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SMi's 5th Annual Pre-Filled Syringes East Coast 2018 Conference and Exhibition returns to Boston on the 11th and 12th of April 2018. Developing on its annual success, this fifth event in the series will give a unique insight the areas of regulation, manufacturing, emerging trends and innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their devices.

This year’s agenda will feature:

  • Guidance on the regulations for device development
  • Human Factors considerations and end-user feedback
  • Highlight common pitfalls of good manufacturing practice and seek to solve these
  • Address the emerging challenges that biologic drugs present to pre-filled syringes
  • Showcase hot topics of combination products, including wearable devices, auto-injectors and patient-centric design
  • Interactive panel discussions led by industry experts

Developing on our annual success, this must-attend conference will gather an international audience to discuss and accelerate pre-filled syringe development in all the related sub-fields. Some notable areas of increased attention have been the broader trends for combination products and biologics in the pharmaceutical industry, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still a number of ongoing challenges that the key-thought leaders are battling to overcome. these include the challenges of chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.

  • Analyse key market trends
  • Explore safety assessments, human factors considerations and compliance issues
  • Consider innovative solutions for combination products
  • Overcome the challenges presented by the increased trends towards biologics
  • Navigate the latest regulations from officially bodies

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:

  • Pre-filled Syringes
  • Autoinjectors
  • Device Engineering
  • Human Factors
  • CMC
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affair 

Previous attendees include:

Actavis; Ajinomoto Althea, Inc.; Allergan; Amgen; Aptar Pharma; AstraZeneca; Biogen; BMS; Cambridge Consultants Ltd; Catalent Pharma Solutions; Datwyler Schweiz AG; DuPont; Eli Lilly & Company; Epione BioPharmaceuticals; FDA; FDAPharma Consulting; Gateway Analytical; Genentech; Genentech Inc; Genzyme ; GSK; Heritage Pharmaceuticals ; Icon Bioscience; Insulet Corporation; Janssen R&D LLC; Janssen, Pharmaceutical Companies of Johnson and Johnson; Kappa Pharmaceuticals Limited; KBI Biopharma; KBI Biopharma, Inc.; Lupin Pharmaceuticals; Medicines Company; Medimmune; Merck & Co., Inc.; Merck, Sharp & Dohme Corp.; Merz; MITSUBISHI GAS CHEMICAL COMPANY, INC; Momenta Pharmaceuticals Inc; Nemera; Nipro; Nipro PharmaPackaging; Novavax; Novavax, Inc.; Novo Nordisk; Noxilizer Inc; Noxilizer, Inc.; Oncobiologics Inc.; Otsuka US; Overlook Industries, Inc.; Owen Mumford; Pfizer; Pfizer CentreOne; Pfizer Pharmaceuticals; Pharmascience Incorporated; Protein Sciences Corporation; Sanofi Pasteur; Sanofi S A; Schreiner MediPharm; Semigator GmbH; Sio2 Medical Products; Smithers Rapra; Team Consulting; Teleflex; Terumo Americas Holding, Inc; Terumo Medical Corporation; The Langford Research Institute; Valeant Pharmaceuticals; W.L. Gore & Associates, Inc.; West Pharmaceutical Services Inc; West Pharmaceutical Services, Inc.; West-Ward Pharmaceuticals; WL Gore & Associates Inc; Zeon Chemicals L.P.; Zoetis;
 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dhairya Mehta

Dhairya Mehta, Associate Director of Device and Combination Products, Shire
View Bio

Stephen Barat

Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis
View Bio

9:10 Navigating regulatory considerations in the PFS market environment

9:50 Syringe filling of high-concentration monocolonal antibody formulation: Challenges and solutions

Kashappa-Goud Desai

Kashappa-Goud Desai, Associate Fellow, GSK
View Bio

  • There has been a steady increase in the number of high-concentration mAb formulations in ready-to-use pre-filled syringes for subcutaneous administration
  • Challenges of successful syringe filling of high-concentration mAb formulations by an automated filling machine
  • Outlining challenges associated with syringe filling of high-concentration formulations
  • This presentation summarizes the key challenges and mitigation strategies
  • 10:30 Morning Coffee Sponsored by Zeon

    11:00 COP - Technical data update

    Toshiro Katayama

    Toshiro Katayama, Product Manager, Zeon Chemicals L.P.
    View Bio

  • 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
  • 11:40 Drug-Device Combination Products Development Challenges

    Susan Neadle

    Susan Neadle, Head, Combination Products Center of Excellence, Janssen
    View Bio

  • Combination Products:  Application of drugs with medical devices minimizes adverse events, while maximizing 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
  • 12:20 Networking Lunch Sponsored by Terumo

    13:20 Session Reserved for Nemera

    Adrien Tisserand

    Adrien Tisserand, Category Manager - Parenteral, Nemera

    14:00 Safety evaluation of leachables when developing a pre-filled syringe drug product

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis
    View Bio

  • Background on leachables from pre-filled syringe drug devices
  • Whys safety assessment of leachables is required
  • How leachable issues related to drug product quality can impact safety and efficacy
  • Best practice recommendations during development
  • 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

    Kashappa-Goud Desai, Associate Fellow, GSK
    View Bio

    Nathan Heacock

    Nathan Heacock, Associate Scientist, GSK
    View Bio

    15:20 Afternoon Tea Sponsored by Zeon

    15:50 The best plastic syringe for biologics

    Shota Arakawa

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical America Inc
    View Bio

  • 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
  • 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

    Justin Lacombe, Senior Manager Process Development, Teva Pharmaceuticals USA
    View Bio

    Gary Henniger

    Gary Henniger, Director Engineering, Teva Pharmaceuticals USA
    View Bio

    17:10 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

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire
    View Bio

    Steve Bowman

    Steve Bowman, Device Program Lead, Shire US Inc

    Justin Wright

    Justin Wright, Vice President, Drug Delivery Innovation, DDR&D Technology, Eli Lilly and Company
    View Bio

    17:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dhairya Mehta

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire
    View Bio

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis
    View Bio

    9:10 Keynote Address: The critical importance of recognizing the considerations, decisions and trade-offs inherent in all combination product developeent

    Steve Bowman

    Steve Bowman, Device Program Lead, Shire US Inc

  • 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?
  • 9:50 The Challenges of Platformization

    Molly Story

    Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals
    View Bio

  • 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?
  • 10:30 Morning Coffee Sponsored by Zeon

    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 and Primary Immunodeficiency Disease)
  • Joke Maes

    Joke Maes, Product Manager, Terumo Pharmaceutical Solutions

    Chris Franzese

    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

    Gary Mills , Associate Director, Drug Product Development , TESARO

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis
    View Bio

    Molly Story

    Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals
    View Bio

    12:20 Networking Lunch Sponsored by Terumo

    13:20 Smart Labeling Solutions for Pre-filled Syringes: Patient Centricity Enhanced

    Eric Caro

    Eric Caro, Key Account Manager, Schreiner Medipharm

  • 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
  • 14:00 Lessons learned from Human Factor studies of pre-filled syringes

    Tieming Ruan

    Tieming Ruan, Associate Director of Device Development, Takeda
    View Bio

  • 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?
  • 14:40 New developments in low temperature VHP terminal surface sterilization and PFS material compatibility

    Juha Mattila

    Juha Mattila, Senior Product Manager, STERIS FINN-AQUA
    View Bio

  • New applications and technology developments on VHP (Vaporized Hydrogen Peroxide)
  • Low temperature terminal surface sterilization
  • PFS material compatibility
  • 15:20 Composite digital monitoring biomarkers come of age: The framework of utilization

    Justin Wright

    Justin Wright, Vice President, Drug Delivery Innovation, DDR&D Technology, Eli Lilly and Company
    View Bio

  • Activity and investments in connected injection systems and platforms continue 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
  • 16:00 Afternoon Tea Sponsored by Zeon

    16:30 PFS tech transfer of in-line products not originally developed as combination prodcuts

    Maria Linzmayer

    Maria Linzmayer, Associate Director, Drug Delivery Devices, Merck

  • Defining Design User Requirements
  • Dealing with suppliers providing device constituent components
  • Systems engineering needs
  • Retrospective design documentation
  • 17:10 Future of digitially connected device and changing paradigm in diseease management

    Michael Song

    Michael Song, Sr. Manager, Drug Delivery and Device Development, MedImmune Inc
    View Bio

  • 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
  • 17:50 Chairman’s Closing Remarks and Close of Day Two

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    FEATURED SPEAKERS

    Dhairya Mehta

    Dhairya Mehta

    Associate Director of Device and Combination Products, Shire
    Justin Lacombe

    Justin Lacombe

    Senior Manager Process Development, Teva Pharmaceuticals USA
    Justin Wright

    Justin Wright

    Vice President, Drug Delivery Innovation, DDR&D Technology, Eli Lilly and Company
    Kashappa-Goud Desai

    Kashappa-Goud Desai

    Associate Fellow, GSK
    Michael Song

    Michael Song

    Sr. Manager, Drug Delivery and Device Development, MedImmune Inc
    Molly Story

    Molly Story

    Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals
    Stephen Barat

    Stephen Barat

    Head of Pre-Clinical and Early Clinical Development, Scynexis
    Susan Neadle

    Susan Neadle

    Head, Combination Products Center of Excellence, Janssen

    Adrien Tisserand

    Category Manager - Parenteral, Nemera
    Adrien Tisserand

    Annie Diorio-Blum

    Principal Industrial Designer, Battelle
    Annie Diorio-Blum

    Chris Franzese

    Lead Clinical Analyst, Matchstick
    Chris Franzese

    Debbie McConnell

    Human Factors Lead, Battelle
    Debbie McConnell

    Dhairya Mehta

    Associate Director of Device and Combination Products, Shire
    Dhairya Mehta

    Dhairya Mehta is Associate Director at Shire. After receiving his MS in Aerospace Engineering, Dhairya began his career in the medical device and combination products. Over the past 15 years, Dhairya has successfully delivered a number of projects related to autoinjectors, wearable patch and infusion pumps, reconstitution kits, airway systems, implantable ophthalmic and cardiac rhythm management devices across several organizations such as Medtronic, Abbott, Amgen, Novo Nordisk. Dhairya holds the several US and international patents and other intellectual properties. Most recently, he is leading Digital Health and Device IoT efforts at Shire.

    Eric Caro

    Key Account Manager, Schreiner Medipharm
    Eric Caro

    Gary Mills

    Associate Director, Drug Product Development , TESARO
    Gary  Mills

    Gary Henniger

    Director Engineering, Teva Pharmaceuticals USA
    Gary Henniger

    Gary is Chemical Engineer with 38 years of medical device and drug-device combination product development experience with companies such as Becton Dickinson, Philips Respironics and Teva, along with other small medical device and biotechnology companies. He has worked in positions in product development, operations and manufacturing with US and international responsibilities. His experience spans injection devices, needle safety devices, pre-filled syringes, respiratory drug delivery devices and respiratory drug-device combination products. He has implemented design control systems within FDA and ISO compliant Quality Management Systems in multiple organizations. He is currently a Director of Engineering in Teva Discovery and Product Development R&D.

    Joke Maes

    Product Manager, Terumo Pharmaceutical Solutions
    Joke Maes

    Juha Mattila

    Senior Product Manager, STERIS FINN-AQUA
    Juha Mattila

    Juha Mattila is Senior Product Manager for STERIS Finn-Aqua Sterilization systems. He has Bachelor’s degree in HVAC & process engineering and Master’s degree in Business Informatics, both from Helsinki Metropolia University of Applied Sciences. He joined STERIS in 2000 and has 18 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D for STERIS FINN-AQUA products and systems. He has worked with several clients in the designs and installations in Europe, North America and Asia, an active conference presenter, and contributes as author/co-author for articles in professional journals. Juha is a member of ISPE Nordic Board of Directors, PDA, and Finnish Biosafety Network.

    Justin Lacombe

    Senior Manager Process Development, Teva Pharmaceuticals USA
    Justin Lacombe

    Justin Lacombe received a B.S. in Chemical Engineering from Virginia Tech and did his Ph.D. thesis research in fluid mechanics at Rutgers with post-doctoral projects with Sepracor and Albemarle. At Catalent, Justin worked on metered dose inhaler development programs, including pre-formulation and physico-chemical characterization. In 2011, Justin joined MicroDose Therapeutx and created a differentiated role in process development. After the purchase by Teva, Justin continues leading process development, adding device manufacturing to his responsibilities, overseeing multiple manufacturing projects for the production of Phase 1 and Phase 2 clinical supplies for inhalation drug-device combinations and advising integrated drug-device development teams.

    Justin Wright

    Vice President, Drug Delivery Innovation, DDR&D Technology, Eli Lilly and Company
    Justin Wright

    Having joined Eli Lilly in June 2015, Justin currently serves as Vice President, Drug Delivery Innovation at
    Lilly’s Cambridge Innovation Center. In his current role, he is tasked to identify and develop distinct and
    novel strategies and product systems for Lilly’s pipeline which cuts across diabetes, oncology, pain,
    autoimmune, and Alzheimer’s disease. He is also leading efforts to establish a maker culture within Lilly
    and developing new innovation and external partnership models in order to accelerate drug delivery
    innovation.
    Prior to joining Lilly, Justin spent 8 years at Becton Dickinson (BD) where he served in various roles
    focused on identifying, developing, and commercializing drug delivery systems for the biotech, vaccine,
    and pharmaceutical industries. During his time at BD he helped commercialize and launch more than 10
    drug delivery systems and led efforts in defining the innovation agenda for BD’s $1bn drug delivery
    portfolio.
    Justin began his career Merck & Company where he spent seven years in roles of increasing
    responsibility across new product development, product commercialization, and franchise management.
    During his time at Merck he helped launch and commercialize 4 new drug products.
    Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research
    fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

    Karen Unterman

    Group Leader, Human Factors Engineering, Cambridge Consultants Ltd
    Karen Unterman

    Kashappa-Goud Desai

    Associate Fellow, GSK
    Kashappa-Goud Desai

    Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of industrial and post-doctoral R&D experience. He earned his BS and MS degrees in Pharmacy, respectively, from Karnatak University and Rajiv Gandhi University of Health Sciences, India. Dr. Desai earned his PhD degree in Biotechnology from Korea University, Republic of Korea.

    Dr. Desai is a recipient of several internationally acclaimed awards for his original research contributions. He has published 50 articles in peer-reviewed international journals, authored one book and book chapter, and presented extensively at numerous conferences. He is serving as a reviewer for several international journals in the field of Pharmaceutical Sciences.
     

    Maria Linzmayer

    Associate Director, Drug Delivery Devices, Merck
    Maria Linzmayer

    Melanie Turieo

    Director, Human Factors Engineering, Cambridge Consultants Ltd
    Melanie Turieo

    Michael Song

    Sr. Manager, Drug Delivery and Device Development, MedImmune Inc
    Michael Song

    Michael Song is Sr. Manager leading Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his role he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; and digital connectivity for biologic products. Prior to his current role, Michael led the Device and Package Engineering team at Adello Biologics. He also have held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Molly Story

    Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals
    Molly Story

    MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

    Nathan Heacock

    Associate Scientist, GSK
    Nathan Heacock

    Nathan earned his BS in Chemistry and Biochemistry from West Chester University in 2015. He started at GlaxoSmithKline as a contract worker with PPD in 2015. After significant contributions to the Syringe Second source stability study he was hired full time as an Associate Scientist in the BioPharm Product Science department of GSK in 2016.

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical America Inc
    Shota Arakawa

    Mr. Shota Arakawa is a researcher of Advanced Business Development Division.
    He gained a Diploma in Science in 2007 and a Master Degree of Science in 2009 from Osaka University.
    Since April 2009 he has been working for Mitsubishi Gas Chemical Company, Inc.
    and in charge of macromolecular science, especially in synthesis of polymers and material development.
    Since 2012 he has joined a development team of multilayer plastic vial & syringe for biologics.
     

    Stephen Barat

    Head of Pre-Clinical and Early Clinical Development, Scynexis
    Stephen Barat

    Dr. Stephen A. Barat is the head of pre-clinical research and early development for Scynexis, a biotechnology company focused on the development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of Scynexis senior management team and has 20+ years of experience in global drug development and registration from large multi-national pharmaceutical companies. Externally, Dr. Barat is a member of the PQRI working group for leachable and extractable for parenteral drug products and a member of the USP expert panel for biocompatibility testing.

     

    Steve Bowman

    Device Program Lead, Shire US Inc
    Steve Bowman

    Susan Neadle

    Head, Combination Products Center of Excellence, Janssen
    Susan Neadle

    Susan Neadle is a member of the Product Quality Leadership Team at Janssen Pharmaceutical Companies of Johnson & Johnson. In her role, she heads the Combination Products Center of Excellence and also has accountability for developing and deploying proactive quality frameworks and risk management for emerging and legacy platforms and technologies.
    She is a Design Excellence Black Belt. Susan’s application of Design Excellence and strong technical and people leadership has resulted in a track record of robust and profitable products with stable manufacturing systems. She has received multiple awards recognizing her positive business impacts, including the Johnson Medal, J&J’s highest honor for innovation excellence. She has numerous patents and publications.
    Susan earned an M.S. in Polymer Science & Engineering, and a B.S. in Biology/Chemistry, as well as Fellowship in the American Academy of Optometry. Prior to joining Johnson & Johnson, she held R&D and Commercialization positions at Unilever, Organon Teknika and IBM.
     

    Tieming Ruan

    Associate Director of Device Development, Takeda
    Tieming Ruan

    Tieming holds his PhD in Mechanical Engineering from the Ohio State University and MBA from New York University. Currently he is Associate Director of Device Development and leading the combination devices development at Takeda. He has been working for various biotech and medical device companies in the past fifteen years and hold 10+ patents of drug delivery devices.

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.
    Toshiro Katayama

    Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Design Considerations for the World Outside the Clinic
    Workshop

    Design Considerations for the World Outside the Clinic

    Sheraton Boston Hotel
    10th April 2018
    Boston, USA

    Human Factors for Connected Drug Delivery Systems
    Workshop

    Human Factors for Connected Drug Delivery Systems

    Sheraton Boston Hotel
    10th April 2018
    Boston, USA

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

    Pre-Filled Syringes Europe 2018

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    Sponsors and Exhibitors


    Mitsubishi Gas Chemical

    Sponsors and Exhibitors
    http://www.mgc.co.jp/

    Mitsubishi Gas Chemical is a leading company in the field 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.


    Nemera

    Sponsors and Exhibitors
    http://www.nemera.net

    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 prefilled syringes to avoid accidental needle-sticks. Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.


    NN Precision Engineered Products

    Sponsors and Exhibitors
    http://www.pep-corp.com

    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

    Sponsors and Exhibitors
    http://omdevicesolutions.com

    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


    SCHOTT North America, Inc. – Pharmaceutical Packaging

    Sponsors and Exhibitors
    http://www.us.schott.com/pharma

    SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental & ophthalmic markets. Products include glass and polymer prefillable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fill & finish equipment.


    Schreiner MediPharm

    Sponsors and Exhibitors
    http://www.schreiner-medipharm.com

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits 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.


    STERIS

    Sponsors and Exhibitors
    http://www.sterislifesciences.com

    For over 100 years STERIS Corporation has been known as a global leader, trusted partner and solutions provider in the field of sterilization and contamination control. From Formulated Chemistries, to Capital Equipment to Parts and Services, STERIS Life Sciences is Science and Solutions for Life.


    Terumo Pharmaceutical Solutions

    Sponsors and Exhibitors
    http://www.terumo-ps.com/

    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 specific requirements.


    ZEON

    Sponsors and Exhibitors
    http://www.zeonex.com

    ZEON’s Zeonex® and Zeonor® cyclo olefin 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.

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.


    American Pharmaceutical Review

    Official Media Partner
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    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Colorado Bioscience

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    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.

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    International Pharmaceutical Industry

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    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


    Inderscience Publishers

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    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Manufacturing Chemist

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    Manufacturing Chemist is among the longest established and most respected information sources in the global pharmaceutical manufacturing industry. Manufacturing Chemist reports on current and future trends in the global marketplace, including the latest developments in drug discovery, biotechnology, drug delivery, ingredients, processing technologies and equipment, packaging, business strategies and regulatory updates.


    Biocompare

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    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Absave

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    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    PharmaVOICE

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    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    Pharmaceutical Technology

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    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


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    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


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    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    Drug Discovery Today

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    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.


    Pharmalicensing

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    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.


    Gate2Biotech

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    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


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    Drug Target Review

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    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    American Laboratory

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    For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.


    Labsave

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    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


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    Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Pharma Marketing Network & Pharma Marketing News provide executive-level content coupled with permission-based e-marketing opportunities.


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    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Pharmaceutical Outsourcing

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    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


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    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Drug Development Technology

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    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Medical Device Network

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    Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.


    Select Science

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    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    Inderscience Publishers

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    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Technology Networks

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    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmacircle

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    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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