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Pre-Filled Syringes
20 January - 21 January 2010
Pre-Filled Syringes

SAE Media Group's Pre-Filled Syringes conference is now in its 3rd year - click here to view our 2011 event 

 


 
2010 Past Event Details:

Recent years have seen a rise for pre-filled syringes from a niche product to the primary container of choice for most parenteral drug delivery systems.  This is the result of a number of factors, although the improved safety and increased convenience of a pre-fillable device is the leading reason.  The global market for pre-fillable syringes today comprises of more than 2.2 billion syringes, with over half of these supplied sterile.

SAE Media Group's 2nd annual Pre-Filled Syringes conference will bring you up to date with the latest developments from Pharma in this rapidly expanding market.  Learn from the experts about overcoming common hurdles in the development of your pre-filled syringe strategies.  Packaging challenges will be addressed, along with drug formulation issues and managing complaints.

Topics to be covered in this year's event include:

  • Advances in devices 
  • Novel drug delivery systems 
  • Pre-filled syringe development 
  • Coding of pre-filled syringes  
  • Joern Koehler, Deputy Head, Liquid Vials & Pre-Filled Syringes, F. Hoffmann – La Roche
  • Herwig Muehleder, Project Engineer, Wyeth

Conference agenda

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13:30

REGISTRATION & COFFEE

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14:00

WELCOME & INTRODUCTIONS

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14:10

QUALITY TARGET PROFILE

  • Different types of prefilled syringes
  • Rubber components
  • Syringability
  • Plunger movement
  • Filling under inert atmosphere and gas/liquid equilibrium
  • Dual chamber systems
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    15:30

    AFTERNOON TEA

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    16:00

    PHARMACEUTICAL FORMULATION

  • Freeze-drying of proteins in dual chamber systems
  • Manufacturing of drug product
  • Injection devices
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    17:00

    CLOSE OF WORKSHOP

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Lars Kreye

    Lars Kreye, Associate Director Aseptic Area 4, Boehringer Ingelheim

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    9:00

    IMPLEMENTING A NEW SYRINGE FILLING LINE - RISKS AND TECHNICAL PITFALLS

    Lars Kreye

    Lars Kreye, Associate Director Aseptic Area 4, Boehringer Ingelheim

  • Time frame
  • Points to consider
  • Solutions
  • Being productive
  • Conclusion
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    9:35

    ENHANCING ADHESIVE POLYMERIZATION OF PRE ATTACHED NEEDLES FOR PREFILLED SYRINGES

  • Adhesive chemistry
  • UV activation (photo-initiators)
  • Materials compatibility (glass/steel)
  • Dimensional compatibility
  • OMPI case study / optimized process / next steps
  • Results
     
  • Gabriele  Peron

    Gabriele Peron, Marketing Manager, Stevanato Group - Glass Division

    Alessandro Morandotti

    Alessandro Morandotti, R&D Department, Stevanato Group

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    10:10

    Morning Coffee

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    10:40

    CODING OF PREFILLED SYRINGES

    Joern Koehler

    Joern Koehler, Deputy Head of Liquid Vials & Prefilled Syringes, F.Hoffman-La Roche

  • Project drivers
  • Requirements
  • Technologies
  • Solutions
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    11:15

    HIGH SPEED INSPECTION OF PREFILLED SYRINGES

    Gert Nielsen

    Gert Nielsen, Director, Chief Executive Officer, InnoScan

  • Overview of inspections
  • Syringe handling for inspection
  • Maximising DR - minimising FRR
  • Addressing potential problems
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    11:50

    INNOVATIVE SYRINGE SOLUTIONS

    Horst Koller

    Horst Koller, Manager Scientific Advisory, SCHOTT forma vitrum

  • Syringe system materials combination for WFI
  • Tests and references
  • Timepoints and storage conditions
  • Results
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    12:25

    Networking Lunch

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    13:35

    PRE-FILLED SYRINGE DEVELOPMENT

    Julien Tirefort

    Julien Tirefort, Packaging Projects Leader, Sanofi Pasteur

  • Design development phases
  • Key drivers
  • Product compatibility and approaches
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    14:10

    IMPACT ON DRUG DELIVERY DEVICES DEVELOPMENT

    Nicolas Bralet

    Nicolas Bralet, Marketing Manager, Europe, BD Medical - Pharmaceutical Systems

  • Current and future trends for drug delivery devices
  • Does one solution fit all?
  • System conception approach integrating prefilled and self-injection devices
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    14:45

    ADVANCED ELASTOMERIC COMPONENTS FOR PFS

    Renaud Janssen

    Renaud Janssen, Technical Support Director, Helvoet Pharma

  • Considerations and functions
  • Interaction potential
  • Coating  
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    15:20

    Afternoon Tea

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    15:50

    NEW PHYSICAL CONTAINER CLOSURE INTEGRITY TEST FOR PREFILLED SYRINGES BY ALTERATION OF DIN EN ISO 7886-1

    Markus Hemminger

    Markus Hemminger, Head of Primary Packaging Development, Boehringer Ingelheim

  • Overview on existing CCIT-methods for pre-filled syringes and cartridges
  • Brief description of CCIT-test method according to DIN EN ISO 7886-1
  • New CCIT approach by alteration of DIN EN ISO 7886-1
  • Capability of altered DIN EN ISO 7886-1 method versus microbiological challenge test
  • Advantages and restrictions of new CCIT method 

     

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    16:25

    CAN RIVA (ROBOTIC IV AUTOMATION) BE THE RIGHT SOLUTION FOR YOUR PRE-FILL BUSINESS?

    Jane Arnot

    Jane Arnot, Vice President, Sales & Customer Support, Intelligent Hospital Systems

  • RIVA introduction and capability
  • ROI and financial considerations
  • Implementation strategies
  • Future development at Intelligent Hospital Systems
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    17:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Dan Wheeler

    Dan Wheeler, Consultant Anaesthetist, Addenbrooke's Hospital, Cambridge and Lecturer in Anaesthesia, University of Cambridge

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    9:10

    NEW FILLING LINE PROJECT AND ITS POTENTIAL FOR IMPROVEMENT

    Herwig Muehleder

    Herwig Muehleder, Senior Process Engineer, Pfizer

  • Lessons learned from previous filling line project
  • Changes for new filling line
  • Design and project execution
  • Start-up, commissioning and qualification
  • Comparison between old and new filling line
  • Operation improvements
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    9:50

    PROCESSING PRE-FILLED SYRINGES

    Dale Charlton

    Dale Charlton, Director of Business Development, Optima Group

  • Options for filling technology
  • New developments in filling technology
  • Inprocess controls
  • Secondary packaging considerations
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    10:30

    Morning Coffee

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    11:00

    A NEW AND NOVEL AUTO-INJECTOR, SAFECLICK

    Bob Sharp

    Bob Sharp, Medical Director, FIT Autoinjectors

  • The changing patient-doctor-pharma dynamic
  • Growth in viscous biological drugs and implications on the market for auto-injectors
  • Advantage of switching to prefilled syringes for existing conventional drugs
  • A look at SafeClickTM
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    11:40

    PRE-FILLED SYRINGE DEVELOPMENT FOR PROTEIN-BASED PHARMACEUTICALS

    Advait Badkar

    Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer

  • Differing issues compared to development of formulation in vials
  • Importance to work with component vendors and manufacturing facilities
  • Clinical vs. commercial needs of packaging and shipping options
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    12:20

    Networking Lunch

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    13:50

    EVIDENCE FOR PREFILLED SYRINGES

    Dan Wheeler

    Dan Wheeler, Consultant Anaesthetist, Addenbrooke's Hospital, Cambridge and Lecturer in Anaesthesia, University of Cambridge

  • Preparation of drugs at the bedside vs. prefilled syringes
  • Problems with drug infusions on Intensive Care
  • Errors and delays during preparation of drug solutions
  • Inherent problems encountered when drawing up infusions from concentrated stock solutions
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    14:30

    MANAGING SYRINGE COMPLAINTS

    Christian Braun

    Christian Braun, Principal Research Scientist,Pharmaceutical Development & Manufacturing Sciences, Johnson & Johnson, Cilag AG

  • Recording complaints from the market
  • Investigation of complaints
  • Compiling the information/trending
  • Case study: managing a negative trend upon change of the application form
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    15:10

    Afternoon Tea

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    15:40

    CASE STUDY: EVALUATION & QUALIFICATION OF READY-TO-FILL SYRINGE SUPPLIERS AND CONTRACTORS

    Raul Soikes

    Raul Soikes, Senior Director of Program Management, Baxter BioPharma Solutions

  • Lessons learned for product development
  • Elements a supplier qualification for PFS should contain
  • Integration of pre-processed systems in the light of ICH Q8, Q9 and Q10
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    16:20

    MONODOSE SELF-INJECTION SYSTEMS FOR PRE-FILLED SYRINGES AND LIQUID/DRY CARTRIDGES

    Ian Thompson

    Ian Thompson, Head of Business Development, Ypsomed

  • Main markets and drivers for self-injection devices
  • Current developments and device details
  • Handling study data
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    17:00

    NOVEL DRUG DELIVERY SYSTEMS

    Andrew  Bryant

    Andrew Bryant, Program Manager - Novel Drug Delivery Systems, Pfizer

  • What next after PFS?
  • Current drivers for pre-filled syringes
  • Market and technical considerations
  • Emerging technologies
  • Place your bets
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    17:40

    Chairman’s Closing Remarks and Close of Day Two

    Workshops

    Formulations for Pre-Filled Syringes

    Formulations for Pre-Filled Syringes

    Crowne Plaza Hotel - St James
    19 January 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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