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SMi is proud to present their 11th annual European conference and exhibition, within the Pre-Filled Syringes series: Pre-Filled Syringes & Injectable Drug Devices Europe. The event will take place on the 16th-17th of January 2019, in London. 

Building on the sell-out success of the 10th annual event in 2018, the 11th annual conference promises to be even bigger, with the addition of a new section to the agenda on Injectable Drug Devices.

Previous attendee testimonials:
"Very interesting, good presentations, good chairman" - Ypsomed AG
"I think that the conference covered a large scope of subjects...thanks to SMi" - Aspen Pharma
"A very educated and enjoyable conference with a good mix of topics and speaking styles" - MHRA
"Good conference - right attendees" Nemera
"Very good conference, good speakers and qualitative attendees" - Nipro

The conference will offer a deep insight into key areas within the field, such as: new technologies and overcoming their hurdles to implementation; connectivity for devices; updates on drug development and the impact on device developments and new regulatory guidelines. Our line-up of expert speakers will enable delegates to learn from market leaders on best practices to overcome common industry hurdles.

Join us in January 2019 to network, benchmark and learn about developments at the forefront of the Pre-Filled Syringes and Injectable Drug Devices industry.

This is our most sought-after event and will be sold out soon.
Early registration is strongly advised to avoid disappointment.
 

  • Engage and interact with like-minded individuals through 5+ hours of dedicated networking time, within the conference programme
  • Learn from fellow field experts through our interactive programme structure and our fantastic delegation with representation from all aspects of the industry, as well as cross-industry thought leaders and decision makers
  • Discover new technologies being developed to circumvent common industry hurdles and discuss ways in which to overcome the barriers of implementation
  • Hear case studies about the streamlining of injectable device development – from development to market
  • Interact with regulatory bodies in order to glean insight into the most recent revisions to regulation and the best ways to integrate them into business practices
  • Learn about current drug development programmes which will have an imminent impact on the PFS and Injectable devices sector and discuss the influence which drug development has on device development
  • Discuss patient centricity and the impact of human factors on design processes

• 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:

3P INNOVATION LTD; AbbVie Ltd; addey and stanhope school; Affibody AB; Aptar; APTAR PHARMA; Ascendis Pharma GmbH; Aspen Pharmacare; AstraZeneca; B. Brauná; BA Consultancy; BAUMANN SPRINGS LTD; Bayer Pharma AG; Becton Dickinson; Bespak Innovation; Biocorp; Biopharm Insight; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Cambridge Consultants Ltd; Colwill Health Ltd.; Consillient Health; DATWYLER PHARMA PACKAGING INTERNATIONAL NV; Datwyler Schweiz AG; DTP Holding; E3D ACA Ltd; F. Hoffmann-La Roche Ltd.; Formycon AG; FRUH VERPACKUNGSTECHNIK AG; Galderma; GALDERMA R&D; Genentech, Inc.; Gerresheimer; Glenmark Pharmaceuticals S A; GROUPE JBT; GSK; GSK R&D; Guerbet; Intertek (Schweiz) AG; Laboratoire Aguettant; LEO Pharma; LEO Pharma A/S; LFB Biotechnologies; LRQA; Medical Device Usability Ltd; Merck Group; MET; MHRA; Midatech Pharma; Mikron S A Boudry; MINAKEM SAS; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mylan; Mylan, Inc.; Nemera; New Injection Systems Ltd; Nipro Europe NV; Nolato Medical; Novartis; Novartis Pharma AG; Octapharma; Owen Mumford; Owen Mumford Ltd.; Pfizer; PFIZER CenterOne; Pharmaceutical Systems; Pharmacircle; Pharmis Biofarmaceutica Lda; Phillips-Medisize; Pliva; Roche; Samedan Ltd ; Sandoz; Sanofi S A; Sanofi-Aventis; SCHOTT; SCHOTT AG; SCHOTT Schweiz AG; Shire; SiO2 Medical Products; teamtechnik Maschinen & Anlagen GmbH; Terumo ; Terumo Europe; Terumo Europe N.V.; Terumo Europe NV; Teva-Pliva; TOPAS Advanced Polymers GmbH; Trinseo Deutschland GmbH; UCB; UCB Celltech; Vetter Pharma International GmbH; W.L. Gore & Associates, Inc.; Weidmann Medical Technology AG; West Pharmaceutical Services; West Pharmaceutical Services Deutschland GmbH & Co. KG; Worrell; Ypsomed AG; Zeon Europe GmbH; Zwick Testing Machines Limited;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

James Mellman

James Mellman, Device Manager, Novartis
View Bio

Anil Busimi

Anil Busimi, Strategy and Innovation Global Product Manager, SCHOTT

9:10 Design Strategy for Delivery Systems Development

Cedric Gysel

Cedric Gysel, Staff Device Engineer, Janssen
View Bio

  • Current strategies towards device development and the hindrances which arise due to current processes
  • Case studies of device development which circumvent current development challenges and how that has an impact on future stages, e.g. manufacturing and distribution
  • How studies conducted have led to a revision and improvement of development practices
     
  • 9:50 Drug / Device parenteral combination products: An approach to defining the overall design space

    Steve Chamberlain

    Steve Chamberlain, Device Engineering Manager, GSK

  • Understanding the interaction between the prefilled syringe and the autoinjector device
  • Executing characterisation studies to build the knowledge space
  • Defining a harmonised control strategy to ensure capability of Critical Quality Attributes
  • 10:30 Morning Coffee

    11:00 Preferred Properties of Pre-Filled Syringes for Biopharmaceuticals

    Reinhard Scheller

    Reinhard Scheller, Commercial Manager Cyclo Olefin Polymers - COP Europe, Zeon Europe GmbH
    View Bio

  • Physico-chemical characterisation of biopharmaceuticals
  • Degradation and stabilisation of biopharmaceuticals
  • Relation to typical container systems
  • 11:40 Development of a Combination Product Control Strategy

    Mathieu Rigollet

    Mathieu Rigollet, Senior PFS Engineer, Roche

  • Steps towards the development of a combination product control strategy
  • The essential performances requirements
  • The critical process parameters for generation on the control strategy
  • Case studies following this approach
  • 12:20 Networking Lunch

    13:20 Computational Model supporting design verification data to estimate occurrence levels of critical quality attributes

    Michael Becker

    Michael Becker, Design Engineer, Boehringer Ingelheim
    View Bio

  • Computational Model for automated injection device
  • Simulation in context of design verification and estimation of occurrence rate for post market
  • Combining models with physical testing to reduce test effort, sample sizes and failure risk
  • 14:00 Application of Quantitative 1H-NMR Spectroscopy for the determination of silicone oil and degradation products hereof

    Joan Malmstrøm

    Joan Malmstrøm, Principal Scientist, Novo Nordisk A/S
    View Bio

  • Non destructive detection of silicone oil and it’s degradation products
  • Linear quantitative method working in aqueous as well as organic solvents
  • Simple to validate according to ICH principles
  • Stability indicating method
  • Orthogonal method to e.g. MFI and ICP
  • 14:40 High throughput testing of injectable devices with a fully automated testing system using special sampling plans

    Alexander Zuern

    Alexander Zuern, Device Testing Manager, Novartis
    View Bio

  • 24/7 measurements of injectable devices using a fully automated testing machine
  • Measuring up to 600 devices within 24 h fully automated and GxP compliant
  • Fully automated testing of different devices in parallel
  • Special sampling plan based on ISO3951-2 with reduced, batch independent sample size
     
  • 15:20 Afternoon Tea

    15:50 Regulatory updates in the Pre-Filled Syringes and Injectable Drug Devices market

    Vikas Jaitely

    Vikas Jaitely , Senior Manager Pharmaceutical Sciences & CMC Regulatory Intelligence, Merck Group

  • Safety legislation and revisions to current guidelines
  • Change in device regulations and what that means for the pharmaceutical side of the industry
  • The added layer of safety assurance through physical, pre-administrative checks. How this not only meets regulatory requirements, but assures patient safety as well
  • Human factors engineering – regulatory challenges
  • Control strategy for combination products
  • 16:30 Regulatory expectations on emerging technologies

    Suraj Ramachandran

    Suraj Ramachandran, Director, MSD
    View Bio

  • Updates on combination product regulation and the view of auto-injectors and pre-filled syringes within that scope
  • The difference between injectors and pre-filled syringes – the line between a drug product and a device
  • Where new technologies fall within the regulatory scope of device development
  • New medical device directives
  • 17:10 Pre-filled syringes and drug-device combination products (DDC) – a regulator’s perspective

    Veronika Ganeva

    Veronika Ganeva, Biologicals Quality Assessor , MHRA
    View Bio

  • Introduction to DDC
  • The current regulatory framework in the EU
  • Times of change – a look to the future                                                                                                           
  • Regulatory challenges
  • 17:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    James Mellman

    James Mellman, Device Manager, Novartis
    View Bio

    Anil Busimi

    Anil Busimi, Strategy and Innovation Global Product Manager, SCHOTT

    9:10 Opportunities and challenges of implementation of platform component for biologic injectable delivery

    Elise Legendre

    Elise Legendre, Head of Late stage PFS Development, Sanofi
    View Bio

  • Why do we need a platform? A standardised approach
  • Where does the platform start and stop in the development process? And are all the area impacted?
  • What are the challenges for the projects? The team and the documentation?

     

  • 9:50 Pre-clinical development of a drug product for injection

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, SCYNEXIS Inc
    View Bio

  • Recognition of molecule and formulation needs to support product development
  • Considerations necessary for early development injectable program vs. bridging to existing program from another route
  • Drug/Device considerations and the need for leachable evaluations and qualifications

     

  • 10:30 Morning Coffee

    11:00 Injection devices and patient’s experience: impact and solutions to improve overall perception

    Severine Duband

    Severine Duband, Global Category Manager for Parenteral Segment, Nemera
    View Bio

  • What could be the main drivers of pain perception (drug formulation, volume, viscosity)?
  • How can parenteral devices influence patient’s comfort?
  • Which solutions could device manufacturers bring to improve the patient’s experience?
  • 11:40 Harnessing the Digital Exhaust: Incorporating wellness into the Pharma Model and how Drug Delivery will be a key enabler

    Justin Wright

    Justin Wright, Global Head of Innovation, Novartis
    View Bio

  • The industry is undergoing a pivotal transformation as traditional drugs are supplanted by next generation product systems where, in some cases, the drug is only a component of the overall product offering
  • This situation has created a compelling entry point for non-traditional competitors and start-ups to access this market and potentially re-define the value model associated with drug pricing
  • A dynamic patient interface which leads to extraordinary patient engagement
  • A review of the current and future state along with perspective and case studies will be provided in order to help shed light on the areas of needed focus and corresponding opportunity

     


     

  • 12:20 Innovative glass pre-filled syringe (PFS) solutions for biotech drugs

    Nicolas Eon

    Nicolas Eon, Global Product Manager Glass PFS syriQ, SCHOTT
    View Bio

  • The R&D pipeline of global pharma industry is full with biotech-based drugs making personalized medicine a reality
  • Most of these drugs are target specific and highly sensitive demanding special attention to all the steps along the development process and value chain
  • Biotech drugs are complex molecules and may interact with the components of the PFS (needle, glue, silicone, elastomer etc.) leading to stability issues, impact efficacy of the drug and worst cases immunogenic response in patients
  • Prefilled syringes are an enabler for market trend hospital to home administration for injectable drugs
  • This presentation will share the solutions and risk mitigation approaches for glass pre-fillable syringes making them the first choice for biotech drugs
  • 13:00 Networking Lunch

    14:00 The best plastic syringe for biologics

    Shota Arakawa

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical
    View Bio

  • OXYCAPT Multilayer Plastic Syringe having Glass-like Oxygen Barrier
  • Excellent Oxygen Barrier Contributes to Stability of Biologics
  • Latest Protein Aggregation Study
  • Latest Container Closure Integrity Study
  • 14:40 Dosing accuracy-and precision of intravitreal injection with 0.5 mL syringe in comparison to 1 mL long syringe

    Markus Hemminger

    Markus Hemminger, Senior Device Engineer, Roche
    View Bio

  • Regulatory requirements on dosing accuracy
  • Significant test parameters
  • Test results and statistical analyses
  • Optimization and verification of dose mark position for 0.5 mL syringe
  • 15:20 PANEL: Glass vs Polymers for primary packaging for injectable drug devices

  • The regulatory perspective surrounding primary packaging
  • Technical standards
  • Component integration
  • James Mellman

    James Mellman, Device Manager, Novartis
    View Bio

    Suraj Ramachandran

    Suraj Ramachandran, Director, MSD
    View Bio

    Anil Busimi

    Anil Busimi, Strategy and Innovation Global Product Manager, SCHOTT

    16:00 Afternoon Tea

    16:30 Change is Inevitable- Post Market considerations for combination products

    Maggie Reiff

    Maggie Reiff, Associate Device Engineer, Pfizer

  • Overview of regulatory expectations for post marketed products
  • Leveraging design controls in order to manage changes and mitigate risks
  • Considerations and best practices
  • Challenges and Opportunities
  • 17:10 Risk Management for injectables drug devices throughout the lifecycle

    Davide Mercadante

    Davide Mercadante, Sr Associate Quality Drug Devices, Biogen
    View Bio

  • Integrated Risk Management model for Drug-Device Combination Products
  • Hazard analysis: Key role to lead the risk management process
  • Risk Analysis and Control
  • Importance of the post-marketing phase to revise the Risk Management File
  • 17:50 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Cedric Gysel

    Cedric Gysel

    Staff Device Engineer, Janssen
    Joan Malmstrøm

    Joan Malmstrøm

    Principal Scientist, Novo Nordisk A/S
    Justin Wright

    Justin Wright

    Global Head of Innovation, Novartis
    Michael Becker

    Michael Becker

    Design Engineer, Boehringer Ingelheim
    Veronika Ganeva

    Veronika Ganeva

    Biologicals Quality Assessor , MHRA

    Alexander Zuern

    Device Testing Manager, Novartis
    Alexander Zuern

    Alexander Zürn is a pharmacist by training. He got a PhD in Pharmacology from the University of Würzburg, Germany and did a postdoc at the University of California Berkeley at the department of bioengineering. From there he joined Novartis in 2012 as a process expert. From the production he join the QC Department of Novartis Stein and was until 2017 a QC team leader and SPOC for the injectable device testing at the release site.
    Since 2017 he has been in the Device Development and Commercialization (DD&C) department at Novartis Basel as a device testing manager and is the Analytics and Testing Network leader.
     

    Anil Busimi

    Strategy and Innovation Global Product Manager, SCHOTT
    Anil Busimi

    Cedric Gysel

    Staff Device Engineer, Janssen
    Cedric Gysel

    Cedric is a device engineer and technical product owner at Janssen (Pharmaceutical Companies of J&J). He holds a master’s in medical device technology with a specialisation in human centered design from the University of Applied Science in Berne. After working for Novartis and Actelion in different research and development roles, he joined Janssen in 2005 where he has held different development and market support roles. He is also a guest lecturer at the Berne University of Applied Science and a member of the Human Centered Design Workgroup of Swiss Medtech.

    Davide Mercadante

    Sr Associate Quality Drug Devices, Biogen
    Davide Mercadante

    Davide Mercadante is a medical engineer with 10+ years of experience within multiple areas of device and combination product development, including design & development, design quality assurance, verification & validation engineering, quality control and supply chain quality. He received his bachelor’s and master’s degree in medical engineering from the Second University of Rome, where is focus was on medical device design and development.
    Davide has a Lean Six Sigma Green Belt and he currently works at Biogen in the Device Development Quality group where he is the quality project lead for both the Risk Management Continuous Improvements and Combination Product DHF 21CFR Part 4 Final Rule enhancement projects. He also has been instrumental with the integration of software as a medical device into the existing Quality Management System.
     

    Elise Legendre

    Head of Late stage PFS Development, Sanofi
    Elise Legendre

    With 15 years of experience across pharma, Elise currently serves as Head of late stage development of primary container in medical device at Sanofi.
    She is responsible of leading the drug integrated product development for both biologics and small molecules on prefilled syringe based delivery system. Her group is mainly leading the operation of the PFS development and the transfer of the developed container and safety system to R&D center and manufacturing groups. Before this position, she was supporting various medical devices combination products, such as auto injectors, prefilled syringes projects as PFS expert and project manager.

    Prior joining Sanofi, Elise was GSK’s packaging head on an industrial site in Normandy. She was managing the LCM activities on primary, secondary packaging.
    Before this, Elise worked in Aseptic and Packaging manufacturing area as operational manager where she served in various roles focused on manufacturing, product commercialization and operational excellence.
     

    James Mellman

    Device Manager, Novartis
    James Mellman

    James is a device manager for Novartis in Basel, Switzerland. His main responsibilities include developing primary packaging systems for combination products and supporting new technologies. He has worked on a multitude of injection device platforms including pre-filled syringes, needle safety devices, auto injectors, and patch injectors. He has also helped to build and implement a renovated CCIT strategy for the Novartis Group. Before Novartis, James worked at Pfizer in their Devices Center of Excellence in Cambridge, UK (2008-2011) and Nutricia in their Advanced Medical Nutrition Division HQ in Amsterdam, NL (2011-2014). He received his PhD from the University of Florida in Materials Science & Engineering in 2007 specializing in biomaterials.

    Joan Malmstrøm

    Principal Scientist, Novo Nordisk A/S
    Joan Malmstrøm

    Joan Malmstrøm is a Principal Scientist at Novo Nordisk A/S holding a Ph.D. degree in chemistry from the University of Copenhagen and +20 years of experience with structural elucidation of organic molecules using nuclear magnetic resonance spectroscopy and mass spectrometry as analytical tools. The projects she has been involved in at Novo Nordisk A/S ranges from small molecules (API’s, raw materials/excipients, etc.) up to peptides/proteins and large molecular weight polymers. During the past years one of her main activities has been the development of analytical methods suitable for analysis of leaching of silicone oil and degradation products hereof into the aqueous phase kept in primary packing material.

    Justin Wright

    Global Head of Innovation, Novartis
    Justin Wright

    With 20 years of experience across med tech and pharma, Justin currently serves as Global Head of Innovation at Novartis where he is responsible leading the enterprise innovation system across the drug development process for both biologics and small molecules. This includes activation of the innovation strategy and leading cross-functional innovation governance internally and externally to Novartis.

    Prior to joining Novartis, Justin helped launch and then lead Lilly’s Cambridge Innovation Center that was tasked with building Lilly’s next generation delivery and connected product systems. This also included developing new innovation and external partnership models in order to accelerate drug delivery innovation along with mapping a number of strategies for digital biomarkers and clinical feedback loops. Before this, Justin worked at Becton Dickinson (BD) where he served in various roles focused on developing and commercializing drug delivery systems for the biotech, vaccine, and pharmaceutical industries. Justin began his career at Merck & Company working across manufacturing, product commercialization, and franchise management.

    Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.
     

    Maggie Reiff

    Associate Device Engineer, Pfizer
    Maggie Reiff

    Markus Hemminger

    Senior Device Engineer, Roche
    Markus Hemminger

    Markus Hemminger is a Senior Engineer who joined Roche in the year 2013, being a member of the prefilled syringe development, a subgroup of device development. Currently he is part of a cross-functional team developing a prefilled syringe for ocular injections where he is in charge of various tasks, e.g. designing and specifying the device components and planning of design verification. Before starting at Roche he was responsible for primary packaging development for biopharmaceuticals at Boehringer Ingelheim for more than 13 years. His main expertise includes selection, development and optimization of container closure systems like vials, cartridges and syringes, as well as transfer-and administration devices, packaging component related method- and process developments and CCI testing. Markus Hemminger studied chemistry at the University of Applied Sciences in Aalen, Germany.

    Mathieu Rigollet

    Senior PFS Engineer, Roche
    Mathieu Rigollet

    Michael Becker

    Design Engineer, Boehringer Ingelheim
    Michael Becker


    Dr. Michael Becker (1983) is working at Boehringer Ingelheim Pharma GmbH & Co. KG since 2016 as Design Engineer for parenteral combination products. Previously, he worked for 5 years at Sanofi-Aventis GmbH in the development of the same products. He studied Physics at the University of Mainz and wrote his PhD thesis about the „Development of an Aerodynamic Particle Model of Powder & Aerosols“ supervised by Mr. Prof. Cameron Tropea (Technical University Darmstadt) at Boehringer Ingelheim. In this time he specialized in writing simulations and statistics.

    Michael Becker is married and lives together with his wife and his daughter near Mainz.
     

    Nicolas Eon

    Global Product Manager Glass PFS syriQ, SCHOTT
    Nicolas Eon

    Dr. Nicolas Eon, graduated from Universities of Nancy and Nantes, holds a Fluid Mechanics & Energy Science Engineering degree, a Master Degree in Energetics and Heat Transfer and a PhD. in Biomechanics. He worked for 10 years in the Automotive Safety Industry where he led the System Engineering Department in a global leading company. He has joined BD Pharmaceutical Systems in 2008 where he was in charge of the Global Product Engineering for Prefillable Syringe Systems. In 2012, Nicolas joined SCHOTT AG as Business Development Manager for Glass and Polymer Prefillable Syringes. Since 2010, he has been an active expert in ISO Technical Committees (ie. TC 76 WG4, TC 210) as part of the French and Swiss delegation. He is now in charge of the Glass PFS Strategy, Innovation and Technology Roadmap at SCHOTT AG as Global Product Manager for syriQ® brand.

    Reinhard Scheller

    Commercial Manager Cyclo Olefin Polymers - COP Europe, Zeon Europe GmbH
    Reinhard Scheller

    Professional Experience
    2003 – present Commercial Manager Cyclo Olefin Polymers (COP) for Europe at Zeon Europe GmbH , Düsseldorf / Germany
    • Responsible for the business development of Zeon’s Cyclo Olefin Polymers (COP) in Europe
    • Focus on medical/pharmaceutical , analytical/diagnostical and optical COP applications

    1996 – 2003 Sales Manager for Germany at Zeon Deutschland GmbH , Düsseldorf / Germany
    1991 – 1996 Sales Representative Speciality Rubbers at Zeon Deutschland GmbH , Düsseldorf / Germany
    1980 – 1991 Scientific co-worker at the Institut of Polymer Technology Dresden / Germany (today: Leibniz-Institute of Polymer Research Dresden)
    Education
    1975 – 1980 Studies of Materials Science (specialisation plastics technology and plastics processing) at Technical University Leuna-Merseburg / Germany
     

    Severine Duband

    Global Category Manager for Parenteral Segment, Nemera
    Severine Duband

    Séverine DUBAND has recently joined Nemera as Global Category Manager of the parenteral segment. She is responsible for developing the parenteral products, including the passive safety systems Safe’n’Sound®, the innovative autoinjector Safelia®, as well as several other projects.
    Graduated from EM Lyon Business School in 2004, Séverine worked 10 years for FMCG in the chemical industry as International Category Manager, supervising strategic planning, NPD launches, project management and brand communication.
     

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical
    Shota Arakawa

    Mr. Shota Arakawa is a researcher of Advanced Business Development Division.
    He gained a Diploma in Science in 2007 and a Master Degree of Science in 2009 from Osaka University.
    Since April 2009 he has been working for Mitsubishi Gas Chemical Company, Inc.
    and in charge of macromolecular science, especially in synthesis of polymers and material development.
    Since 2012 he has joined a development team of multilayer plastic vial & syringe for biologics.

    Stephen Barat

    Head of Pre-Clinical and Early Clinical Development, SCYNEXIS Inc
    Stephen Barat

    Stephen A. Barat, PhD, is currently the Head of Preclinical Research and Early Development for Scynexis. Dr. Barat has more than 20 years of global drug development and registration experience across multiple therapeutic areas. Prior to joining Scynexis, he served in various leadership positions in preclinical development in Allergan, Forest Laboratories, and Schering-Plough. Dr. Barat is also a recognized expert in the interface between safety assessment and CMC requirements and is a member of the PQRI working group for leachables from parenteral drug products and the USP expert panel on biocompatability of packaging materials. He has spoken extensively in numerous international venues on a variety of topics on drug development.

    Steve Chamberlain

    Device Engineering Manager, GSK
    Steve Chamberlain

    Suraj Ramachandran

    Director, MSD
    Suraj Ramachandran

    Suraj Ramachandran, MS, RAC, is a Director, Regulatory Affairs in the Drug Device Center of Excellence at Merck based in Rahway, NJ. Suraj is currently responsible for supporting various medical devices combination products, such as auto injectors, prefilled syringes, inhalers and contraceptives. In addition, he is heavily involved in providing guidance for digital solutions and has led many development efforts regarding medical device software, intended for both domestic and international markets. In previous roles within industry, he was responsible for an infusion pump platform as well as supporting all new product development and lifecycle maintenance activities including regulatory submissions, design control, audits, and CAPAs. Suraj holds a Master’s in biomedical engineering from the University of Michigan. In addition, he has earned the RAPS RAC certification.

    Veronika Ganeva

    Biologicals Quality Assessor , MHRA
    Veronika Ganeva

    Veronika is a quality assessor at the MHRA, where she is responsible for the evaluation of a diverse portfolio of biological medicinal products, which includes recombinant and non-recombinant proteins, monoclonal antibodies, plasma-derived products, vaccines, ATMPs and others. She has a PhD degree in Stem Cell and Developmental Biology from the University of Edinburgh and has worked on a range of research and regulatory positions in academia, the pharmaceutical industry and two regulatory agencies. Veronika is passionate about helping bring high quality medicinal products to the market and a fair and science-based regulatory process. She has an additional interest in medical devices and drug-device combination products.

    Vikas Jaitely

    Senior Manager Pharmaceutical Sciences & CMC Regulatory Intelligence, Merck Group
    Vikas Jaitely

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    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.

     

    HOTEL BOOKING FORM

    Workshop B

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    Workshop A

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    Speaker Line-up

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    Conference Programme

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    Presentation by Steve Chamberlain, GSK

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    Presentation by Takuya Minezaki, Mitsubishi Gas Chemical

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    Presentation by Vikas Jaitely, Merck

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    Presentation by Marcel Muller, Novartis

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    Presentation by M. Hemminger PTDE-D, Roche

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    Presentation by Liz Baker, MHRA

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    Chair Letter

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    Pre-Filled Syringes & Injectable Drug Devices Infographics

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    Sponsors and Exhibitors


    Früh Verpackungstechnik AG

    Sponsors and Exhibitors
    http://www.fruh.ch/

    Früh Verpackungstechnik AG is located in Switzerland and Europe’s leader for contract packaging of medical devices. We have as well the Swiss Medic approval for secondary packaging of pharmaceuticals. Our expertise is the assembling (in ISO class 7 clean rooms) and packaging of pre-filled syringes for sterile applications with respecting cold chain requirements. Früh offers as well the production of pre-made packaging materials (blisters and pouches) in class 7 clean rooms.


    Harro Höfliger

    Sponsors and Exhibitors
    http://www.hoefliger.com

    Harro Höfliger is located in Southern Germany with over 1250 employees. With an extensive portfolio of technical platforms, Harro Höfliger offers customer specific, special solutions for growing market segments, innovative products and new drug delivery systems. Its technology platforms and turnkey system solutions are always precisely tailored to the needs of the customer. This 100% customer focus and a high level of innovation have earned the company a leading market position. With a worldwide sales and service network. A member of Excellence United.


    Mitsubishi Gas Chemical

    Sponsors and Exhibitors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Nemera

    Sponsors and Exhibitors
    http://www.nemera.net

    Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology & generics industries. Nemera always puts patients first, providing services and products for several key delivery routes: Parenteral, Ophthalmic, Nasal, Buccal, Auricular, Inhalation, Dermal/Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: - Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. - Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.


    PHC Holding Corporation

    Sponsors and Exhibitors
    http://www.phchd.com/global

    In April 2018, Panasonic Healthcare Holdings Co., Ltd. changed its name to PHC Holdings Corporation. For all the people who wish for better health. Over the approximately 70 years since our establishment, we have delivered ground-breaking products to the world. The newly created “PHC” will take on the challenge of providing ever new innovations, drawing on the spirit of monozukuri (Japanese manufacturing).We will continue to evolve as a provider of devices and services marked by PHC's precision technology in our three core business areas of Medical Devices, Healthcare IT, and Life Sciences.


    Schott AG Pharmaceutical Systems

    Sponsors and Exhibitors
    http://www.schott.com/uk/english/index.html

    SCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. With more than 130 years of outstanding development, materials and technology expertise we offer a broad portfolio of high-quality products and intelligent solutions that contribute to our customers’ success. SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of primary packaging and specialized analytical lab services for the pharmaceutical industry. We provide our customers quality solutions while meeting their highest demands with our expertise and broad product portfolio; including ampoules, cartridges, vials and syringes made of glass and COC polymer. Our state-of-the-art production facilities and our products comply with the highest international quality standards for pharmaceutical needs.


    ZEON Europe GmbH

    Sponsors and Exhibitors
    http://www.zeon.eu/cop-copf-zeonex-zeonor-zeonorfilm.html

    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.


    Zwick Roell

    Sponsors and Exhibitors
    http://www.zwick.co.uk

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

    Media Partners


    Drug Discovery Today

    Official Media Partner
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.


    Drug Development & Delivery

    Official Media Partner
    http://www.drug-dev.com

    Drug Development & Delivery is a print/online content provider that presents the latest scientific methods in drug development for professionals.


    World Pharma News

    Official Media Partner
    http://www.worldpharmanews.com/



    Pharma Journalist

    Official Media Partner
    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.


    Samedan

    Official Media Partner
    http://www.samedanltd.com/magazine/13.

    International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.

    Media Partners


    Mednous

    Supporters
    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


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    GBI

    Supporters
    http://www.gbihealth.com/

    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    pharmanews hq

    Supporters
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the 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. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Select Science

    Supporters
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Farmavita

    Supporters
    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    pharmaphorum

    Supporters
    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


    European Biotechnology Network

    Supporters
    http://european-biotechnology.net/

    The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. The non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships.


    Pharmacircle

    Supporters
    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….


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.

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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.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, 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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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