Home
overview

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

 


 
2009 Past Event Details:

With the market demand for prefilled syringes rising in recent years as they become the parenteral packaging and delivery system of choice for many pharmaceutical companies, SMi are proud to announce their first Prefilled Syringes Conference. Highlighting crucial aspects such as regulation, drug product stability, and manufacturing logistics, this conference will bring together the key players of the prefilled syringes field.

 

  • Discover the latest on Prefilled Syringe technology from case studies and analyses
  • Learn about the newest developments on PFS materials and the interface to devices
  • Understand today's PFS market, how it has evolved and what to expect in the future
  • Gain insight into the industry and manufacturer view of prefilled syringes
Heads, Directors, Vice/Presidents of:
 
 
  • Packaging
  • Labelling
  • Manufacturing
  • Product Design
  • Technical Support
  • Drug Product Process Development
  • Drug Device Process Development
  • Pharmaceutical Sciences
  • Safe Medication Practice
  • Drug Device Safe

Registered delegates for this event include:

  • Head of CM Biotech Projects, Bayer Schering Pharma AG, Germany
  • Leader of Labor, Abbott Biotechnology GmbH Deutschland, Germany
  • Head of Technical Developments, F. Hoffmann-La Roche, Switzerland
  • Senior Packaging Engineer, UCB Pharma SA, Belgium
  • Strategic Advisor, Novo Nordisk A / S, Denmark
 
 
  • External Project Manager, Mundipharma Research, United Kingdom
  • Senior Project Manager, Novo Nordisk A/S, Denmark
  • RD Scientist, Novo Nordisk A/S, Denmark
  • F Hoffmann -La Roche Inc, Denmark
  • Pharmaceutical Assessor, MHRA
  • Plus many more!

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Thomas Schoenknecht

Dr Thomas Schoenknecht, Director Drug Product & Device Development, Amgen

9:10 ADVANCES IN MATERIALS, COMPONENTS AND DEVICES AND ITS IMPACT ON PRODUCT STABILITY

Dr Thomas Schoenknecht

Dr Thomas Schoenknecht, Director Drug Product & Device Development, Amgen

  • Novel materials used in PFS production
  • Glass alternatives: COC polymers
  • Processing and characteristics of COC syringes
  • Coating materials for components
  • 9:50 ENSURING AUTOINJECTOR FUNCTIONALITY AND HANDLING

    Andrew  Bryant

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

    AutoInjectors are a "common companion" of PFS in premium products

    So what is an AutoInjector ?

  • How does it interface to the PFS ?
  • Functionality and Handling Needs
  • Regulatory needs
  • Risk Mitigation in Development
  • Ensuring Robustness
  • 10:30 Morning Coffee

    11:00 THE FUTURE OF PFS AND ALTERNATIVE TECHNOLOGIES

    Andreas  Rothmund

    Andreas Rothmund, Qualified Person, Vetter Pharma-Fertigung Gmbh & Co K G

  • Microarray devices
  • Needle-free injuction systems
  • Syringe based alternatives
  • Novel pipeline technologies
  • 12:20 Networking Lunch

    13:50 MARKET TRENDS IN PROCESSING PREFILLED SYRINGES - A MACHINE MANUFACTURER'S POINT OF VIEW

    Matthias Poslovski

    Matthias Poslovski, Director Technical Sales, Optima Group Pharma

  • How to debag and deline (manual/automatic), 
  •  What kinid of filling technology to use
  • What kind of plunger rod insertion method to use
  • How to make fill weight checks
  • New developments - syringe filling machines
  • Inprocess weighing control for prefilled syringes - what is available on the market
  • 14:30 PRE-FILLED SYRINGES: AN NHS PERSPECTIVE

    Peter Rhodes

    Peter Rhodes, Principal Pharmacist , University of Southampton

    15:10 Afternoon Tea

    15:40 PARALLEL TRADE AND COUNTERFEITING OF PFS

    David Stubbs

    David Stubbs, Managing Consultant, Europe Economics

  • The economics of prefilled syringes
  • The effect of parallel trade on prefilled syringes
  • Does parallel trade compromise product safety?
  • How to secure the supply chain of prefilled syringes
  • 16:20 SENSITIVE DRUGS AND PREFILLED SYRINGES: NOVEL AND APPROPRIATE TECHNOLGIES TO MEET CURRENT & FUTURE NEEDS OF BIOTECHNOLOGY INDUSTRY

  • External factors affecting protein stability
  • BD Sensitive Drug Initiative Approach
  • Silicone oil issue : Study first the science
  • Key drivers for Coating Technology selection
  • Nicolas Bralet

    Nicolas Bralet, Marketing Manager, B D Medical

    Christophe  Bureau

    Christophe Bureau, , B D Medical - Pharmaceutical Systems

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Thomas Schoenknecht

    Dr Thomas Schoenknecht, Director Drug Product & Device Development, Amgen

    9:10 VALIDATION OF AN AUTOMATED INSPECTION LINE FOR SYRINGES

    Michael Lammel

    Michael Lammel, Head of Parenteral Bulk Production, Roche Diagnostics GmbH

  • Basic principles of manual and automated inspection
  • The validation program - basic decisions,
  • Preparation of sample sets for qualification purposes
  • Performance comparison with the manual inspection
  • Practical experience points to consider from a production perspective
  • 9:50 DEVELOPMENT AND IMPLEMENTATION OF THE PREFILLED S-WFI TOPPACTM PLASTIC SYRINGE

    Markus Hemminger

    Markus Hemminger, A BP Process Science, Boehringer Ingelheim GmbH & Co.KG

  • Characterictics and advantages of Topas®
  • Regulatory requirements
  • Feasibility- and handling studies
  • Label compatibility
  • Registration Batches
  • Challenges during development
  • 10:30 Morning Coffee

    11:00 THE INSPECTION OF PRE-FILLED SYRINGES

    Michael de la Montaigne

    Michael de la Montaigne, President, Eisai Machinery

  • Overview of syringe components
  • Areas of possible quality deficiency
  • Testing schemes
  • Application of Quality System Guidelines
  • 11:40 PROCESSING OF PFS ON ASCEPTICAL FILLING LINES: USE OF E-BEAM TECHNOLOGY

    Dieter Bachmann

    Dieter Bachmann, Qualification & Validation, Cilag

  • Reasons, types and methods of siliconisation
  • Methods and limitations of siliconisation processes
  • Test methods
  • Creation of specific siliconisation patterns
  • Characteristics of silicone oil on glass surfaces
  • 12:20 Networking Lunch

    13:50 REGULATORY ASPECTS FOR PFS IN EUROPE

    Dima Al-Hadithi

    Dima Al-Hadithi, Pharmaceutical Assessor, MHRA

  • EU directives, EU guidelines and state of the art manufacturing
  • Deficiencies and observations from regulatory bodies
  • Effect of changing regulatory climate on PFS market
  • 14:30 WHY DO WE NEED PRE-FILLED SYRINGES: WHAT IS THE EVIDENCE?

    Dan Wheeler

    Dan Wheeler, Consultant Anaesthesist, University of Cambridge

  • Effect of freeze/thaw on container closure
  • Differentiating between shipping/handling marks and tampering
  • Elimination of stopper movement during shipping
  • Formulation, product storage and other aspects taken into account
  • 15:20 Chairman’s Closing Remarks and Close of Conference Followed by Afternoon Tea

    +

    Workshops

    Understanding siliconization by measuring silicone oil layer distributions
    Workshop

    Understanding siliconization by measuring silicone oil layer distributions

    Crowne Plaza Hotel - St James
    20th January 2009
    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

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    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




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.