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SAE Media Group’s 15th Annual Conference
Pre-Filled Syringes and Injectable Drug Devices Europe
January 10 - 12 2023 | All Timings are GMT
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NEW FOR 2023:

Pre-Conference Focus Day: Advances in PFS Design for Enhanced Delivery


Main Conference Afternoon Streams
DAY 1: A) Novel Drug Products and Large Volume Delivery B) Sustainability for Injectable Delivery Devices
DAY 2: A) Primary Packaging Development B) Connected Delivery Devices
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The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to increase patient centricity, aid self-administration and deliver biologics that have large-volumes and novel formulations. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.


SAE Media Group's 15th Annual Pre-Filled Syringes and Injectable Drug Devices Conference will be bigger than ever, with 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:


• Novel Drug Products and Large Volume Delivery
• Sustainability for Injectable Delivery Devices
• Primary Packaging Development
• Connected Drug Delivery Devices


With the injectable drug delivery industry growing exponentially year-to-year, administration using pre-filled syringes, auto-injectors, and pen-injectors are increasingly common. Innovations in device technology, such as smart devices are leading the way in device design in addition to injectable delivery devices for novel and long-acting therapeutics. We are starting to see environmental sustainability being incorporated into aspects of device manufacturing, design and the use of the device. This year’s conference looks to address the hot topics of the injectable drug delivery industry through case studies and industry insights.


This event will not only bring you key insights you need 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 2023.
 

  • Engage with industry representatives 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
  • Explore updates to drug device combination product design approaches considering patient preference at the forefront with case studies from big pharma representatives
  • Understand the latest regulatory requirements from regulatory experts surrounding medical devices and digital health
  • Delve into the considerations for material components for the development of primary packaging
  • Gain insight into how big pharma are incorporating sustainable approaches into drug device design

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 programme

8:00 Registration & Coffee

8:50 Chair's Opening Remarks

Mitali Aon

Mitali Aon, VP and Global Head of Device Development, Sanofi

9:10 Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology

Theresa Scheuble

Theresa Scheuble, Head Enterprise Design & Innovation, Johnson & Johnson
View Bio

  • Historical review of various routes of administration
  • Role of the Patient driving changes in delivery approaches
  • Convergence of Drug Development and Minimally Invasive procedures
  • Examples of Current and Future Technologies
  • 9:30 Quality by Design: Enhancing Safety, Efficacy and Manufacturability of your PFS

    Sebastian Stening

    Sebastian Stening, Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer AG
    View Bio

  • Introduction to the quality by design framework
  • How to maximise product safety and manufacturing efficacies
  • Insight into improving development efficiency and aligning design controls
  • Example Quality by Design Approach
  • 10:00 Reserved Lead Sponsor Session

    10:30 Morning Coffee

    11:00 A blueprint for patient-centric drug delivery device development

    Olaf Lebau

    Olaf Lebau, Device Manager, Boehringer Ingelheim
    View Bio

  • New molecular formats enable a new range of modalities but bring additional requirements for drug delivery
  • A blueprint for a device development process which is independent of disease, drug, and device type
  • Clinical Study Designs with Fast to Clinic Delivery Device Platforms
  • Guide Patient Insights and Customer Centric Design Paradigms into Device Platforms
  • How to aggregate User needs, technical Requirements, Business requirements, Manufacturing Requirements, and development requirements for key decision criteria
  • 11:30 Reserved Sponsor Session

    12:00 Collaboration for a Strategic Combination Product Development: A Case Study

    Carsten  Bech

    Carsten Bech, Medical Device Executive, Amgen

  • Considerations for a collaborative development process across teams
  • Patient centric design approaches to support a strong and diverse product pipeline
  • Meeting essential performance requirements
  • 12:30 Networking Lunch

    13:30 Combination Products in Global Market: Regulatory Approach

    Abha Raveau Violette

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

  • Regulatory development in global market
  • Effective collaboration and speed to market
  • Case Studies
  • Key learnings and take away
  • 14:00 Reserved Sponsor Session

    14:30 Using Simulations to improve Combination Product Designs

    Nima Aghajari

    Nima Aghajari, Senior Simulation Engineer, Sanofi
    View Bio

  • Use of simulations to understand the design of combination products
  • Insight into modelling analysis and digital perspective on assembly processes evaluation
  • Lessons learned: Challenges of a machine guided product assembly process
  • Challenges faced and further advancing design with simulation
  • 15:00 Afternoon Tea

    15:30 Reserved Sponsor Session

    16:00 Challenges of long-acting injectable delivery of fragile molecules

  • An industry outlook of long-acting injectable technologies and unmet needs for delivery technologies
  • Competitive advantages of in situ forming implant technologies
  • Overcoming challenges of molecular structure and stability for fragile molecule delivery
  • Examples of current approaches for delivery of fragile molecules like peptides and proteins
  • Joel Richard

    Joel Richard, Senior Expert and Former Chief Scientific Officer, Medincell

    16:30 Overcome challenges of intravitreal (IVT) injections with low volume ophthalmic pre-filled syringes (PFS)

    Petra Renne

    Petra Renne, Senior Expert Engineering, Packaging Technology, Novartis Pharma AG

  • What developments have we seen in dual chambered devices over recent years?
  • Facilitating the administration of lyophilised and liquid formulations
  • Exploring the diverse applications dual chambered devices have
  • Composition and manufacturing challenges with these devices and potential solutions to overcome these
  • 17:00 Chair’s Closing Remarks and Close of Focus Day

    7:45 Registration & Coffee

    8:20 Chairman's Opening Remarks

    Steve Hoare

    Steve Hoare, Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
    View Bio

    8:30 Case study: Strategic selection of injection device platform and suppliers: Why and How

  • Strategic importance of Drug Delivery System (DDS) selection
  • Background and timing for initiating the DDS device decision making process
  • Cross-functional approach for evaluation and selection of device DDS options
  • Facilitating and completing the strategic decision process
  • Kim Anker Kristiansen

    Kim Anker Kristiansen, Principal Scientist, LEO Pharma A/S
    View Bio

    Troels Keldmann

    Troels Keldmann, DDS Device Consultant and Interim, Keldmann Healthcare A/S
    View Bio

    9:00 Sustainable, optimized packaging platform development for drug/device combination portfolio

    Michael Becker

    Michael Becker, Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
    View Bio

  • Defining a packaging platform as an answer to a broad drug/device combination portfolio
  • Major challenges during the platform development
  • Material selection, platform variability and add-on features under the aspects of value proposition, product individualization, economy, and ecology
  • Reducing complexity and risk during the design and process development as well as for the transfer by using a packaging platform
  • 9:30 What does the Future Hold for Pre-Filled Syringes and Injectable Drug Devices

  • How can we enhance partnerships across inter-departmental teams and with suppliers throughout device development and post-launch?
  • Sharing challenges in regulatory submissions and examples of industry experiences to help you overcome these
  • As we look to advance technology and innovations, how can we ensure stakeholder buy-in for the evolution of the injectables landscape?
  • What are the expectations from market?
  • Sustainability as a driver for advancing technology and innovations?
  • Looking at providing smart solutions for the future: what are the benefits of connected health?
  • Fatima Bennai-Sanfourche

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

    Steve Hoare

    Steve Hoare, Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
    View Bio

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Director, Novo Nordisk
    View Bio

    Joel Richard

    Joel Richard, Senior Expert and Former Chief Scientific Officer, Medincell

    Guy Furness

    Guy Furness, Proprietor and Publisher, ONdrugDelivery

    10:00 Reserved Lead Sponsor Session

    10:30 Morning Coffee

    11:00 Developing Sustainable Practices for your Injectable Portfolio

  • The current landscape and industry movement towards a circular economy
  • Examples of current approaches and critical steps to introduce recycling to the device delivery industry
  • How can the supply chain be optimised?
  • An outlook to the coming years of sustainability and how pharma can implement recycling for drug delivery devices
  • Steve Hoare

    Steve Hoare, Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
    View Bio

    11:30 Reserved Sponsor Session

    12:00 Panel Discussion: Collaborating to Advance Sustainability in the Pharmaceutical Industry

  • How can the pharma industry and other stakeholders collaborate to advance sustainability?
  • What are the biggest challenges we are facing and what can be done to overcome them?
  • Takeaways from beyond the pharma industry: what can we learn?
  • Sebastian Gerner

    Sebastian Gerner, President, Alliance to Zero

    Cedric Gysel

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

    Niels Otterstrom Jensen

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

    Aaron Gowson

    Aaron Gowson, Public Affairs Manager, Chiesi Ltd

    Sean McPike

    Sean McPike, Global Product Stewardship Lead, Eli Lilly

    12:30 Reserved Sponsor Session

    13:00 Networking Lunch

    14:00 Day One Afternoon Parallel Streams

    STREAM A: Novel Drug Products and Large Volume Delivery
    14.00 Chair’s Opening Remarks
    Claus Geiger, Global Medical Device Leader, Sanofi
     

    14.10 Developing Wearable Injectors for Large Volume and Highly Viscous Drugs

  • An insight into the current landscape and examples large volume wearable injectors on the market
  • Establishing the optimal volume range for an on-body device
  • Assessing the impact of viscosity on injection force and reducing intermolecular interactions
  • Case study on a wearable injector: delivering monoclonal antibodies
  • Using connectivity to assess performance of the wearable injector and medication administration

    Claus Geiger, Global Medical Device Leader, Sanofi


    14.40 Delivering large volume at home with a sustainable wearable injector platform

  • 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
  • Cecile Gross, Category Manager for Parenteral Devices, Nemera

    15.10 Platform Approaches to increase the Efficiency of your Injectable Portfolio

  • What delivery systems and devices are suitable for platforms and tailoring for a range of delivery volumes
  • Proven risk, clinical and usability testing for a successful platform
  • Challenges in using platforms for novel drug products and assessing when a platform is most beneficial for a product portfolio
  • How can platforms be utilised to maximise product success: A case study

    Eleanor Kimber, Principal Device Engineer, GSK


    15.40 Reserved sponsor session

     

    STREAM B: Sustainability for Injectable Delivery Devices
    14.00 Co-Chair’s Opening Remarks
    Cedric Gysel
    , Healthcare Solutions Manager, Johnson and Johnson
    Els Ducheyne, Senior Manager, Materials Compliance, Johnson and Johnson

    14.10 Recycling Injectable Drug Devices: An Update

  • Discussion of creating end-of-life product solutions such as take-back pilots
  • Exploring the current challenges in re-purposing drug delivery devices
  • How can the challenges in launching take-back schemes be overcome?
  • Case Study on a real-world TakeBack Program and key takeaways
  • How can these programs be scaled-up?

    Niels Otterstrøm Jensen, Head of TakeBack Program, Novo Nordisk A/S Reusable devices


    14.40 Reserved Sponsor Session



    15.10 Applying Circularity: Moving Towards Net Zero Drug Delivery Devices

  • Introduction to Alliance to Zero’s mission and work
  • Practical ways to calculate a product’s carbon footprint and assess the product life cycle
  • Strategic approaches to enable circular transformation
  • How stakeholders can collaborate to effectively develop more sustainable injection devices?

    Sebastian Gerner, President, Alliance to Zero


    15.40 Reserved sponsor session
     

  • Claus Geiger

    Claus Geiger, Global Device Leader, Sanofi

    Cedric Gysel

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

    Els Ducheyne

    Els Ducheyne, Sr Manager Material Compliance & EPR, Johnson & Johnson (Janssen Pharmaceutical)
    View Bio

    16:10 Afternoon Tea

    16:40 Day One Afternoon Parallel Streams Continued

    STREAM A: Novel Drug Products and Large Volume Delivery Continued

    16:40 Practical Considerations for Wearable Injector Development: Controlling Temperature

  • Storage challenges for primary drug containers
  • Critical design considerations: minimum waist and low depth space
  • How to control drug temperature to extend shelf life of wearable injection devices
  • EPIWatch case study: a wearable drug delivery device for both IM and SQ pathway

    Amber Witteman, Founder, Managing Director, EPIWatch

    17.10  Human Factors and Clinical Actual Use Testing
  • When does the U.S. FDA expect actual use human factors testing?
  • How to decide when simulated use is sufficient for your human factors program
  • What are some common pitfalls when working with a traditional CRO to conduct Actual Use testing?

    Shannon Clark, Founder and CEO, UserWise

     

    STREAM B: SUSTAINABILITY FOR INJECTABLE DELIVERY DEVICES CONTINUED

    16:40  Embedding sustainability into medical device product life cycle

  • Incorporating eco-design and circular economy into products
  • Standards for consistency in approach 
  • Current barriers - are there any and how can they be overcome
  • Assurance for greater recognition and credibility

    Murray Sayce, Global Head, Sustainability Assurance, BSI Group

     

    17.10  Sustainable solutions: circular materials and end of life thinking

  • Exploring innovations in packaging: plastic free
  • Discussion of product end of life solutions 
  • Case study on the work being done at Johnson and Johnson
  • Challenges with new technologies: wearable injectors containing electronics and batteries 
  •  The future need for collaboration to enhance sustainability throughout the drug device industry

    Cedric Gysel, Healthcare Solutions Manager, Johnson and Johnson

     

    17.40  Implementing a sustainable approach for parenteral delivery device development

  • An overview of roadmap to reduce environmental impact
  • Insights into sustainable approaches to class I medical devices and packaging
  • Optimising device development practices for a reduced environmental footprint
  • Challenges in sustainable device development for a current parenteral portfolio

    Session Reserved for ABPI (The Association of the British Pharmaceutical Industry)

     

  • Claus Geiger

    Claus Geiger, Global Device Leader, Sanofi

    Cedric Gysel

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

    Els Ducheyne

    Els Ducheyne, Sr Manager Material Compliance & EPR, Johnson & Johnson (Janssen Pharmaceutical)
    View Bio

    18:10 Day One Afternoon Parallel Stream Chair Closing Remarks and Close of Day One

    7:45 Registration & Coffee

    8:20 Chairman's Opening Remarks

    Fatima Bennai-Sanfourche

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

    8:30 Extractables and leachables assessment in PFS drug products

    Carsten Worsoe

    Carsten Worsoe, Principle Scientist Extractables and Leachables, Novo Nordisk
    View Bio

  • Choice of critical components for drug compatibility in PFS
  • Predictive tools for interactions in PFS
  • Considerations for PFS platforms
  • Case studies on leachables assessments in prefilled syringes
     
  • 9:00 Cell & Gene Therapy: Best Practices for an Evolving Drug Product Portfolio

    Cinzia Federico

    Cinzia Federico, New Technologies Device Project Leader, Novartis
    View Bio

  • An update on the landscape of cell and gene therapy and identifying when injectable delivery is the appropriate approach
  • Assessing the impact of COVID and the use of frozen PFS
  • Potential benefits and challenges of a parenteral approach to delivery of cell and gene therapies using pre-filled syringes
  • Future development strategies for cell and gene therapy
  • 9:30 Centralising Scientific and Medical Input for Patient Safety Considerations with Innovative Device Technologies

    Danielle Middleton

    Danielle Middleton, Associate Medical Director, AstraZeneca
    View Bio

  • Insight into centralising device input and supporting the development of medical devices
  • Case study on the process of device development leveraging a centralised patient safety team
  • Critical considerations for the safety of medical devices
     
  • 10:00 Reserved Sponsor Session

    10:30 Morning Coffee

    11:00 Be prepared! Combination products under MDR (article 117)

    Heinrich Martens

    Heinrich Martens, Vice President Regulatory Affairs, Fresenius Kabi
    View Bio

  • 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
  • 11:30 Reserved Sponsor Session

    12:00 Panel discussion: Harmonising global device regulations: producing a product for a global market

  • Discussion of the varying regulations across the US, Europe, China and Japan
  • Defining terminology to harmonise understanding throughout the industry
  • How can collaboration between stakeholders be improved to overcome these challenges in variation?
  • What are the emerging markets and what can we expect moving forward?

     

  • Blake  Green

    Blake Green, Director Regulatory Affairs, Amgen Ltd
    View Bio

    Fatima Bennai-Sanfourche

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

    Abha Raveau Violette

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

    Shannon Clark

    Shannon Clark, Founder and Principal, UserWise
    View Bio

    12:30 Networking Lunch

    13:30 Day Two Afternoon Parallel Streams

    STREAM A: Primary Packaging Development
    13.30 Chair’s Opening Remarks

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer


    13.40 A New Approach for Container Closure Integrity Testing of Prefilled Syringes

  • Aim of new CCI test method addressing unmet questions
  • Method development approach
  • CCI robustness testing
  • Potential of new test method

    Markus Hemminger, Principal Medical Device Engineer, Roche

     

    14.10 Technical overview of COP for Pharma Packaging
  • The advantages and key properties of Cyclo Olefin Polymers in plastic primary packaging
  • About Protein Adsorption/Aggregation
  • Study on Nucleic Acid Adsorption
  • Jun Sato, Product Manager, Zeon

    14.40 Safety Assessment of Nitrosamine Impurities

  • Interpreting the updated guidance on nitrosamines: what does industry need to consider?
  • What are acceptable limits for nitrosamines in drug products?
  • Understanding the sources of the impurities and how to avoid them

    Risk assessment on nitrosamines from a toxicology perspective

     

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer

     

    15.10 Document improvements to your instructions for use with this framework

     

  • Understand a driver of regulator requests for additional information when reviewing human factors protocols and submissions of combination products.
  • Learn how to quickly and easily evaluate the content and design of your instructions for use for adherence to best practices in informational and user-centered design, as well as how they follow regulator-published prescriptive and directional recommendations for content and format of combination product labelling.
  • Facilitate more effective and productive discussions with cross-functional team members, including regulatory, by referencing a framework to promote adherence to underlying principles rather than prescriptive recommendations where appropriate.

     

     Korey Johnson, Managing Partner, Bold Insight US

    STREAM B: CONNECTED DRUG DELIVERY DEVICES
    13.30 Chair’s Opening Remarks
    Bjorg Hunter, Director, Novo Nordisk

    13.40 Risk Management for Connected Delivery Devices

     

  • Assessing the EU MDR requirements on devie risk management process
  • Impact of usability engineering and human factors

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Device, Combination Products and eHealth, Bayer

     

    14.10 Principles of successful connected injection device development
  • Introduction to key aspects of device development that are critical to the success of connected devices
  • Examples of key challenges that need to be overcome and how the key aspects are interwoven
  • Thoughts to take away on what are the most important factors for success and how the challenges can be overcome

    Paul Draper, Senior Sector Manager - Medical and Scientific, DCA Design

     

    14.40 Digitisation of injection systems: recent successes in the field of Diabetes

  • Introduction to what can digitalisation bring as value in Diabetes
  • Case study of a connected pen, first learnings 
  • Case study of a DTX algorithm, first learnings 
  • Looking into the future of digitalisation for diabetes

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

    Salim Bouaidat, Programme Director, Novo Nordisk

    15.10 Reserved sponsor session  

     

     

  • Clemens Gunther

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG
    View Bio

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Director, Novo Nordisk
    View Bio

    15:40 Afternoon Tea

    16:10 Day Two Afternoon Parallel Streams Continued

    STREAM A: Primary Packaging Development
    16.10 Evaluation of a second source for a pre-filled syringe

  • Comparison of commercially available PFS qualities
  • Selection criteria
  • Case study: How to deal with challenges

    Klaus Boje, Scientist, Boehringer Ingelheim

     

    16.40 Challenges of sWFI vial replacement with sWFI PFS during product lifecycle
  • Requirements of co-packaging vs integrated drug device combination
  • Essential performance requirements vs critical quality attributes
  • Guiding CMOs through root cause investigations

    Kevin Kusmierek, Scientist, Primary Packaging and Medical Devices, CSL Behring

     

    STREAM B: CONNECTED DRUG DELIVERY DEVICES

    16.10 Creating a user centric digital health product: Technology and Design considerations

  • Critical considerations for patient experience and how emerging technologies can enhance patient adoption and adherence
  • Understanding and implementing behaviour design into development to develop products that are user centric
  • Case study on the development of a user centric digital health product
  • Accurately establishing documented evidence that the software is installed correctly, meeting user needs and function according to intended use

    Blaine Martin, Digital Health, New Product Planning and Portfolio Expansion, Franchise Lead, Fertility, Merck

     


     
  • Clemens Gunther

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG
    View Bio

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Director, Novo Nordisk
    View Bio

    17:10 Day Two Afternoon Parallel Stream Chair Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Aaron Gowson

    Aaron Gowson

    Public Affairs Manager, Chiesi Ltd
    Abha Raveau Violette

    Abha Raveau Violette

    Associate Director, Devices and Digital Therapeutics, AstraZeneca
    Amber Witteman

    Amber Witteman

    Founder - Managing Director, EPiWatch
    Bjorg Kaae Hunter

    Bjorg Kaae Hunter

    Director, Novo Nordisk
    Blaine Martin

    Blaine Martin

    Director, Customer Success & Training, New Product & Portfolio Expansion, Merck KGaA
    Blake  Green

    Blake Green

    Director Regulatory Affairs, Amgen Ltd
    Carsten  Bech

    Carsten Bech

    Medical Device Executive, Amgen
    Carsten Worsoe

    Carsten Worsoe

    Principle Scientist Extractables and Leachables, Novo Nordisk
    Cecile Gross

    Cecile Gross

    Global Category Manager - Parenteral, Nemera
    Cedric Gysel

    Cedric Gysel

    Health Care Solutions Manager, Johnson & Johnson
    Cinzia Federico

    Cinzia Federico

    New Technologies Device Project Leader, Novartis
    Claus Geiger

    Claus Geiger

    Global Device Leader, Sanofi
    Clemens Gunther

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    Danielle Middleton

    Danielle Middleton

    Associate Medical Director, AstraZeneca
    Eleanor Kimber

    Eleanor Kimber

    Principal Device Engineer , GlaxoSmithKline
    Els Ducheyne

    Els Ducheyne

    Sr Manager Material Compliance & EPR, Johnson & Johnson (Janssen Pharmaceutical)
    Fatima Bennai-Sanfourche

    Fatima Bennai-Sanfourche

    Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
    Guy Furness

    Guy Furness

    Proprietor and Publisher, ONdrugDelivery
    Heinrich Martens

    Heinrich Martens

    Vice President Regulatory Affairs, Fresenius Kabi
    Joel Richard

    Joel Richard

    Senior Expert and Former Chief Scientific Officer, Medincell
    Kevin Kusmierek

    Kevin Kusmierek

    Senior Scientist Technical Device Leader, CSL Behring GmbH
    Kim Anker Kristiansen

    Kim Anker Kristiansen

    Principal Scientist, LEO Pharma A/S
    Klaus Boje

    Klaus Boje

    Scientist in Primary Packaging Development, Boehringer Ingelheim
    Marc Moal

    Marc Moal

    Corporate Programme Vice President, Devices & Delivery Solutions, Novo Nordisk
    Markus Hemminger

    Markus Hemminger

    Principal Device Engineer, Hoffmann-La Roche
    Michael Becker

    Michael Becker

    Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
    Mitali Aon

    Mitali Aon

    VP and Global Head of Device Development, Sanofi
    MURRAY SAYCE

    MURRAY SAYCE

    Global Head Sustainability Solutions, BSI Group
    Niels Otterstrom Jensen

    Niels Otterstrom Jensen

    Head of TakeBack Program, Novo Nordisk A/S
    Nima Aghajari

    Nima Aghajari

    Senior Simulation Engineer, Sanofi
    Olaf Lebau

    Olaf Lebau

    Device Manager, Boehringer Ingelheim
    Paul Draper

    Paul Draper

    Senior Sector Manager - Medical and Scientific, DCA Design International
    Peter Morgan

    Peter Morgan

    Medicines Net Zero Assistant Director, NHS
    Petra Renne

    Petra Renne

    Senior Expert Engineering, Packaging Technology, Novartis Pharma AG
    Salim Bouaidat

    Salim Bouaidat

    Programme Director, Novo Nordisk A/S
    Sandra Beltran Rodil

    Sandra Beltran Rodil

    Associate Director, Teva Pharmaceuticals Ltd
    Sebastian Gerner

    Sebastian Gerner

    President, Alliance to Zero
    Sebastian Stening

    Sebastian Stening

    Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer AG
    Shannon Clark

    Shannon Clark

    Founder and Principal, UserWise
    Steve Hoare

    Steve Hoare

    Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
    Theresa Scheuble

    Theresa Scheuble

    Head Enterprise Design & Innovation, Johnson & Johnson
    Troels Keldmann

    Troels Keldmann

    DDS Device Consultant and Interim, Keldmann Healthcare A/S

    Aaron Gowson

    Public Affairs Manager, Chiesi Ltd
    Aaron Gowson

    Abha Raveau Violette

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

    Amber Witteman

    Founder - Managing Director, EPiWatch
    Amber Witteman

    Amber Witteman is responsible for filling the EPIWatch’s strong IP’s containing a few novel techniques in the Med Tech industry, highlighted by Cortellius – Clarivate, ranked on number 1 out 10 and said to be “The Most Important Patents of The Med Tech Industry”. Amber is inventor of the NIP (Needle in Plunger, an ultra compact micro sized Pre-Filled Syringe Unit, with a focus on “Low Dept Space” and “Minimum Waist”- especially designed for replacement of syringes used in reusable Connected Drug Delivery Devices, The NIP is half the size of traditional syringes. Amber is also the inventor of a novel coating which extends the shelf life of PFS, vials, ampoules, cartridges, and other primary drug containers significantly, keeping the drugs, vaccines, etc. within the container cooled and protected from UV rays and Sunlight.

    Bjorg Kaae Hunter

    Director, Novo Nordisk
    Bjorg Kaae Hunter

    Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK, UK in 2010 and has held different roles within the Device development field primarily in the late stage parenteral area. She has held positions with increased responsibility stating as device project lead for key GSK parenteral devices and progressing into leading a device management team, where she has had the accountability of project management and regulatory compliance for parenteral devices. Later Bjorg moved into a key management role in CMC regulatory where she was responsible for the global regulatory and advocacy strategy for GSK’s portfolio of devices across modalities and lifecycle. In 2020 Bjorg moved to NovoNordisk where she is Director of the RA Digital Health area within RA CMC and Devices. Bjorg has been very active in external advocacy especially related to combination products, connected devices and SaMD including driving industry positions in collaboration with industry working groups.

    Blaine Martin

    Director, Customer Success & Training, New Product & Portfolio Expansion, Merck KGaA
    Blaine Martin

    Since December 2013, I have led the Medical Device Customer Success & Training team within the Digital Health function based in Eysins, Switzerland, part of the Healthcare division of Merck Group, Darmstadt, Germany. I have worked with many culturally diverse teams to deliver engaging, easy-to-use digital solutions that foster innovation and help address unmet customer needs. Projects have included mobile digital health apps, patient education materials, innovative AR-based medical device training applications, global and local training programs, marketing communications and Web-based applications for biopharma, consumer goods and luxury brand industries.

     

    Blake Green

    Director Regulatory Affairs, Amgen Ltd
    Blake  Green

     Blake Green is a Regulatory Affairs Director within Amgen’s Global Medical Devices Regulatory team. Based in the UK, Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector. Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.


     

    Carsten Bech

    Medical Device Executive, Amgen
    Carsten  Bech

    Carsten Worsoe

    Principle Scientist Extractables and Leachables, Novo Nordisk
    Carsten Worsoe

    Carsten Worsøe is a principal scientist within extractables and leachables (E&L) at Novo Nordisk. In over 24 years his main responsibility has been to analytical E&L documentation for container closure systems (vials, cartridges and pre-filled syringes), production materials and devices. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, production, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for E&L testing in development projects. In addition to that work, Carsten is a member of the E&L industry groups BioPhorum (BPOG), executive committee member in ELSIE (Extractables and Leachables Safety Information Exchange) and member of the EfPIA and Pharma ICH Q3E support groups.

    Cecile Gross

    Global Category Manager - Parenteral, Nemera
    Cecile Gross

    ? Cécile Gross is Marketing Global Category Manager at Nemera, focusing on Parenteral Devices. She oversees the product portfolio strategy, development and life-cycle for safety system, pen injector and on-body injector platforms. She has an experience of more than two decades in the Medical Device Industry, marketing BtoB technological products and implementing product lifecycle management for various kinds of devices. Graduated in International Business, she completed her initial training with a master’s degree in Marketing and Management in the Healthcare Industry at IMIS Institute, Lyon France.

    Cedric Gysel

    Health Care Solutions Manager, Johnson & Johnson
    Cedric Gysel

    Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, driving human-centered solutions for patients and customers and leading key innovation projects for device & packaging sustainability as we all product end of life programs across the pharmaceutical and medical device sectors of Johnson & Johnson. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science.

     

    Cinzia Federico

    New Technologies Device Project Leader, Novartis
    Cinzia Federico

    Cinzia holds a MSc degree in Pharmacy and a PhD from the University “Magna Graecia” of Catanzaro (Italy). During her studies and after as a Postdoc at the Washington University in St. Louis (USA), she focused on developing nanoparticles and biodegradable implants for application in gene delivery, tumor targeting and cancer therapy. In 2018, she moved to the ASST Spedali Civili di Brescia (Italy), where she worked on the analysis of transcriptomic aberrations within tumor-microenvironment in hematologic malignancies. Since 2019, she has been working at Novartis as a Drug Product Lead and Device Project Lead in Cell&Gene Therapy Technical Development.


     

    Claus Geiger

    Global Device Leader, Sanofi
    Claus Geiger

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    Clemens Gunther

    Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
    He started his professional career in 1990 at Schering AG, Berlin-Germany.
    From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.
    After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care and later-on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals.


    Meanwhile Dr. Clemens Günther has gained over 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products in various medical indications.
     

    Danielle Middleton

    Associate Medical Director, AstraZeneca
    Danielle Middleton

    Danielle Middleton gained a BSc (Hons) in Medicinal Chemistry and a PhD in Organic Chemistry, prior to studying for her medical degree (MBBChir) at The University of Cambridge, UK. Danielle worked for 10 years in the NHS, gaining board certification in General Practice, before moving into industry. Initially as a Scientific Advisor MD, at Signant Health, and subsequently as an Associate Medical Director, Patient Safety Physician at AstraZeneca within the Devices and Digital Centre of Excellence. Danielle works collaboratively and cross functionally to provide medical/clinical input to device and/or digital programs, supporting device and digital programmes through the lifecycle from development to post-marketing.

    Eleanor Kimber

    Principal Device Engineer , GlaxoSmithKline
    Eleanor Kimber

    Els Ducheyne

    Sr Manager Material Compliance & EPR, Johnson & Johnson (Janssen Pharmaceutical)
    Els Ducheyne

    Els Ducheyne is senior manager within the Janssen Environmental Product Compliance & Sustainability team, part of Johnson & Johnson Enterprise Sustainability. She supports the design of sustainable products and solutions through assurance of material compliance, end-to-end data management and life cycle assessments.
    Els leads the ChemLeg taskforce on material compliance through which a harmonized restricted and declarable substance list for the pharma industry was developed and where best practices are shared. During the last years, she has been working closely with the device community and sustainability experts in the pharmaceutical industry. She is also deeply involved in shaping policy for initiatives under the EU Green Deal.
    Els holds a PhD in Bio-engineering from the Ghent University, Belgium.
     

    Fatima Bennai-Sanfourche

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

    Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.
    Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.
    She has more than 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation.
    She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays.
    In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the Pharmaceuticals portfolio.
    She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP).
    She is also leading the project of the implementation of euMDR for PH-Bayer AG.
    She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according the medical Device regulation. The period of nomination is of five years starting on 01 March 2019.
     

    Guy Furness

    Proprietor and Publisher, ONdrugDelivery
    Guy Furness

    Heinrich Martens

    Vice President Regulatory Affairs, Fresenius Kabi
    Heinrich Martens

    Heinrich Martens, VP Regulatory Affairs, with more than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams. Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role. Beside his work, he spends time and supports social projects. Traveling and time with his family is also important.

    Joel Richard

    Senior Expert and Former Chief Scientific Officer, Medincell
    Joel Richard

    Kevin Kusmierek

    Senior Scientist Technical Device Leader, CSL Behring GmbH
    Kevin Kusmierek

    Kim Anker Kristiansen

    Principal Scientist, LEO Pharma A/S
    Kim Anker Kristiansen

    Dr. Kristiansen has spent more than a decade in medical devices, the last 7 in LEO Pharma working with injection devices. He has held positions as senior medical device specialist, life cycle manager of marketed injection devices and currently hold a position as Device Technical Lead in early pipeline projects and Design Control Lead for AI in late pipeline projects. He partnered with Dr. Keldmann in the strategic work on platform selection for LEO Pharma and he headed the supplier evaluation and selection process. He is Principal Scientist and holds a M.Sc in Biology and a Ph.D in Cell Biology.

    Klaus Boje

    Scientist in Primary Packaging Development, Boehringer Ingelheim
    Klaus Boje

    Klaus Boje studied mechanical engineering. He has been working for Vetter as a supervisor
    of the QC of packaging material. Since 1999 he is
    working for Boehringer Ingelheim, first in the pharmaceutical development of biopharmaceuticals. Since 2014 he is a Scientist in primary packaging development and responsible for early and
    late stage NBE and NCE projects for parenteral products.
     

    Marc Moal

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

    Marc is a multi-industry experienced leader who led major international programs (outsourcing, new product launch, new greenfield factory) in leading companies such as Swatch Group and Medtronic who then successfully built and led major R&D and Operations organizations in Heraeus, Nespresso and Merck. Now at Novo Nordisk since August 2021, he is in charge of the execution of the growing pipeline of Devices and Delivery Solutions in various therapeutic areas such as Diabetes, Obesity and Rare Diseases.

    Markus Hemminger

    Principal Device Engineer, Hoffmann-La Roche
    Markus Hemminger

    Michael Becker

    Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
    Michael Becker

    Dr. Michael Becker (born in 1983) is working at Boehringer Ingelheim Pharma GmbH & Co. KG since 2016 as a Design Engineer for parenteral combination products and for two years for packaging and labelling. Previously, he worked for 5 years at Sanofi-Aventis GmbH in the development of Autoinjectors, Pre-filled Syringes and Injection Pens. He studied Physics at the University of Mainz and wrote his PhD thesis about the Dry Powder Inhalers supervised by Mr. Prof. Cameron Tropea (Technical University Darmstadt).


     

    Mitali Aon

    VP and Global Head of Device Development, Sanofi
    Mitali Aon

    MURRAY SAYCE

    Global Head Sustainability Solutions, BSI Group
    MURRAY SAYCE

    Murray leads in the design, development and deployment of new solutions and services across Sustainability
    Assurance at global, regional and country level in line with the stream strategy and priorities. This includes the
    development of the Assurance Services stream strategy for Sustainability, new solutions development and product
    management in full collaboration with regional leaders, teams and functions across BSI’s 90 offices in 30+
    countries.
    BSI’s aim is to inspire trust for a more resilient world with business solutions and services that improve
    sustainability position and performance against internationally recognised standards and frameworks, as well as
    customised solutions for a quickly changing world. This is underpinned by its role as the UK national standards
    body and its prestigious Royal Charter.

    Niels Otterstrom Jensen

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

    Nima Aghajari

    Senior Simulation Engineer, Sanofi
    Nima Aghajari

    Education:

    • Master and PhD in mechanical engineering with a specialization in numerical simulation at Technical University Darmstadt (TUD)

    Career:

    • Research Assistant at TUD (2009-2014): Development of simulation methods for aviation, automotive and medical engineering industries
    • Simulation Engineer at Sanofi (2014-Today)
    • Integration of state-of-the-art computational and analytical methods
    • Execution and supervision of critical simulation activities related to parenteral drug delivery

     

    Olaf Lebau

    Device Manager, Boehringer Ingelheim
    Olaf Lebau

    Lead Device Project Manager for Combination Products, Boehringer Ingelheim

    Olaf is an applied physicist by training with a broad knowledge in interdisciplinary fields like nanotechnology and biomimetics, married with an interest in design and human psychology.
    Over the years, he has worked on extracorporeal circuits, in vitro diagnostic, predictive algorithms and complex drug delivery systems.

    At Boehringer Ingelheim, he is currently leading interdisciplinary teams, developing innovative delivery devices for new pharmaceuticals.

     

    Paul Draper

    Senior Sector Manager - Medical and Scientific, DCA Design International
    Paul Draper

    Paul is one of the senior management team at DCA servicing the medical sector. His 19 years of product development experience has been almost entirely on drug delivery device development projects. His mechanical engineering degree and years of experience working on and leading medical device projects culminates in the hands-on leadership of complex multi-disciplinary projects encompassing strategy, research, design, mechanical engineering, electronic engineering, software engineering and industrialisation. Paul has experience of low part count mechanical devices through to advanced electro-mechanical devices including IEC 62304 software development for embedded software and supporting mobile applications.

    Peter Morgan

    Medicines Net Zero Assistant Director, NHS
    Peter Morgan

    Petra Renne

    Senior Expert Engineering, Packaging Technology, Novartis Pharma AG
    Petra Renne

    Salim Bouaidat

    Programme Director, Novo Nordisk A/S
    Salim Bouaidat

    Sandra Beltran Rodil

    Associate Director, Teva Pharmaceuticals Ltd
    Sandra Beltran Rodil

    Sandra Beltran Rodil is an Associate Director in Specialty European Regulatory Affairs at Teva Pharmaceuticals, based in Harlow, United Kingdom. Her experience covers medicinal products, drug device combination products as well as medical devices, including software as medical devices. She is a subject matter expert within Teva for drug device combination products and medical devices, supporting the company with the implementation of the Medical Device Regulation. Sandra holds a PhD in Synthetic Organic Chemistry by The University of York (United Kingdom) and a M.Res. in Organic Chemistry by the University of Santiago de Compostela (Galicia, Spain).

    Sean McPike

    Global Product Stewardship Lead, Eli Lilly
    Sean McPike

    Sebastian Gerner

    President, Alliance to Zero
    Sebastian Gerner

    Sebastian Stening

    Vice President and Global Head Medical Device Manufacturing Science and Technology, Bayer AG
    Sebastian Stening

    Sebastian Stening is responsible for Late-Stage Development, New Product Introduction/ Industrialization and Life Cycle Engineering of Medical Devices and Drug-Device Combination Products at Bayer located in Berlin. To ensure efficient manufacturability, the mission of the Medical Device Manufacturing Science and Technology Organization is an end-to-end integration of product, process, and automation designs.
    Prior to Bayer, he worked for Sanofi in various positions in Medical Device and Drug-Device Combination Product Development, Industrialization, and Manufacturing.
    Sebastian holds a M.Sc. in Business Engineering focused on Physics and Medical Device Technologies from the University of Applied Science Muenster (Germany).

     

    Shannon Clark

    Founder and Principal, UserWise
    Shannon Clark

    Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

    Before founding UserWise in 2014, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

    Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.

     

    Steve Hoare

    Consultant and Former Quality, Regulatory Science & Safety Policy Director, Association of the British Pharmaceutical Industry
    Steve Hoare

    Steve Hoare was previously the Policy Director, Quality, Regulatory Science and Safety at the Association of the British Pharmaceutical Industry.


    An analytical chemist by training, Steve Hoare has spent most of his career leading quality functions within pharmaceutical companies.
     

    His experience covers the full lifecycle of medicines from early drug discovery through to manufacture, supply, and now on circularity. In his previous role, Steve led policy development in both sustainability and regulatory science for the ABPI. Steve continues to work with other stakeholders on both a UK ePI Taskforce and a Roadmap for medicines packaging recycling in the UK.
     

    Theresa Scheuble

    Head Enterprise Design & Innovation, Johnson & Johnson
    Theresa Scheuble

    Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.
    Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.

     

    Troels Keldmann

    DDS Device Consultant and Interim, Keldmann Healthcare A/S
    Troels Keldmann

    Dr Keldmann has spent 25 years in DDS devices and medical devices industry, working cross-functionally covering development, sourcing, innovation, IPR-strategy, business development, partnering and commercialization. As Interim Technical Lead on Injection Devices, LEO Pharma A/S, he headed identification, evaluation and selection of SC injection devices. Prior DDS experience include co-founding & heading innovative DDS startups, and consultant in DDS devices for pulmonary, nasal, SC (needle/needle-free) and IM delivery. He is appointed Business Coach by European Innovation Council EIC and Industry Fellow at Technical University of Denmark. He holds a B.Sc, M.Sc. and Ph.D. in Mechanical Engineering & Innovation, and MBA.

    Sponsors

    Exhibitors

    Key Media Partners

    Supporters

    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

    Speaker Interview - Abha Raveau Violette - AstraZeneca

    Download

    Speaker Long Video Interview - Sebastian Stening - Bayer AG

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    Speaker Short Video Interview - Sebastian Stening - Bayer AG

    Download

    Preliminary Attendees 2023

    Download

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

    Download

    Sponsorship Prospectus

    Download

    Conference Brochure

    Download

    Past Speaker Presentation - Raphael Nudelman - Teva

    Download

    Past Speaker Presentation - Julia Frese - TUV SUD

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    Past Speaker Presentation - Eleanor Kimber - GSK

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    Past Speaker Presentation - Richard Simcock - Teva

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    Past Attendees List

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    Pre-filled Syringes and Injectable Drug Devices Worldwide Survey 2022

    Download

    Full Agenda

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    Short Agenda

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    Speaker Biographies

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    Advisory Board Welcome Letter

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    Sponsors


    Bold Insight

    Sponsors
    https://boldinsight.com/

    Bold Insight is a UX and human factors research agency based in London and Chicago. Executing projects across the product development lifecycle, we conduct user research informing early product design to global human factors validation. We work with digital, next-generation technology—medical devices to mobile apps, IFUs to customer journeys.



    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.



    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.



    ZEON

    Sponsors
    https://www.zeon.eu/

    ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    Gerresheimer

    Exhibitors
    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.


    Harro Höfliger

    Exhibitors
    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


    Haselmeier

    Exhibitors
    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.



    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/



    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


    Pharmacircle

    Key Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    ONdrugDelivery Magazine

    Key Media Partners
    http://ondrugdelivery.com

    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.


    Pharmaceutical Technology

    Key Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Gene Therapy Net

    Key Media Partners
    http://www.genetherapynet.com

    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    pharmaphorum

    Key Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Technology Networks

    Key Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Mednous

    Key Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharmiweb

    Key Media Partners
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Pharma Journalist

    Key Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    World Pharma Today

    Key Media Partners
    http://www.worldpharmatoday.com



    World Pharma News

    Key Media Partners
    http://www.worldpharmanews.com/



    ASD MEDIA

    Key Media Partners
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    evvnt Ltd

    Key Media Partners
    http://www.evvnt.com

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com

    Media Partners


    Raumedic

    Supporters
    http://www.raumedic.com

    Together with its customers, the medical technology company is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, Raumedic focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care. Raumedic has a global presence and a headcount of approximately 1,000. In its core markets of Europe and North America, the company manufactures using its own clean room production facilities.


    10 times

    Supporters
    http://10times.com

    10Times connect professionals with right information & people at the right place and time. Our name defines our audience & vision: Help Business Professionals grow. Events bringing together the right ingredients to generate value for the target audience. Over 2 million professional events are hosted for various topic, attracting over a billion knowledge audience around the world. We aim to ensure these events reach the right audience.


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

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    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.

     

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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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    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




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