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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

Anil Busimi

Anil Busimi, Strategy and Innovation Global Product Manager, SCHOTT Schweiz AG

9:10 Current strategies for developing combination product delivery systems

James Mellman

James Mellman, Device Manager, Novartis

  • Defining combination products – a regulatory perspective
  • The current state of increasing complexity
  • Learning how to engineer the design space
  • Setting up a platform system for multiple products
  • 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

  • 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 SESSION RESERVED FOR ZEON

    Reinhard Scheller

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

    11:40 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
  • 12:20 Networking Lunch

    13:30 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?

     

  • 14:10 High throughput testing of injectable devices with a fully automated testing system using special sampling plans

    Alexander Zuern

    Alexander Zuern, Device Testing Manager, Novartis International AG

  • 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
     
  • 14:50 SESSION RESERVED FOR SCHOTT

    15:30 Afternoon Tea

    16:00 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
     
  • 16:40 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
  • 17:20 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

    Suraj Ramachandran

    Suraj Ramachandran, Director, Merck
    View Bio

    Anil Busimi

    Anil Busimi, Strategy and Innovation Global Product Manager, SCHOTT Schweiz AG

    18:00 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

    Anil Busimi

    Anil Busimi, Strategy and Innovation Global Product Manager, SCHOTT Schweiz AG

    9:10 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
  • 9:50 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
  • 10:30 Morning Coffee

    11:00 SESSION RESERVED FOR NEMERA

    11:40 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
  • 12:20 Regulatory expectations on emerging technologies

    Suraj Ramachandran

    Suraj Ramachandran, Director, Merck
    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
  • 13:00 Networking Lunch

    14:10 The best plastic syringe for biologics

    Shota Arakawa

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical Company, Inc.

  • 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
  • 14:50 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
  • 15:30 Afternoon Tea

    16:00 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

     


     

  • 16:40 Computational Model supporting design verification data to estimate occurrence levels of critical quality attributes

    Michael Becker

    Michael Becker, Design Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
    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
  • 17:20 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

  • 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
  • 18:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Cedric Gysel

    Cedric Gysel

    Staff Device Engineer, Janssen
    Davide Mercadante

    Davide Mercadante

    Sr Associate Quality Drug Devices, Biogen
    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 Pharma GmbH & Co. KG

    Alexander Zuern

    Device Testing Manager, Novartis International AG
    Alexander Zuern

    Anil Busimi

    Strategy and Innovation Global Product Manager, SCHOTT Schweiz AG
    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

    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

    Mathieu Rigollet

    Senior PFS Engineer, Roche
    Mathieu Rigollet

    Michael Becker

    Design Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
    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.
     

    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
     

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical Company, Inc.
    Shota Arakawa

    Stephen Barat

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

    Steve Chamberlain

    Device Engineering Manager, GSK
    Steve Chamberlain

    Suraj Ramachandran

    Director, Merck
    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.

    Vikas Jaitely

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

    Sponsors and Exhibitors

    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

    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.

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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
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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