Home
overview

SAE Media Group’s 5th Annual Conference
Injectable Drug Delivery
10 - 11 May, 2023 |
-------------------------------------------------------------------------
As Part of Europe’s leading Injectable conference series, the 5th annual Injectable Drug Delivery conference will assess innovations in drug product formulation and biologics, new technologies in device design, along with the latest regulatory considerations for optimal drug delivery.

With increasing demand for vaccines, insulin, and many other modern medicines administered via the injectable route, there is significant growth projected in the biologics market, particularly the injectable drug delivery and prefilled syringe market which is expected to rise at a compound annual growth rate of 12.9% reaching £915 billion by 2027. It is due to this rising demand and increased growth that the industry must come together to discuss and critically evaluate the next generation of injectable drug delivery.

At this year’s event we will highlight the most recent innovations within the industry, with regard to injectable device design and the formulation challenges of long-lasting, highly viscous and high-volume drug delivery. In silico modelling will be addressed as we continue to see a move towards AI utilisation, alongside key CMC concerns and usability of injectable devices in digital health. The conference will also highlight the significance of sustainability within the industry, whilst providing regulatory insight on the changes that have occurred and are forecast in the coming years.
 

  • Explore the latest trends within the Injectable drug delivery field, with new insights into in-silico modelling
  • Expand on current knowledge of device design, with special considerations for primary and secondary packaging
  • Examine injectable drug formulation strategies, including novel formulation methodologies
  • Learn how to advance the injectable drug delivery landscape through a review of current regulatory compliance
  • Realise how Chemical Manufacturing and Control can further expand the industry through digitalisation strategies

 

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:
• Autoinjectors
• Wearables
• Device Engineering
• Human Factors
• CMC
• Injectables
• Sterile Manufacturing
• Packaging
• Regulatory Affairs
 

Previous Attendees Include:

Advanz Pharma; AstraZeneca; Bayer AG; Boehringer Ingelheim GmbH; Boehringer Ingelheim Pharma AG; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI Group; Chiesi Ltd; EVEON; Gerresheimer; GlaxoSmithKline; GSK; IPSEN Pharmsciences; Janssen Pharmaceutical Companies; MedinCell; MHRA; Midas Pharma Gmbh; Midatech Pharma; Novartis; Owen Mumford Ltd; PDM solutions; Pfizer; PHC Corporation; Sabic; SI02 Medical Products ; Stevanato Group S.P.A.; Stewart Urquhart consulting Ltd; Sustainable Healthcare Coalition; Team Consulting Limited; Telstar; Teva; TUV SUD Japan Ltd.; Tyndall National Institute; University of Southern Denmark; Vetter Pharma International GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; Victrex Plc; Viridian Therapeutics;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

Tiffany McIntire

Tiffany McIntire, Principal Human Factors Engineer, Roche
View Bio

Thomas Wejs Moeller

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

9:10 Streamlining injectable product development through correct CMC practices and regulatory governance

Louise Place

Louise Place, Director, Devices Global CMC Regulatory Affairs, GSK
View Bio

  • Key considerations for injectable drug product strategies from pre-NME to post-NDA/MAA approval, including Life Cycle Management (LCM)
  • A review of current European regulatory guidance for drug delivery devices and lessons from MDR implementation
  • Strengthening device optimisation with a review of article 117 and available EMA guidance
  • Future labelling requirements and next steps in regulatory guidance for injectable devices
  • 9:50 Pairing physical testing with FEA to investigate and prevent glass cartridges cracking in injectable

    Jonny Waller

    Jonny Waller, Senior Mechanical Engineer, Kinnier Dufort
    View Bio

  • An example of how to get the best from physical testing and FE analysis by understanding the limitations of each
  • An investigation into an injection pen showing glass cartridge cracking issues during drop tests
  • Physical drop testing, involving the use of high-speed photography to investigate and categorise failures
  • FEA simulations to look inside the device throughout the impact
  • Deciding when to use physical tests vs FEA

     

  • 10:30 Morning Coffee

    11:00 An update on insights into the EU MDR from a Notified Body Expert Perspecitve

    Julia Frese

    Julia Frese, Director, TUV SUD Japan Ltd.
    View Bio

  • A review of the industry landscape following MDR implementation and key notified body considerations
  • Lessons in the development of strategic partnerships between the injectable drug industry and the relevant Notified Bodies
  • Assessing the most recent challenges associated with working alongside the EU MDR and ways to overcome them
  • Exploring future directions for the industry, what additional guidance is required for the injectable regulatory landscape
  • 11:40 Regulatory considerations and opportunities for next generation injectables made with high performance materials

  • Market trends and opportunities impacting the design of autoinjector and wearable devices
  • Update on regulatory considerations for selecting pharmaceutical-grade high performance polymers

     

     

  • Caroline Prisk

    Caroline Prisk, Head of Regulatory Affairs & Product Stewardship, Victrex Plc
    View Bio

    Yann Treguier

    Yann Treguier, Drug Delivery Global Segment Leader, Victrex Plc
    View Bio

    12:10 Networking Lunch

    13:10 Challenges and mitigation for the development of low concentration Drug Products for highly potent immunotherapy molecules

    Naila El Kechai

    Naila El Kechai, Section Head, Sanofi

  • Protein adsorption characterization tools
  • Overcoming adsorption challenge to ensure concentration consistency during DP manufacturing process
  • Ensuring safety and dose accuracy during preparation and clinical administration
     
  • 13:50 Designing a differentiating injectable device through qualitative research

    Alper Hulusi

    Alper Hulusi, Head of Medical Devices Market Insights, Harvey Medical
    View Bio

  • Conducting research outside of the viewing facility – the value of in-home interviews
  • Being mindful not to inhibit your device design, from the outset, when choosing a primary drug container
  • Enhancing the out of the box experience
  • Utilising focus groups and exploratory interviews
  • Including the right participants in your study by using novel technology during screening
     
  • 14:30 Addressing challenges Cell & gene therapy injectable delivery

    Annie Zavadil

    Annie Zavadil, Device Project Leader, Novartis

  • On overview of the cell and gene therapy injectable landscape
  • A review of current challenges in the administration of cell and gene therapy formulations
  • Exploring novel injectable device technologies as potential delivery options in cell and gene therapies
  • Discussing future development strategies for cell and gene therapy delivery
  • 15:10 Afternoon Tea

    15:40 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
  • 16:20 Injectable Drug Delivery under Article 117 of the MDR

    Arabe Ahmed

    Arabe Ahmed, Medicinal Technical Specialist, BSI
    View Bio

     Injectable Drug Delivery under Article 117 of the MDR

  • Overview of the regulatory requirements in relation to Article 117; Definitions, applicability and requirements
  • Technical Documentation Requirements for Article 117 submissions
  • Exploring evidence and fulfilment of the General Safety and Performance Requirements (GSPRs)
     
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 From regulator to regulated – working under combination product regulation

    Thomas Wejs Moeller

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

  • 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
  • 9:50 Global Regulatory Strategy for Combination Product Licensing

    Blake  Green

    Blake Green, Director Regulatory Affairs, Amgen Ltd
    View Bio

  • Exploring planning Input strategies for injectable devices
  • Global licensing application models
  • Shared vs country-specifi c documentation
  • Challenges to global harmonisation
  • 10:30 Morning Coffee

    11:00 E Health and IoMT Digital Health

    Carlos Perez Ruiz

    Carlos Perez Ruiz, Global Digital & Connected Product Certification Director, BSI Group

  • IoMT enabled connected healthcare ecosystem
  • Digital health industry challenges
  • Outlining a framework to allow certain trusted data from consumer wearables to be used by SaMD through a process that is safe, secure and compliant
     
  •  

    11:40 Considerations in pediatric injections

    Tiffany McIntire

    Tiffany McIntire, Principal Human Factors Engineer, Roche
    View Bio

  •  Aspects of use to consider
  • Relevant disease states
  • The Patient journey and the transition of responsibility
  •  Evolving ISO standard(s) and FDA expectations in human factors testing
  • 12:20 Networking Lunch

    13:20 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
    View Bio

  • Assessing the EU MDR requirements on device risk management process
  • Impact on usability engineering and human factors
  • Benefi t -risk assessment of drug-device combination products
  • 14:00 Panel Discussion: How to improve patient centricity of drug-device combination

  • How to reach a stage where the voices of both patients and researchers are equally represented during the drug development process
  • Discuss strategies to accelerate clinical development and trials, patient recruitment and retention through successful patient involvement
  • Addressing how the digital healthcare provides opportunities to address and to improve patient centricity.
  • Delving into global landscape changes.
  • Fatima Bennai-Sanfourche

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

    Tiffany McIntire

    Tiffany McIntire, Principal Human Factors Engineer, Roche
    View Bio

    Mark Milton-Edwards

    Mark Milton-Edwards, Head of Health Solutions, Teva UK Ltd
    View Bio

    Julia Frese

    Julia Frese, Director, TUV SUD Japan Ltd.
    View Bio

    14:40 Afternoon Tea

    15:10 Digital inhaler Case Study – and lessons from Aircraft Crashes!

    Mark Milton-Edwards

    Mark Milton-Edwards, Head of Health Solutions, Teva UK Ltd
    View Bio

  • Healthcare Lessons can be learnt from outside Healthcare
  • Real-World User Design and enduring needs must be clearly defi ned
  • Machine Learning & Prospective Research can be used to predict attacks
  • 15:50 Maximising pharmaceutical development of novel injectable delivery technologies through sustainable approaches

    Cedric Gysel

    Cedric Gysel, Health Care Solutions Manager, Johnson & Johnson
    View Bio

  • 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
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    Head of Medical Devices Market Insights
    Harvey Medical
    Device Project Leader
    Novartis
    Medicinal Technical Specialist
    BSI
    Director Regulatory Affairs
    Amgen Ltd
    Global Digital & Connected Product Certification Director
    BSI Group
    Senior Engineer
    AstraZeneca
    Head of Regulatory Affairs & Product Stewardship
    Victrex Plc
    Head of Regulatory Affairs
    Victrex Plc
    Health Care Solutions Manager
    Johnson & Johnson
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Senior Mechanical Engineer
    Kinnier Dufort
    Director
    TUV SUD Japan Ltd.
    Director, Devices Global CMC Regulatory Affairs
    GSK
    Head of Health Solutions
    Teva UK Ltd
    Section Head
    Sanofi
    Director Global Regulatory Affairs - Device
    Novo Nordisk
    Principal Human Factors Engineer
    Roche
    Drug Delivery Global Segment Leader
    Victrex Plc

    Sponsors

    Exhibitors

    Official Media Partner

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Past Attendee List

    Download

    Sponsors


    Kinneir Dufort

    Sponsors
    http://www.kinneirdufort.com

    KD is a world-leading device development consultancy focusing on designing a better world and creating value through tomorrow’s delivery systems and experiences. Combining expertise in design, engineering and user-experience, KD support progressive and ambitious companies to deliver successful new devices and improved patient adherence to a global market. Our +45 years’ experience across the entire development process helps our clients address new challenges and opportunities, deliver on business outcomes, and create enjoyable user experiences that drive demand.


    Victrex

    Sponsors
    http://www.victrex.com

    Victrex is an innovative world leader in high performance polymer solutions, focused on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications which contain our sustainable materials – from smartphones, aeroplanes and cars to oil and gas operations and medical devices. With over 40 years’ experience, we develop world leading solutions in PEEK and PAEK based polymers, semi-finished and finished parts which shape future performance for our customers and our markets, provide environmental and societal benefits, and drive value for our shareholders. Find out more at www.victrex.com

    Exhibitors


    Credence MedSystems

    Exhibitors
    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.


    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.

    Media Partners


    Pharma network magazine

    Official Media Partner
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    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.

    SAVE TO


    Outlook Calendar  OUTLOOK CALENDAR
    Google Calendar  GOOGLE CALENDAR
    ICal Calendar  ICAL CALENDAR
    Yahoo! Calendar  YAHOO! CALENDAR

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out