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SAE Media Group’s 10th Annual Conference
Pre-Filled Syringes East Coast
April 24- 25, 2023 | Boston, USA
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The 10th annual Pre-Filled Syringes East Coast conference will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the pre-filled syringes industry, helping attendees to secure global success for their devices.

The past year has seen significant developments in the injectables landscape with the evolving regulatory landscape, accelerating opportunities in digitilization and simulation to improve device design efficiency, and increased opportunities for connectivity to improve the user experience.


Furthermore, with a growing need for circular economy, this year’s conference will assess case studies of sustainable approaches for device packaging and life cycle management, while panel discussions, FDA and BioPhorum addresses will evaluate current and upcoming combination product guidelines and the potential for harmonization.

As part of SAE Media Group’s leading drug delivery portfolio of events, this event will bring you the key insights you need to expand and enhance your injectable device portfolio and the opportunity to network with senior players throughout the industry.


We hope to welcome you to this must attend event in April 2023.
 

  • Discover the latest industry developments for improved large volume and high viscous delivery via advanced autoinjector and on body delivery system design 
  • Assess the growing opportunities of digitalization and simulation for improved device development efficiency and potential
  • Engage in an FDA regulatory roundup from the office of combination products, insights into EPR identification from BioPhorum and a panel discussion assessing harmonization of the regulatory landscape
  • Delve into emerging technologies in injectable device design and case studies on digital integration of medical devices for improved user experience
  • Benchmark against sustainable device packaging case studies driving the combination product industry towards circular economy
  • 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:

 

Alexion Pharmaceuticals; Alnylam; Amgen; AstraZeneca; BAUMANN SPRINGS LTD; Baumann Springs USA Inc.; BD; BD Medical - Pharmaceutical Systems; Biogen; Bristol Myers Squibb; BSI; BSI Group; Celanese; Clexio Biosciences; Coherus Biosciences; Corning, Inc.; CP Pathways LLC; Credence MedSystems; Datwyler Pharma Packaging Belgium; Elcam E3d ACAL Ltd; Eli Lilly and Company / DDCS; EPiWatch; Fruh Verpackungstechnik AG; Genentech; GERRESHEIMER AG; Gerresheimer Buende GmbH; Glenmark Pharmaceuticals Inc.; Groupe Jbt; Haselmeier, Inc; Johnson & Johnson; Kaleo, Inc.; Kokoku Rubber Inc.; Kokoku Rubber, Inc.; Lyndra Therapeutics; Merck & Co., Inc; Merck / MRL Device Development; Merck and Co; Nipro PharmaPackaging Americas Corporation; Novartis; Nye Lubricants; Office of Combination Products, FDA; Owen Mumford; Pfizer; Pharmacircle; PHC Corporation; PHC Corporation of North America; Polyplastics US; RAUMEDIC, Inc.; Regeneron; Regeneron Pharmaceuticals; Rx Bandz; Sagentia Innovation; Sanofi; Sanofi US; Schott North America, Inc.; Schreiner Medipharm; SHL - Pharma; Steri-Tek; SureMed Technologies, Inc.; Takeda; Terumo Solutions; UserWise, Inc.; Vertex; W.L. Gore & Associates, Inc.; Weiss-Aug Company Inc; West Pharmaceutical Services; West Pharmaceutical Services, Inc.; Zeon Specialty Materials ; Zeon Specialty Materials Inc; Zwickroell; ZwickRoell GmbH & Co.KG;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

Alie Jahangir

Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
View Bio

9:10 A regulatory round up from the office of combination products

John Barr Weiner

John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
View Bio

  • An insight into the office of combination products current focus with regard to pre-filled syringes and injectable drug delivery devices
  • Updates and clarifications on current projects including:
  • Reliability guidance for emergency use injection systems
  • Essential performance requirements
  • Human factors studies
  • ICH Q9
  • Bridging studies guidance
  • Looking to the future, what can we expect from the office of combination products; evaluating feedback from industry and assessing needs for clarified or updated guidance
  • 9:50 Combination Product Essential Performance Requirements; Interpretation and Control Strategy Development – A BioPhorum Appraisal

  • Interpretation and classification of EPR’s along the lines of ICH Q9 
  • Challenges to define and identify EPRs during the development of a combination product
  • Applying EPR’s during device development and manufacture via control strategies. Review of an acceptable test plan or control strategy for each EPR, including evaluation of potential substitute testing and reducing burden on batch-release testing.
  • Traceability matrix demonstrating all the essential performance requirements have been adequately verified and validated 
  • Anticipated feedback in response to FDA Q1 2023 draft-guidance
  • Eric Houde

    Eric Houde, Senior Manager Combination Products, Regeneron
    View Bio

    Edwin Lyons

    Edwin Lyons, Associate Director – Head of Medical Devices, CSL Behring
    View Bio

    10:30 Panel Discussion: Evaluating the pre-filled syringes and injectables drug devices regulatory landscape

  • Delving into the FDA’s efforts towards harmonization and convergence
  • Key challenges in multi-market launches, industry examples and experiences
  • Where are we seeing challenges in consistencies across jurisdictions internationally and across the EU
  • How can the FDA and industry align to improve processes for engaging with regulatory bodies
  • John Barr Weiner

    John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
    View Bio

    John Schalago

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

    Theresa Scheuble

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson
    View Bio

    Matthew  Ondeck

    Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals
    View Bio

    Joyce Zhao

    Joyce Zhao, Director, Combination Product, Takeda
    View Bio

    11:10 Morning Coffee

    11:40 Regulatory considerations for large volume injectors: autoinjectorscompared to on body delivery systems

    John Schalago

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

  • Drawing on previous projects and a review of FDA approvals
  • What are the complexities that need to be addressed and the similarities and nuances between autoinjector and wearable systems
  • Perspectives from individual device development stages and how do the regulatory considerations of each impact development strategy?
  • Assessing user needs and reviewing when the preferred large volume delivery system has been different to original assumptions
  • Impacts from health authorities in the US and the EU
  • 12:20 High dose/ high volume Subcutaneous Drug Delivery Systems - Patient Preference Study (PPS)

  • High dose/ high volume subcutaneous drug delivery project objective
  • Patient Preference Study (PPS) creation and its role in achieving the project objective
  • Implementing IMI PREFER in PPS design
  • Lauren Ziegler

    Lauren Ziegler , Senior Director Medical Devices, Novartis
    View Bio

    Andrew Susott

    Andrew Susott, Director of Human Factors / User Experience, Global Device & Packaging Development, Novartis
    View Bio

    13:00 Enhancing Primary Containers With Smart Labelling Solutions

    Christian Liebl

    Christian Liebl, Senior Innovations and Process Manager, Schreiner MediPharm
    View Bio

  • Enhancing Primary Container With Smart Labelling Solutions
  • Digital and Analog Tamper Evidence / Proof of Sterility
  • Enhanced UV protection to mitigate photo instability
  • Significantly reduce Oxygen ingress in polymer containers
  • Enhance RFID performance
  • And much more!
  • 13:30 Networking Lunch

    14:30 Collaboration to meet market demand for dual chamber drug/device combination products: Combining innovation in drug delivery devices and pharmaceutical contract manufacturing

  • The need for various Dual Chamber solutions to meet ‘Ready-to-Use’ requirements
  • Trends in Dual Chamber applications: Reconstitution and Sequential injection
  • Credence MedSystems and Bryllan: The capabilities the collaboration provides to pharmaceutical manufacturers 
  • Accelerated scaling approaches to meet increased industry demand for dual chamber syringe technologies
  • John Merhige

    John Merhige, Chief Commercial Officer, Credence MedSystems
    View Bio

    15:00 Assessing the industry landscape and growing advances for subcutaneous delivery of high-dose and high-volume biologics

    Deep S Bhattacharya

    Deep S Bhattacharya, Senior Scientist Formulation and Process, Development- Biotherapeutics, Pfizer
    View Bio

  • The challenges and opportunities for subcutaneous delivery of high dose/volume biologics
  • The potential to apply novel subcutaneous technologies to several therapeutic areas through collaborations across industry
  • Summarizing key patient and HCP perceptions of high dose/volume subcutaneous delivery
  • Insights into developing subcutaneous technologies that could further facilitate high dose/volume subcutaneous administration
  • 15:40 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
  • 16:10 Afternoon Tea

    16:40 Latest data for multilayer plastic vial

    Hiroki  Hasegawa

    Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc
    View Bio

  • Multilayer plastic vial
  • Oxygen barrier for stabilization of biologics
  • Ultraviolet light barrier for stabilization of biologics
  • Extremely low inorganic extractables & pH stability
  • Low risk of breakage at extremely low temperature
  • 17:10 Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Produc

    Lynne Liao

    Lynne Liao, Sr. Engineer, Device Development, Alexion Pharmaceuticals
    View Bio

  • Specific drug product formulations could have a propensity to rapidly dry, which may cause needle clogging either at the point of use (once the needle shield is removed) or upstream (during the syringe filling process).
  • This study was designed to characterize the time for prefilled syringes to clog after the needle shield was removed.
  • A Weibull analysis was used to predict the time to clog. This approach allowed for product reliability to be directionally established (and the risk of rapid drying to be assessed) with limited samples.
  • 17:50 Chairman’s Closing Remarks and Close of Day One

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
    View Bio

    18:00 End-of-Day-One Networking Reception

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
    View Bio

    9:10 Digital Transformation’s Impact on Quality Engineering and Combination Products

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
    View Bio

  • Quality 4.0 provides an effective framework to transition from a compliance-based, reactive, error-prone, and siloed Quality Management System (QMS) to the one that is proactive, integrated, efficient, and most importantly patient centric, thanks to current digital tools.
  • Adoption of Quality Management System would result in process and systems agility, efficiency, and flexibility, while breaking the silos in product development and validation.
  • Digital transformation will improve efficiency and productivity of Combination Product's Development and Qualification
  • 9:50 Investigating Factors that Affect Plunger Stopper Motion During Simulated Shipping of Pre-Filled Syringes

    Kirk Roffi

    Kirk Roffi, Senior Scientist, Pfizer
    View Bio

  • During high-altitude shipping of pre-filled syringes, pressure differentials can cause the elastomer stopper to move unintentionally
  • This motion represents a risk to container closure integrity and drug product sterility
  • We applied laser displacement sensors to measure stopper motion in real-time under laboratory conditions 
  • A physical interpretation is developed by comparing experiments with 1) a frictionless ideal gas model (Boyle’s Law), and 2) a dynamic model in Matlab-Simulink that uses empirical friction laws to represent the elastomer-glass and elastomer-silicone oil contacts inherent to the lubricated interference fit
  • 10:30 Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology

    Theresa Scheuble

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson
    View Bio

  • Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology
  • Historical review of various routes of administration
  • Role of the Patient driving changes in delivery approaches
  • Convergence of Drug Development and Minimally Invasive procedures
  • Examples of Current and Future Technologies
  • 11:10 Morning Coffee

    11:40 Device Development for Long Acting Injectables

    Scott Nunn

    Scott Nunn, Director, Device Development, Gilead Sciences, Inc
    View Bio

  • Patient Drivers for Long Acting Injectables
  • How have long-acting injectable devices evolved in recent years
  • Formulation and device considerations for long acting injectables
  • Common pitfalls and challenges in long-acting combination product design
  • 12:20 Digital Integration of Medical Devices

    Ning Yu

    Ning Yu, Director, Product and Technology Development, Biogen
    View Bio

  • Considering human-centred design and producing devices tailored to improve adherence
  • Case studies on the use of digital solutions
  • Challenges with regulatory guidance
  • How to capture novel opportunities in digital health
  • The future of digital systems and increasing acceptance
  • 13:00 Challenges and Root Cause Mechanisms for Container Closure Integrity During Freeze/Thaw Cycles in Deep-Cold Storage of Pre-filled Systems

    Ludovic Gil

    Ludovic Gil, R&D Senior Engineer - Product Engineering, BD Medical - Pharmaceutical Systems
    View Bio

  • The emergence of new drug technologies, such as mRNA (messenger ribonucleic acid), has driven increased demand for delivery solutions capable of withstanding deep-cold storage conditions sometimes down to -80°C [1]. While significant data exist for deep-cold storage in vial format [2,3], not much information is available for the pre-filled syringe (PFS) format. 
  • Since PFS serve as both storage container and final delivery system, additional requirements such as plunger-stopper break-loose and gliding forces, and stability of the syringe’s lubrication must be evaluated after Freeze-and-Thaw (F/T) cycle [4]. In addition, container closure integrity (CCI) must be maintained during F/T cycle and storage, including stopper movement during multiple F/T cycles. Previous studies have demonstrated that maintaining CCI down to -80°C in glass PFS is one of the main challenges as the plunger stopper-barrel sealing tightness is significantly impacted by rubber glass transition [4, 5, 6]. 
  • In this study, we confirm that the rubber Tg is one of the main parameters determining the CCI performance in deep-cold storage conditions. Moreover, we show that additional physics need to be accounted for to characterize the complex coupled mechanisms of CCI breach.
  • 13:30 Networking Lunch

    14:30 Unlocking Blow-Fill-Seal Technology for Prefilled Injectables

    Tony Wasilewski

    Tony Wasilewski, Vice President, Pharmaceutical Development Services, Apiject
    View Bio

  • Creating the Next Generation of Prefilled Injectables
  • Evolution of Delivery Devices to Address User Needs
  • Key Considerations When Transitioning to a Novel Device
  • The Future of Connectable Components, Designed to Provide Flexibility for a Wide Range of Injection Needs
  • 15:00 Innovation in Drug Delivery Combining Human Factors and AI

    James Leamon

    James Leamon, Director Device Development, Device Development
    View Bio

  • New developments in Drug Delivery
  • Human Factors impact on device development and human safety
  • Artificial Intelligence and Human Factors
  • The New Needs for the next generation Delivery Device
  • 15:40 Releasing pen injectors as combination products for clinical trial use: regulatory, QA and QC aspects

    Konrad Betzler

    Konrad Betzler, Vice President Quality, Haselmeier
    View Bio

  • Regulatory hiking map
  • Drug Product and Pen Injector Development in parallel
  • Pen Injectors as combination products
  • Requirements for releasing a batch for clinical trial use
  • Controlling finished batch compliance
  • 16:10 Afternoon Tea

    16:40 Design for Sustainability - Pharmaceutical Packaging & Medical Devices

    Shruti Parikh

    Shruti Parikh, Associate Director Product Development, Takeda Pharmaceuticals
    View Bio

  • The current landscape and industry movement towards sustainable practices
  • The role LCAs can play in strategic decision making at the corporate level
  • Design for sustainability process
  • Trends & Case Studies
  • 17:20 Finished Good Packaging Development for Device and Combination Product

    Ellie Younger

    Ellie Younger, Head of Sustaining Engineering, Biogen
    View Bio

  • Key packaging challenges related to device selection and impact to the supply chain
  • Case study: Sustainable Packaging as a LCM project for a commercial PFS product
  • Development of new pharma packaging standard
  • 18:00 Chairman’s Closing Remarks and Close of Day Two

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
    View Bio

    +

    Sr. Principal Engineer, Product Quality Management
    Johnson & Johnson
    Director of Human Factors / User Experience, Global Device & Packaging Development
    Novartis
    Senior Innovations and Process Manager
    Schreiner MediPharm
    Senior Scientist Formulation and Process, Development- Biotherapeutics
    Pfizer
    Associate Director – Head of Medical Devices
    CSL Behring
    Head of Sustaining Engineering
    Biogen
    Senior Manager Combination Products
    Regeneron
    Researcher
    Mitsubishi Gas Chemical Company, Inc
    Director Device Development
    Device Development
    Associate Director for Policy and Product Classification Officer
    Office of Combination Products, FDA
    Chief Commercial Officer
    Credence MedSystems
    Executive Director, Senior Global Program Director Regulatory Affairs
    Novartis
    Director, Combination Product
    Takeda
    Sr Engineer III
    Biogen International GmbH
    Senior Scientist
    Pfizer
    Vice President Quality
    Haselmeier
    Strategic Business Development Manager
    Zeon Specialty Materials
    Senior Director Medical Devices
    Novartis
    Head of Packaging Development
    Biogen International GmbH
    R&D Senior Engineer - Product Engineering
    BD Medical - Pharmaceutical Systems
    Sr. Engineer, Device Development
    Alexion Pharmaceuticals
    Senior Manager Regulatory Affairs
    Regeneron Pharmaceuticals
    Director, Product and Technology Development
    Biogen
    Director, Device Development
    Gilead Sciences, Inc
    Associate Director Product Development
    Takeda Pharmaceuticals
    Head of Design & Innovation
    Johnson & Johnson
    Vice President, Pharmaceutical Development Services
    Apiject

    Sponsors

    Exhibitors

    Official Media Partner

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    Pre-Filled Syringes East Coast Preliminary Attendee list

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    Pre Filled Syringes East Coast 2023 Brochure

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    Past Attendee List

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    Pre-filled Syringes and Injectable Drug Devices Worldwide Survey 2022

    Download

    Short Programme

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    Long Programme

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    Speaker Biographies

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    Conference Chair Invitation Letter

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    Sponsors


    ApiJect™

    Sponsors
    http://www.apiject.com

    ApiJect™ is a medical technology company creating the future of medical injections.

    ApiJect™ is a medical technology company creating the future of medical injections. ApiJect products are designed to provide the advantages of prefilled syringes (quality, convenience, safety) at the cost-efficiency of multi-dose formats, regardless of manufacturing volume.

    Our Platform achieves this by bringing together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high precision injection molding. Our Platform’s simple, compact supply chain uses widely-available raw materials, ensuring reliability and resilience. And in the future, the Platform will include dose-level validation technology on every device to screen out counterfeits and expired medicines.



    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    Credence MedSystems

    Sponsors
    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.


    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    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.


    Schreiner MediPharm

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

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.


    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


    Exela

    Exhibitors
    https://www.exelapharma.com

    Exela Pharma Sciences, established in 2005 is a US based specialty pharmaceutical company located one hour west of Charlotte Douglas International Airport in Lenoir, North Carolina. Exela has two distinct and separate business units, a Finished Drug Products organization, manufacturing proprietary and generic sterile injectable products and a Contract Development and Manufacturing Organization (CDMO). Both businesses leverage significant cGMP sterile injectable manufacturing capabilities with capacity in liquid vials, lyophilized vials, pre-filled syringes, and IV bags. Exela has a proven track record of program execution under intense time pressures with exceptional service.

    The CDMO business is fully capable of meeting the manufacturing of pharmaceutical and biotech industry needs. Exela offers end to end contract manufacturing capabilities, from analytical development to large scale cGMP manufacturing, along with automated inspections, labeling and packaging services. Exela can also provide a dedicated team to address your warehousing, storage, and global distribution needs. Exela has the capacity for commercial supply in the tens of millions of units.

    For more information, or to receive a quote on our CDMO services, please contact Matt Delaney, VP Business Development for Exela at 512-922-2839, or by email at: gdelaney@exela.us.



    MESA LABS

    Exhibitors
    https://mesalabs.com/

    Known globally for our experience and expertise, Mesa Labs manufactures ANSI/AAMI/ISO-, and USP-compliant indicators for a wide range of sterilization modalities. Our products and custom solutions offer convenient and consistent ways to validate and monitor the compliance of your processes and products.



    Nipro PharmaPackaging

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

    Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform. Through our personnel, products, and services, Nipro PharmaPackaging enables you to provide a safer and healthier administration to your customers. Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 35,000 employees worldwide, Nipro serves the Pharmaceutical, Medical Device, and Pharmaceutical Packaging industries.


    Noble

    Exhibitors
    https://www.gonoble.com/

    Noble and Metaphase an Aptar pharma company, provide expertise and the “voice of the patient” in product design, user-experience research, human factors, along with tailored training & on-boarding solutions to help our clients Ideate, Validate, and Educate throughout the product development process. In addition, Noble manufactures and commercializes training devices. These devices mimic the exact feel, force, and function of drug delivery devices such as autoinjectors, prefilled syringes, onbody, nasal and pulmonary devices in order to increase patient adherence and confidence and decrease usage errors. Noble was founded in 1994 and is based in Orlando, Florida. For more information, visit www.gonoble.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/



    Raumedic

    Exhibitors
    http://www.raumedic.com

    Together with its customers, the medical technology company is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, Raumedic focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care. Raumedic has a global presence and a headcount of approximately 1,000. In its core markets of Europe and North America, the company manufactures using its own clean room production facilities.


    teamtechnik

    Exhibitors
    https://www.teamtechnik.com/en/medtech

    At teamtechnik, we have been living automation since 1976. As part of the Dürr Group, we are specialists in assembly and functional test systems. Globally, with more than 1,100 Employees, teamtechnik develops sophisticated production systems for high-tech products in the fields of e-mobility, medical technology and new energy. Our slogan… WE LIVE AUTOMATION.

    Our customers have to manufacture sophisticated injection products in large quantities. This requires highly accurate assembly and functional test processes. teamtechnik has developed a unique expertise in this area and provides reliable assembly solutions for pre-assembly, final assembly and function testing - the complete production chain from a single source.



    Terumo

    Exhibitors
    https://www.terumopharmaceuticalsolutions.com/en-EMEA

    As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

    Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.

    We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.

    Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.

    We listen. We question. We deliver.


    Media Partners


    pharmaphorum

    Official Media Partner
    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


    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


    ASD MEDIA

    Official Media Partner
    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


    World Pharma News

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    evvnt Ltd

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    http://www.evvnt.com

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    Gene Therapy Net

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    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    Pharmaceutical Technology

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


    Medical Design Briefs

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    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.


    Pharmaceutical Outsourcing

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    http://www.pharmoutsourcing.com

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


    Pharma Journalist

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    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.


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    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.


    Drug Discovery Today

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    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.


    Pharmiweb

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    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.

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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, SAE Media 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@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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