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Prefilled Syringes West Coast
June 10 - June 11, 2024
Prefilled Syringes West Coast

Conference Overview

SAE Media Group’s 8th Annual Conference
Pre-Filled Syringes West Coast
10th - 11th June 2024, CA, USA
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SAE Media Group’s 8th Annual Pre-Filled Syringes West Coast Conference will be back for 2024 in the West Coast to bring together device developers, biotech and big pharma. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.

As part of SAE’s leading injectable drug delivery conferences this is a must attend event; not only will the conference bring you key insights to enhance your drug device portfolio, but it will also give you the opportunity to network with key industry players. We hope to welcome you in June 2024!
 

FEATURED SPEAKERS

Amin Sedighiamiri

Amin Sedighiamiri

Director, Device Development, AstraZeneca
Bidisha Nandi

Bidisha Nandi

Human Factors Engineer, Regeneron Pharmaceuticals
Jian Liu

Jian Liu

Sr Principal Scientist, Amgen
Kimberly VanCuren

Kimberly VanCuren

Senior Principal Human Factors Engineer, AbbVie
Kinsuk Shah

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Li-Chun Tsou

Li-Chun Tsou

Director, Global Device Engineering and Technologies, GSK
Marie Printz

Marie Printz

Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics
Mitch  Zhao

Mitch Zhao

Engineering Fellow, JnJ Innovative Medicine
Natalie Abts

Natalie Abts

Head of Human Factors Engineering, Genentech
Paul Upham

Paul Upham

Head, Smart Devices, Roche-Genentech
Ram Halthore

Ram Halthore

Director of Engineering, Merck
Respresentative to be confirmed

Respresentative to be confirmed

, Food and Drug Administration
Speaker to be confirmed

Speaker to be confirmed

, Instron Corp.
Speaker to be confirmed

Speaker to be confirmed

, Credence MedSystems
Speaker to be confirmed

Speaker to be confirmed

, Haselmeier GmbH
Speaker to be confirmed

Speaker to be confirmed

, Mitsubishi Gas Chemical Company, Inc
Speaker to be confirmed

Speaker to be confirmed

, Zeon Specialty Materials
Stephanie Smith

Stephanie Smith

Principal Human Factors Engineer, Genentech
Tina Rees

Tina Rees

Associate Director, Human Factors, Regeneron Pharmaceuticals
Tyler A Novak

Tyler A Novak

Associate Director, Device Development, Gilead Sciences
Wenjing Wang

Wenjing Wang

Associate Principal Scientist in Regulatory Affairs, Merck & Co

Amin Sedighiamiri

Director, Device Development, AstraZeneca
Amin Sedighiamiri

Amin Sedighiamiri is Director of Device Development at AstraZeneca, where he is leading cross-functional product teams to develop and bring drug-device combination products to market. Additionally, he spearheads the evaluation and integration of digital solutions for injectable biologics, with the aim of improving the overall patient experience and adherence. Before joining AstraZeneca, Amin worked in Delivery, Device and Connected Solutions organization of Eli Lilly and Company, where he led design and development of connected solutions for drug delivery devices. He also serves as a board member at the Society of Plastics Engineers – Medical Plastics Division, which aims to share technical knowledge within the scientific and engineering community regarding medical uses of plastics. Amin holds BSc, MSc and PhD in Mechanical Engineering and over 13 years of experience in product innovation and commercialization across multiple industry segments.
 

Bidisha Nandi

Human Factors Engineer, Regeneron Pharmaceuticals
Bidisha Nandi

Bidisha Nandi is a Human Factors Engineer at Regeneron where she has been working for two years on a variety of combination products. Prior to Regeneron, she completed a Master’s at Duke University in Biomedical Engineering, specializing in Medical Device Design. She was born and raised in Houston, TX until her move up to upstate New York.

Jian Liu

Sr Principal Scientist, Amgen
Jian Liu

Kimberly VanCuren

Senior Principal Human Factors Engineer, AbbVie
Kimberly VanCuren

Kimberly VanCuren

Senior Principal Human Factors Engineer, AbbVie
Kimberly VanCuren

Kimberly VanCuren is a Senior Principal Human Factors Engineer at AbbVie Inc., driving several HF projects within various product development phases. She has been a part of usability and risk management in software systems, medical devices, combination devices for more than 20 years. Kimberly holds a master’s degree in systems and another master’s degree in human-Computer Interaction.

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Kinsuk Shah

Li-Chun Tsou

Director, Global Device Engineering and Technologies, GSK
Li-Chun Tsou

Brought 25+ years of drug delivery device experiences to lead a dynamic and growing team across geographic boundaries. Expand global commercialization footprint, stay in control via disciplined quality-by-design principles and design-control processes, ensure licensure through regulatory and quality compliance and freedom-to-operate. Most importantly, collaborate to win by building win-win alliance and partnership to get ahead of disease through data-driven influence and shoulder-to-shoulder engineering knowledge to develop the extended-release device platforms for our patients.

Marie Printz

Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics
Marie Printz

Marie is the Executive Director of Bioanalytical and Nonclinical Sciences at Halozyme and has 15 years of experience in the subcutaneous delivery of drugs. She supports nonclinical, clinical and commercial programs that utilize Halozyme’s Enhanze drug delivery and autoinjector technologies. A bioanalytical scientist by training, she’s authored a number of publications focused on SC drug pharmacology and immunogenicity assessment. Prior to Halozyme, she spent 2 decades in the gene therapy industry in bioanalytical and analytical/CMC roles.

Mitch Zhao

Engineering Fellow, JnJ Innovative Medicine
Mitch  Zhao
  • 19 years at JNJ
    • 15 years at Janssen as a multi-discipline drug/device combination product development team leader responsible for developing primary containers and drug delivery devices for various programs including guselkumab (Tremfya) and ustekinumab (Stelara)
    • 4 years at JNJ medical device section as technical leader on insulin pump and infusion set development
  • 6 years at two biotech companies in the bay area as team leader on developing microfluidic chips for bioanalytical applications
  • 10 issued patents and ~ 10 pending patents on drug delivery devices and microfluidics;
  • Over 20 peer-reviewed papers with total citations of > 8000
  • Ph.D in Chemistry; B.En and M. En in App. Chem.
     

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.

Paul Upham

Head, Smart Devices, Roche-Genentech
Paul Upham

Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.


Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
 

Ram Halthore

Director of Engineering, Merck
Ram Halthore

Respresentative to be confirmed

, Food and Drug Administration
Respresentative to be confirmed

Speaker to be confirmed

, UserWise
Speaker to be confirmed

Speaker to be confirmed

, Instron Corp.
Speaker to be confirmed

Speaker to be confirmed

, CCL Industries
Speaker to be confirmed

Speaker to be confirmed

, Credence MedSystems
Speaker to be confirmed

Speaker to be confirmed

, Haselmeier GmbH
Speaker to be confirmed

Speaker to be confirmed

, Mitsubishi Gas Chemical Company, Inc
Speaker to be confirmed

Speaker to be confirmed

, Zeon Specialty Materials
Speaker to be confirmed

Speaker to be confirmed

, Datwyler
Speaker to be confirmed

Stephanie Smith

Principal Human Factors Engineer, Genentech
Stephanie Smith

Stephanie joined Genentech in August 2020 as a human factors engineer. Before joining Genentech, Stephanie has a decade of experience working in the Medical Device and Biotechnology space with over 5 years in Human Factors. Stephanie has also worked as a Global Product Manager and product developer and completed a 2-year rotation part-time as a project manager at Genentech. Stephanie has Bachelor's degrees in Biomedical and Electrical engineering from Marquette University and an MSc from Queen Mary University in London in Biomedical engineering. Stephanie has experience in conducting ethnography, formative and validation studies, and providing user requirements.

Tina Rees

Associate Director, Human Factors, Regeneron Pharmaceuticals
Tina Rees

Tina Rees is the Associate Director of Human Factors at Regeneron, where she leads a team of human factors engineers that manage all aspects of human factors integration across the development and commercialized platforms. Prior to Regeneron, she also led Human Factors at Ferring Pharmaceuticals and was a Principal Research Scientist in Human Factors at Eli Lilly. She has experience with a wide variety of combination products and medical devices and has participated in a number of submissions resulting in approval of combination products and clearance of medical devices. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN and was a Midwesterner until her move to the East Coast 5 years ago.

Tyler A Novak

Associate Director, Device Development, Gilead Sciences
Tyler A Novak

Tyler Novak is Associate Director of Device Development at Gilead Sciences, leading and coaching cross-functional teams in the discovery, development, and commercialization of drug delivery technologies within Gilead’s strategic focus. Prior to Gilead, Tyler held product-development focused positions at Intersect ENT and Cook Biotech. Tyler holds a BS and PhD in Biomedical Engineering, with nearly 10 years of experience developing advanced, long-acting bioactive delivery systems and engineering biologic/synthetic regenerative medicine products across pharmaceutical and surgical industry segments.

Wenjing Wang

Associate Principal Scientist in Regulatory Affairs, Merck & Co
Wenjing Wang

Wenjing Wang is a seasoned regulatory affairs expert with over eight years of industry experience in medical devices, combination products and in vitro diagnostic devices. Her latest experience includes regulatory registration for digital health technologies (DHTs) being utilized in decentralized clinical trials and DHTs being part of the combination product. Wenjing has master’s degrees in Biochemistry and Regulatory Affairs and a bachelor’s degree in biotechnology. She has extensive experience in global registrations including FDA, Health Canada, EMA, JMHW, NMPA, and other foreign agencies for various types of medical devices.

What will you gain?
  • Engage in discussions on evolving EU and US regulations as well as reviewing the latest FDA guidance on human factors and drawing insights from successful notified body opinions for streamlined regulatory compliance.
  • Gain insight into advancements in large volume drug delivery devices with a case study from Halozyme and a panel discussion assessing key considerations, benefits and barriers of such devices for stakeholders including patients, HCPs and pharma companies.
  • Delve into comprehensive strategies for maximizing combination product manufacturing and effectively managing your product’s lifecycle with key insights from GSK and Merck
  • Acquire insights into human factors best practices from AbbVie and Regeneron, and discover ways to effectively apply testing and validation approaches for combination products.
  • Explore collaborative opportunities to advance innovation in the injectables field and gain insight into the latest technology updates and challenges these pose such as leaching in electro-mechanical devices.

Who should attend?

Directors, Heads of Departments and Managers for the following areas:

Device Development
Device Engineering
Combination Product Development
Drug Delivery Devices
Primary Packaging Development
Digital Health
Large Volume Drug Delivery
Novel Drug Product Formulation
Regulatory Affairs

sponsors

Conference agenda

clock

8:00

Registration & Coffee

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8:50

Co-Chairs' Opening Remarks

Natalie Abts, Head of Human Factors Engineering, Genentech

Amin Sedighiamiri, Director, Device Development, AstraZeneca

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9:00

US and EU regulations on drug delivery methods being part of combination products

Wenjing Wang, Associate Principal Scientist in Regulatory Affairs, Merck & Co

  • The definition of combination product and different types of combination products
  • US FDA’s requirements on drug delivery methods being part of the combination products
  • EU requirements on drug delivery methods being part of the combination products
  • clock

    9:30

    Session reserved for gold sponsor CCL

    Speaker to be confirmed

    Speaker to be confirmed, , CCL Industries

    clock

    10:00

    Successfully Gaining Combination Product Notified Body Opinion

    Mitch Zhao, Engineering Fellow, JnJ Innovative Medicine

  • Reviewing challenges with combination product regulations and gaining notified body opinions
  • Experiences and lessons learned from notified body submissions
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Session reserved for gold sponsor Instron

    Speaker to be confirmed

    Speaker to be confirmed, , Instron Corp.

    clock

    11:30

    An Update: ISO Standards for Needle Injection Systems and Successful Applications

    Respresentative to be confirmed

    Respresentative to be confirmed, , Food and Drug Administration

  • Assessing the need for clarified or updated guidance
  • Reviewing international standards such as ISO 23908, ISO 11040 and ISO11608
  • Further insight into successfully applying these standards when developing prefilled syringes with needle safety devices and autoinjectors
     
  • clock

    12:00

    Session reserved for Credence MedSystems

    Speaker to be confirmed

    Speaker to be confirmed, , Credence MedSystems

    clock

    12:30

    Updates on the Regulatory Landscape for Human Factors in Combination Product Development

    Natalie Abts, Head of Human Factors Engineering, Genentech

  • The FDA has recently released their final guidance on applying human factors engineering in the development of combination products, replacing the draft guidance released in 2016
  • Though the new guidance is substantially different from the draft, the impact to developers is likely to vary based on the maturity of their human factors programs
  • This presentation will include an overview of the updates to the document, insights on how regulators have applied it since the release, and the key considerations for developers
  • clock

    13:00

    Networking Lunch

    clock

    14:00

    Session reserved for Haselmeier

    Speaker to be confirmed

    Speaker to be confirmed, , Haselmeier GmbH

    clock

    14:30

    Panel Discussion: Challenges and opportunities of high-dose, large volume drug delivery

  • Benefits and barriers of large-volume delivery devices from the perspectives of patients, HCPs and pharmaceutical companies
  • On-body, near-body or handheld: The potential of each delivery method in meeting the diverse needs and preferences of patients
  • Patient-filled, patient-loaded or pre-filled/pre-loaded? strategies for balancing safety, technical complexity and usability
  • The current landscape of large-volume delivery systems in terms of sustainability and areas for further innovation
  • Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Marie Printz, Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics

    Kinsuk Shah

    Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

    Stephanie Smith, Principal Human Factors Engineer, Genentech

    clock

    15:00

    Session reserved for Mitsubishi

    clock

    15:30

    Facilitating Rapid High Volume Subcutaneous (SC) Drug Delivery

    Marie Printz, Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics

  • Case study on ENHANZE™: technology breaking through subcutaneous volume limitations to facilitate rapid high-dose, high-volume subcutaneous drug delivery
  • Converting long IV infusions to short SC injections
  • Enabling large volumes to be given SC at a single site
  • clock

    16:00

    Afternoon Break

    clock

    16:30

    Session reserved for Zeon

    Speaker to be confirmed

    Speaker to be confirmed, , Zeon Specialty Materials

    clock

    17:00

    Implementing Behaviour Design into Connected Device Development

    Paul Upham, Head, Smart Devices, Roche-Genentech

  • Working through the design and launch of a digital solution
  • Importance of utilising behaviour design principles early in device development to ensure devices are usable
  • Case study examples of a behaviour design service
  • Outlook on the future of connectivity
  • clock

    17:30

    Co-Chairs' Closing Remarks and Close of Day One

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech

    clock

    8:15

    Registration & Coffee

    clock

    8:50

    Co-Chairs' Opening Remarks

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech

    clock

    9:00

    Manufacturing and scale up challenges for injectable drug delivery systems

    Ram Halthore

    Ram Halthore, Director of Engineering, Merck

  • Utilising platform technologies to enable increased manufacturing efficiencies
  • Building a bridge between design and manufacturing - voice of manufacturing during the development of injectable drug delivery systems
  • Effective supplier qualifications for device development to enable scalability
  • clock

    9:30

    Device Life Cycle Strategies for Drug Delivery and Combination Products

    Li-Chun Tsou, Director, Global Device Engineering and Technologies, GSK

  • Expand Global Footprint: multiple indications, proper formulations, differentiated devices
  • Enhance Patient Access: broaden therapeutic area, patient-centric design, robust training
  • Enable Novel Device Design: ergonomic considerations, appropriate dosing, sustained release
  • clock

    10:00

    Session reserved for sponsor

    clock

    10:30

    Morning Coffee

    clock

    11:00

    PANEL DISCUSSION: Accelerating Injectable Innovation: Emerging technologies and future opportunities for injectable drug delivery

  • Reviewing the current landscape of emerging technologies to support injectable drug delivery and opportunities for development of more effective subcutaneous devices
  • What are the current gaps in industry and what areas should be focused on to accelerate innovation?
  • How can collaboration and partnerships throughout industry and device development be enhanced?
  • Sharing challenges in regulatory submissions and examples of industry experiences to help you overcome these
  • Ram Halthore

    Ram Halthore, Director of Engineering, Merck

    Mitch Zhao, Engineering Fellow, JnJ Innovative Medicine

    Wenjing Wang, Associate Principal Scientist in Regulatory Affairs, Merck & Co

    Li-Chun Tsou, Director, Global Device Engineering and Technologies, GSK

    Tyler A Novak, Associate Director, Device Development, Gilead Sciences

    clock

    11:30

    Session reserved for sponsor

    clock

    12:00

    Opportunities for Innovation with Biosimilars

    Kinsuk Shah

    Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

  • Reviewing innovations in biosimilars and how this impacts device requirements
  • Sharing challenges and experiences faced
  • Enabling device platforms to be more easily adapted to a wide portfolio of drugs
  • clock

    12:30

    Networking Lunch

    clock

    13:30

    Session reserved for Datwyler

    Speaker to be confirmed

    Speaker to be confirmed, , Datwyler

    clock

    14:00

    Extractables and Leachables in Injectable Devices:A Case Study

    Jian Liu

    Jian Liu, Sr Principal Scientist, Amgen

  • Examining extractables and leachables from non-product contact materials such as batteries in electromechanical devices
  • Learnings and strategies to overcome non-product contact leaching
  • Utilizing predictive tools for interactions in devices
  • clock

    14:30

    Bridging Human Factors Studies for Injectable Devices

  • Exploring bridging strategies to enable efficient human factors work
  • Successfully leveraging human factors data in new development programs
  • Insight into patient population considerations
  • Reviewing experiences of when leveraging isn’t appropriate
  • Tina Rees, Associate Director, Human Factors, Regeneron Pharmaceuticals

    Bidisha Nandi, Human Factors Engineer, Regeneron Pharmaceuticals

    clock

    15:00

    Afternoon Tea

    clock

    15:30

    Reserved sponsor session

    clock

    16:00

    Applying effective human factors testing and validation approaches for combination product platforms

    Kimberly VanCuren, Senior Principal Human Factors Engineer, AbbVie

  • Strategies to identify research scope and results during the early use error analysis process
  • Ways to generate high-value results to engage constructive design and development decision making
  • Best practices on platform human factors formative and validation protocol development
  • Factors to consider for balancing requirements (e.g. technical, commercial, user needs)
  • clock

    16:30

    Findings and Implications of U.S FDA-UserWise Training Decay Research

    Speaker to be confirmed

    Speaker to be confirmed, , UserWise

  • An overview of Training Decay and why it matters
  • What does the FDA say about Training Decay
  • Insights and revelations from our FDA-backed training decay research study
  • How our findings affect future regulatory policy
  • clock

    17:00

    Co-Chairs' Closing Remarks and Close of Day Two

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech


    Director, Device Development
    AstraZeneca
    Human Factors Engineer
    Regeneron Pharmaceuticals
    Sr Principal Scientist
    Amgen
    Senior Principal Human Factors Engineer
    AbbVie
    Senior Principal Human Factors Engineer
    AbbVie
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Director, Global Device Engineering and Technologies
    GSK
    Executive Director, Bioanalytical & Nonclinical Sciences
    Halozyme Therapeutics
    Engineering Fellow
    JnJ Innovative Medicine
    Head of Human Factors Engineering
    Genentech
    Head, Smart Devices
    Roche-Genentech
    Director of Engineering
    Merck
    Food and Drug Administration
    UserWise
    Instron Corp.
    CCL Industries
    Credence MedSystems
    Haselmeier GmbH
    Mitsubishi Gas Chemical Company, Inc
    Zeon Specialty Materials
    Datwyler
    Principal Human Factors Engineer
    Genentech
    Associate Director, Human Factors
    Regeneron Pharmaceuticals
    Associate Director, Device Development
    Gilead Sciences
    Associate Principal Scientist in Regulatory Affairs
    Merck & Co

    Gold Sponsor

    Sponsors

    Exhibitors

    Official Media Partner

    VENUE

    San Diego Marriott La Jolla

    4240 La Jolla Village Drive, La Jolla , San Diego, Callifornia, 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

    Sponsors and Exhibitors


    CCL Healthcare

    Gold Sponsor
    https://cclhealthcare.com/

    CCL Healthcare excels in pharmaceutical labeling for injectables for vials, syringes, prefilled syringes, and autoinjectors. Our expertise covers labels, cartons, patient instructions, and smart labeling solutions, enhancing patient experience and adherence. With our high-speed RFID packaging line management, we enable encoding with speeds of 700 injectable items per minute, ensuring peak performance for hard-to-tag items through custom RFID product design. Contact us to discuss how we can enhance your injectable solutions with smart labels and packaging.


    Instron

    Gold Sponsor
    https://www.instron.com/en-gb/

    Instron® brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Our equipment and services are primed to help you investigate new technologies and ensure product quality, all while maintaining the highest levels of data integrity and security. Instron has been embedded in the biomedical industry for more than 75 years, and the technological, regulatory, and manufacturing challenges facing our customers have driven us to develop products and services to address their needs. These developments include specialized fixturing, compliant software, and automation capabilities. Our most valuable asset is our extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMOs, universities, test houses, and startups.


    Sponsors


    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.


    Datwyler

    Sponsors
    https://datwyler.com/company/innovation/softpulse

    Datwyler is a leading manufacturer of system-critical elastomer components for advanced applications in healthcare, mobility, and other industries. Based on our core competencies solution design, material expertise, and operational excellence, we deliver customer value from idea to industrialization.

    SoftPulse™ soft dry electrodes are Datwyler solution for long-term and gel-free ExG monitoring. Our electrodes made from conductive elastomer offer high wear comfort thanks to the softness of the material. Dry signal acquisition without use of gel shortens preparation time and allows ambulatory ExG applications. Robust design and easy cleanability enable repeated use. The combination of superior materials and optimized production processes leads to best-in-class signal quality among soft dry electrodes with excellent stability against ageing and abrasion.

    SoftPulse™ are available in three standard designs. Thanks to Datwyler core competences, electrodes are produced using fully scalable manufacturing processes. Customization according to customer needs are as well possible for small and serial volumes.



    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.


    ZEON

    Sponsors
    https://www.zeon.eu/

    o ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    ApiJect™

    Exhibitors
    https://info.apiject.com/industry-events

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

    Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume. 

    Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.  

    The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.



    KORU

    Exhibitors
    https://www.korumedical.com/

    KORU is, first and foremost, a patient-centric organization that will go the extra mile for our customers, providers, and partners who depend on our devices. We are a world-class manufacturer of subcutaneous infusion devices that deliver life-saving immunoglobulin therapies to patients with chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).



    Kymanox

    Exhibitors
    https://www.kymanox.com/

    Kymanox® is your life science solutions partner with a diverse team of experts who know how to connect the dots and make sure you have the right end-to-end solutions for your modern medicine development & commercialization challenges.

    We are experts in providing our clients in the combination products, biologics, pharmaceutical, and medical device industries with support from early development to post-market. We help bring products from bench to patient.



    Lyophilization Technology

    Exhibitors
    https://lyotechnology.com/

    Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.

    Clients leverage our abilities for bringing new products to the clinic and implementing improvements for current products. LTI is recognized as an industry leader with unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

    To the benefit of our clients, LTI has provided Development and Clinical Trial Material Manufacturing services to more than 500 biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations for over 25 years. Our proven track record of performance comes from successfully developing formulations, manufacturing processes, and prepared material for clinical trials for over 900 diverse products.

    A talented and dedicated staff, skilled with over 300 years of combined experience, enjoys the reputation of providing innovative solutions, achieving desired results, and exceeding client expectations.

    Gain the benefits of our experience and capabilities for creating solutions for the unique needs of your lyophilized product.



    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.


    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/


    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


    Pharma Journalist

    Official Media Partner
    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.


    On Drug Delivery

    Official Media Partner
    http://www.ondrugdelivery.com/subscribe

    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.


    The Medicine Maker

    Official Media Partner
    https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

    The Medicine Maker is a print and digital publication as well as a weekly newsletter. At The Medicine Maker, we bring people into the limelight, showcasing the industry’s success stories and examining its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward. Register for your FREE print or digital magazine or subscribe to our newsletter here! https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

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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
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