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SMi’s 9th Annual Conference
Pre-Filled Syringes East Coast
April 25 - 26, 2022 | Boston, USA
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The global pre-filled syringes market was valued at $1139.6 million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. With that in mind, the 9th annual Pre-Filled Syringes East Coast conference will bring together leading industry experts representing big pharma and device developers to discuss the key drivers accelerating the expansion of the industry.

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. As part of SMi’s leading injectable series, the 2022 conference will provide an exclusive insight into the latest developing technologies for device design, advances in parenteral device platforms and development, insights into growing integration of digital health and deep dives into recent case studies on novel delivery systems.

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.

To register your interest or to get involved please contact: yalsadoon@smi-online.co.uk

 

  • Explore the latest developments in innovative technologies for device design accelerating the path to self-administration 
  • Assess the evolving regulatory landscape for pre-filled syringes and discuss approaches to work with regulators as guidance is updated
  • Engage in panel discussions with industry leaders to navigate the accelerating digital health landscape for combination products and drug delivery systems
  • Understand the landscape of delivery for novel drug products and key considerations to overcome challenges in CCI

 

  • 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

Gretchen  Vandal

Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs, Takeda USA

9:10 Approaches and considerations to building an efficient and de-risk combination product development program

Michael Song

Michael Song, Associate Director, Takeda Pharmaceutical Company Limited
View Bio

  • Cross functional interconnection and ways to ensure program success
  • EU MDR GSPR and leveraging from program success
  • Understanding essential performance requirement
  • How an effective control strategy can help ensure program success
  • Design control and risk reduction activities
  • 9:50 Lessons learned: on-body delivery system design and development

    Amber Witteman

    Amber Witteman, Founding Director, EPIWatch
    View Bio

  • Learning from user experiences in early development of delivery systems
  • Current regulatory guidance for wearable devices and understanding international requirements
  • Case Study: designing patient-centric on-body delivery systems
  • How have we seen device design evolving in recent years and a future forecast
  • 10:30 Morning Coffee Sponsored by Zeon

    11:00 Improvement of complaint intake process for combination products: a patient centric approach

    Amir Fakhari

    Amir Fakhari, Senior Engineer, Combination Products, AstraZeneca
    View Bio

  • Overview of complaint intake process and current limitations for complaint analysis
  • Harmonization, accuracy, and time reduction for complaint analysis
  • 11:40 A Glass Alternative: ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) for Pre-Filled syringes

    Larry Atupem

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials
    View Bio

  • Key Benefits of COP for Medical Devices 
  • Case Study on Delamination: COP Syringe vs Glass Syringe
  • Case Study on Protein Adsorption/Aggregation and its effect on Immunogenicity

     

  • 12:20 Networking Lunch

    13:20 Panel Discussion: Learnings from the past year to accelerate combination product development

  • Assessing regulatory developments for combination products over the past year 
  • Emerging device design innovations for parenteral delivery
  • Assessing the landscape of connected technology applications, how can we ensure smart features are aiding the user?
  • Encouraging flexibility and collaborations throughout the combination product development process across all teams
  • Gretchen  Vandal

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs, Takeda USA

    Amir Fakhari

    Amir Fakhari, Senior Engineer, Combination Products, AstraZeneca
    View Bio

    Gretchen Piwinski

    Gretchen Piwinski, Manager, Combination Products Laboratories, Regeneron Pharmaceuticals, Inc.
    View Bio

    John Schalago

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

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Merck & Co., Inc
    View Bio

    14:00 Considerations for Designing Test Method Validation Studies

    Gretchen Piwinski

    Gretchen Piwinski, Manager, Combination Products Laboratories, Regeneron Pharmaceuticals, Inc.
    View Bio

  • Identification of critical variables affecting test output
  • Establishing test limits and acceptance criteria
  • Understanding the manufacturing process for sample parts
  • Special considerations for destructive testing
  • 14:40 Afternoon Tea Sponsored by Zeon

    15:10 Leveraging supplier information for pre-filled syringe development

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Merck & Co., Inc
    View Bio

  • Biocompatibility basics in drug delivery device development
  • Engaging in supplier information in drug delivery development
  • Assessing ISO 10993 and the phased approach 
  • Understanding materials safety concerns and the critical questions to ask suppliers
  • 15:50 Combination Product Essential Performance Requirement Identification and Control Strategy Development

    Joyce Zhao

    Joyce Zhao, Associate Director, Combination Product, Takeda
    View Bio

  • Challenges to define and identify essential performance requirement (EPR) during the development of a combination product
  • EPR to be developed in accordance with the risk profile of the entire combination product as well as the intended function of the device constituent part.
  • A control strategy is developed based on essential performance requirements of the combination product. Traceability matrix should demonstrate all the essential performance requirements have been adequately verified and validated.
  • 16:30 EPR and Control Strategy of Prefilled Syringe

    Tieming Ruan

    Tieming Ruan, Senior Director of Device Development, Alexion Pharmaceuticals
    View Bio

  • Discuss the latest EPR feedback of a Prefilled Syringe 
  • Discuss the control strategy practice of a prefilled syringe
  • Discuss a case study of prefilled syringe control strategy
  • 17:10 Chair’s Closing Remarks and Close of Day One

    Gretchen  Vandal

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs, Takeda USA

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Gretchen  Vandal

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs, Takeda USA

    9:10 An update on FDA regulatory guidance from the office of combination products

    John Barr Weiner

    John Barr Weiner, Associate Director for Policy and Product Classification Officer, Food and Drug Administration
    View Bio

  • Summary of recently issued premarket and postmarket policies for combination products, and status of pending policy projects, including on such topics as:
  • Essential performance requirements
  • Human factors studies and related clinical study considerations
  • Principles of premarket pathways for combination products
  • Post market safety reporting
  • Facility inspections
  • Looking to the future, how can we expect the regulatory landscape to evolve for combination products, and opportunities to promote cross-jurisdiction collaboration and convergence
  • 9:50 Combination Product Verification and Validation: Leveraging Data for Regulatory Submissions

    Heather  L. Guerin

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

  • Discussion of how verification and validation data can be bridged from one product to another, review of FDA Guidance
  • Examples of successful human factors validation data leveraging
  • Review of current thinking on Essential Performance Requirements for combination products submitted to FDA
  • 10:30 Morning Coffee Sponsored by Zeon

    11:40 EU MDR Article 117: Notified Body update on the quality of submissions and lessons learnt

    Theresa Jeary

    Theresa Jeary, Technical Specialist & Scheme Manager, BSI
    View Bio

  • Recap of requirements and products impacted
  • Update on NB experience of process and submissions
  • Common gaps in applications
  • Available Guidance
  • 12:20 Networking Lunch

    13:20 Cold Temperature Performance of Glass and Polymer PFS

    Daniele Tartini

    Daniele Tartini, Business Development Manager for Glass Syringes, SCHOTT North America, Inc.
    View Bio

  • Current Covid-19 mRNA vaccines on the market are available in vials, which is great for vaccine time-to-market, but because of the drug preparation time and the potential risk for medical errors, vaccine manufacturers are looking for a second generation drug presentation in the form of a PFS. 
  • Because of the demanding requirements for the vaccine stability and the low temperature supply chain, multiple aspects of the PFS need to be considered. 
  • In this presentation we want to share our experience and data on syringe functionality and CCI to help accelerate mRNA manufacturers in their life cycle quest from vials into PFS.
  • 14:00 Assessment of structural integrity of biologics through simulated sub-cutaneous environment using the SCISSOR

    Deep S Bhattacharya

    Deep S Bhattacharya, Senior Scientist, Pfizer
    View Bio

  • Structural assessment of simulated in vitro conditions of biologics using the SCISSOR
  • Understanding of destabilizing mechanisms of biologics in the sub-cutaneous environment
  • Deeper dive into peptide hotspots to identify potential sites for destabilization and re-iterative formulation development
  • 14:40 Afternoon Tea Sponsored by Zeon

    15:10 Connected device considerations and the evolving digital landscape

    Gretchen  Vandal

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs, Takeda USA

  • An update on the evolving digital health landscape and how it has developed for combination products in recent years
  • An insight into regulations for connected devices and recent updates
  • Ensuring patient usability and human factors is kept at the forefront when adding connected features
  • A future outlook for digital health: forecasting the potential of connected delivery devices
  • 15:50 Product lifecycle development from pre-filled syringes to digital ecosystem

    John Schalago

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

  • Smart Device and connected health platforms – regulatory considerations and industry outlooks
  • Combination product lifecycle management and post market safety reporting for connected combination products
  • Software as a Medical Device and connected device regulatory submission case studies
  • 16:30 Technology and design considerations in developing easy-to-adopt user centric digital health products

    Jason Song

    Jason Song, Chief Technology Officer, SureMed Technologies, Inc.
    View Bio

  • Creating easy to adopt user centric products through smart utilization of sensor and technology fundamentals.
  • Software update considerations and minimize life cycle management complexity
  • Understand societal and behaviour imprints to develop solutions with easier adoption and simple learning curve for patient.
  • User centric design considerations in product design beyond the patient
  • 17:10 Chair’s Closing Remarks and Close of Day Two

    Gretchen  Vandal

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs, Takeda USA

    +

    FEATURED SPEAKERS

    Amber Witteman

    Amber Witteman

    Founding Director, EPIWatch
    Amir Fakhari

    Amir Fakhari

    Senior Engineer, Combination Products, AstraZeneca
    Christine Lynn Lanning

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Merck & Co., Inc
    Daniele Tartini

    Daniele Tartini

    Business Development Manager for Glass Syringes, SCHOTT North America, Inc.
    Deep S Bhattacharya

    Deep S Bhattacharya

    Senior Scientist, Pfizer
    Gretchen  Vandal

    Gretchen Vandal

    Sr. Director, Head of Global Regulatory Affairs, Takeda USA
    Gretchen Piwinski

    Gretchen Piwinski

    Manager, Combination Products Laboratories, Regeneron Pharmaceuticals, Inc.
    Heather  L. Guerin

    Heather L. Guerin

    Associate Director, Regulatory Affairs - CMC, Janssen Pharmaceuticals
    Jason Song

    Jason Song

    Chief Technology Officer, SureMed Technologies, Inc.
    John Barr Weiner

    John Barr Weiner

    Associate Director for Policy and Product Classification Officer, Food and Drug Administration
    John Schalago

    John Schalago

    Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    Joyce Zhao

    Joyce Zhao

    Associate Director, Combination Product, Takeda
    Larry Atupem

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Michael Song

    Michael Song

    Associate Director, Takeda Pharmaceutical Company Limited
    Theresa Jeary

    Theresa Jeary

    Technical Specialist & Scheme Manager, BSI
    Tieming Ruan

    Tieming Ruan

    Senior Director of Device Development, Alexion Pharmaceuticals

    Amber Witteman

    Founding Director, EPIWatch
    Amber Witteman

    Amber Wittman, Managing Director, EPIWatch, is an entrepreneur and inventor of the EPIWatch autoinjector. Ms Wittman is also responsible for the intellectual property landscape, device component developments and is continuously working on project prosperity.

    Amir Fakhari

    Senior Engineer, Combination Products, AstraZeneca
    Amir Fakhari

    Amir Fakhari is a Senior Engineer in Global Technical Operations at AstraZeneca. He has more than ten years of experience with biological and pharmaceutical product development, life cycle management, combination products, and drug delivery systems. At AstraZeneca, Amir works on development, commercialization, and life cycle management of combination products. Prior to his current role, he has worked for Emergent BioSolutions, Lonza, and Teva Pharmaceuticals. He received his PhD in Bioengineering from University of Kansas.
     

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Merck & Co., Inc
    Christine Lynn Lanning

    Dr. Christine Lynn Lanning is a Distinguished Scientist in Safety Assessment at Merck. In this role, she provides oversight of the biocompatibility of medical devices and medical device combination products. She has a PhD from Duke University in Pharmacology/Toxicology and is Six Sigma Green and Black Belt Certified. She has been at Merck over 20 years with experience with both drug and device development. She has authored over 200 scientific reports and over 50 regulatory submissions.

    Daniele Tartini

    Business Development Manager for Glass Syringes, SCHOTT North America, Inc.
    Daniele Tartini
    • Background in Chemical engineering (degree from ETH Zurich)
    • 5 years experience in the primary packaging industry in different functions, from production to customer facing roles
    • Worked on many projects with pharmaceutical companies to develop the right PFS for the respective applications
    • Mainly focused on PFS for vaccines and biologics

    Deep S Bhattacharya

    Senior Scientist, Pfizer
    Deep S Bhattacharya

    Deep S Bhattacharya is a senior scientist working with DPDD since November 2019. He received his Ph.D. from the University of Nebraska Medical Center, College of Pharmacy in Pharmaceutical Sciences with a focus in engineering polymer-protein conjugates and polymeric nanoparticles using computational chemistry, biophysical tools, formulation developments, to in vivo characterizations in multiple animal models. After joining Pfizer, he has worked with DMD gene therapy, CD80, p40-TL1A bispecific, and currently leading CpG/Alhydrogel adjuvant program for C.Diff and Tetra-Fab LTβR programs. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilizing NMR for structural determination of biologics, subcutaneous assessments of biologics, early-stage development of biologics, interfacing with early-stage discovery teams for candidate selection, and understanding business strategies for developments of biopharmaceuticals. He also is involved group functions involving CPED DPDD and new colleague recruitments efforts with the St. Louis DPDD.

    Gretchen Vandal

    Sr. Director, Head of Global Regulatory Affairs, Takeda USA
    Gretchen  Vandal

    Gretchen Piwinski

    Manager, Combination Products Laboratories, Regeneron Pharmaceuticals, Inc.
    Gretchen Piwinski

    Gretchen Piwinski is the Manager of the Combination Product Development Laboratory at Regeneron Pharmaceuticals Inc. She leads a team responsible for providing test engineering and laboratory support to the development of drug delivery systems for Regeneron’s products. Gretchen has been at Regeneron for four years and spent 12 years prior working on implantable medical devices. She holds a Bachelor of Science degree and a Master of Engineering degree, both in Chemical Engineering.

    Heather L. Guerin

    Associate Director, Regulatory Affairs - CMC, Janssen Pharmaceuticals
    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.
     

    Jason Song

    Chief Technology Officer, SureMed Technologies, Inc.
    Jason Song

    Jason Song is Chief Technology Officer and cofounder of SureMed Technologies, Inc. that develops holistic novel technologies and products to meet the needs of patients, industry and society for easy deployment. Prior to SureMed Tech, he held various technical and leadership positions at Amgen, Eli Lilly, GE Healthcare, Motorola and Novo Nordisk in areas including injectable & inhaled drug delivery device development, fill and finish, packaging and assembly automation, biochips, and establishing new production sites. Jason's experience includes in US, Europe and Asian. Jason is a certified licensed Professional Engineer (P.E.) and holds BS & MS in Mechanical Engineering, MS in Automation MFG, and MBA.

    John Barr Weiner

    Associate Director for Policy and Product Classification Officer, Food and Drug Administration
    John Barr Weiner

    John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a B.A. from Princeton University and a J.D. with honors from the Columbia University School of Law.

    John Schalago

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

    John is Regulatory/Quality/Clinical professional with over 30 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. John has extensive experience with global health authorities as well as with CDRH, CBER, and CDER managing submission strategies, HA interactions and submissions. John has a diverse background which includes expertise in combination products, software-controlled medical device submissions including, sensors (implantable, minimally invasive and in-vitro diagnostics, and software as a medical device, including, mobile applications and web-based clinical decision software.

     

    Joyce Zhao

    Associate Director, Combination Product, Takeda
    Joyce Zhao

    Dr. Zhao has more than 10 year experience on medical device development including combination product device such as Autoinjector, Wearable/Patch injector, Pen Injector, Prefill Syringe (PFS), as well as needle technology, and other drug delivery devices. Currently Dr. Zhao is the Associate Director of Combination Product Development at Takeda Pharmaceuticals, prior to Takeda, Dr. Zhao was an Associate Director at Dr. Reddy’s Laboratories responsible for all device development activities. Prior to Dr. Reddy’s, Dr. Zhao has been with Becton Dickinson and Company (BD) at Franklin Lakes, NJ USA for 9 years. Her work at BD was focused on drug delivery systems. She was the technical lead and project leader at R&D for various device development projects and has hands on experience on device concept, design, characterization, analysis and manufacturing.
    Dr. Zhao holds a Ph.D in mechanical engineering from University of Washington, Seattle, WA USA.
     

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Larry Atupem

    Larry Atupem is the Business Development Manager at Zeon Specialty materials with responsibility of Cyclic Olefin Polymer business in North America. He also assists with ZEON’s strategic interests in the region looking for new opportunities in the diagnostic space. 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.

    Michael Song

    Associate Director, Takeda Pharmaceutical Company Limited
    Michael Song

    Michael currently is Associate Director of Device Development at Takeda. Prior to his current role he was head of Combination Product Manufacturing at Heron Therapeutics where he led medical device and combination product commercial readiness. Prior to Heron, he formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process 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.

    Suzette Roan

    Associate VP and Head of Global Device Regulatory Affairs, Sanofi US
    Suzette Roan

    Theresa Jeary

    Technical Specialist & Scheme Manager, BSI
    Theresa Jeary

    Theresa Jeary has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle. She holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

    Additionally, Theresa has over 12 years Notified Body experience, at BSI as a technical expert and LRQA as the Head of Notified Body. Before re-joining BSI as a technical specialist in the Medicinal and Biologics team, Theresa worked as a consultant to the Medtech sector.
     

    Tieming Ruan

    Senior Director of Device Development, Alexion Pharmaceuticals
    Tieming Ruan

    Tieming holds his PhD in Mechanical Engineering from the Ohio State University and MBA from New York University. Currently he is Sr. Director of Combination Products at Alexion Pharmaceuticals. He has been working for various biotech and medical device companies in the past 18 years and hold 10+ patents of drug delivery devices.

    Sponsors

    Exhibitors

    Supporters

    Workshops

    EU MDR 2017/745 article 117 Requirements
    Workshop

    EU MDR 2017/745 article 117 Requirements

    Sheraton Boston Hotel
    27th April 2022
    Boston, USA

    Developing User-Centric Next Generation Combination Products
    Workshop

    Developing User-Centric Next Generation Combination Products

    Sheraton Boston Hotel
    27th April 2022
    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

    Conference Chair Letter

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    Chair & Speaker Biographies

    Download

    Workshop A Agenda

    Download

    Workshop B Agenda

    Download

    Pre Filled Syringes East Coast 2022 Brochure

    Download

    Past Attendees

    Download

    Past Presentation - Alie Jahangir, Janssen Pharmaceuticals

    Download

    Past Presentation - Megan Heft, AstraZeneca

    Download

    Past Presentation - Rajiv Gupta, Takeda

    Download

    Past Presentation - Tina Kiang, FDA

    Download

    Sponsors


    Schott

    Sponsors
    https://www.schott.com/en-us/markets/health/pharma

    SCHOTT is a global manufacturer of high-tech materials for specialty glass. With more than 130 years of experience, and represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy, and Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. SCHOTT is one of the world’s leading experts for parenteral packaging and supplies the pharma industry with more than 12 billion syringes, vials, ampoules, and cartridges of tubing glass and polymer per year.



    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.

    Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    Buamann Medical

    Exhibitors
    http://www.baumann-group.com

    BAUMANN MEDICAL is a reliable, experienced partner for tailor-made solutions in medical devices. As an independent division within BAUMANN Group our medical approach is a cornerstone of our corporate vision and long-term strategy. Our dedicated, ISO13485 certified medical sites addresses the customer needs in the medical and pharmaceutical industries. BAUMANN MEDICAL has the know-how, the capabilities, and the processes to fulfil the sector specific requirements and is therefore recognized as an expert in this field.

    A specialized medical team of professionals based in the USA, Europe, and Asia, works closely with customer teams to support the development of the best component for a device, as well as to provide the most valuable solution for a specific customer project.

    Thus our partners benefit from our expertise as a long-standing world-leading springs and stampings manufacturer. BAUMANN MEDICAL has the same high standard in business ethics, mind-set, and level of aspiration at all sites.

    More Information about the BAUMANN Group on www.baumann-group.com



    Owen Mumford

    Exhibitors
    http://www.owenmumford.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.

    For more information please visit https://www.ompharmaservices.com/



    PHC

    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
    http://www.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 and vials. 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.


    Media Partners


    ONdrugDelivery Magazine

    Supporters
    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.


    Pharmaceutical-Tech

    Supporters
    http://www.pharmaceutical-tech.com

    In the realm of Pharmacy, where innovation is rapid, Pharmaceutical-Tech stands adept at conceptualizing unique ideas relevant to the B2B space. Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. Pharmaceutical-Tech.com covers in-depth trends that shape industry dynamics and metamorphose global economics. With services like search engine optimization, global magazine, social media marketing, product video showcase, e-mail marketing, e-newsletter sponsorship, banner advertising, event marketing and micro-website within our platform, www.pharmaceutical-tech.com has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    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.


    Pharmalicensing

    Supporters
    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.


    Medical Design Briefs

    Supporters
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com/

    American Pharmaceutical Review is the leading review journal for business and technology in the pharmaceutical industry throughout North America. Each issue offers American Pharmaceutical Review's 30,000 readers unbiased editorial coverage of the latest developments in: drug delivery, information technology, research & development, analytical development and control, equipment and facility manufacturing and regulatory affairs. With its in-depth coverage, American Pharmaceutical Review is able to keep its readership of senior executives, technical personnel, scientists, and others fully abreast of the latest trends and developments in the process of pharmaceutical manufacturing.


    Pharmaceutical Technology

    Supporters
    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.


    Pharmaceutical Outsourcing

    Supporters
    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.


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    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.


    pharmaphorum

    Supporters
    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


    Pharma Journalist

    Supporters
    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.


    Biocompare

    Supporters
    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.


    Pharma network magazine

    Supporters
    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


    Mednous

    Supporters
    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


    Drug Discovery Today

    Supporters
    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.


    Technology Networks

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    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


    Pharmacircle

    Supporters
    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….

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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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