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Wearable Injectors And Connected Devices 2023
9 October - 10 October 2023
Wearable Injectors And Connected Devices 2023

SAE Media Group's 4th Annual Conference
Wearable Injectors and Connected Devices
9th-10th October, 2023 | London, UK

SAE Media Group’s 4th 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.
 

FEATURED SPEAKERS

Andrew Chapman

Andrew Chapman

Senior Director, AstraZeneca
Caroline  Zakrzewski

Caroline Zakrzewski

Senior Engineer, AstraZeneca
Cedric Gysel

Cedric Gysel

Manager Health Care Solutions Design, Johnson & Johnson
Fatima Bennai-Sanfourche

Fatima Bennai-Sanfourche

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
Ian Wallace

Ian Wallace

Connected Health, Lead Systems Engineer, Novartis
Jacqueline Schendel

Jacqueline Schendel

Head of Laboratory, Boehringer Ingelheim
Julian Dixon

Julian Dixon

Senior Director, Biopharmaceutical Development - Human Factors, AstraZeneca
Marie Picci

Marie Picci

Delivery Systems Strategy Director, Device Development & LCM, Novartis
Mark Milton-Edwards

Mark Milton-Edwards

Head of Health Solutions, Teva Pharmaceuticals
Min Wei

Min Wei

Senior Director, AstraZeneca
Paula Antunes

Paula Antunes

Global Regulatory Lead, Novo Nordisk
Richard Crowther

Richard Crowther

Snr Manager Regulatory Affairs, Amgen
Sabine Kattenbeck

Sabine Kattenbeck

Head of Device Project Management, Boehringer Ingelheim Pharma GmbH & Co. KG
Simon Wilson

Simon Wilson

Device Development Lead, Pfizer
Soren Skov

Soren Skov

Senior Human Factors Engineer, Roche
Thomas Wejs Moeller

Thomas Wejs Moeller

Director Global Regulatory Affairs - Device, Novo Nordisk

Andrew Chapman

Senior Director, AstraZeneca
Andrew Chapman

Caroline Zakrzewski

Senior Engineer, AstraZeneca
Caroline  Zakrzewski

Cedric Gysel

Manager Health Care Solutions Design, Johnson & Johnson
Cedric Gysel

Eleanor Kimber

Principal Device Engineer , GlaxoSmithKline
Eleanor Kimber

Fatima Bennai-Sanfourche

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

Graeme Davies

DEVICE TECHNOLOGY LEAD, Boehringer Ingelheim
Graeme Davies

Ian Wallace

Connected Health, Lead Systems Engineer, Novartis
Ian Wallace

Ingo Herbert Waschulewski

Business Development, Gerresheimer AG
Ingo Herbert Waschulewski

Jacqueline Schendel

Head of Laboratory, Boehringer Ingelheim
Jacqueline Schendel

Julian Dixon

Senior Director, Biopharmaceutical Development - Human Factors, AstraZeneca
Julian Dixon

Marie Picci

Delivery Systems Strategy Director, Device Development & LCM, Novartis
Marie Picci

Mark Milton-Edwards

Head of Health Solutions, Teva Pharmaceuticals
Mark Milton-Edwards

Min Wei

Senior Director, AstraZeneca
Min Wei

Paula Antunes

Global Regulatory Lead, Novo Nordisk
Paula Antunes

My name is Paula, and I am an experienced engineer with a passion for innovation, design, and making a positive impact on people's lives.
With 10 years of experience in the medical device, IVD, and digital health industry, I am an accomplished regulatory affairs expert with a deep understanding of global regulatory requirements. I have developed and executed regulatory strategies for a variety of products across different regions, including the EU, China, US, Japan, and Brazil, ensuring compliance and market access globally.
My extensive experience in connected devices has given me a keen understanding of the unique challenges faced by these technologies, specially cybersecurity and interoperability considerations.
I am currently a Global Regulatory Lead at Novo Nordisk, working closely with my team to support product launches in the digital health domain worldwide. I hold a Master's degree in Biomedical Engineering.
 

Richard Crowther

Snr Manager Regulatory Affairs, Amgen
Richard Crowther

Sabine Kattenbeck

Head of Device Project Management, Boehringer Ingelheim Pharma GmbH & Co. KG
Sabine Kattenbeck

Simon Wilson

Device Development Lead, Pfizer
Simon Wilson

Soren Skov

Senior Human Factors Engineer, Roche
Soren Skov

Soroosh Bagheriasl

Global Project Leader Facilitator, BioPhorum
Soroosh Bagheriasl

Thomas Wejs Moeller

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

sponsors

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

Towards a Patient-Centric Device Portfolio

Julian Dixon

Julian Dixon, Senior Director, Biopharmaceutical Development - Human Factors, AstraZeneca

  • Understanding patient diversity – what is it that makes a particular device the best one for each us, individually, on a particular occasion?
  • Art of the possible - are we achieving close to optimal trade-offs within our constraints?
  • Psychological innovation - can we harness storytelling to change the way our users experience our devices?
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    9:50

    A systems perspective on pharmaceutical medical device

    Ian Wallace

    Ian Wallace, Connected Health, Lead Systems Engineer, Novartis

  • Systems engineering and design thinking in early stage development
  • The patient is at the center, but who, and where is everyone else?
  • Navigating the dynamic landscape of complex devices in pharma
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    10:30

    Morning Coffee

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    11:00

    Drug Delivery Systems - Patient Preference Study (PPS)

    Marie Picci

    Marie Picci, Delivery Systems Strategy Director, Device Development & LCM, Novartis

  • Implementing IMI PREFER in PPS design
  • Patient Preference Study (PPS) creation and its role in achieving the project objective
  • Case study
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    11:40

    Maximising pharmaceutical development of novel injectable delivery technologies through sustainable approaches

    Cedric Gysel

    Cedric Gysel, Manager Health Care Solutions Design, Johnson & Johnson

  • An introduction to early phase primary packaging requirements of novel devices
  • Exploring drug formulation considerations for device optimisation and strategies to reduce wastage
  • Implementing end of life procedures for device disassembly and correct material disposal
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    12:20

    Networking Lunch

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    13:20

    PATIENT-CENTRIC DESIGN FOR A SUSTAINABLE, CONNECTED DRUG DELIVERY DEVICE FOR BIOPHARMACEUTICAL DRUGS

    Ingo Herbert Waschulewski

    Ingo Herbert Waschulewski, Business Development, Gerresheimer AG

    Designing an on-body drug delivery device to respond to the growth of biopharmaceuticals and the associated challenges of high viscosity, sensitive molecules, and large volumes. The importance of incorporating “voice of patient” when developing devices for subcutaneous self-administration that support patient life quality. Enhancing a device with connectivity and how this can contribute to patient adherence and monitoring. Incorporating a sustainable approach in device design that also reduces costs through the value chain.
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    14:00

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

    Richard Crowther

    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 infl uencing piston position in the drug product manufacturing process
  • Optimising the process development approach can reduce lead times into manufacturing change session to: Piston Placement in Prefi lled Cartridges – The Journey is more important than the destination
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    14:40

    Afternoon Tea

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    15:10

    Risk Management for Connected Delivery Devices

    Fatima Bennai-Sanfourche

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

  • Impact on usability engineering and human factors
  • Assessing the EU MDR requirements on device risk management process
  • Benefit - risk assessment of drug-device combination products
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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

    Form regulator to regulated – working under combination product regulation

    Thomas Wejs Moeller

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

  •  As former member of MDCG (authorities) and now heading Novo Nordisk RA devices Thomas will share his experience working with both sides of the EU combination product regulation. Addressing topics like:
  • Challenges with art 117 in the MDR - Notifi ed Bodie Opinions
  • EMA/NB - and approvals vs. opinions 
  • Where to be cognisant of gaps and how to move forward
  • clock

    9:50

    The Importance of a Primary Container Selection Strategy in Combination Product Development

    Caroline  Zakrzewski

    Caroline Zakrzewski, Senior Engineer, AstraZeneca

  •  Standardisation of primary container formats
  • Engagement of manufacturing and device development functions
  • Adaptation for novel presentations
  • Improved sustainability and cost saving
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    10:30

    Morning Coffee

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    11:00

    Breaking down the global market access for digital health and connected devices

    Paula Antunes, Global Regulatory Lead, Novo Nordisk

  • Regulatory categorization across the globe.
  • Current priorities in multiple regions: cybersecurity, interoperability, and AI
  • Global regulatory landscape: how to work with it!
     
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    11:40

    Panel Discussion: How to improve patient centricity of drug-device combination products and maximise value to patients throughout the product lifecycle:

  • Ensuring patient-population specific perspectives are considered throughout the development process
  • The importance of characterising the complete patient journey including the barriers and opportunities
  • Addressing how digital patient support solutions can improve patient centricity and the role of connected devices.
  • Andrew Chapman

    Andrew Chapman, Senior Director, AstraZeneca

    Caroline  Zakrzewski

    Caroline Zakrzewski, Senior Engineer, AstraZeneca

    Thomas Wejs Moeller

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

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    12:20

    Networking Lunch

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    13:20

    Connected Devices: Responding to Patient’s Expectations and Some Simple Rules to Deliver a Great Product.

    Simon Wilson

    Simon Wilson, Device Development Lead, Pfizer

  • Looking at the world in which we now live, do we the pharma industry, need to change to way we interact with our patients?
  • Should we expect them to record their treatment in paper diaries or should we get them to do it on their smart phones? How do we know what they want?
  • Well, we could ask them and then give them what they asked for. We should aim to give them a great experience with their treatment. If possible, this could be more than just an app.
  • Explaining how Swiss Army knives, Dyson air purifiers and trainspotting fit into all of this.
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    14:00

    Afternoon Tea

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    14:30

    Connectivity – in search of patient centric value

  •  Reflection on the history of connectivity at Boehringer Ingelheim
  •  Overview of Autoinjector connectivity options 
  • Introduction to a high level evaluation framework
  •  Obesity case study with a focus on smart labelling
  •  Learnings and Conclusions
  • Sabine Kattenbeck

    Sabine Kattenbeck, Head of Device Project Management, Boehringer Ingelheim Pharma GmbH & Co. KG

    Graeme Davies

    Graeme Davies, DEVICE TECHNOLOGY LEAD, Boehringer Ingelheim

    clock

    15:10

    Digital inhaler Case Study – and lessons from Aircraft Crashes!

    Mark Milton-Edwards

    Mark Milton-Edwards, Head of Health Solutions, Teva Pharmaceuticals

  • Healthcare Lessons can be learnt from outside Healthcare
  • Real-World User Design and enduring needs must be clearly defined
  • Machine Learning & Prospective Research can be used to predict attacks
  • clock

    15:50

    Chairman’s Closing Remarks and Close of Day Two


    Senior Director
    AstraZeneca
    Senior Engineer
    AstraZeneca
    Manager Health Care Solutions Design
    Johnson & Johnson
    Principal Device Engineer
    GlaxoSmithKline
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    DEVICE TECHNOLOGY LEAD
    Boehringer Ingelheim
    Connected Health, Lead Systems Engineer
    Novartis
    Business Development
    Gerresheimer AG
    Head of Laboratory
    Boehringer Ingelheim
    Senior Director, Biopharmaceutical Development - Human Factors
    AstraZeneca
    Delivery Systems Strategy Director, Device Development & LCM
    Novartis
    Head of Health Solutions
    Teva Pharmaceuticals
    Senior Director
    AstraZeneca
    Global Regulatory Lead
    Novo Nordisk
    Snr Manager Regulatory Affairs
    Amgen
    Head of Device Project Management
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Device Development Lead
    Pfizer
    Senior Human Factors Engineer
    Roche
    Global Project Leader Facilitator
    BioPhorum
    Director Global Regulatory Affairs - Device
    Novo Nordisk

    Sponsors

    Exhibitors

    Official Media Partner

    Audience Breakdown

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    2023 Brochure

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    Past Presentation: Min Wei, AstraZeneca

    Download

    Past Presentation: Samir A Shah, AstraZeneca

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    Speaker interview: Ian Wallace, Connected Health, Lead Systems Engineer, Novartis

    Download

    Sponsors


    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is the innovative system and solution provider and global partner for the pharma and biotech industry. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health and cosmetics industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets. With over 11,000 employees, the company generated revenues of around €1.82bn in 2022. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).

    Exhibitors


    Früh Verpackungstechnik AG

    Exhibitors
    https://www.fruh.ch/en/home/

    Früh provides medical and pharmaceutical contract packaging solutions and offers comprehensive services – from cleaning, assembling and packaging under clean room conditions to sterilizing implants.

    With our new modern packaging production, we manufacture under clean room conditions ISO class 7 or 8 flexible and rigid packaging as primary or secondary packaging for medical devices and pharmaceutical products. As experienced packaging engineers for the Pharma and Medical Device technology sectors, we advise you competently and comprehensively.

    You are looking for a packaging solution to protect your valuable product? Or validated and accredited laboratory services? We offer you the complete solution: From the idea of your individual solution to the choice of material and the design of the packaging. As experienced packaging engineers for the Pharma and Medical Device technology sectors, we advise you competently and comprehensively.

    We serve four segments with our range of services and products:

    A) Packaging material production (flexographic printing, lamination, bag production and blister production (ISO 7)

    B) Contract packaging of medical devices (ISO 7)

    C) Contract packaging of pharmaceutical products such as PFS systems (single-use syringes) and vials or ampoules (ISO 7)

    D) Laboratory services



    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


    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.

    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.”
    HOTEL BOOKING FORM

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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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