SMi Group's Prefilled Syringes East Coast 2018 conference
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This document summarizes a two-day conference on pre-filled syringes taking place in Boston on April 10-11, 2018. The conference will include two pre-conference workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic. The main conference will focus on challenges and solutions for PFS manufacturing and processes, integrating quality by design principles, and trends toward increasing biologics and their implications for PFS. It will feature speakers from major pharmaceutical companies and include panel discussions on challenges of biologics delivery and PFS development.
SMi Group's Prefilled Syringes East Coast 2018 conference
- 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: [email protected] 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: [email protected] 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. 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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 [email protected] 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 [email protected] □ please contact me to book my hotel alternatively call us on +44 (0) 870 9090 711, email: [email protected] 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.