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SAE Media Group’s 16th Annual Conference
Pre-Filled Syringes and Injectable Drug Devices Europe
9 - 11 January 2024 | London, UK
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Kick off 2024 and set the tone for the year at SAE Media Group's 16th Annual Pre-Filled Syringes and Injectable Drug Devices Conference will return to London in January to unite leaders from the industry, bringing you the latest advances in the combination product drug delivery space and the chance to collaborate across a 3 day programme.

As part of SAE’s leading Injectable Drug Delivery Series, the 3-day event will comprise of a pre-conference focus day exploring the advances in PFS design for enhanced drug delivery proceeded by a two-day main conference comprising of morning keynote plenaries and parallel afternoon topic streams as detailed below addressing the industry’s hottest topics:

  • Device Innovations for Large Volume and Highly Viscous Drug Delivery
  • Sustainability by Design and Material Selection
  • Primary Packaging Development
  • Digital Integration for Connected Devices

This event will not only bring you key insights needed to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in January 2024!

This year's agenda has been validated by our 2024 advisory board:

  • Abha Violette, Associate Director Regulatory Affairs, AstraZeneca
  • Alphons Fakler, Director Human Factors Engineering/User Experience, Novartis
  • Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk
  • David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB
  • Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Device, Combination Products and eHealth, Bayer
  • Guy Furness, Proprietor and Publisher, ONdrugDelivery Magazine
  • Joel Richard, Chief Development Officer, Enterome
  • Khaudeja Bano, Vice President, Combination Product Quality, Amgen
  • Mitali Aon, VP and Global Head of Device Development, Sanofi
  • Steve Chamberlain, Director Device Engineering, GSK

Why attend?

  • The only conference in Europe with 3 full days of dedicated injectable drug delivery presentations
  • 3 full days of networking opportunities
  • 40+ presentations with 70% of speakers from the top 20 big pharma companies
  • The agenda has been curated by an advisory board of big pharma, biotech and drug delivery editorial opinion leaders providing expertise focused on device development, regulatory affairs, human factors and digital health
  • A focus day and 4 dedicated streams addressing the hottest topics in the industry

What you will gain:

  • Opportunity to engage with pharma, biotech and device developers on the latest trends within the pre-filled syringe and injectable device market
  • Hear about new technological advances in the delivery of large volume drugs and novel drug products
  • Understand the latest regulatory requirements from experts surrounding medical devices and digital health
  • Gain insight into how big pharma is incorporating sustainable approaches into drug device design
  • Delve into the growing potential of digital health to improve patient experience and treatment
  • Explore key considerations for material components for the development of primary packaging

 

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
  • Sustainability and Circular Economy
  • Large Volume Drug Delivery
  • Novel Drug Product Formulation
  • Regulatory Affairs
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Advanz Pharma; AstraZeneca; Balda Medical GmbH & Co. KG; Bayer AG; Bayer Pharma; BD Medical; BD Medical - Pharmaceutical Systems; Becton Dickinson (BD); Boehringer Ingelheim; Boehringer Ingelheim GmbH & Co. KG; Boehringer Ingelheim Pharma GmbH & CO KG; Boehringer Ingelheim Pharma Gmbh & Co. Kg; BSI; BSI Group; Chiesi Ltd; Crux Product Design Ltd; DCA Design International; Device Development; Dr.Reddys; Eli Lilly; GSK; Hoffmann-La Roche; Horizon Therapeutics GmbH; Halozyme; Ichnos Sciences; Janssen Pharmaceutical Companies; Johnson & Johnson; Johnson & Johnson (Janssen Pharmaceutical); Medincell; Merck Group; Midas Pharma Gmbh; Nemera; Novartis; Novo Nordisk; Novo Nordisk A/S; Owen Mumford; Pfizer; Pfizer UK; PharmaEssentia; Prescient Healthcare Group; RAUMEDIC AG; Sanofi; SCHOTT AG; SPM MEDICARE PVT LTD, INDIA; Sustainable Healthcare Coalition; Takeda; Teva; Teva Pharmaceuticals; Teva Pharmaceuticals Industries Ltd.; Teva, Combination Products; TUV Italia SRL; TUV SUD Japan Ltd.; TUV SUD Product Service GmbH; University of Liverpool; University of Southern Denmark; Zeon Europe GmbH; Zeon Specialty Materials ;

Conference agenda

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8:00

Registration & Coffee

The  Pre-Conference Focus Day on Advances in PFS Design for Enhanced Delivery will showcase cutting-edge innovations in pre-fi lled syringe and injectable combination device design and development. Industry experts will explore new technologies, innovative strategies in the design process and approaches to ensure safe and efficient product development. The session will emphasise developing robust, reliable and high-quality delivery devices through a risk-based approach and the development of effective control strategies. Given the growing demand for self-administration solutions, case studies will delve into patient-centric device development and opportunities for producing injection devices for the future.

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8:50

Chair's Opening Remarks

Elise Legendre, Head of Primary Container & Safety System Development, Sanofi

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9:00

Post market safety reporting for combination products and injectable devices

Khaudeja Bano, Vice President, Combination Product Quality, Amgen

  • How have we seen industry adapting to meet evolving regulations through effective compliance strategies
  • Current guidance for industry on postmarket safety reporting for combination products
  • Case study examples for effective approaches to efficiently maintain reporting for combination products and injectable devices
  • Looking to the future how can we expect the global regulatory landscape to evolve for combination product reporting and advice to be best prepared
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    9:30

    Case study: PFS Development from Concept to The Shelf

    Anna Sawicki, DPDD Combination Product Development Engineer Lead, Pfizer R&D UK Limited

  • Insight into the development of a PFS and learnings from challenges encountered along the way
  • Insight into improving development efficiency and aligning design controls
  • Implementing a control strategy for EPRs
     
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    10:00

    Session Reserved for Lead Sponsor

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    10:30

    Morning Coffee

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    11:00

    Ensuring Effective Life Cycle Management of New Products

    Alexander Prisacar

    Alexander Prisacar, Scientific Expert for Devices, Boehringer Ingelheim

  • Outlining the LCM process for maintaining devices on market
  • Approaches for setting up an effective LCM strategy
  • Experiences and best practices to apply to your work

     

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    11:30

    Advancements in Intravitreal Drug Delivery: the Past and the Future

    Hans Jensen, Business Development Leader, Cambridge Design Partnership

  • Brief intro and history of Intravitreal drug delivery devices
  • Challenges and unmet needs
  • The future: a glimpse into advancements and new technologies
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    12:00

    ADVISORY BOARD FIRESIDE CHAT: Producing Pre-Filled Syringes and Injectable Drug Devices for the Future

  • Collaboration and speed to market: How can teams across device and drug development, regulatory and quality work together to ensure speed to market clinic?
  • Worldwide launches: Sharing experiences, challenges and industry examples in regulatory submissions and multi-market launches. Our experiences and what can we as an industry do to ensure that our products meet patient needs worldwide?
  • Being ready for new technologies: Reviewing opportunities for advancing technology, expectations from market and ensuring stakeholder buy-in for the evolution of the injectables landscape. What can we proactively do to be ready for new technologies?
  • Patient needs: Ensuring we continue to met our customer needs. What can we as an industry do to ensure we continue to understand and meet our patient needs world-wide?
     
  • Abha Raveau Violette

    Abha Raveau Violette, Associate Director, Devices and Digital Therapeutics, AstraZeneca

    Joel Richard

    Joel Richard, Chief Development Officer, Enterome

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

    Alphons Fakler, Director Human Factors Engineering/User Experience, Novartis

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    12:30

    Networking Lunch

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    13:30

    Notified Body Submissions Under Combination Product Regulation

    Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

  • Experiences with the EU MDR as a former member of MDCG (authorities) and now heading Novo Nordisk RA devices
  • Outlining Challenges with article 117 in the MDR and gaining Notified Body Opinions
  • EMA/NB - and approvals vs. opinions
  • Where to be cognisant of gaps and how to move forward
     
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    14:00

    Session Reserved for Sponsor

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    14:30

    Notified Bodies’ Perspective

    Julia Frese, Director, TUV SUD Japan Ltd.

  • Outlining key Primary packaging requirements
  • What is needed for a successful submission and NB opinion?
  • How industry can work more closely with regulators and notified bodies in implementation of new regulations
  • Challenges in lifecycle management of combination products
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    15:00

    Afternoon Tea

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    15:30

    Session Reserved for Sponsor

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    16:00

    What should combination product human factors engineering (CP HFE) look like in 2034?

    Julian Dixon

    Julian Dixon, Senior Director, AstraZeneca

  • Are we still on a learning curve or have we reached a knowledge plateau?
  • Our business is one of platforms. How will the reuse of existing drug delivery platforms – and the creation of new ones - be reflected in CP HFE?
  • In what ways will we be more truly patient-centric?
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    16:30

    Controlling Stability of Biologics During Product Lifecyle in PFS

    Joel Richard

    Joel Richard, Chief Development Officer, Enterome

  • Defining stability, biocompatibility, key quality attributes for submission to health authorities
  • Strategically generating a toxicology/immunogenicity risk assessment and mitigating risks in design by taking a risk- based approach
  • Complying with requirements for extractables and leachables
     
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    17:00

    Chair's Closing Remarks and Closing of Focus Day

    Elise Legendre, Head of Primary Container & Safety System Development, Sanofi

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    7:45

    Registration & Coffee

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    8:20

    Chair's Opening Remarks

    David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma sprl

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

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    8:30

    Cooperation Scheme: Partnering Strategically to Advance Injectable Drug Device Recycling

    Niels Otterstrom Jensen

    Niels Otterstrom Jensen, Head of TakeBack Program, Novo Nordisk A/S

  • Insight into collaborating and forming strategic partnerships
  • Exploring the preparation process of the scheme
  • Delving into the current work of the partnership and update on the status of the pen injector takeback scheme
  • Challenges faced so far and how these have and can be overcome
  • Injector pen takeback schemes
     
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    9:00

    PANEL DISCUSSION: Collaboration is Key to Solve Highly Complex Sustainable Challenges

  • Further opportunities for collaboration to accelerate sustainability in industry
  • How can pharma and device manufacturers work together towards producing more sustainable injectors
  • How can industry, NHS and regulators work together and find scalable solutions to tackle waste to minimise the environmental footprint of injectable devices
  • Discussing the current barriers to strengthen collaboration to solve industry’s sustainability challenges
  • Niels Otterstrom Jensen

    Niels Otterstrom Jensen, Head of TakeBack Program, Novo Nordisk A/S

    Oli Gould, Sustainable Solutions Lead, Owen Mumford Ltd.

    Sean McPike, Global Product Stewardship Lead, Eli Lilly

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

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    9:30

    The Regulator as an Enabler for Sustainable Medical Products

    Steve Hoare

    Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)

  • Placing patients’ interests and priorities first
  • Consult and Inform: “building compliance in”
  • What a medical devices regulator cannot do
  • Getting the Balance Right: Legislation, Guidance, Guidelines and advice
  • The Agency “Net Zero” Policy and next steps
     
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    10:00

    Session Reserved for Gold Sponsor ApiJect

    Bo Kowalczyk, Chief Commercial Officer, ApiJect

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    10:30

    Morning Coffee

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    11:00

    Be prepared! Combination products under MDR (article 117)

    Heinrich Martens, Vice President Regulatory Affairs, Fresenius Kabi

  • MDR – Article 117 / Combination Products under MDR
  • What is a combination product
  • The meaning of Article 117
  • Manufacturer responsibilities evidence and fulfilment of the GSPRs
  • Notified Body Opinion
     
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    11:30

    Medical Device Simultaneous Engineering

    Ulrich Stahl, Director New Technology, Harro Hofliger

  • As medical devices seek to meet ever more challenging patient needs, they get more and more complex, and the industrialisation process is getting more complex.
  • The more innovative the device to meet these needs, the more likely that the assembly process is to require proof of principle work to become established.
  • If the medical device Developer just finishes their design and throws the problem “over the wall” into the Engineering department, delivery of the project can only be in series and likely to suffer serious delays as it is found, too late, that redesign is required. Instead simultaneous engineering with parallel working with a machinery supplier is recommended.
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    12:00

    Medical devices and in-vitro diagnostics used in drug clinical trials: principles of use and sponsor responsibilities under the medical device and IVD regulations requirements

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

  • Regulatory Landscape Changes
  • Overview of medical devices used in drug clinical trial
  • Sponsor responsibilities for medical devices used in the clinical trial according the requirements of MDR/IVDR
  • Combined trial and management of the dual submissions
     
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    12:30

    Reserved Sponsor Session

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    13:00

    Networking Lunch

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    14:00

    Chair's Opening Remarks

    Claus Geiger, Global Medical Device Project Leader, Sanofi

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    14:10

    Developing Wearable Injectors for Large Volume and Highly Viscous Drugs

    Claus Geiger, Global Medical Device Project Leader, Sanofi

  • Advances in establishing the optimal volume range for an on-body devices
  • Assessing the impact of viscosity on injection force and reducing intermolecular interactions
  • What does industry need to advance further? What is needed from vendors?
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    14:40

    Delivering large volume at home with a sustainable wearable injector platform

    Cecile Gross, Category Manager Parenteral, Nemera

  • Challenges of large volume drugs for the Industry
  • Addressing chronic diseases with large volume drugs
  • Challenges for delivering large volume injections at home
  • Drivers for designing a sustainable platform to address all these challenges
  • Necessity of a patient-centric approach
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    15:10

    Industry perspective on design considerations for large volume and highly viscous drug delivery systems

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

  • Features
  • Delivery approaches
  • Patient and end user considerations
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    15:40

    Afternoon Tea

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    16:10

    Advanced modalities and formulation in the injectable space

    Tina Arien

    Tina Arien, Associate Director, Janssen Pharmaceutica

  • An overview of the current requirements effecting injectable drug product formulation
  • Challenges in high viscosity and high concentration formulation for injectables
  • Advances for injectable delivery >2ml and industry considerations
  • Challenges in development of injectable oligonucleotide therapies
     
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    16:40

    Session Reserved for Gerresheimer

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    17:10

    Bridging Human Factors Studies for Injectable Devices

    Ali Matour

    Ali Matour, Principal Device Engineer, GSK

  • Exploring bridging strategies
  • Using the threshold analyses to make decisions
  • Case study examples on human factors studies and bridging
  • Overcoming challenges
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    17:40

    Self-Injection: The Patient Journey

    Annie Zavadil

    Annie Zavadil, Device Project Leader, Novartis

  • Exploring the history of self-injection around diabetes
  • Outlining innovations and recent acceleration in the self-injection space
  • Optimising IFUs to aid the patient journey
     
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    18:10

    Chair's Closing Remarks and Close of Day One

    Claus Geiger, Global Medical Device Project Leader, Sanofi

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    14:00

    Chair's Opening Remarks

    Steve Hoare

    Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)

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    14:10

    Tackling Eco-Design for Sustainability, Devices and Primary Containers

    Jennifer Keane, PSL - Procurement Site Lead, Category Buyer Packaging & Devices Manufacturing and Supply, Sanofi

  • Insight into how Sanofi are tackling eco-design
  • Exploring eco-design strategies and incorporating circular economy into design
  • How to implement life cycle assessment driven problem solving: what to consider?
  • Current barriers and how they can be overcome
  • Opportunities for industry collaboration
     
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    14:40

    Sustainable Drug Delivery: The Device Supplier’s Perspective

    Chris Muenzer

    Chris Muenzer, Vice President Innovation and Development, Haselmeier

  • Role of the device supplier in the overall product sustainability
  • Benefits of lifecycle assessment (LCA) in device development
  • Trade-offs between usability, cost of goods, and carbon footprint
  • Challenging Pharma to close the circle and enable better solutions
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    15:10

    Circular Solutions for the Pharmaceutical Industry

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

  • A changing World
  • Towards Circular Materials and Products: Challenges and Opportunities
  • Enabling Transformative Change through Circular Solutions
  • Case Studies
     
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    15:40

    Afternoon Tea

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    16:10

    The power of collaboration to deliver sustainable healthcare

    Fiona Adshead, Chair, Sustainable Healthcare Coalition

  • Outlining how the Sustainable Healthcare Coalition, a partnership of leading companies and public sector agencies, addresses some of the most pressing sustainability issues in global healthcare
  • Case studies will demonstrate how healthcare sector industry partners can help the NHS achieve NetZero and bring together clinicians and industry to meet the challenges of improving sustainability through innovation
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    16:40

    Thinking Big for Sustainable Devices

    Matthew Jones, Senior Medical Sector Manager, DCA Design International

  • Whatever your perspective on climate change, the necessity to improve the impact of products we use every day has become more pressing.
  • The medical sector has largely been exempted so far but this is changing. We are already starting to see sustainability becoming a major driver in the decision making of national governments and healthcare payers.
  • Opportunities to improve the environmental impact of injection devices exist in many aspects of their specification, design, manufacture, distribution, disposal and recycling. The challenge for everyone involved in device development, is to make sense of all these options.
  • We will summarise the strategies available to improve the sustainability of injection delivery devices and how best to implement them. We will provide guidance on which of the potential initiatives that could be put into practice are likely to be most effective. This will enable a hierarchy to be established that allows us to think big and prioritise the most effective options.
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    17:10

    Measuring environmental impact – end of life use and carbon, an over-arching lens

    Courtney Soulsby, Global Director, Healthcare, BSI Group

  • Remanufacturing and reprocessing of medtech products – how to embed end of life use in the design process?
  • The need and align on the methodology that medtech companies use to evidence product level visibility of environmental impact
  • Comparing environmental impact categories for smart decision-making and evidencing to meet health systems’ requirements
     
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    17:40

    Biophorum’s sustainability roadmap and what it means for drug delivery devices

    Lucy Shering

    Lucy Shering, Global Change Facilitator, BioPhorum

  • Operating context for environmental sustainability in the healthcare sector
  • What this means for the biopharmaceutical industry and where the opportunities lie
  • Designing circular drug delivery devices -challenges and opportunities
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    18:10

    Chair's Closing Remarks and Closing of Day One

    Steve Hoare

    Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission, Medicines and Healthcare products Regulatory Agency (MHRA)

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    7:45

    Registration & Coffee

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    8:20

    Chair's Opening Remarks

    Thomas Wejs Moeller, Director Global Regulatory Affairs - Device, Novo Nordisk

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    8:30

    Impact of Regulatory change on Drug Device Combination Products

    Louise Place

    Louise Place, Director, GSK

  • Recent learnings from MDR Implementation
  • Latest requirements for Drug Device Combination Products in the UK
  • Important considerations for making changes to established products
     
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    9:00

    The benefits of a smart device with a case study on SmartClic® development

    Kyle Berman, Principle Engineer, Pfizer Ltd

  • Comparisons between purely mechanical and smart injectors
  • The benefits of smart injectors to the Patient, Pharma company and Device Development Team
  • Evolution of the SMARTCLIC’s design, graphical user interface and packaging through preference and usability studies
  • Challenges faced during development of SMARTCLIC: learnings and takeaways to apply to connected injector development
     
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    9:30

    Trends in Regulations of Digtial Health Technologies

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk

  • How can digital health products be integrated into drug development
  • What are the regulatory challenges in implanting digital health technologies
  • What are the opportunities for harmonization on a global level
     
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    10:00

    Reserved Sponsor Session

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    10:30

    Morning Coffee

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    11:00

    PANEL DISCUSSION: Devices for the Future: Bringing value to both the patient and company

  • Striking a balance between a user-friendly device and a profitable asset to the company
  • Effectively balancing the level of connectivity with user needs
  • Practically and successfully gaining good user acceptance
  • How will the ecosystem evolve and what will patient care look like beyond the injector?
     
  • Cristiana Heese, P&L Development, Boehringer Ingelheim

    Charles  Potter

    Charles Potter, Technical Project Leader, Chiesi Ltd

    David Harrison, Senior Director, Head of Device Manufacturing Partnerships, UCB Biopharma sprl

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    11:30

    Reserved Sponsor Session

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    12:00

    How to bring patient centricity into development of secondary packaging for combination products

    Cristiana Heese, P&L Development, Boehringer Ingelheim

  • Exploring new ways to enhance patient centricity in the development of secondary packaging for combination products
  • Plan and time Usability and UX activities right
  • Assess the interaction with Usability and UX during the development process
  • Opportunities to increase patient centricity in the development of secondary packaging
     
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    12:30

    Reserved Sponsor Session

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    13:00

    Networking Lunch

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    14:00

    Chair's Opening Remarks

    Cinzia Rotella, Project Leader, Sanofi

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    14:10

    Selection of a new primary component: an interdisciplinary approach

    Cinzia Rotella, Project Leader, Sanofi

  • The project was about the selection of a new plunger stopper for 2 mL syringes for mAbs products inside Sanofi
  • The selection required a multidisciplinary effort from different departments: Development (MED - Medical devices), Procurement, Quality and Industrial department
  • The original approach that has been put in place for the project is now leveraged for other projects as an example of play to win behaviour inside the company
     
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    14:40

    Solutions for Emerging Challenges in Injectable Drug Delivery

    Mark Hassett, Vice President of Business Development, Credence MedSystems

  • Delivery of medications is moving from formal healthcare settings to the home
  • Injection volume ranges are broadening and viscosities are increasing
  • Solutions and suspensions risk needle clogging
  • Solutions are requiring reconstitution at the time of use
  • What solutions are available to address these challenges?
     
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    15:10

    Piston Placement in Prefilled Cartridges – The Journey is more important than the destination

    Richard Crowther, Snr Manager Regulatory Affairs, Amgen

  • Prefilled cartridges are a common primary container for drug product to be used in wearable injectors
  • Case study explores the factors influencing piston position in the drug product manufacturing process
  • Optimising the process development approach can reduce lead times into manufacturing
     
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    15:40

    Afternoon Tea

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    16:10

    A case study: Evaluation of Silicone Oil Free Pre-Filled Syringes

    Jacopo Michieli, Sr. Device Engineer, CSL Behring AG

  • Background and reason to choosing a SOF PFS system.
  • Selection process of potential options: Glass and Polymer syringe PFS.
  • Stability results with worst case molecule for drug container interaction.


     

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    16:40

    Understanding the ISO 11608 Series: Design and Testing of Needle-Based Injection Systems

    Steven Malbon

    Steven Malbon, Combination & Physical Devices Manager, Medical Engineering Technologies Ltd

  • Providing comprehensive insights into 11608-1:2022, a crucial standard governing the design and testing of needle-based injection systems.
  • Gaining a deep understanding of the standard’s significance, design considerations, testing methodologies, and its impact on patient safety and product quality
  • Exploration of the standard’s key concepts, design guidelines, and testing protocols
     
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    17:10

    Optimisation of Stopper Position in PFS

    Sanjay Kumar Rout, Senior Manager, Device development and Technology Transfer of Medical device Drug device combination product, Biocon Biologics Ltd

  • Approaches to enable delivery of desired drug volume with appropriate glide force and break loose force
  • Gaining shipping validation for plunger stopper movement
  • Key considerations for autoinjector pen design to enable proper functioning
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    17:40

    Chair's Closing Remarks and Closing of Day Two

    Cinzia Rotella, Project Leader, Sanofi

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    14:00

    Chair's Opening Remarks

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk

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    14:10

    Partnerships and Collaborations in Digital Health

    Alex Russell

    Alex Russell, Digital Health Partnerships, Takeda

  • Examining the relationship between stakeholders- pharma companies and app/software developers
  • What makes a successful digital therapeutic collaboration?
  • How to ensure compliance to regulatory requirements
     
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    14:40

    Reserved Sponsor Session

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    15:10

    Connecting the dots: Focus on connected delivery solutions

    Daanish Ahmed Khan, Director, Novo Nordisk A/S

  • How are we moving from a product mindset to a solution one
  • What does it require to have focus on connected delivery solutions
  • Where is the industry now and where are we headed to?
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    15:40

    Afternoon Tea

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    16:10

    Incorporating Behaviour Design into Connected Devices

    Haydyn  Phillips

    Haydyn Phillips, Director of User Experience, AstraZeneca

  • Applying strategic behavioural research to connected device development
  • Insight into the behaviour design process
  • Leveraging this to better support patients and increase adherence and engagement
     
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    16:40

    Reserved Sponsor Session

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    17:10

    Using Artificial Intelligence to Design an Enhance Injection Device

    Louisa Harvey

    Louisa Harvey, Founder and Principal, Harvey Medical

  • How responsible AI can revolutionize user research.
  • Novel research methodology.
  • Ethical considerations
     
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    17:40

    Chair's Closing Remarks and Closing of Day Two

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk


    Associate Director, Devices and Digital Therapeutics
    AstraZeneca
    Digital Health Partnerships
    Takeda
    Scientific Expert for Devices
    Boehringer Ingelheim
    Principal Device Engineer
    GSK
    Director Human Factors Engineering/User Experience
    Novartis
    DPDD Combination Product Development Engineer Lead
    Pfizer R&D UK Limited
    Device Project Leader
    Novartis
    Chief Commercial Officer
    ApiJect
    Category Manager Parenteral
    Nemera
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Technical Project Leader
    Chiesi Ltd
    Vice President Innovation and Development
    Haselmeier
    Project Leader
    Sanofi
    Global Medical Device Project Leader
    Sanofi
    Global Director, Healthcare
    BSI Group
    P&L Development
    Boehringer Ingelheim
    Director
    Novo Nordisk A/S
    Senior Director, Head of Device Manufacturing Partnerships
    UCB Biopharma sprl
    Head of Primary Container & Safety System Development
    Sanofi
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Chair
    Sustainable Healthcare Coalition
    Senior Global Regulatory Professional
    Novo Nordisk
    Business Development Leader
    Cambridge Design Partnership
    Director of User Experience
    AstraZeneca
    Vice President Regulatory Affairs
    Fresenius Kabi
    Sr. Device Engineer
    CSL Behring AG
    PSL - Procurement Site Lead, Category Buyer Packaging & Devices Manufacturing and Supply
    Sanofi
    Chief Development Officer
    Enterome
    Director
    TUV SUD Japan Ltd.
    Senior Director
    AstraZeneca
    Vice President, Combination Product Quality
    Amgen
    Principle Engineer
    Pfizer Ltd
    Founder and Principal
    Harvey Medical
    Director
    GSK
    Global Change Facilitator
    BioPhorum
    Vice President of Business Development
    Credence MedSystems
    Senior Medical Sector Manager
    DCA Design International
    Senior Medical Sector Manager
    DCA Design International
    Combination & Physical Devices Manager
    Medical Engineering Technologies Ltd
    Head of TakeBack Program
    Novo Nordisk A/S
    Sustainable Solutions Lead
    Owen Mumford Ltd.
    Snr Manager Regulatory Affairs
    Amgen
    Senior Manager, Device development and Technology Transfer of Medical device Drug device combination product
    Biocon Biologics Ltd
    Global Product Stewardship Lead
    Eli Lilly
    Cormica
    Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission
    Medicines and Healthcare products Regulatory Agency (MHRA)
    Combination & Physical Devices Manager
    Medical Engineering Technologies Ltd
    Head of Design & Innovation
    Johnson & Johnson
    Director Global Regulatory Affairs - Device
    Novo Nordisk
    Associate Director
    Janssen Pharmaceutica
    Director New Technology
    Harro Hofliger

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    Sponsors

    Exhibitors

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    5 Minutes with George Moore-Arthur Senior Global Regulatory Professional Novo Nordisk

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    Brochure

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    Sponsorship Prospectus

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    Letter from advisory board

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    Past Presentation: Carsten Worsøe, Novo Nordisk A/S

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    Past Presentation: Abha Raveau-Violette, AstraZeneca

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    Past Presentation: Shannon Clark, Userwise

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    Past Presentation: Petra Renné, Novartis

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    Past Presentation: M. Hemminger, Roche

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    Past Presentation: Ella Kimber, GSK

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    Past Presentation: Dr. Clemens Günther, Bayer AG

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    Past Presentation:Nima Aghaja Sanofi

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    Past Presentation:Cinzia Federico, Novartis

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    Past Presentation: Dr Kim Kristiansen & Dr Troels Keldmann

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    Past Attendee list

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    Sponsors and Exhibitors


    ApiJect™

    Gold Sponsor
    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.



    Harro Höfliger

    Gold Sponsor
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.

    The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production.


    Sponsors


    Cambridge Design Partnership

    Sponsors
    https://www.cambridge-design.com/

    Cambridge Design Partnership is an end-to-end innovation partner. We build breakthrough products and services – from insight to ideas, prototypes to production. Our Drug Delivery sector focus on injection systems including auto injectors, pen injectors, wearable (OBDS) devices and infusion pumps, as well as Digital Health applications including connected drug delivery devices, diagnostics/biomarker devices, app development and cloud services.


    CORMICA LTD

    Sponsors
    https://www.cormica.com/

    Cormica helps medical device manufacturers and pharmaceutical companies globally. Our one-stop-shop offers reliable testing services, including analytical chemistry, microbiology, and packaging testing. With GMP, GLP, ISO17025 certifications, we deliver high-quality testing and excellent customer service. Joined by Wickham Miro and Medical Engineering Technologies.



    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.


    DCA

    Sponsors
    https://www.dca-design.com/

    DCA offer comprehensive design, development and analysis solutions for the medical devices industry.

    Our multidisciplinary team offers an integrated, evidence based service focused on helping our clients achieve success through great product design.

    With a wealth of experience in developing leading injection devices for global markets, DCA’s work includes: variable dose pen injectors, single and multi-fixed dose injectors, disposable and reusable products, autoinjectors, wearable patch injectors, large volume injectors, connected and electro-mechanical devices.

    Our portfolio encompasses mass-market injectors that are manufactured in multi-billions, as well as lower volume devices targeting specific user populations and regional market needs. Alongside device design, we provide comprehensive support for industrialisation/production and create innovative instructions and product packaging solutions.

    Since 2000 our team have created over 1,700 granted patents for our clients. In the last 10 years we have received over 100 major design awards and supported our clients to launch more than 100 new products. We can provide expert support for device strategy, usability, due diligence, connectivity, mechanical engineering, electronics, medical device software, industrial design, UX/UI development, prototyping, industrialisation/production support, packaging and instruction design. We are certified to ISO13485 and work to ISO14971, IEC62304 and IEC62366.



    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence, focus on quality and customers. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 10,000 employees and generates annual sales of more than €1.4 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.


    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.



    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. 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.



    Owen Mumford

    Sponsors
    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/


    Exhibitors


    Althena Medical

    Exhibitors
    http://www.althenamedica.it/

    Althena Medical is an Italian company specialized in the development and production of medical devices in the pharmaceutical field (pre-fillable syringes, oral liquid dispensers, droppers, etc.). In our catalogue we currently have COP pre-fillable syringes in several volumes. We also offer filling service and turn-key products.

    We work for small, medium and big brands for which we have designed, created and produced patented products.

    We differ from our competitors because we are flexible, reliable and we develop medical devices on demand very quickly.

    100% Made in Italy!



    IMA AUTOMATION

    Exhibitors
    https://imautomation.com/

    IMA AUTOMATION is the division of the IMA Group composed of leading companies in the automation and assembly industry, which designs and manufactures advanced technology solutions for handling and assembling parts in different industries. IMA AUTOMATION has a long experience in the medical industry, specifically for the assembly of Drug Delivery devices, Wearables and Diagnostics.

    At PFS 2024 X-PEN will be under the spotlight! Let our experts introduce you to our new technology, the standard modular platform for pen and autoinjector final assembly. With robust latest technologies, labelling as standard, quick time-to-market, compact design, standard machine bases and a fast ROI, our X-PEN systems use state-of-the-art technology: at your fingertips.



    MESA LABS

    Exhibitors
    https://mesalabs.com/

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



    Pharmalink

    Exhibitors
    https://prasfarma.com/

    Prasfarma is a pharmaceutical company with more than 50 years of experience in the manufacturing of pharmaceutical products, specialized in oncology and HPAPI products. Prasfarma manufactures products based on the demand of its customers in a wide range of dosage forms such as PRE-FILLED SYRINGES, LYOPHILISED products, high potency products and also oral solid forms. Both cytostatics and non cytostatics.

    We are located in Barcelona with a manufacturing plant for Medical Devices of 15.000 sq meters, and a manufacturing plant for Drugs of 7.500 sq meters.

    Our facilities are adapted to manufacture pre-filled syringes of drugs (EU-GMP) and pre-filled syringes with Medical Devices (MDR).



    PHC Group

    Exhibitors
    https://www.phchd.com/global/ivd

    The PHC Group provides products and services for diabetes management, life sciences and diagnostics, as well as enhanced healthcare solutions that are used by patients, healthcare professionals and researchers in over 125 countries. By integrating digital solutions with our expertise in precision technology that has been nurtured over decades, we provide the best-in-class devices and services for advancing basic research, diagnosis and medical treatment.


    Syntegon Technology

    Exhibitors
    https://www.syntegon.com/

    Processing and packaging for a better life – this is what Syntegon works for every day. Be it individual machines, systems, or services, with intelligent and sustainable solutions Syntegon helps its customers in the global pharmaceutical and food industries to improve people's lives.

    FLEXIBLE AND SCALABLE SOLUTIONS FOR ASSEMBLY AND LABELING OF MEDTECH DEVICES

    Medical devices such as auto-injectors and pens contribute to beneficial patient outcomes, as they support easy administration and therapy adherence. Before the medication reaches the patients, the devices must be reliably assembled, labeled and packed. This is where the Syntegon solutions come into play: our systems cover the safe assembly, labeling, handling, and secondary packaging of medical devices. Thanks to their modular platform design, our manual, semi and fully automated systems allow for a high level of customization, helping you meet market requirements, while always having patient safety in mind.

    About Syntegon

    Syntegon Technology is a leading global process and packaging technology provider with 6,000 employees and annual sales of 1.3 billion euros. Syntegon Technology helps customers in the pharmaceutical industry to facilitate global access to safe medication. The comprehensive portfolio of intelligent technologies ranges from individual machines to complete lines for all process steps in the development, production, filling, inspection, assembly and packaging of liquid and solid dosage forms. Syntegon Technology supports pharmaceutical companies in project planning, development and implementation as well as with comprehensive digitization, qualification and validation services. In addition, customers have access to a global service network that provides support throughout the entire machine life cycle. The following product brands are included in the portfolio: Hüttlin, Klenzaids, Pharmatec, SBM Schoeller-Bleckmann Medizintechnik and Valicare.


    Media Partners


    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
    http://www.themedicinemaker.com

    The Medicine Maker

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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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