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Wearable Injectors and Connected Devices UK
14 October - 15 October 2024
Wearable Injectors and Connected Devices UK

SAE Media Group's 5th Annual Conference
Wearable Injectors and Connected Devices
14th-15th October, 2024 | London, UK
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SAE Media Group’s 5th Annual Wearable Injectors and Connected Devices Conference will explore on-body device design and development whilst also engaging in the latest advances in connectivity and digital health applications for wearable devices with industry perspectives from big pharma representatives. The conference will consider key developments in the wearable injectors field, including the enhanced demand for on-body injectors and digitalised health as the need for at home self-administration and routes for delivery of time-dependent, high volume and viscous drugs grow.

The conference will also cover key regulatory updates such as guidance on MDR requirements from regulatory and notified bodies, and the importance of considering user-experience and developing patient-centric devices. The two-day conference will bring you high-quality insights and industry connections on the latest advances in wearable injectors and connectivity, and a platform for exchanging ideas.
 

Why to attend:

  • 2 full days of networking opportunities.
  • 16+ sessions with 75% of speakers from big pharma companies.
  • An agenda designed for professionals within the injectables space, focused on the development, implementation and application of wearable injectors and connected devices.
  • The only conference discussing wearable injectors and connected devices together, other than our USA version of this event.

The Experience:

  • A collaborative environment for pharma, biotech and device developers to discuss the latest trends and challenges within the wearable injectors and connected device market.
  • Learn from key industry players about new technologies, strategies and processes for the development of wearable injectors.
  • Gain insights into the regulatory processes for the approval of wearable injectors and develop a greater understanding of how-to bring devices to market.
  • Create a dialogue with industry leaders and develop a network with the key stakeholders in the market.
  • Delve into the world of digital health for the healthcare sector and discuss implementation of connectivity with on-body drug delivery systems.
  • Examine the importance of usability for at home injectors, and what is needed to make a device appropriate for patient administration.

 

Who should attend:

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

  • Device Development
  • Smart Devices
  • Digital Health and Connectivity
  • Connected Devices
  • Device Engineering
  • Drug Delivery
  • Formulation for Wearables
  • Combination Product Development
  • On Body Device Development
  • Large Volume Drug Delivery
  • Regulatory Affairs
  • Medical Devices

Our Wearable Injectors and Connected Devices Conference is the only event that delves into the world of connectivity and digital healthcare through the lens of wearable drug delivery devices. Over two days, executives and leaders within the pharmaceutical industry come together to discuss and collaborate on the unique challenges that face this space. This event provides an intimate environment to network with peers and experts across the industry and learn from each other’s experiences, and to meet with solutions providers who are working hard to supplement the ever-changing industry.

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

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9:10

Streamlining Drug/Device Combination Product Development Collaboration

Esther Grandal Delgado

Esther Grandal Delgado, Senior Regulatory Affairs Devices, Novo Nordisk

  • Designing a device to use with a drug versus designing a drug with a device inside? Bespoke vs platform devices.
  • Large volume/high concentration drug deliveries. Considerations when making the switch from IV to subcutaneous administration.
  • Communications between drug R&D and device R&D – how do separate teams communicate and collaborate to streamline device development.
  • How has the industry progressed in making the switch from IV to subcutaneous injections
     
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    9:50

    Accelerating Progress for Large Volume Wearable Injectors

    Julian Dixon, Former Senior Director, Human Factors, AstraZeneca

  • Only two wearable injectors have made it to market over years of conversation and innovation - what is holding companies back, and what can we do to overcome this?
  • What lessons can we learn from successful devices on the market?
  • What challenges can we anticipate as the market continues to grow?
  • The importance of the story we tell alongside our technology
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    10:30

    Morning Coffee

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    11:00

    Hitting the Sweet Spot: What Trade-Offs Need To Be Made For Wearable Injectors?

  • Sustainability – mechanical vs electronics, single use vs reusable, ‘real’ vs ‘perceived’ sustainability? 
  • Recyclability – should future devices be designed with recycling in mind?
  • Where is connectivity useful and where is it creating more problems than it solves? How do we decide the line between smart and overly complicated? 
  • Usability – What does the patient want / need to ensure compliance? What is the optimum frequency of injections without being a burden but so the patient remembers how and when to take their medication?
     
  • Charles  Potter

    Charles Potter, Technical Project Leader, Chiesi Ltd

    Julian Dixon, Former Senior Director, Human Factors, AstraZeneca

    Soren Skov

    Soren Skov, Senior Human Factors Engineer, Roche

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    11:40

    CCI Compliance Challenges After (Recent) Regulatory Updates

    Christian Proff, Senior Verification Engineer, Roche

  • USP<1207> and EU Annex 1
  • Expectations for pharmaceutical packaging development and lifecycle management
  • Details available from thorough packaging development which supports compliance to regulatory requirements
  • Typical examples we will shed light on selected aspects of individual packaging solutions
     
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    12:20

    Networking Lunch

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    13:20

    The Regulatory Challenge: Fireside Chat with Blake Green

    Blake  Green

    Blake Green, Director Regulatory Affairs, Amgen

  • What regulatory strategies should we be employing during device development to streamline submissions?
  • Understanding the structure of approval bodies and navigating uncertainties throughout the device approval process.
  • Strategies for collecting useful data and evidence during the device development process.
  • Managing conflicting requirements of global regulatory agencies and industry news for harmonisation.
     
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    14:00

    Sustainability Considerations For On Body Drug Delivery Devices

    Marion Briggs

    Marion Briggs, Circularity Solutions, Johnson & Johnson

  • Single use versus reusable injectable devices: pros and cons?
  • Regulatory hurdles for reusing plastic waste from devices
  • Creating an eco-friendly injector while maintaining sterility and safety for patient use
  • Electronic waste versus plastic waste 
  • Closing a loop on circular economy – design for disassembly so we can recover these materials
  • Device cost considerations to ensure a device is feasible at market level.
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    14:40

    Afternoon Tea

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    15:10

    Notified Body Opinion Considerations For Post-Authorization Changes

    Berna Kosekaya, Regulatory Professional, Novo Nordisk

  • What constitutes a non-substantial change?
  • What is the threshold for requiring an updated Notified Body Opinion?
  • What are the main challenges?
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    15:50

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

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    9:10

    Fireside Chat: Emerging Technologies for Health Data and AI for Connected Devices

    Fausto Artico

    Fausto Artico, Former Global Head of Innovation, GSK

  • Understanding difficulties and challenges in the healthcare sector
  • Discuss how Emerging Technologies can help you and your teams
  • Utilising connectivity for at home devices to improve adherence and safety
  • Discussing the sensitive nature of health data, and how to manage it securely
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    9:50

    The Value of Digital Healthcare for Drug Delivery Devices

    Scott Ewan

    Scott Ewan, MediPhorum - Program Manager, Biophorum

  • What benefits can be gained from digital? For the patients, the payers and the industry.
  • Clarifying the meaning of value in the drug delivery space
  • Overcoming challenges of digital healthcare within the medical device space
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    10:30

    Morning Coffee

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    11:00

    Utilising Connectivity and Digital Health to Develop a Patient Friendly Device

    Soren Skov

    Soren Skov, Senior Human Factors Engineer, Roche

  • Behaviour design and digital health – how to maximise usability when designing connected devices?
  • Patient preferences beyond usability.
  • How do we smoothly integrate technology with injectable drug delivery systems?
  • Patient considerations when developing connected devices, from usability to access systems.
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    11:40

    Medical Devices & MDR Article 117

    Senior Representative

    Senior Representative, , TUV SUD Limited

  • MDR latest state of play and what happens next
  • Additional Regulations & Directives in the EU affecting your device & development
  • Security for connected devices
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    12:20

    Networking Lunch

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    13:20

    The Future of SaMD and Digital Health For Drug Delivery Devices

    Senior Representative

    Senior Representative, , BioPhorum

  • What are the unique challenges with bringing SaMD and digital health products to market? 
  • How do we smoothly integrate technology with injectable drug delivery systems?
  • Patient considerations when developing connected devices, from usability to access system
  • clock

    14:00

    Empirical And Digital Tools For Plunger Stoppers Characterization

    Cinzia Rotella

    Cinzia Rotella, Project Leader, Sanofi

  • The presentation describes the approach used to characterize and discriminate different plunger stoppers
  • The characterization was performed by using empirical tests – standards & ad-hoc methods – and model digital twins
  • The approach was used to build a guideline for stopper selection inside Sanofi
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    14:40

    Afternoon Tea

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    15:10

    Panel: More Than A Concept – Bringing Wearable Injectors To The Market

  • Overcoming regulatory hurdles for large volume injectors
  • Recognising the unique challenges for wearables, from human factors to health data safety
  • Developing a gold standard for clinical trials and evidence-based approval submissions
  • Working together as an industry to create an environment that nurtures innovation
     
  • Andrew Chapman

    Andrew Chapman, Senior Director, AstraZeneca

    Berna Kosekaya, Regulatory Professional, Novo Nordisk

    Blake  Green

    Blake Green, Director Regulatory Affairs, Amgen

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    16:00

    Chairman’s Closing Remarks and Close of Day Two

    Official Media Partner

    VENUE

    Hilton London Kensington

    179-199 Holland Park Avenue, London, United Kingdom

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”

    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.
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    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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    Hilton London Kensington

    179-199 Holland Park Avenue
    London W11 4UL
    United Kingdom

    Hilton London Kensington

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”
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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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    UK Office
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    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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