Home
overview

SAE Media Group’s 16th Annual Conference
Pre-Filled Syringes and Injectable Drug Devices Europe
January 9 - 11 2024 | London, UK
-------------------------------------------------------------------------

SAE Media Group's 16th Annual Pre-Filled Syringes and Injectable Drug Devices Conference will return to London in January 2024 to unite leaders from the industry and bring you the latest advances in the combination product drug delivery space.
 

Year on year, the field of injectable drug delivery has witnessed remarkable progress, marked by advancements in device technology, including smart devices and those designed for large volume drug administration. There has been a shift towards enhancing the patient experience through innovative device design. Moreover, the industry is now moving towards a circular approach for environmental sustainability, incorporating it into device manufacturing and design, as well as device usage. The upcoming conference aims to tackle pressing industry challenges by exploring them through real-world case studies and valuable insights while also considering opportunities for the future.

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!
 

  • 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
  •  

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; GlaxoSmithKline; GSK; Hoffmann-La Roche; Horizon Therapeutics GmbH; 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

clock

8:00

Registration & Coffee

clock

8:50

Chair's Opening Remarks

Mitali Aon

Mitali Aon, Associate Vice President, Device Development-Quality Operations , Sanofi Pharmaceuticals

clock

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
  • clock

    9:30

    Design Controls for Combination Products

    Torsten Kneuss

    Torsten Kneuss, Quality Product Medical Devices / Head of Project Office Medical Devices, Bayer Pharma

  • Application of design controls to combination products
  • A global perspective
  • Introduction to design controls for combination products
  • Challenges with design controls for combination products

     

  • clock

    10:00

    Session Reserved for Lead Sponsor

    clock

    10:30

    Morning Coffee

    clock

    11:00

    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
     
  • clock

    11:30

    Session Reserved for Sponsor

    clock

    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

    Khaudeja Bano, Vice President, Combination Product Quality, Amgen

    Mitali Aon

    Mitali Aon, Associate Vice President, Device Development-Quality Operations , Sanofi Pharmaceuticals

    Joel Richard

    Joel Richard, Chief Development Officer, Enterome

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

    clock

    12:30

    Networking Lunch

    clock

    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
     
  • clock

    14:00

    Session Reserved for Sponsor

    clock

    14:30

    Collaboration for a Strategic Combination Product Development

    Jussi Haikarainen

    Jussi Haikarainen, Senior Principal Device Engineer, AbbVie

  • Considerations for a collaborative development process across teams
  • Patient centric design approaches to support a strong and diverse product pipeline
  • Importance of teams being aligned and results from strategic collaboration 
  • clock

    15:00

    Afternoon Tea

    clock

    15:30

    Session Reserved for Sponsor

    clock

    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?
  • clock

    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
     
  • clock

    17:00

    Chair's Closing Remarks and Closing of Focus Day

    Mitali Aon

    Mitali Aon, Associate Vice President, Device Development-Quality Operations , Sanofi Pharmaceuticals

    clock

    7:45

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

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

    clock

    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
     
  • clock

    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, 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

    clock

    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
     
  • clock

    10:00

    Session Reserved for Gold Sponsor Harro Höfliger

    clock

    10:30

    Morning Coffee

    clock

    11:00

    Be prepared! Combination products under MDR (article 117)

    Heinrich Martens

    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
     
  • clock

    11:30

    Reserved Sponsor Session

    clock

    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
     
  • clock

    12:30

    Reserved Sponsor Session

    clock

    13:00

    Networking Lunch

    clock

    14:00

    Chair's Opening Remarks

    Claus Geiger, Global Medical Device Project Leader, Sanofi

    clock

    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?
  • clock

    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
  • clock

    15:10

    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
     
  • clock

    15:40

    Afternoon Tea

    clock

    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
     
  • clock

    16:40

    Session Reserved for Gerresheimer

    clock

    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
  • clock

    17:40

    Chair's Closing Remarks and Close of Day One

    Claus Geiger, Global Medical Device Project Leader, Sanofi

    clock

    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)

    clock

    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
     
  • clock

    14:40

    Session Reserved for Haselmeier

    clock

    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
     
  • clock

    15:40

    Afternoon Tea

    clock

    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
  • clock

    16:40

    Session Reserved for DCA Design

    clock

    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
     
  • clock

    17:40

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

  • 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
  • clock

    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)

    clock

    7:45

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

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

    clock

    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
     
  • clock

    9:00

    Trends in Regulations of Digtial Health Technologies

    Speaker to Be Confirmed

    Speaker to Be Confirmed, , 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
     
  • clock

    9:30

    Considerations in paediatric injections

    Tiffany McIntire

    Tiffany McIntire, Principal Human Factors Engineer, Roche

  • 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
  • clock

    10:00

    Reserved Sponsor Session

    clock

    10:30

    Morning Coffee

    clock

    11:00

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

    Cristiana Heese

    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
     
  • clock

    11:30

    Reserved Sponsor Session

    clock

    12:00

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

    Marc Moal, Corporate Programme Vice President, Devices & Delivery Solutions, Novo Nordisk

    Charles  Potter

    Charles Potter, Technical Project Leader, Chiesi Ltd

    Cristiana Heese

    Cristiana Heese, P&L Development, Boehringer Ingelheim

    clock

    12:30

    Reserved Sponsor Session

    clock

    13:00

    Networking Lunch

    clock

    16:20

    Topic Heading 8

    clock

    14:00

    Chair's Opening Remarks

    Cinzia Rotella, Project Leader, Sanofi

    clock

    14:10

    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
  • clock

    14:40

    Session Reserved for Credence MedSystems

    clock

    15:10

    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
     
  • clock

    15:40

    Afternoon Tea

    clock

    16:10

    Piston Placement in Prefilled 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 influencing piston position in the drug product manufacturing process
  • Optimising the process development approach can reduce lead times into manufacturing
     
  • clock

    16:40

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

    Speaker To Be Confirmed

    Speaker To Be Confirmed, , Cormica

  • 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
     
  • clock

    17:10

    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.


     

  • clock

    17:40

    Chair's Closing Remarks and Closing of Day Two

    Cinzia Rotella, Project Leader, Sanofi

    clock

    14:00

    Chair's Opening Remarks

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Director, Novo Nordisk

    clock

    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
     
  • clock

    14:40

    Reserved Sponsor Session

    clock

    15:10

    Regulatory challenges in PFS when integrating digital technologies

    Vikas Jaitely

    Vikas Jaitely , Head Digital Health and Devices, Regulatory CMC and Devices, Merck

  • Regulatory frameworks for pre-filled syringes
  • Integrating connected technologies
  • The current global regulatory environment
  • Challenges for a connected platform
     
  • clock

    15:40

    Afternoon Tea

    clock

    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
     
  • clock

    16:40

    Reserved Sponsor Session

    clock

    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
     
  • clock

    17:40

    Chair's Closing Remarks and Closing of Day Two

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Director, Novo Nordisk


    Associate Director, Devices and Digital Therapeutics
    AstraZeneca
    Digital Health Partnerships
    Takeda
    Principal Device Engineer
    GSK
    DPDD Combination Product Development Engineer Lead
    Pfizer R&D UK Limited
    Device Project Leader
    Novartis
    Director
    Novo Nordisk
    Category Manager Parenteral
    Nemera
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Technical Project Leader
    Chiesi Ltd
    Project Leader
    Sanofi
    Global Medical Device Project Leader
    Sanofi
    Global Director, Healthcare
    BSI Group
    P&L Development
    Boehringer Ingelheim
    Senior Director, Head of Device Manufacturing Partnerships
    UCB Biopharma sprl
    Microbiologist
    FDA
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Chair
    Sustainable Healthcare Coalition
    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
    Senior Principal Device Engineer
    AbbVie
    Vice President, Combination Product Quality
    Amgen
    Founder and Principal
    Harvey Medical
    Director
    GSK
    Corporate Programme Vice President, Devices & Delivery Solutions
    Novo Nordisk
    Associate Vice President, Device Development-Quality Operations
    Sanofi Pharmaceuticals
    Head of TakeBack Program
    Novo Nordisk A/S
    Sustainable Solutions Lead, Owen Mumford
    Owen Mumford Ltd.
    Snr Manager Regulatory Affairs
    Amgen
    Global Product Stewardship Lead
    Eli Lilly
    Novo Nordisk
    Cormica
    Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission
    Medicines and Healthcare products Regulatory Agency (MHRA)
    Director Global Regulatory Affairs - Device
    Novo Nordisk
    Principal Human Factors Engineer
    Roche
    Associate Director
    Janssen Pharmaceutica
    Quality Product Medical Devices / Head of Project Office Medical Devices
    Bayer Pharma
    Head Digital Health and Devices, Regulatory CMC and Devices
    Merck

    Gold Sponsor

    Sponsors

    Exhibitors

    VENUE

    Leonardo Royal Hotel London Tower Bridge

    45 Prescot Street, London, United Kingdom

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

    Sponsors and Exhibitors


    Harro Höfliger

    Gold Sponsor
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical, medical device applications and consumer products. Our core expertise with innovative machine platforms is in packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology. The portfolio of upscalable test machines and modules, as well as technology platforms to meet your precise requirements, comes from many years of experience in targeted research and development. Therefore, Harro Höfliger covers all phases of your project from the laboratory to high efficiency production

    Sponsors


    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. We are passionate about delivering world-class drug delivery devices.

    Our ISO13485 certified services include research and strategy, mechanical engineering, usability, industrial design, electronics, medical device software to IEC62304, systems engineering, UX/UI development and prototyping.



    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


    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.

    SAVE TO


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

    Leonardo Royal Hotel London Tower Bridge

    45 Prescot Street
    London E1 8GP
    United Kingdom

    Leonardo Royal Hotel London Tower Bridge

    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