvariouschemicals toshiro katayama, Product Manager, zeon

11.40 DRug-DeviCe ComBiNatioN pRoDuCts DevelopmeNt ChalleNges

•CombinationProducts:Applicationofdrugswithmedicaldevicesminimizesadverseevents,whilemaximisingtreatment response and positive user experiences

•Compareandcontrastthedruganddevicedevelopmentprocesses and integration of the two

•Combinationproductsriskmanagement •Dynamiccombinationproductsregulatoryenvironment 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

• Backgroundonleachablesfrompre-filledsyringedrugdevices •Whyissafetyassessmentofleachablesrequired? •Howleachableissuesrelatedtodrugproductqualitycan

impactsafetyandefficacy •Bestpracticerecommendationsduringdevelopment 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

•UnderstandingQualitybyDesign(QbD) •Aglobalregulatoryinitiativewiththegoalofenhancingthe

qualityofcombinationproducts •SummaryoftheapplicationofQbDprinciplesfor

combination product development • EvaluationofsyringesecondsourcebyapplyingQbDprinciples 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 •OXYCAPTMultilayerPlasticSyringehavingGlass-like

Oxygen Barrier •ExcellentOxygenBarriercontributestoStabilityofBiologics •VeryLowExtractablescontributetoStabilityofBiologics •GoodUVBarriercontributestoStabilityofBiologics shota arakawa, Researcher, mitsubishi gas Chemical

16.30 iNtegRatiNg DRug-DeviCe ComBiNatioN pRoDuCt DevelopmeNt

•Integratingthedesignprocesswithmethodicalpharmaceutical development

•QbDanddesigncontrolsasaparadigmforaligningcombination development

•ComparisonwithregulatoryguidanceonCombinationProducts 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

•Whatarethebiggestchallengesforbiologicdrug products at the interface of formulation, primarypackagingandapplications?

•Howshouldwebridgethegapsindrug-deliveryinnovationstoaddressthechallengesofdeliveringcomplexbiologics?

•Howshouldwemaintainpatientcentricitytoourdevelopmentprocesses?

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.comDaY oNe | WeDNesDaY 11th apRil 2018

Register online at www.pfsamericas.com alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Network with industry and pharma leadership

in the exhibition area

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 aDDRess09.10 the CRitiCal impoRtaNCe of ReCogNiziNg the CoNsiDeRatioNs,

DeCisioNs aND tRaDe-offs iNheReNt iN all ComBiNatioN pRoDuCt DevelopmeNt

•Yourproducthasmultiplecustomersbeyondpatients-doyouknowallofthem?Howwell?Areyousure?Proveit!

•Thesaying“achainisasstrongasitsweakestlink”appliestocombinationproductdevelopmenttoo.What’syours(likelytherearemany)?Whatareyoudoingtoaddressthem?

•Thefutureofcombinationproductsisbright-butareweconfidentweknowwhatitwilllooklike?

steve Bowman, Device Program Lead, shire

09.50 the ChalleNges of platfoRmizatioN •Fromahumanfactorsperspective,whatwouldittaketo

createadevicethatisatrueplatformwhichcanbeutilizedformultiplemoleculesandavarietyofusergroups?

•Whateffectsmightthechoiceofmoleculehaveondesignofthedevice?

•Whateffectsmightthechoiceofmoleculehaveontheuser’sinteractionswiththedevice?

•Forwhichusersshouldthedevicebedesigned? 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

•Empathizingwithtotaldiseaseburdenforcomplex disease states

•Challengesofmanagingdrugdelivery(usesteps) from patient perspective

•Howtoidentifyopportunitiestoreducecomplexity for patients

•Twocasestudies(Hemophilia&Primary ImmunodeficiencyDisease)

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?

•Arewemisunderstandingpatientcompliance? •Realworldcase-studiesandconsideringend-usergroup

needs-areweusingthebiggerpicture? •HowisIoTassistinginHumanFactorsstudiesandisthis

actuallyahinderancetodeviceinteraction? 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

•InnovativeRFID/NFCsolutionstoimproveuserexperienceand patient safety through connectivity

•Customizinginjectiondeviceswithmulti-functionallabels •User-friendly,label-integratedneedlestickprevention •LowmigrationlabelsandchallengesofCOC/COPmaterials •Ensuringcontainerintegritythroughnoveltechnologies eric Caro, Key Account Manager, schreiner medipharm 14.00 lessoNs leaRNeD fRom humaN faCtoR stuDies of

pRe-filleD sYRiNges •FormativestudyversusSummativestudy •Numberofarms(IFUonlyversusIFU+QRG) •FormativestudyversusSummativestudy:Arebothformative

andsummativestudiesrequiredifanoff-shelfproductisusedwithcertainmodification?

•Numberofarms:Howmanyarmsneedtobeincludedinthehumanfactorstudies?IFUonly,IFU+QRGorQRGonly

•UseErrors:HowtodealwithUseErrorsfoundfromHumanFactorstudiesandwhatiftheseUseErrorscan’tbemitigated?

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

•NewapplicationsandtechnologydevelopmentsonVHP(VaporizedHydrogenPeroxide)

•Lowtemperatureterminalsurfacesterilization •PFSmaterialcompatibility Juha mattila, Senior Product Manager, steRis

15.20 Composite Digital moNitoRiNg BiomaRkeRs Come of age: the fRameWoRk foR utilizatioN

•Activityandinvestmentsinconnectedinjectionsystemsandplatforms continues to increase

•Theopportunityexiststocombineconnectedsystemswithcomposite digital monitoring biomarkers to create hybrid closed loop systems for all diseases.

•Theincorporationofdigitalmonitoringbiomarkersintohealth, wellness and disease management will be reviewed on the context of next generation drug delivery systems

Justin Wright, Vice President, Drug Delivery Innovation, DDR&D Technology, eli lilly

16.00 afteRNooN tea spoNsoReD BY

16.30 pfs teCh tRaNsfeR of iN-liNe pRoDuCts Not oRigiNallY DevelopeD as ComBiNatioN pRoDCuts

•DefiningDesignUserRequirements • Dealingwithsuppliersprovidingdeviceconstituentcomponents •Systemsengineeringneeds •Retrospectivedesigndocumentation maria linzmayer, Associate Director, Drug Delivery Devices, merck

17.10 futuRe of DigitiallY CoNNeCteD DeviCe aND ChaNgiNg paRaDigm iN Disease maNagemeNt

•Digitalization:Benefitsofelectronic-enableddrugdeliverydevices in patient disease management beyond adherence

•Tacklinghurdlesofconnectivityforcombinationproducts:cost, technology, regulatory and time-to-market considerations

•Evaluatingadd-onplatformsasasteptowardsintegrateddevice ecosystem

•Exploringopportunitiesforpharma,patientandHCPengagement 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.comDaY 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-MyersSquibb• Centurion Medical

Products

• Connecticut Spring & Stamping

• Cook Pharmica LLC• Daicel Corporation• DatwylerSchweizAG• 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

Register online at www.pfsamericas.com alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Register online at www.pfsamericas.com

smi’s upComiNg eveNts iN the pRe-filleD sYRiNge seRies:pRe-filleD sYRiNges euRope COPTHORNE TARA HOTEL, LONDON, UK 17TH-18THJANUARY2018

pRe-filleD sYRiNges West CoastCROWNE PLAZA, SAN DIEGO, CA, USA 4TH - 5TH JUNE 2018

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 BtuesDaY 10th apRil 2018 | 13.30 - 17.00 sheRatoN BostoN hotel, BostoN, usa

humaN faCtoRs foR CoNNeCteD DRug DeliveRY sYstems

Workshop overviewThis workshop will cover how to successfully incorporate Human Factors into the development process for connecteddrugdeliverysystemstoachievebothcommercialgoalsandmeetregulatoryrequirements.TheHumanFactorsengineeringprocessandregulatoryrequirementsfortraditionalmedicaldevicedevelopmentare fairly well established and will be reviewed to ensure there is a common understanding of the current landscape.Wewillthenexplorehowtoadaptthisprocesstomeettheneedsandrequirementsforasystemwhich includes digital as well as physical elements.

Why you should attendFor 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, methodologiesandbestpracticesacrossdevicedevelopment,UserInterface(UI),andUserExperience(UX)development.

about the workshop leadersmelanie 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

stageneedsassessmentandproductdefinitionthroughconceptgeneration,detaileddevelopment,andHF 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, facilitatingcreativeworkshops,assessingproductrisk,anddesigning,conductingandanalyzingFormativeand

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 organisationCambridge 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 theyare launchingfirst-to-marketproducts,enteringnewmarkets,orexpandingexistingmarketsthroughtheintroductionofnewtechnologies.withateamofover700staffandofficesinCambridge,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 •HumanFactorsEngineeringprocess •Regulatoryrequirements •Commercialgoals 14.45 overview of the regulatory landscape

for digital health •Isitamedicalsystemornot? •Consumerdigitalsystems •Medicaldigitalsystems 15.30 afternoon tea and Networking Break 16.00 Bringing digital into the hf process •Howdoesitimpacttheprocess? •WhatisUXandhowisitinterpreted

forhybridsystems? •Tools,methodologiesandbest

practices 16.30 validation of the digital system 17.00 Closing Remarks from Workshop leaders

and end of Workshop

Workshop overviewThisworkshopwillprovideapracticalapproachtoensuringthatyourprefilledsyringedesignfitstheneedsof laypersonsandsupportsuseoutsidetheclinic.You’ll learnhowtocharacterizethe intendedusersanduseenvironments,discoverandfillgaps inyourunderstandingof theusers,explorepossible risks,convertuserneedsintouserinterfacerequirements,andprovideacompletesupportsystemwhenyourproductisincommercial 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•Understanddiverseusers,fromparentscaringforchildrentoagingadultscaringfortheirspouses•Exploreenvironmentsrangingfromthehomeandworkplacetoworldwidetraveldestinations•Planforfieldresearch•Mapuserneedstodemonstrableuserinterfacerequirements•Provideacompletesupportsystem,includingeffectiveinstructionsforhomeuse•Capitalizeonearlyresearchtoreducethenumberofdesigniterations

about the workshop leadersms. 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-Blumhas10+years’experienceinthemedicaldevicedesignandproductdevelopmentfield. 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 hasextensiveexperienceindataanalysis,synthesis,andtranslatingresearchfindingsintouserrequirementsfor 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 organisationOurmissionatBattelle istotranslatescientificdiscoveriesandtechnologyadvances intosocietalbenefits.Battelle was formed in 1925, as a charitable trust, from the will of industrialist Gordon Battelle. Today, Battelle isthelargestprivate,independentresearchanddevelopmentorganizationintheworld.Battellehasabout22,000employees.OurheadquartersisinColumbus,OHandwehaveover130locationsworldwide.

programme 8.30 Workshop Registration and

morning Coffee 9.00 Workshop leaders’ opening Remarks

and introduction 9.10 exploring diverse users and use

environments •Breakoutgroups:Howtodraftprofiles

for users and environments with design inputs in mind

10.10 getting the most out of early user

research •CaseStudies:Howuserand

environmentprofilesinformplansforearly user research

10.30 morning Coffee 11.00 mapping user needs to user interface

requirements •CaseStudies:Howtotraceuser

researchfindingstouserneedsanduserinterfacerequirements

11.30 providing a complete support system •Discussion:useoutsidetheclinic

requiresmultipleformsofsupport •Discussion:Instructionsforusearepart

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 atuesDaY 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

alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Register online at www.pfsamericas.com

pRouDlY spoNsoReD BY:

suppoRteD BY

spoNsoRship aND exhiBitioN oppoRtuNitiessmi 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 specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conference please call:

alia malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

maRketiNg oppoRtuNitiesWant 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 ChemicalMitsubishiGasChemical isa leadingcompany in thefieldofoxygenbarrierandabsorbing technologies.Basedon thesetechnologies 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

NemeraNEMERA 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 devicesegmentfromfulldevelopmenttopurecontractmanufacturing,throughcustomizedsolutions.Nemeradeveloped:Safe’n’Sound®,afullypassivesafetydeviceforprefilledsyringestoavoidaccidentalneedle-sticks.Safelia®,anewgenerationof2-stepsauto-injectorforfluidandviscousformulations. 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.Weprovidecomponents,complexassembliesandcleanroompackaging,specializinginmetalstamping,injectionmolding and ISO Class VIII clean room assembly. Learn more at www.pep-corp.com

owen mumfordOwen 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

sChottSCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic,analytical,dental&ophthalmicmarkets.Productsincludeglassandpolymerprefillablesyringes(bulkandsterile),cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fill&finishequipment. www.us.schott.com/pharma

schreiner medipharmSchreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefitsforthepharmaceuticalindustry.Theproductportfolioincludeslabelswithintegratedhangers,withdetachablepartsand multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering andcounterfeitingprotection solutionsaswellasNFC/RFID labels. Theseproducts simplifydispensingandadministeringofpharmaceuticals,enhancedrugsafetyandclearlyreduceprocesscosts.Thankstoitsstrongsolutionsexpertiseandspecializedknow-howSchreinerMediPharmhasestablisheditselfworldwideasahighlycapabledevelopmentpartnerandreliablequalitysupplier to leading pharmaceutical companies. www.schreiner-medipharm.com

steRis CorporationForover100yearsSTERISCorporationhasbeenknownasagloballeader,trustedpartnerandsolutionsproviderinthefieldofsterilizationandcontaminationcontrol.FromFormulatedChemistries,toCapitalEquipmenttoPartsandServices,STERISLifeSciences is Science and Solutions for Life. www.sterislifesciences.com

terumo pharmaceutical solutionsTerumoPharmaceuticalSolutionsoffersthepharmaceuticalandbiotechnologyindustryuniquesolutionsinmedicaltechnology.Inadditiontoofferingourvaluedproducts,ourspecializedteamalsoprovidescustomizedanddedicatedsolutionsdesignedtomeetyourspecificrequirements. www.terumo-ps.com

zeon CorporationZEON’sZeonex®andZeonor®cycloolefinpolymer(COP)allowforadvanced,break-resistantsyringes,vialsandlyophilizationcontainersforprotein-basedbiopharmaceuticals,highviscositydrugs,andcontrastmedia.Theyalsoofferhighpurity,“glass-like”transparency,sterilization,lowwaterabsorption,andsuperiormoldability,aswellasovercomeproteinadsorptionandphshift concerns. www.zeonex.com

offiCial meDia paRtNeRs

pRe-filleD sYRiNges east CoastConference: Wednesday 11th & Thursday 12th April 2018, Sheraton Boston Hotel, Boston, USA

Workshops: Tuesday 10th April 2018, Sheraton Boston Hotel, Boston, USA

4 WaYs to RegisteRwww.pfsamericas.com

fax yourbookingformto+44(0)8709090712

phoNeon+44(0)8709090711 post your booking form to: Events Team, SMi Group Ltd,

Ground&FirstFloor,1WestminsterBridgeRoadLondon,SE17XW,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 creditcarddetailswillberequestedandpaymenttakenbeforeentrytotheevent.Bookingswithin7daysofeventrequirepaymentonbooking.AccesstotheDocumentPortalwillnotbegivenuntilpayment 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,thenwewillrefund/credit50%oftheduefeelessa£50administrationcharge,providingthat 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 toattendforanyreason.DuetotheinteractivenatureoftheBriefingswearenotnormallyabletoprovide documentation in these circumstances. We cannot accept cancellations of orders placed forDocumentationortheDocumentPortalasthesearereproducedspecificallytoorder.Ifwehaveto 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 offering complementaryproductsorservices.Ifyouhaveanyqueriesorwanttoupdateanyofthedatathat we hold then please contact our Database Manager databasemanager@smi-online.co.uk orvisitourwebsitewww.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 AccountName:SMi(Group)Ltd□ Wire transfer Sort Code: 30-00-09, Account: 11775391 LloydsTSBBankPlc,39ThreadneedleStreet,London,EC2R8AU Swift(BIC):loYDgB21013, Account 11775391 IBAN gB75 loYD 3000 0911 7753 91□ Cheque WecanonlyacceptUSDollarChequesdrawnonaUSBank□ 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 □□□□ 3digitsecurityonreverseofcard,4digitsforAMEXcard

Cardholder’s Name:

signature: Date:I agree to be bound by SMi’s Terms and Conditions of Booking.

Card Billing address(Ifdifferentfromabove):

VATat20%ischargedonDocumentportalandliteraturedistributionforallUKcustomersand 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 hotelalternatively 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

(oronly£300iforderedwiththeDocumentPortal)

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: (Pleasetickasappropriate) 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.