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SMi are proud to announce the 7th Pre Filled Syringes East Coast conference taking place on 26th and 27th October 2020.

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.

This comprehensive overview will help attendees understand the changing global market and the challenges faced within the industry.

Following the success of last year’s event, the upcoming conference will cover key topics driving the industry including: 

  • Container Closure Interaction and Formulation
  • On-body Injectors
  • Digital connectivity in the parenteral space
  • A regulatory outlook with industry and recognised body experts
  • Patient centricity and device development
  • Developments in device technology
  • Parenteral gene therapy
  • Two interactive Post-Conference Workshops

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.


We look forward to welcoming you to the conference in April.
 

  • EXPLORE the latest case studies parenteral drug delivery
  • GAIN insights into the use of pre-filled syringes for gene therapy
  • NETWORK with leading industry experts, key opinion leaders and regulatory body representatives
  • ENGAGE in the key challenges and topics of the field in the interactive post-conference workshops

 

  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers
  • Previous attendees include:

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc;

Conference programme

8:00 Registration & Coffee

9:00 Chair's Opening Remarks

Michael Song

Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca
View Bio

9:10 Wearable and Digital Devices – a hybrid view between pharmaceutical and medical devices

Michael Song

Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca
View Bio

• How lessons learned from medical device can help with wearable device development
• Electronics, batteries, and IEC requirements – let’s not reinvent the wheel
• Testing approach for novel / unique devices
 

9:50 The evolving regulatory landscape of combination products and the connected ecosystem

John Schalago

John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
View Bio

  • Overview of recent regulation and guidance
  • Key considerations and handling post-market surveillance reporting with the growing connected ecosystem
  • What should be submitted for legacy and new combination products?
     
  • 10:30 Morning Coffee - Sponsored by Zeon

    11:00 Challenges and Opportunities in Developing a System-Wide Stability Program for Combination Products

    • Combination Products
    • Stability Indicating Attributes
    • Design Control process
    • End-to-End Stability
    • Drug/Biologics- Device Interactions
     

    Alie Jahangir

    Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceutical
    View Bio

    11:40 Technical Overview of COP for Prefilled Syringes

    Larry Atupem

    Larry Atupem, Sr Business Development Specialist, Zeon Specialty Materials
    View Bio

  • Key properties of COP
  • Case Study (New):
  • Protein Adsorption of Abatacept – COP vs Glass
  • Immunogenicity test of the aggregates 
  • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass
  • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • Leachable data on COP syringes
     

     

  • 12:20 Networking Lunch

    13:20 How Quality can help drug-device combination teams become agile in a changing regulatory landscape

    Leonel Vanegas

    Leonel Vanegas, President / Principal , Resmedica Consulting LLC
    View Bio

  • The role of quality and CMC during drug-device combination products evolution
  • Five steps towards becoming agile and flexible anticipating formulation changes before NDA/BLA filings
  • From pre-filled into a different presentation format after marketing approvals
  • Life-Cycle Management considerations (e.g. data you’ll need to demonstrate to the regulatory agencies)
  • 14:00 Qualification and validation of VH2O2 industrial low temperature terminal sterilizer process and equipment - Case study on process control and monitoring

    Juha Mattila

    Juha Mattila, Director, Sterilisation Technologies, STERIS Corporation
    View Bio

  • Brief introduction to VH2O2 sterilization process, technology and applications
  • Discuss validation and meeting ISO14937 standard requirements - and looking at the scenario of future VH2O2 specific standards
  • Present the essential process variables forVH2O2 sterilization
  • Case study on testing and comparing performance of various hydrogen peroxide concentration measurement methods – and proposing an applicable approach

     

  • 14:40 Afternoon Tea - Sponsored by Zeon

    15:10 A Regulatory Outlook and Update of the Combination Product Industry

    Tina Kiang

    Tina Kiang, Director, division of drug delivery and General Hospital Devices, and Human Factors, FDA

    • Affect of TPLC re-organization in CDRH on combination product review (premarket and compliance)
    • New guidance updates
     

    15:50 EU MDR Impact on Premarket Regulatory Requirements for Combination Products

    Heather  L. Guerin

    Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen
    View Bio

  • Overview of new requirements of EU MDR Article 117, which could result in significant changes in practice, and potential impact to product development timelines
  • Collaborations between industry regulatory networks and EMA and Notified Bodies to clarify requirements
  • Discussion of recognized issues in interpreting Article 117 requirements and potential paths forward to meet new requirements
     
  • 16:30 Chair’s Closing Remarks and Close of Day One

    Michael Song

    Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca
    View Bio

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Michael Song

    Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca
    View Bio

    9:10 Integrated Strategy and Approach to Combination Product Development for Biologics

    Rajiv Gupta

    Rajiv Gupta, Director Medical Devices Center of Excellence, Takeda

  • Combination products such as pre-filled syringes and autoinjectors continue to be developed and commercialized for biologics.
  • Such product presentations provide patient-centric delivery options to patients in a home environment for self-administration and health care professionals in an office environment.
  • The development of these drug-device combination products from concept to commercial requires input from several functions working in a collaborative manner.
  • This presentation discusses an integrated strategy and considerations around device platform approaches and how to potentially bridge between devices.
  • It also discusses the high-level process and feasibility/development activities that are typically conducted in a cross-functional team structure to enable the start of clinical trials and regulatory submissions.
  •  

    9:50 Considerations of Closed System Transfer Devices

    Roger Chen

    Roger Chen, Scientist II, MedImmune
    View Bio

  • Interface between close system transfer device and vial
  • Approach for characterization
  • Insights though characterization 


     

  • 10:30 Morning Coffee - Sponsored by Zeon

    11:00 Lifecycle Management of Combination Products - A Regulatory Perspective

    11:40 Regulatory Perspective on Human Factors Requirements for Combination Products

    Doug Mead

    Doug Mead, Principal Consultant and President, CP Pathways LLC
    View Bio

  • Overview of Human Factors topics including platform approaches, training programs, and Instructions for Use
  • Importance of risk analysis and risk considerations in development of Human Factors Studies and communication of results
  • Best practices for incorporating Human Factors Studies results into regulatory filings
     
  • 12:20 Design considerations for optimizing the user experience of prefilled syringes and injection devices

    Megan Heft

    Megan Heft, Senior Device Engineer, AstraZeneca
    View Bio

  • Device features of prefilled syringes and injection devices to support candidate device selection
  • Design considerations for minimizing pain upon injection
  • Building the user experience through understanding platform capabilities in characterization
  • 12:20 Networking Lunch

    13:20 Combination Products Evolving Trends

  • What are some of the significant challenges that people face in implementation of combination product regulations?
  • Is there anything uniquely challenging from a drug-led manufacturer versus a device-led manufacturer?
  • Can you comment on Post-Marketing Safety Reporting for Combination Products as it relates to risk management?
  • Leonel Vanegas

    Leonel Vanegas, President / Principal , Resmedica Consulting LLC
    View Bio

    Alie Jahangir

    Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceutical
    View Bio

    Michael Song

    Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca
    View Bio

    Rajiv Gupta

    Rajiv Gupta, Director Medical Devices Center of Excellence, Takeda

    14:00 Latest Date of OXYCAPT Multilayer Plastic Vial & Syringe

    Shota Arakawa

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

  • Comparison among OXYCAPT, COP and Glass
  • Excellent Oxygen & Ultraviolet Barrier
  • Oxidation and Aggregation Studies of Antibody
  • Development of Staked Needle Syringe
  • 14:40 Afternoon Tea - Sponsored by Zeon

    15:10 Design Characterization and Verification Best Practices to Maximize Patient Centered Design

    Brittney Pachucki

    Brittney Pachucki, Device Engineer, AstraZeneca

  • Test device in design phase on specific technical characteristics
  • Create model from characterization testing to ensure full understanding of design element(s)
  • Redesign (if necessary) to ensure patient’s interest is being met
  • Verify design elements to increase confidence that design is patient friendly

     

  • 15:50 Chair’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alie Jahangir

    Alie Jahangir

    Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceutical
    Brittney Pachucki

    Brittney Pachucki

    Device Engineer, AstraZeneca
    Doug Mead

    Doug Mead

    Principal Consultant and President, CP Pathways LLC
    Heather  L. Guerin

    Heather L. Guerin

    Associate Director, Regulatory Affairs - CMC, Janssen
    John Schalago

    John Schalago

    Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    Juha Mattila

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Larry Atupem

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Leonel Vanegas

    Leonel Vanegas

    President / Principal , Resmedica Consulting LLC
    Marc  Egeth

    Marc Egeth

    Senior Director, Core Human Factors, Inc
    Megan Heft

    Megan Heft

    Senior Device Engineer, AstraZeneca
    Michael Goehring

    Michael Goehring

    Medical & Pharmaceutical Industry Manager, ZwickRoell
    Michael Song

    Michael Song

    Senior Manager, Dosage Form Design and Development, AstraZeneca
    Patricia Anderson

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc
    Rajiv Gupta

    Rajiv Gupta

    Director Medical Devices Center of Excellence, Takeda
    Roger Chen

    Roger Chen

    Scientist II, MedImmune
    Shota Arakawa

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical Company, Inc
    Tina Kiang

    Tina Kiang

    Acting Director, Food and Drug Administration

    Alie Jahangir

    Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceutical
    Alie Jahangir

    Dr. Jahangir is a Senior Manager in Combination Product at Janssen Pharmaceutical in PA. His work has been focused on development and deployment of robust design quality framework for Janssen’s advance Drug/Biologic-Device combination products. He is the Combo Product Stability SME and has implemented Janssen’s detailed, practical and consistent E2E strategies. He has recently completed a book chapter on the same topic, to be published in 2020. Previously, Alie has led a 15-year successful R&D career managing, developing and commercializing cutting-edge polymeric technologies in consumer, medical devices and pharma sectors. He holds a PhD in Polymer & Biomedical Engineering from University of Toronto and completed his Post-Doctoral Fellowship at Harvard University.

    Brittney Pachucki

    Device Engineer, AstraZeneca
    Brittney Pachucki

    Doug Mead

    Principal Consultant and President, CP Pathways LLC
    Doug Mead

    Doug Mead is Principal Consultant at CP Pathways LLC, focused on regulatory submissions and strategy related to combination product submissions. Previously, he was Senior Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Janssen Research & Development LLC, and, for 13 years, was responsible for establishing and implementing the worldwide regulatory strategy for the development of drug delivery systems and drug-device combination products. These included a variety of injector and infusion systems, microcatheters, and nasal spray devices. Before joining Janssen, he held positions at a regulatory law firm, a pharmaceutical company specializing in drug delivery, various surgical instrument companies, and a medical device testing laboratory. He has an M.S. Degree in Biomedical Engineering from Drexel University and over 35 years of experience in the medical device, pharmaceutical, and combination products industries.

    Heather L. Guerin

    Associate Director, Regulatory Affairs - CMC, Janssen
    Heather  L. Guerin

    Heather Guerin is an Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products at Janssen. She has responsibility for developing worldwide regulatory strategies related to Janssen drug delivery devices and combination products. Prior to Janssen, Heather was with the DePuy Synthes/Synthes Craniomaxillofacial and Spine divisions for 5 years where she supported US and global filings for orthopaedic implants and instruments.

    Heather holds a Ph.D. in mechanical engineering from the University of Pennsylvania and a B.S. in mechanical engineering from Villanova University. She is a registered Professional Engineer in the state of Pennsylvania.
     

    John Schalago

    Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    John Schalago

    John is a Regulatory/Quality/Clinical professional with over 25 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. Experience with CDRH, CBER, and CDER managing all FDA interactions and submissions. John started his career as an analytical chemist before moving into regulatory affairs. John has an undergraduate degree in chemistry and a Master’s degree in Biomedical Engineering. John also has certification in regulatory affairs, healthcare compliance and drug development.


     

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Juha Mattila

    Juha Mattila is Director, Sterilization Technologies, and responsible for STERIS Finn-Aqua steam and low temperature sterilization and biodecontamination technologies. He has B. Sc. with Hons in HVAC and process engineering, and M. Eng. in Business Informatics, both from Helsinki University of Applied Sciences. He joined STERIS in 2000 and has nearly 20 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D, engineering and product management. He has led several new product development projects, worked on many customer projects in Europe, North America and Asia, is an active conference presenter, and contributes to industry articles in professional journals. Juha is a member of PDA, ISPE and Finnish Biosafety Network and a member of relative ISO and CEN standard work groups, representing Finland.

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Larry Atupem

    Larry Atupem is the Sr. Business development specialist at Zeon Specialty materials with responsibility for development and marketing of Cyclic Olefin Polymer business in North America. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a Bachelor of Science degree in Chemical & Biological Engineering from Tufts University along with management business coursework from Boston University.

    Leonel Vanegas

    President / Principal , Resmedica Consulting LLC
    Leonel Vanegas

    Leonel Vanegas founded ResMedica Consulting LLC. in 2016 , a company specializing in
    regulatory and quality assuranc e global compliance for drug s , devices, and combination
    products . Since then, the firm has provided services to a select group of Fortune 100 and
    privately held clients in small and large medical d evices, pharmaceutical and biotech
    companies.
    Prior to founding his own firm, Leonel was a Global Director of Medical Devices and
    Combination products at Merck &Co, a position he held for almost 3 years. At Merck, he
    directed end to end act ivities for new product introduction s , commercialization, and
    lifecycle management of combination products in prefilled syringes, injectors, and co
    pack presentations, with annual revenue of $6 billion . Earlier in his career, Leonel gained
    extens ive experience in Quality Engineering, Design and Quality Assurance, Quality
    Control, and Reliabi lity with Johnson & Johnson, Abbot, Medtronic, and Amgen.

    Marc Egeth

    Senior Director, Core Human Factors, Inc
    Marc  Egeth

    Pati and Marc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing.

    Megan Heft

    Senior Device Engineer, AstraZeneca
    Megan Heft

    Megan Heft is a Senior Device Engineer at AstraZeneca, where she leads device teams in the development of parenteral combination products, including early technology selection and feasibility. Megan has over ten years’ experience, with prior roles as device team lead in Combination Products R&D at Teva Pharmaceuticals and technical lead in Primary Container R&D at West Pharmaceutical Services. Megan holds a Master of Engineering in Biomedical Engineering from Cornell University and a Bachelor of Science in Biomedical Engineering from Bucknell University.

    Michael Goehring

    Medical & Pharmaceutical Industry Manager, ZwickRoell
    Michael Goehring

    BSEE – Instrumentation and Systems – University of Connecticut
    Field Systems Engineer for materials and component test systems
    Territory Manager for Laboratory Information Management Systems
    District and Regional Sales Manager for materials and component test system
    North America Sales Manager for material preparation and analysis
    Industry Manager – Medical & Pharmaceutical
     

    Michael Song

    Senior Manager, Dosage Form Design and Development, AstraZeneca
    Michael Song

    Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc
    Patricia Anderson

    Pati and Marc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing.

    Rajiv Gupta

    Director Medical Devices Center of Excellence, Takeda
    Rajiv Gupta

    Roger Chen

    Scientist II, MedImmune
    Roger Chen

    Roger Chen is a member of the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where he supports device characterization, feasibility and design verification as well as digital connectivity design and development. Prior to his current role, Roger worked on combination product development at Amgen supporting molecule teams and interfacing with BD/Safety Syringes, Inc. on the development of passive needle guards, design verification testing for autoinjectors, as well as device disassembly equipment for device Container Closure Integrity Testing (CCIT). Roger has also served as mechanical design engineer at Boston Scientific on the development of Neuromodulation devices. Roger holds a BS in Bioengineering from University of California, Berkeley and a MS in Bioengineering from California Polytechnic State University, San Luis Obispo.

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical Company, 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.
     

    Tina Kiang

    Acting Director, Food and Drug Administration
    Tina Kiang

    Dr. Tina Kiang is the Director of the Division of Drug Delivery and General Hospital Devices and Human Factors, in the Office of Health Technology 3 of the Office of Product Evaluation and Quality, in the Center for Devices and Radiological Health . She received her Bachelor of Engineering in Chemical Engineering in 1997 from the Cooper Union for the Advancement of Science and Art, and her PhD in Biomedical Engineering from the Johns Hopkins University School of Medicine in 2005. She began her career at FDA in 2005 as a chemistry and engineering reviewer in the Division of Ophthalmic and Ear, Nose and Throat Devices, where she became the branch chief of the Intraocular and Corneal Implants Branch in 2009. She then became the Deputy Division Director for DAGRID in January of 2015, and has served as the Acting Director from July of 2016 until the CDRH Reorganization was finalized in May 2019.

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    Workshops

     Drug Delivery Device Testing Solutions
    Workshop

    Drug Delivery Device Testing Solutions

    Sheraton Boston Hotel
    28th October 2020
    Boston, USA

    How to pass a Human Factors validation study
    Workshop

    How to pass a Human Factors validation study

    Sheraton Boston Hotel
    28th October 2020
    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.
     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Workshop Day Programme

    Download

    Susan Neadle, Senior Director, Global Value Chain Quality Design

    Download

    Speaker interview - Krystin Meidell Manager, Regulatory Affairs CMC Combination Products and Medical Devices

    Download

    Speaker Biographies

    Download

    Event Programme

    Download

    An interview with Michael Goehring, ZwickRoell

    Download

    An interview with Alie Jahangir, Janssen Pharmaceutical

    Download

    2020 Chair Letter

    Download

    Remote access pdf

    Download

    Infographic 2020

    Download

    Past Attendees

    Download

    Past Presentation Shota Arakawa - MGC

    Download

    Past Presentation Patrick Gallagher - Schott

    Download

    Past Presentation Joyce Zhao - Takeda Pharmaceuticals

    Download

    Past Presentation Hemal Mehta - Janssen

    Download

    Past Presentation Ling Lu - Pfizer

    Download

    Past Presentation Carl Dabruzzi - West Pharmaceutical Services

    Download

    Past Presentation Brian Lewis - Eli, Lilly and Company

    Download

    Sponsors


    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    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, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    STERIS

    Sponsors
    http://www.sterislifesciences.com

    STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.



    ZEON

    Sponsors
    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.

    Exhibitors


    Aptar Pharma

    Exhibitors
    http://www.aptar.com/pharma

    Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


    Bold Insight

    Exhibitors
    http://Boldinsight.com

    Bold Insight is a user experience (UX) and human factors (HF) research agency based in Chicago. We span the product development life cycle; our research informs early product design to human factors validation. Specializing in large-scale and global research in a variety of testing environments, including in-lab and simulated-use, we work with digital, next-generation technology—medical devices to mobile apps, IFUs to websites, back office systems to end-to-end customer journeys. Our team has been UX consulting for almost 20 years which offers unique insight to avoid project pitfalls; saving time, money, and resulting in better data. Applying human factors best practices to medical device development is much more than a validation study. Yes, we have the expertise to plan, manage, and execute your human factors validation study… but creating safer and more efficient, effective, and engaging experiences for your customers starts much earlier than that and so do we. The foundation for safe and effective use begins with exploratory research and spans the entire development process.

    We have been applying HFE/UE to medical device development longer than the FDA has been regulating it! HFE/UE best practices and industry standards are part of our DNA; our research is conducted according to the guidelines found in IEC 62366-1, TR 62366-2, FDA Guidance on applying HFE/UE to medical device development, AAMI HE75, and other standards wherever appropriate. We are ISO-9001 certified. We understand how to operate in a regulated space and conduct our research according to the procedures defined in our ISO-9001 certified quality system. We don't just adhere to best practices, we help define them through our corporate memberships with AAMI and other organizations. Learn more about our services and what it’s like working with us by visiting http://boldinsight.com.



    Credence MedSystems

    Exhibitors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    CSS (Connecticut Spring & Stamping)

    Exhibitors
    http://www.ctspring.com

    CSS (Connecticut Spring & Stamping) is a customer-focused advanced manufacturing company. We engineer and manufacture precision metal springs, stampings, metal forms and assemblies, especially for the medical device industry. Our experience ranges from auto-injectors and infusion devices, to surgical instruments, sensors and wearables. CSS facilities are ISO 13485 certified. Leading OEMs and CMOs partner with CSS for design assistance and consistent volume production.


    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.


    PHC Corporation

    Exhibitors
    http://www.phchd.com/global/

    PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries.


    Polyplastics – TOPAS

    Exhibitors
    https://topas.com

    Polyplastics is the leading maker of TOPAS COC (cyclic olefin copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes, vials and cartridges. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission.


    Weiss-Aug

    Exhibitors
    http://www.weiss-aug.com/

    The Weiss-Aug Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery components and sub-assemblies.

    With specialized knowledge and state-of-the-art equipment, The Weiss-Aug group delivers the latest technologies for Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery.



    ZwickRoell

    Exhibitors
    www.zwickroell.com

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

    Media Partners


    American Pharmaceutical Review

    Official Media Partner
    http://www.americanpharmaceuticalreview.com

    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


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.

    Media Partners


    Pharma Journalist

    Supporting Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    World Pharma News

    Supporting Media Partners
    http://www.worldpharmanews.com/



    pharmaphorum

    Supporting Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    SciDoc Publishers

    Supporting Media Partners
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    Absave

    Supporting Media Partners
    http://www.absave.com

    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!


    Pharma network magazine

    Supporting Media Partners
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    Gate2Biotech

    Supporting Media Partners
    http://www.gate2biotech.com

    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.


    Pharmacircle

    Supporting Media Partners
    http://www.pharmacircle.com

    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….


    Swiss Biotech Association

    Supporting Media Partners
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Biosave

    Supporting Media Partners
    http://www.Biosave.com

    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.


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    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 online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    Biocompare

    Supporting Media Partners
    http://www.biocompare.com

    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.


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    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


    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    International Pharmaceutical Industry (IPI)

    Supporting Media Partners
    http://ipimediaworld.com/

    IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.


    pharmanews hq

    Supporting Media Partners
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the 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. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Mednous

    Supporting Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharmaceutical Technology

    Supporting Media Partners
    http://www.pharmaceutical-technology.com

    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.


    Labsave

    Supporting Media Partners
    http://www.labsave.com

    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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    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
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