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SMi’s 14th Annual Conference
Pre-Filled Syringes and Injectable Drug Devices Europe
January 12 - 13, 2022 | London, UK
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The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. This year’s conference will explore the exciting advances in the combination product delivery space including insights into how the industry is adapting to the delayed EU MDR, takeaways from the global pandemic and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation. Part of the leading injectables series of events, SMi’s 14th annual conference will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.


Topics of discussion will include the latest updates on the EU MDR, Article 117 and UK regulatory guidance, insights into the evolving digital health landscape for connected delivery devices, containment considerations for novel delivery, patient centric approaches to device design and much more…
 

The two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.


As Europe’s first Pre-Filled Syringes Conference of 2022, this event is not to be missed. We look forward to welcoming you to the conference in January.
 

 

  • Engage with industry leaders on the key takeaways from the pandemic and how this can be applied to future accelerated development
  • Explore updates to drug device combination product design approaches putting the user first with industry case studies from big pharma
  • Assess the current landscape of device delivery mechanisms and how industry can work together to promote innovation
  • Understand the landscape of delivery for novel drug products, fragile molecules and long acting injectables in the interactive panel discussion
     
  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

Previous attendees include:
 

AbbVie; Alnylam Pharmaceuticals; Amgen; Aptar Pharma; AstraZeneca; Bayer AG; BD Medical; Bd Medical-Pharmaceutical Systems; Becton dickinson; Becton Dickinson (BD); Bespak Europe Ltd; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI; BSI Group; Cardiff University; CSL Behring AG; Eveon; F. Hoffman-La Roche Ltd.; F. Hoffmann-La Roche Ltd.; Ferring Pharmaceuiticals Pvt. Ltd.; FERRING PHARMACEUTICALS PVT LTD; Gerresheimer Buende GmbH; GlaxoSmithKline; GlaxoSmithKline (GSK); GSK; Haughton Design Ltd; Institute BCN Esthetics, S.L.; Ipsen; Ipsen Group; IPSEN Pharmsciences; Janssen; Janssen Pharmaceutica NV; Janssen Pharmaceutical Companies of Johnson and Johnson; Janssen Research and Development, LLC; Johnson & Johnson (Janssen Pharmaceutical); kaleo, Inc.; LEO Pharma A/S; Medicines & Healthcare Products Regulatory Agency (MHRA); MedinCell; Merck; MHRA; Minapharm Pharmaceuticals; Nemera; Nipro PharmaPackaging Germany; Novartis; Novartis – Global Drug Development; Novartis Pharma AG; Novartis Pharmaceuticals; Novo Nordisk; Novo Nordisk A/S; Novo Nordisk Pharma; Owen Mumford; PCI Pharma Services; Pfizer; Pfizer Inc.; Pfizer Ltd UK; Pfizer UK Limited; Pfizer, INC.; Regeneron Pharmaceuticals, Inc.; Rhein Minapharm; Roche; RSK-Solutions/ RSK Life Science Media; Sanofi; Sanofi SWI; TERUMO coeporation; Teva Ltd; Teva Pharmaceuticals; Teva UK; Teva, Combination Products; TUV SUD Japan Ltd.; UCB; UCB Pharma; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; Zeon Corporation; Zeon Europe GmbH; Zeon Specialty Materials ;

Conference programme

8:30 Registration & Coffee

9:00 Chairs' Opening Remarks

Bjorg Kaae Hunter

Bjorg Kaae Hunter, Department Manager, RA CMC & Device, Novo Nordisk Pharma
View Bio

Daniel Latham

Daniel Latham, Head Connected Health Product Development, Novartis Pharma AG
View Bio

9:10 On the regulatory interface of digitalisation and drug-device combination products

  • How do we manage regulatory submissions of drug-device combination products in the interface of digitalisation ?
  • Engaging with regulators on areas of uncertainty to improve guidance for all parties
  • How can we create harmonization across global regulations that can keep up with rapid development?
  • What does the future hold in this space?
  • Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Department Manager, RA CMC & Device, Novo Nordisk Pharma
    View Bio

    Mathilde Barbeau

    Mathilde Barbeau, Senior Regulatory Professional, Novo Nordisk A/S

    9:50 Navigating Connected Health to enhance drug portfolio

    Daniel Latham

    Daniel Latham, Head Connected Health Product Development, Novartis Pharma AG
    View Bio

  • Opportunities to enhance current treatment offerings with Connected Health
  • Development of connected ecosystems and impacting the patient journey
  • Overcoming challenges in developing a successful connected parenteral delivery portfolio
  • 10:30 Morning Coffee

    11:00 Connected delivery device value creation

    David Braun

    David Braun, Global Head of Connected Health and Devices, MerckGroup KgAa
    View Bio

  • An insight into the current landscape and examples of connected health and delivery devices 
  • Design thinking and optimising value creation
  • Challenges and opportunities in data generation for personalised treatments

     

  • 11:40 Can Behavioral Science be the key to unlocking patient adherence?

    Andrea  Pisa

    Andrea Pisa, Usability Design Lead, Crux Product Design, Ltd
    View Bio

  • The continued challenge of patient adherence and engagement to treatment - impact on patient outcomes and health system
  • Historic informational material - one size does not fit all
  • Two applied examples - development of digital solutions effective in on boarding users onto treatments and enabling successful self-management of their treatments over time
  • Key learnings - implementation lessons learned of applying Behavioural Science to instructional material development and technologies used to assess the intervention effectiveness
  • Project significance - Generation of medical solutions that better meet user needs and engage users with their treatments
  • 12:20 Long-acting injectable medicine as a potential route to COVID-19 therapy

    Andrew Owen

    Andrew Owen, Professor, University of Liverpool
    View Bio

  • The use case for a long-acting intervention in COVID-19
  • Repurposing an existing drug as a long-acting injectable therapy to treat COVID-19
  • Requirements for a successful long-acting injectable antiviral candidate
  • The critical importance of early work to establish availability of COVID-19 therapies in low- and middle-income countries?
  • 13:00 Networking Lunch

    14:00 Tackling high-volume administration challenges with a smart, sustainable on-body injector platform

    Severine Duband

    Severine Duband, Global Category Director, Devices, Nemera
    View Bio

  • Challenges facing modern drug delivery devices
  • Delivering large volumes at home in sustainable and user-friendly way
  • A differentiated approach in the wearables’ landscape: Nemera Symbioze platform
  • 14:40 Long acting injectable, application of aqueous suspensions

    Rene Holm

    Rene Holm, Professor, University of Southern Denmark
    View Bio

  • Long acting injectables – why?
  • Which compounds fits the technology
  • PK and formulation considerations
  • Biopharmaceutical considerations of LAIs
  • 15:20 Challenges of injectable delivery for fragile molecule

    Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

  • An industry outlook of in situ forming implant technologies
  • Overcoming challenges of molecular structure for fragile molecule delivery
  • Unmet needs for delivery technologies
  • Examples of current approaches for fragile molecule delivery
  • 16:00 Afternoon Tea

    16:30 Assessing the landscape of delivery for novel drug products, fragile molecules and long acting injectables

  • The current landscape of fragile molecule formulations and delivery
  • Considerations and strategies for successful long acting injectable delivery
  • Key barriers facing development in industry and strategies in overcoming hurdles of novel drug product delivery
  • Selecting appropriate technology for a molecule of interest 
  • Opportunities offered by therapeutic areas where long acting injectable do not yet exist and future industry trends for optimal novel and sustained injectable delivery
  • Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

    Rene Holm

    Rene Holm, Professor, University of Southern Denmark
    View Bio

    Andrew Owen

    Andrew Owen, Professor, University of Liverpool
    View Bio

    Raphael Nudelman

    Raphael Nudelman, Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals
    View Bio

    17:10 Challenges in Cell & gene therapy

    Annie Zavadil

    Annie Zavadil, New Technologies Device Project Leader, Novartis Pharma AG

  • An introduction into the landscape of cell and gene therapy
  • Current challenges and barriers to delivery 
  • Potential benefits and challenges of a parenteral approach to delivery using pre-filled syringes
  • Future development strategies for cell and gene therapy
  • 17:50 Subcutaneous administration of biotherapeutics – pre-filled syringes and beyond

    Sachin Dubey

    Sachin Dubey, Head of Drug Product and Analytical Development, Ichnos Sciences, SA
    View Bio

  • Subcutaneous as a route of administration 
  • Prefilled syringes for biologics
  • Foreseeable development hurdles and strategies to overcome them
  • Dual chamber systems as an alternative to liquid PFS
  • 18:30 Chairs' Closing Remarks and Close of Day One

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Department Manager, RA CMC & Device, Novo Nordisk Pharma
    View Bio

    Daniel Latham

    Daniel Latham, Head Connected Health Product Development, Novartis Pharma AG
    View Bio

    8:30 Registration & Coffee

    9:00 Chairs' Opening Remarks

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Department Manager, RA CMC & Device, Novo Nordisk Pharma
    View Bio

    Daniel Latham

    Daniel Latham, Head Connected Health Product Development, Novartis Pharma AG
    View Bio

    9:10 Industry Perspective: Implementation of the EU MDR

    Louise Place

    Louise Place, Director, Devices, GlaxoSmithKline
    View Bio

  • Aligning with new regulatory requirements for stand-alone devices and combination products
  • Case Study examples: GSK’s vaccines/pharma portfolio
  • Considerations and challenges in implementation of the MDR for injectables
  • Assessing clarifications that are still needed to understand what is expected from industry
  • 9:50 Working with notified bodies – lessons learned and advice

    Julia Frese

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

  • Experiences and takeaways from Team-NB over the past year
  • Common challenges in applications for notified body opinions and guidance on working with notified bodies
  • How industry can work more closely with regulators and notified bodies in implementation of new regulations
  • What gaps have we seen since the EU MDR implementation and how can this be improved
  • 10:30 Morning Coffee

    11:00 Regulatory updates following implementation of the MDR

    Arabe Ahmed

    Arabe Ahmed, Medicinal Technical Expert, BSI

  • How has industry adapted with the full implementation of the EU MDR and Article 117
  • Change management considerations for article 117 regulatory submissions
  • Key takeaways from implementation of the MDR and what guidance is still needed
  • Considerations for legacy products and implementation for device platforms
  • 11:40 Dealing with Nitrosamines in the Generic Drug Industry

    Raphael Nudelman

    Raphael Nudelman, Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals
    View Bio

  • Assessing the recent regulatory guidance for industry on nitrosamine impurities 
  • Setting acceptable intake limits for nitrosamines without published carcinogenicity data
  • Update on the adequacy of the Ames test for nitrosamines
  • 12:20 Session Reserved for Zeon

    Session Reserved for

    Session Reserved for, , Zeon

    13:00 Networking Lunch

    14:00 Making a difference; considering usability throughout the design lifecycle

    Richard Simcock

    Richard Simcock, Human Factors Scientist, Teva Ltd
    View Bio

  • Why it is important to identify factors affecting usability early in the design lifecycle
  • How to make this a normal part of your processes
  • The importance of usability testing
  • Project examples of the importance and impact of good usability engineering
  • 14:40 Designing the First Impression of a Drug/Device Combination Product

    Michael Becker

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

  • Packaging and Labelling is the first interface between the user and the combination product creating the first device impression at the user.
  • To develop user centric folding boxes, labels and “Instruction for Use”s the design control process can be useful.
  • Beside the needs of the users/patients regulatory requirements and the product protection must be considered and integrated into this development process making the product safe and effective
  • 15:20 Accelerating innovation in the drug delivery landscape

  • How can device developers, big pharma and regulators work together to encourage innovations in parenteral delivery?
  • How have we seen drug device combination product development evolve in recent years and where are the biggest growth areas in the space?
  • Understanding when connectivity is beneficial for delivery devices and how can this be enhanced for improved patient experience?
     
  • Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Department Manager, RA CMC & Device, Novo Nordisk Pharma
    View Bio

    Richard Simcock

    Richard Simcock, Human Factors Scientist, Teva Ltd
    View Bio

    Louise Place

    Louise Place, Director, Devices, GlaxoSmithKline
    View Bio

    Arabe Ahmed

    Arabe Ahmed, Medicinal Technical Expert, BSI
    View Bio

    16:00 Afternoon Tea

    16:30 The Use of Digital Twins in Pharma

    Eleanor Kimber

    Eleanor Kimber, Device Engineer, GlaxoSmithKline
    View Bio

  • Potential of Digital Twins in Pharma
  • Process of developing a Digital Twin 
  • Validation, Verification and Uncertainty Quantification of the Digital Twin
  • Challenges Faced
  • 17:10 Digitalization meets assembly process

    Jochen Zenker

    Jochen Zenker, Head of Laboratory Process Engineering, Boehringer Ingelheim Pharma GmbH & Co. KG
    View Bio

  • Lessons learned: Challenges of a machine guided PFS assembly process
  • Machine parameter, device constituent parts and physical interactions are essential inputs for a robust assembly process
  • Digital perspective on assembly processes evaluation
  • Insights of closure integrity and behavior of rubber components associated with the assembly process
  • 17:50 Chairs' Closing Remarks and Close of Day Two

    Bjorg Kaae Hunter

    Bjorg Kaae Hunter, Department Manager, RA CMC & Device, Novo Nordisk Pharma
    View Bio

    Daniel Latham

    Daniel Latham, Head Connected Health Product Development, Novartis Pharma AG
    View Bio

    +

    FEATURED SPEAKERS

    Andrea  Pisa

    Andrea Pisa

    Usability Design Lead, Crux Product Design, Ltd
    Andrew Owen

    Andrew Owen

    Professor, University of Liverpool
    Annie Zavadil

    Annie Zavadil

    New Technologies Device Project Leader, Novartis Pharma AG
    Arabe Ahmed

    Arabe Ahmed

    Medicinal Technical Expert, BSI
    Bjorg Kaae Hunter

    Bjorg Kaae Hunter

    Department Manager, RA CMC & Device, Novo Nordisk Pharma
    Daniel Latham

    Daniel Latham

    Head Connected Health Product Development, Novartis Pharma AG
    David Braun

    David Braun

    Global Head of Connected Health and Devices, MerckGroup KgAa
    Eleanor Kimber

    Eleanor Kimber

    Device Engineer, GlaxoSmithKline
    Jochen Zenker

    Jochen Zenker

    Head of Laboratory Process Engineering, Boehringer Ingelheim Pharma GmbH & Co. KG
    Joel Richard

    Joel Richard

    Chief Development Officer, MedinCell
    Julia Frese

    Julia Frese

    Director, TUV SUD Japan Ltd.
    Louise Place

    Louise Place

    Director, Devices, GlaxoSmithKline
    Michael Becker

    Michael Becker

    Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
    Raphael Nudelman

    Raphael Nudelman

    Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals
    Richard Simcock

    Richard Simcock

    Human Factors Scientist, Teva Ltd
    Sachin Dubey

    Sachin Dubey

    Head of Drug Product and Analytical Development, Ichnos Sciences, SA
    Severine Duband

    Severine Duband

    Global Category Director, Devices, Nemera

    Andrea Pisa

    Usability Design Lead, Crux Product Design, Ltd
    Andrea  Pisa

    Andrea Pisa leads the Human Factors and Usability team at Crux Product Design Ltd (Bristol, UK), ensuring that the Human Factors process is seamlessly integrated into product development to produce safe, effective and user empathic solutions. She has supported leading pharmaceutical clients on projects spanning the entire design process, taking medical and drug-delivery devices from design input to market submission. With a passion for uncovering latent user needs and a global background in design engineering, Andrea brings a wealth of knowledge when tailoring usability strategies to maintain the integrity of design development whilst keeping the user at the core.

    Andrew Owen

    Professor, University of Liverpool
    Andrew Owen

    Andrew Owen is a Director of the Centre of Excellence in Long-acting Therapeutics (CELT) at the University of Liverpool. He is principal investigator for LONGEVITY, an international project that aims to translate long-acting medicines for malaria, tuberculosis, and Hepatitis C Virus. Owen co-leads a modelling core and sits on the executive group for the Long-acting/Extended-release Antiretroviral resource Program (LEAP). He is also Director and CSO for Tandem Nano Ltd. and co-inventor of patents relating to drug delivery.

    Annie Zavadil

    New Technologies Device Project Leader, Novartis Pharma AG
    Annie Zavadil

    Arabe Ahmed

    Medicinal Technical Expert, BSI
    Arabe Ahmed

    Trained as a Pharmacist at the University of Aston in Birmingham, graduating with a BPharmS. Arabe has a Master’s degree in Pharmaceutical Technology at King’s College London. PhD in Pharmaceutical Sciences from Julius Maximilian University, Würzburg (JMU), Germany.

    Bjorg Kaae Hunter

    Department Manager, RA CMC & Device, Novo Nordisk Pharma
    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 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 resistibility stating as device 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 May 2020 Bjorg took up a new position in NovoNordisk where she lead the NexGen Drug-Device RA department within RA CMC and Devices where she has RA accountability for both early and late stage drug-device combination products.

    Daniel Latham

    Head Connected Health Product Development, Novartis Pharma AG
    Daniel Latham

    Daniel Latham is the Head of Connected Health Product Development at Novartis, where he leads the organisation responsible for the development of connected health ecosystems comprising smart drug / device combinations, SaMD apps for web and mobile applications and tele-health solutions. Prior to this he was Head of Device Development and LCM for 5 years leading an organisation developing drug/device combinations for new biologic entities, biosimilars, and new chemical entities. Over the past 14 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer healthcare, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, University of London and a bachelor’s degree and master’s degrees in Engineering from the University of Sheffield.

    David Braun

    Global Head of Connected Health and Devices, MerckGroup KgAa
    David Braun

    David Braun is Global Head of Digital Health and Connected Devices Business for Merck HealthCare. In this role David is supporting the efforts of Merck to improve patients’ journey, disease management, patient engagement, adherence monitoring and healthcare professionals decision making with smart devices and digital solutions. David is an executive leader with 20 years of experience in Strategy, R&D, Operations, business management and transformation working in Europe, USA and Asia, in small startups and large multinational companies. Through his career David gained significant experience managing strategic projects, designing winning organizations, leading and coaching cross functional teams bringing innovative products from ideation to launch, defining and implementing wining strategies.

    Before joining Merck, David served as Head of EMEA Operations and Global R&D of the Technology Business unit at Newell Brands, a Fortune 500 company, where he led R&D teams and manufacturing sites across the globe, organizational transformation, growth initiatives and multimillion-dollar projects. Prior to that, he worked as Vice President of R&D and Operations at Biosafe SA a medical device company acquired by GE Healthcare, developing and launching products in the field of stem cell banking, bioprocessing and cellular therapies. David also held various senior management and engineering roles in the aerospace and high-tech industry.

    David participated in Executive Leadership and General Management programs at the Harvard Business School in Boston and at IMD in Switzerland. He holds a degree in electronical and optical engineering and a master’s degree in applied physics from the Louis Pasteur University and from the Jerusalem College of Technology.
     

    Eleanor Kimber

    Device Engineer, GlaxoSmithKline
    Eleanor Kimber

    Eleanor Kimber has an MEng in Biomedical Engineering, and has worked as a project manager, clinical trial manager and device engineer. She currently works at GlaxoSmithKline in the Device Engineering department and is leading the validation of the digital twin being developed.

    Jochen Zenker

    Head of Laboratory Process Engineering, Boehringer Ingelheim Pharma GmbH & Co. KG
    Jochen Zenker

    Jochen Zenker is the head of Process Engineering Combination Products at Boehringer Ingelheim GmbH & Co Kg. Prior to BI Pharma he worked for an CMO as a leader and managing engineer in a Device Development Department.

    He has had more than 13 years of experience in pharmaceutical development and has a bright range of expertise in numerous customer projects for Prefilled Syringes, Cartridges and Drug Delivery Devices.
    Jochen holds several issued patented innovations in the field of combination products.

    He started his career as a head and managing engineer for automotive interior design at Hymer LMB before changing to the pharmaceutical industry.
    Jochen has a degree in mechanical engineering from the University of Stuttgart
     

    Joel Richard

    Chief Development Officer, MedinCell
    Joel Richard

    Dr Joël Richard is currently Chief Development Officer at MedinCell (Montpellier, France) that he joined 3 years ago. He is leading all the development activities of the company, based on the proprietary technology BEPO® for Long-Acting Injectables. (LAIs). These activities comprise formulation and process development, device development, analytical development, process transfer and scale-up, manufacturing and supply of clinical batches, regulatory affairs, non-clinical and clinical development operations, quality and regulatory compliance. Dr Richard has more than 30 years of experience in chemistry and (bio)pharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Ipsen (France), Serono (Italy), MerckSerono (Germany), Ethypharm (France). Dr Richard has focused his research activity on new formulation technologies and innovative drug delivery systems (nanosystems, microspheres, self-assembling gels, implants), especially for injectable peptide and protein formulations. He has graduated from Ecole Normale Supérieure (Cachan, France), and got a PhD in Materials Science (Paris VI, France), and the “Habilitation à Diriger les Recherches” in Chemistry (Bordeaux I, France). He has published 72 peer-reviewed scientific papers, 8 book chapters and 2 review editorials in various fields. He is the author of 140 international communications and 55 patent families. He has also been serving as an APGI Board Member for 3 years and is a Member of the Controlled Release Society (CRS).

    Julia Frese

    Director, TUV SUD Japan Ltd.
    Julia Frese

    By education biomedical engineer with a Master degree in business administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was further involved in the development of standards for ATMP products. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organisation. She is further co-chair of the Team NB working group for article 117

    Louise Place

    Director, Devices, GlaxoSmithKline
    Louise Place

    Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.
    Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.
    With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.
     

    Mathilde Barbeau

    Senior Regulatory Professional, Novo Nordisk A/S
    Mathilde Barbeau

    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).
     

    Raphael Nudelman

    Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals
    Raphael Nudelman

    Raphael has over 20 years of pharmaceutical industry experience. He has a M.Sc. degree in Pharmaceutical Sciences from the Hebrew University in Jerusalem, Israel, and a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel. After completing two postdoctoral positions, one in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and the other in Duke University Medical Center, North Carolina. In 2001 he joined in a startup biotech company in Israel that performed rational drug design by molecular modeling. In 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals and in 2010 he established the Chemical & Computational Toxicology group in Teva, which he headed until June 2021. As of July 2021, Raphael has been appointed Sr. Director, Impurity Expert R&D Operations in the R&D Operations and Biosimilars department. Raphael's main topics of expertise are impurity and excipient qualification in drug substances and drug products.
    From 2011 to 2016, Raphael was the President of the Medicinal Chemistry Section of the Israel Chemical Society, and was as a Council member of the European Federation of Medicinal Chemistry (EFMC). From 2012 to 2020 he was a member of the Advisory Council of High School Chemistry Education in the Israel Ministry of Education.
     

    Rene Holm

    Professor, University of Southern Denmark
    Rene Holm

    René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science covering both small and large molecules and is now responsible for the functional unit ensuring development of all non-solid formulations for Janssens small molecule value stream.

    Dr. Holm is (co-) author of more than 185 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is a honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark.
     

    Richard Simcock

    Human Factors Scientist, Teva Ltd
    Richard Simcock

    Richard is a chartered human factors specialist (Chartered Institute for Ergonomics and Human Factors (CIEHF)) with over 20 years’ experience applying human factors in high-risk sectors including nuclear decommissioning, medical device development, defence and transport.

    Richard’s primary interests are usability engineering and user interface design, with experience in control room and control system design, device design and user testing, human reliability assessment, task design and organisational human factors. Outside of work Richard likes to walk, run, lift, eat, drink, play and sing.
     

    Sachin Dubey

    Head of Drug Product and Analytical Development, Ichnos Sciences, SA
    Sachin Dubey

    I am presently working with Ichnos Sciences, Switzerland (A part of Glenmark Pharmaceuticals SA, Switzerland) and heading three major functions for the company – formulation, analytical, and drug product development groups. I have more than 15 years of experience in this area with > 9 years in an industrial setting (with previous global experience with Novozymes A/S Denmark and Glenmark Pharmaceutical SA Switzerland). Twelve products developed by me and my team are currently in clinical trials. These products are in different markets including the USA, EU, and Asia – this gave us very rich hands-on experience. In addition, I have 18 PCT patents, 24 publications in high-impact journals like Trends in Biotechnology, Journal of Controlled Release, Molecular Pharmaceutics, etc., 7 book chapters, and have been invited speaker on the topic in several international conferences (> 50). Industry and academia have equally recognized my contribution with 20 research awards including prestigious industry awards from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International bio camp), and the Swiss Society of Pharmaceutical Sciences (Best publication).

     

    Session Reserved for

    , Zeon
    Session Reserved for

    Severine Duband

    Global Category Director, Devices, Nemera
    Severine Duband

    Séverine Duband is Marketing Director for drug delivery Devices at Nemera, steering overall category strategy, product portfolio and innovation development for five key delivery routes. She has been leading the parenteral segment at Nemera since 2018, focusing on proprietary products such as safety systems, pen injectors and on-body injectors. Ms Duband graduated from Emlyon Business School (Lyon, France) in 2004, and joined Nemera’s Global Marketing team in 2018 as a Global Category Manager, focusing on the parenteral segment.

    Sponsors

    Exhibitors

    Focus Days

    Sustainability for Drug Delivery Devices
    Focus Day

    Sustainability for Drug Delivery Devices

    Venue To Be Confirmed
    11th January 2022
    London, United Kingdom

    VENUE

    Venue To Be Confirmed

    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

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    Past Attendees

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    Focus Day Speaker Bios

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    Short Programme - Focus Day 2022

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    Long Programme - Focus Day 2022

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    Speaker Bios

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    Long Programme 2022

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    Short Programme 2022

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    Sponsors


    Crux

    Sponsors
    http://www.cruxproductdesign.com

    Established in 2003, Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems.



    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.

    Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions.



    Zeon

    Sponsors
    http://www.zeonex.com

    Zeon Europe GmbH is the European marketing/sales organisation of Zeon Corporation / Japan. As part of specialty materials operations Zeon produces Cyclo-Olefin Polymers (COP) under the tradenames ZEONEX® and ZEONOR®. The balance of outstanding water barrier properties in combination with high purity, excellent chemical resistance, high transparency and low interaction with drugs, put ZEONEX® and ZEONOR® as a perfect alternative to glass or other plastics solutions for pharmaceutical and biopharmaceutical containers - such as Pre-filled syringes, cartridges and vials.

    Exhibitors


    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

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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, SMI 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@smi-online.co.uk

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