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SMi is proud to present the 5th Annual Pre-Filled Syringes West Coast Virtual Conference on 14th and 15th June 2021 | ALL TIMINGS ARE PDT
 

Following the success of the last event, the Pre-Filled Syringes West Coast conference is back to uncover the latest innovations in combination product development, device design, human factors engineering and drug product formulation to give a holistic overview of the industry and what we can expect for the future.


With the global market for prefilled syringes estimated to exceed $9.7bn by 2025, this year’s agenda will encompass key drivers and hot topics of the industry including; updates to regulatory guidance from industry experts and regulatory bodies, case studies on device design and complex formulation, life cycle and control strategies, and innovations in connectivity and digital health.
 

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

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

This is one of our most sought-after event and will be sold out soon.
 

Early registration is strongly advised to avoid disappointment.
 

 

  • ENGAGE in case study presentations from leading pharma and biotech companies on complex product formulation and optimising device design to aid delivery
  • DISCUSS how to optimise current processes to align with global regulatory updates
  • DELVE into human factors engineering best practices
  • UNCOVER how industry is incorporating connectivity and digital health to optimise the user experience
     

• 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:

 

Abbott Laboratories; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; AstraZeneca; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Hofliger Verpackungsmaschinen GmbH; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical Company, Inc; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services; West Pharmaceutical Services,; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON CORPORATION; Zeon Specialty Materials ; Zeon Specialty Materials Inc

Conference programme

All timings are in Pacific Daylight Time (BST-8)

8:00 Chairs' Opening Remarks

Natalie Abts

Natalie Abts, Head of Human Factors Engineering, Genentech
View Bio

Tina Rees

Tina Rees, Associate Director, Regeneron Pharmaceuticals

8:10 Human factors – best practices

Tina Rees

Tina Rees, Associate Director, Regeneron Pharmaceuticals

  • Human factors regulatory requirements
  • Timing of Human Factors studies during development
  • Attributes for good pre-filled syringe design considering common syringe tasks
  • Key considerations for future best practices
     
  • 8:40 Scope and Method Selection for Human Factors Assessments

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

  • Different types of human factors assessments that can be used during development
  • Choosing the right assessment method for project needs
  • Factors in appropriately scaling human factors efforts
  • Adapting strategy to accommodate timeline and cost constraints

     

  • 9:10 Leveraging the patient journey to optimize device use in home care environment

  • A changing landscape for parenteral administration
  • Understanding the patient journey to provide better outcomes
  • A new generation of passive, add-on safety devices for larger volume biologic drugs
  • How can integrated services support the development of safe, effective, and differentiated combination products
  • Severine Duband

    Severine Duband, Global Category Manager, Nemera
    View Bio

    Mark Tunkel

    Mark Tunkel, Global Category Director Services, Nemera
    View Bio

    9:50 Morning Break and Virtual Exhibitor Hall Open

    10:20 Selection and development considerations for on-body injectors

    Aly McDonald

    Aly McDonald, Human Factors Engineer, Genentech
    View Bio

    • On-body injector features to evaluate during device selection
    • Usability study considerations and insights
    • Common usability challenges for on-body injectors and guidance in overcoming these
     

    10:50 Regulatory Expectations for Real-Life Patient Handling Studies

    Patricia Hojnoski

    Patricia Hojnoski, Associate Director, Janssen (Johnson & Johnson)
    View Bio

  • When are Real Life Patient Handling (RLPH) studies expected?
  • Aligning with FDA on meeting RLPH expectations
  • Leveraging RLPH data between different products
  • Examples of recent FDA RLPH feedback
  • 11:20 Networking Break and Virtual Exhibitor Hall Open

    12:20 Regulatory Considerations for Combination Products

    Sarah Mollo

    Sarah Mollo, Combination Product Policy Analyst, Food and Drug Administration

  • Overview of combination products
  • Update on current FDA guidance for combination products
  • Review considerations for combination products
  • Recommendations for engagement with the Agency
  • 12:50 FDA training decay research initiative – an update

    Shannon Clark

    Shannon Clark, Principal, UserWise, Inc.
    View Bio

  • An overview of the pilot study
  • A review and assessment of the findings
  • How the findings can be applied in practice
     
  • 13:20 Afternoon Break and Virtual Exhibitor Hall Open

    13:50 Post-Market safety reporting (PMSR) for combination products - FDA perspective and the global impact

    Khaudeja Bano

    Khaudeja Bano, Executive Medical Director, Combination Product Safety Head, Amgen
    View Bio

  • FDA has pushed out their post-market reporting for the second year in a row – how has it changed and what does industry need to be aware of? 
  • How does FDA review and regulate combination products? 
  • How can industry adapt to the global divergence of reporting in the marketplace? 
  • Considerations for PMSR compliance and drug/device application
  • We are now close to implementation – what are some of the immediate things you can do as a preparation check?
     
  • 14:20 Latest data on OXYCAPT Multilayer Plastic Vial & Syringe

    Takuya Minezaki

    Takuya Minezaki, Research Manager, Mitsubishi Gas Chemical Company, Inc.
    View Bio

  • New Extractables Study
  • Oxygen and Ultraviolet Barrier 
  • Container Closure Integrity by Dye and Helium
  • Staked Needle Syringe
     
  • 15:00 Chairs' Closing Remarks and Close of Day One

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Tina Rees

    Tina Rees, Associate Director, Regeneron Pharmaceuticals

    8:00 Chairs' Opening Remarks

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Tina Rees

    Tina Rees, Associate Director, Regeneron Pharmaceuticals

    8:10 Designing a Smart Pre-Filled Syringe Platform to Create Value for Patients and Industry

    Jace  Blackburn

    Jace Blackburn, Smart Device Engineer, Genentech

  • Establishing an internal market research plan to understand the value of Smart Devices for your organization 
  • Structuring and executing an external market research program to understand value to users
  • Following a defined process for selecting platform features
  • What to consider when creating a platform to serve multiple different digital strategies for the business
     
  • 8:40 The promise and challenges of connected drug delivery devices

    Amin Sedighiamiri

    Amin Sedighiamiri, Engineering Manager, Device Development, AstraZeneca
    View Bio

    • Potential value of connected drug delivery devices and barriers to their adoption.
    • Challenges and considerations of designing and developing connected devices

    9:10 Morning Break and Virtual Exhibitor Hall Open

    9:40 Leveraging Platforms for Combination Product Development

    Tracy Hsu

    Tracy Hsu, Senior Director, CMC Program Management, Alexion Pharmaceuticals, Inc
    View Bio

  • Devices suitable for platform approach
  • Design control documentation efficiencies
  • Clinical and Human Factors considerations and case studies
     
  • 10:10 Panel Discussion: Platform approaches for combination products and pre-filled syringes

  • When is it appropriate to develop a platform for a device?
  • Design and development considerations
  • Preparing the technical development of the platform
  • Selecting a design and development partner for platform devices
     
  • Jace  Blackburn

    Jace Blackburn, Smart Device Engineer, Genentech

    Tracy Hsu

    Tracy Hsu, Senior Director, CMC Program Management, Alexion Pharmaceuticals, Inc
    View Bio

    Mark DeStefano

    Mark DeStefano, Director CPD – Feasibility, New Technology and Prototyping Development, Teva Pharmaceuticals

    James Wabby

    James Wabby, Executive Director Regulatory Affairs Devices & Combination Products, Allergan
    View Bio

    10:50 Networking Break and Virtual Exhibitor Hall Open

    11:50 Technical Overview of COP for Prefilled Syringes

    Larry Atupem

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

  • Key properties of COP
  • Case Study (New): 
  • Protein Adsorption of Abatacept – COP vs Glass
  • Immunogenicity test of the aggregates
  • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass
  • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • Leachable data on COP syringes
     
  • 12:30 PATH’s Initiatives in Developing Next Generation Injectables – The Journey from Needle Free to Micro-Array Patches

    Darin Zehrung

    Darin Zehrung, Global Program Leader , PATH
    View Bio

  • PATH’s overview of work on injectable device and vaccine innovations, and Center of Excellence for Microarray Patch (microneedle) technology
  • Value proposition and cost modelling of alternatives to traditional PFS
  • Clinical data to demonstrate efficacy of novel vaccine delivery devices
  • Engineering challenges and opportunities ahead
     
  • 13:00 Afternoon Tea

    13:30 Usability considerations for large-volume injectors

    Mark DeStefano

    Mark DeStefano, Director CPD – Feasibility, New Technology and Prototyping Development, Teva Pharmaceuticals

  • Target users vs right technology 
  • How easy can you make it, simpler is better but users need to know what is happening.
  • Familiarity, Leveraging what user already know or have seen.
  • Dosing Frequency Considerations vs technology complexity. What does the user remember
     
  • 14:00 How Safe Are My Devices? Regulatory Compliance Lifecycle Management of Combination Products

    James Wabby

    James Wabby, Executive Director Regulatory Affairs Devices & Combination Products, Allergan
    View Bio

  • Understanding User Needs and Usability
  • Quality System Requirements
  • Design Control and Product Development Management
  • Case Studies on Clinical Trials and Complaint Management
     
  • 14:30 Chairs' Closing Remarks and Close of Day Two

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Tina Rees

    Tina Rees, Associate Director, Regeneron Pharmaceuticals

    +

    FEATURED SPEAKERS

    Aly McDonald

    Aly McDonald

    Human Factors Engineer, Genentech
    Amin Sedighiamiri

    Amin Sedighiamiri

    Engineering Manager, Device Development, AstraZeneca
    Darin Zehrung

    Darin Zehrung

    Global Program Leader , PATH
    Jace  Blackburn

    Jace Blackburn

    Smart Device Engineer, Genentech
    James Wabby

    James Wabby

    Executive Director Regulatory Affairs Devices & Combination Products, Allergan
    Khaudeja Bano

    Khaudeja Bano

    Executive Medical Director, Combination Product Safety Head, Amgen
    Larry Atupem

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Mark DeStefano

    Mark DeStefano

    Director CPD – Feasibility, New Technology and Prototyping Development, Teva Pharmaceuticals
    Natalie Abts

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Patricia Hojnoski

    Patricia Hojnoski

    Associate Director, Janssen (Johnson & Johnson)
    Robert Ovadia

    Robert Ovadia

    Engineer II, Genentech
    Sarah Mollo

    Sarah Mollo

    Combination Product Policy Analyst, Food and Drug Administration
    Severine Duband

    Severine Duband

    Global Category Manager, Nemera
    Shannon Clark

    Shannon Clark

    Principal, UserWise, Inc.
    Takuya Minezaki

    Takuya Minezaki

    Research Manager, Mitsubishi Gas Chemical Company, Inc.
    Tina Rees

    Tina Rees

    Associate Director, Regeneron Pharmaceuticals
    Tracy Hsu

    Tracy Hsu

    Senior Director, CMC Program Management, Alexion Pharmaceuticals, Inc

    Aly McDonald

    Human Factors Engineer, Genentech
    Aly McDonald

    Aly is a Human Factors Engineer at Genentech, where she acts as the primary HF representative on several project teams, including a digital health program, a novel drug-device platform, a non-combination product project, and multiple late stage drug-device combination product programs. She has experience conducting human factors activities from early-stage research through design validation. Prior to joining the Human Factors team, Aly held various roles within Pharma Technical Operations at Genentech.

    Amin Sedighiamiri

    Engineering Manager, Device Development, AstraZeneca
    Amin Sedighiamiri

    Amin Sedighiamiri has a PhD in Mechanical Engineering with more than 12 years of technical leadership experience, including product innovation and commercialization across multiple industry segments, like medical device, combination product, automotive and water management in Europe and the US. Currently, he is Device Development Engineering Manager in Dosage Form Design and Development organization of AstraZeneca where he is leading combination product development as well as smart drug delivery device technology development projects.

    Before joining AstraZeneca, Amin worked as Sr. Engineer in Delivery, Device and Connected Solutions Organization of Eli Lilly and Company, where he led cross-functional teams of engineers to develop connected solutions for drug delivery devices.

    He is also Board Member and Technical Programming Committee Chair at Medical Plastics Division in Society of Plastics Engineers.
     

    Darin Zehrung

    Global Program Leader , PATH
    Darin Zehrung

    Darin Zehrung, MBA, leads PATH’s Medical Devices and Health Technologies Program. Mr. Zehrung also serves on the leadership team for PATH’s Center for Vaccine Innovation and Access and serves as co-chair of the World Health Organization’s Immunization Practices Advisory Committee Delivery Technologies Working Group.

    Mr. Zehrung previously led PATH’s portfolio in vaccine and pharmaceutical delivery technologies, helping position PATH as a globally recognized expert in delivery and packaging technologies for vaccines and essential medicines. He also led the work to establish a Center of Excellence at PATH for microarray patches and serves as the director.
     

    Jace Blackburn

    Smart Device Engineer, Genentech
    Jace  Blackburn

    James Wabby

    Executive Director Regulatory Affairs Devices & Combination Products, Allergan
    James Wabby

    Over 15 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas.

    Regularly provides Allergan therapeutic franchise units regulatory counsel to all aspects within the quality management system arena pertaining to medical devices and combination products regarding:

    • Regulatory Affairs – CMC Global Dossiers and Device Regulatory Strategy Registrations
    • MDR/IVDR – Person Responsible for Regulatory Compliance
    • ISO 13485:2016/MDSAP
    • Product Development – Design Controls
    • Risk Management
    • Human Factors Engineering
    • Acquisitions/Divestitures
    • Import/Export – U.S. Agent
    • CAPA
    • Production Controls
    • Regulatory Inspection Management
    • Materiovigilance
    • Health-Care Related Laws and International Regulations

     

     


    Education


    2000 – BSc., Biology, Duquesne University
    2002 – MHMS, Health Law/Policy and Medical Informatics, Duquesne University
    2011 - Certificate, Health Care Compliance Certificate, Seton Hall University Law School

    Industry

    Member of various regulatory and quality work groups including DIA, RAPS, AAMI, AHLA and the ASQ Orange Empire Section.
     

    Khaudeja Bano

    Executive Medical Director, Combination Product Safety Head, Amgen
    Khaudeja Bano

    Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

    She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

    She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

    Khaudeja Bano

    Senior. Medical Director, Abbott Diagnostics
    Khaudeja Bano

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Larry Atupem

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

    Mark DeStefano

    Director CPD – Feasibility, New Technology and Prototyping Development, Teva Pharmaceuticals
    Mark DeStefano

    Mark Tunkel

    Global Category Director Services, Nemera
    Mark Tunkel

    Mark Tunkel is Director of Business Development for Insight Innovation Center Chicago at Nemera. With more than 20 years of global business development experience and a deep understanding of the marketplace challenges and trends impacting the pharmaceutical industry, Mr Tunkel has advised many of the world’s leading companies on their product development and innovation strategies with an emphasis on driving realisation and the most favourable business outcomes.

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Natalie Abts

    Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

    Patricia Hojnoski

    Associate Director, Janssen (Johnson & Johnson)
    Patricia Hojnoski

    Patricia Hojnoski is an Associate Director in Janssen’s Global CMC Regulatory Affairs department. She has over twenty years of Regulatory experience working in devices, drugs, diagnostics, and combination products. She is currently responsible for developing global regulatory strategies related to Janssen combination products and giving guidance to combination product development teams on regulatory requirements. She is a member of the Marketing Submissions Combination Products Coalition (CPC) working group.
    Patricia has a Bachelor of Science degree in Biology from University of Scranton and a Master of Science degree in Microbiology from Seton Hall University. Additionally, Patricia holds the Regulatory Affairs Certification (RAC-US).
     

    Robert Ovadia

    Engineer II, Genentech
    Robert Ovadia

    Robert Ovadia graduated magna cum laude from the University of California, Davis with a BS in Biochemistry and Molecular Biology. He joined Genentech in 2012 in their two year Process Development Rotation Program and has been in drug product engineering since then.

    Sarah Mollo

    Combination Product Policy Analyst, Food and Drug Administration
    Sarah Mollo

    Severine Duband

    Global Category Manager, Nemera
    Severine Duband

    Severine Duband joined the marketing team at Nemera in 2018, and is in charge of the parenteral franchise. Ms Duband holds a Masters in Science in Business Marketing from EMLYON Business School, (Lyon, France). She has over ten years’ marketing experience with key competencies including strategic planning, NPD launches, project management, and team leadership in an international environment. At Nemera, she particularly focuses on the range of proprietary products, including Safe’n’Sound® add-on passive safety system & Safelia® autoinjector device.

    Shannon Clark

    Principal, UserWise, Inc.
    Shannon Clark

    Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

    Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

    Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.
     

    Shannon Clark

    Principal, UserWise, Inc.
    Shannon Clark

    Takuya Minezaki

    Research Manager, Mitsubishi Gas Chemical Company, Inc.
    Takuya Minezaki

    Mr. Minezaki joined Mitsubishi Gas Chemical in 2005. He specializes in the field of synthesis and injection molding of polymer, and has worked in the development of oxygen absorbing polymers. Since 2017, he has worked in the project of new pharmaceutical containers by utilizing oxygen absorbing resins. Also he is in charge of the development of secondary materials, such as plunger stopper and top cap. He holds a Master of Engineering in Applied Chemistry from the University of Tokyo.

    Tina Rees

    Associate Director, Regeneron Pharmaceuticals
    Tina Rees

    Tracy Hsu

    Senior Director, CMC Program Management, Alexion Pharmaceuticals, Inc
    Tracy Hsu

    Tracy Hsu is Senior Director, CMC Program Management at Alexion Pharmaceuticals. Prior to this, she was Associate Director in the Pharmaceutical Development group at Ionis Pharmaceuticals where she led the drug product and device development aspect for combination products from early stage through commercialization. Prior to Ionis, Tracy led the Biologics Combination Product Development group at Gilead Sciences and served as the Drug Product Technical lead for late stage combination product programs at Amgen. Her experience includes the development of oligonucleotide and biologic drug products in prefilled syringes and autoinjectors.

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    VENUE

    Online Virtual Event

    Online Virtual Event , USA

    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

    Short Programme 2021

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    Full Programme 2021

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    Chair Letter 2021

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    Infographic 2021

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    Speaker interview James Wabby, Allergan

    Download

    Presentation by Lori Burton, Bristol Myers Squibb

    Download

    Presentation by Delma L. Broussard, CSL Behring

    Download

    Presentation by Shannon Clark, UserWise

    Download

    Presentation by Dr. Benjamin Werner, Boehringer Ingelheim

    Download

    Presentation by Valerie Fenster, Kaleidoscope Innovation

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    Presentation by Tina Rees, Ferring Pharmaceuticals

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    Presentation by Severine Duband, Nemera

    Download

    Presentation by Natalie Abts, Genentech

    Download

    Presentation by Diane Doughty, AstraZeneca

    Download

    Speaker Biographies

    Download

    Presentation by Ed Israelski, HFE

    Download

    Presentation by Toshiro Katayama, ZEON

    Download

    Sponsors


    Mitsubishi Gas Chemical

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

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are the utmost holistic partner and help our customers succeed in the sprint to market. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed - Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks and - Wearables, technological bricks combined together into a smart wearable to improve patients’ life.


    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


    Almac Group

    Exhibitors
    http://www.almacgroup.com

    Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms (vials, ampoules, pre-filled syringes, auto-injector pens) includes:
    • - Pack design and prototype generation
    • - Labeling, assembly and secondary packaging
    • - Complex kit assembly
    • - Temperature sensitive storage
    • - Serialization
    Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner.


    Heuft

    Exhibitors
    https://pharma.heuft.com/en

    Quality, safety and efficiency: this is what matters when filling and packaging pharmaceuticals! The modular solutions from HEUFT SYSTEMTECHNIK GMBH put these key factors into practice simply and effectively. They ensure, during maximum productivity, that only perfect pharmaceutical products reach the market! The Heuft Syringer ensures the safeguarding of the integrity, quality and functionality of pre-filled syringes right from the start. The HEUFT Syringer can be integrated into the assembly process easily for this purpose. It detects safety, functional and quality defects on pre-filled syringes during the assembly process with smart optics and a unique pulsed X-ray inspection to peer below the needle shield!



    Novo Engineering

    Exhibitors
    http://www.novoengineering.com

    NOVO provides contract product development services to medical device and life science customers, helping them to bring better devices to market. Faster. Our team of 55 hardware and software developers has delivered hundreds of commercialized products and are inventors on more than 400 patents.

    NOVO’s systems engineering expertise makes us well-suited to the development of complex devices that communicate to cloud servers directly or via mobile device hosts.

    Medical device experience includes endoscopy – drug delivery – continuous glucose monitoring – transcatheter delivery systems – intragastric implants – infusion devices – on-body injectors – cardiac monitoring – closed-loop insulin delivery – and connected devices.

    For our customer’s convenience, both our California and Minnesota locations offer onsite rapid prototyping, CNC machining and product testing facilities. Advanced facilities combined with an ISO 13485-certified quality system tailored to product development, create the ideal environment for the innovations that our customers demand. Visit us at www.novoengineering.com.



    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.com

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

    Media Partners


    American Pharmaceutical Review

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

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


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

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

    Media Partners


    PharmaVOICE

    Supporting Media Partners
    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.


    IPI

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

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    Pharmiweb

    Supporting Media Partners
    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.


    pharmanews hq

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

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


    Biocompare

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

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


    Pharmalicensing

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

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc


    World Pharma News

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



    Pharmavision

    Supporting Media Partners
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Drug Discovery Today

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

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


    Pharmaceutical Outsourcing

    Supporting Media Partners
    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.


    Pharmacircle

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

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


    Technology Networks

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

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


    Gate2Biotech

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

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


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

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


    Pharma Journalist

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

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


    Pharmaceutical Technology

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

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


    pharmaphorum

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

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

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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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