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SMi present their 4th annual market leading..

 

European Pre-Filled Syringes

London, 18th - 19th January 2012

 


SMi present Europe's leading European Pre-Filled Syringes event, now in it's 4th year it promises to be bigger and better! Building on the continual success of both our European and Asia Pacific events, this year's agenda will provide an unparalled opportunity for debate and problem solving of key challenges currently facing the parenteral market.
 

With a reputation for attracting the industries leading figures, this years forum will look at key areas including device development and the design concept; secondary packaging and quality assurance; technological and regulatory updates and will provide essential advice on how to create strategies for future commercial success. Providing an indepth market overview, whilst delivering insightful looks into regulatory considerations, formulations and sterilization;  this year's event promises to be the best yet!

 Delegate reviews of last year's conference included:

"A good conference on the current issues of PFS market.  A good balance of suppliers and issues in manufacturing"

“Analytical and relevant“   

The conference will address

  • Seconday Packaging - Process and manufacturing
  • Entry Level Machines - The benefits of high value and low volume
  • Needle safety - EU guidlines and planning for needle prick injuries
  • Market Perspectives Technology Trends - Preparing for the future of advanced injection technologies, new technology developments and safety devices
  • Regulatory Considerations Expectations - US & EU regulatory updates, considerations and strategies
  • Glass v Plastic - Tackling glass breakages and silicon distribution
  • Development & Manufacturing Considerations - PFS formulation, manufacturing considerations and inspection strategies
  • Networking - Share valuable experiences and network with key industry figures 
 
    Image Source: SCHOTT Pharmaceutical Packaging

 Sponsored by:  

      

 

Interested in shaping the agenda or speaking at the conference?

Please email smiproduction@smi-online.co.uk for more information on how you can get involved.

Interested in sponsoring or exhibiting?

SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime Networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences, please contact emailing sponsorshipdept@smi-online.co.uk  

Chief Executives, Chief Scientific Officers, Vice Presidents, Heads, Directors, Principal Scientists and Managers in the following areas:

  • Business Development
  • Chemistry, Manufacturing, Controls
  • Commercial Operations
  • Contract Management and Partnering
  • Drug Delivery Systems
  • Drug Device Process Development
  • Drug Device Safety
  • Drug Product Process Development
  • Formulation & Aseptic Filling Technologies
  • Industrial Development
  • Labelling
  • Manufacturing
  • Novel Drug Delivery Systems
  • Packaging Development
  • Parenterals
  • Pharmaceutical Sciences
  • Product/Pharmaceutical Design & Development
  • Quality Assurance
  • Regulatory Affairs
  • Safe Medication Practice

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Raul  Soikes

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

9:10 Current and future prefillable syringe capabilities

Horst Koller

Horst Koller, Manager Scientific Advisory, Schott Schweiz A G

Current dimensional, functional and cosmetic capabilities of state-of-the-art prefillable syringe manufacturing
Outlook on future developments to lower total cost of ownership for prefillable syringes

9:50 Designing combination products for use in the real world

David Post

David Post, Director of Device CMC, Parenteral Products , Abbott Laboratories

  • Designing for user success
  • Understanding the process
  • Planning for the future - what's next?
  • 10:30 Morning Coffee

    10:50 Advanced innovation for a new generation of needle-free plastic pre-filled syringes

    Danielle Labreche

    Danielle Labreche, Business Development & Innovation Director, Laboratoire Aguettant

  • The unmet needs and reasons to introduce innovation
  • Presenting the fundamental characteristics of a new patented device
  • Two studies results supporting PFS introduction within hospitals
  • 11:30 KEYNOTE ADDRESS: Syringe and cartridge development for biotherapeutics and vaccines: Formulation and compliance drivers

    Sandeep Nema

    Sandeep Nema, Executive Director, Pfizer

  • Formulation factors influencing choice of primary packaging
  • Compliance with manufacturing and regulatory requirements
  • Patient needs
  • Key challenges and future direction
  • 12:10 Hospira's success story: Nivestim solution for injection in prefilled syringes: from development to commercialization

    Mirela Bubenik  Bilicic

    Mirela Bubenik Bilicic, Director, Program Management , Hospira Zagreb

  • Biosimilars introduction
  • Filgrastrim
  • Filgrastrim formulation development considerations with respect to container closure system - prefillable syringes
  • Filgrastrim fill and finish process development considerations from process scale-up to manufacturing of first commercial batches
  • Nivestim (Filgrastim) commercialization
  • 12:50 Networking Lunch

    14:00 Development considerations for biologics as pre-filled syringe products: a QbD approach

    Advait Badkar

    Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer

  • Quality attributes for pre-filled syringe products that are of concern
  • Component selection and risk assessment
  • Co-development with component manufacture
  • Taking these lessons and making immediate improvements
  • 14:40 One Step Closer to Zero Defect: Decreasing defective levels in elastomeric closure manufacturing

    Renaud Janssen

    Renaud Janssen, Global Director of Scientiffic Affairs, Datwyler Pharma Packaging

    The elastomeric closure manufacturing process
    Responding to increasing market requirements
    Preventive measures for improvement
    Corrective measures for improvement

    15:20 The role of pre-filled syringes in patient safety

    David Whitaker

    David Whitaker, Consultant Anaesthetist, Manchester Royal Infirmary

    Current trends in parenteral therapy
    Intravenous medication safety
    New international recommendations and regulations
    Advantages of pre-filled syringes
    Barriers to the introduction of pre-filled syringes
     

    16:00 Afternoon Tea

    16:20 Automatic 100% inspections to secure product integrity

    Gert Nielsen

    Gert Nielsen, Director, Chief Executive Officer, InnoScan

    • Focus areas for container integrity
    • Overview of  100% automatic inspections
    • Detailing out examples of achievable defect sensitivity
    • Handling for inspection (plastics)
    • Maximising DR – minimising FRR
    • Addressing potential problems
     

    17:00 Facility design of a new clinical prefilled syringes line capable to handle high potent drugs

  • Requirements of a late stage development PFS line for global purposes
  • Innovative containment design
  • Features to preserve high flexibility
  • IPC concept
  • Karoline Bechtold-Peters

    Karoline Bechtold-Peters, Head, Clinical Manufacturing, Roche Pharmaceuticals

    17:40 Automatic visual inspection system for prefilled syringe plungers

    Damien Saleur

    Damien Saleur, Technical Support Manager, Stelmi

  • The 'cosmetic approach'
  • System and technology adapted to elastomer plungers and production process
  • Definition and detection limits linked to specifications and process
  • Identification of defects
  • 18:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Raul  Soikes

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

    9:10 Next generation quality syringe components and systems

    Mike Schäfers

    Mike Schäfers, Vice President, Marketing Europe, West Pharmaceutical Services

  • Environment enhancements
  • Extractable control of components
  • Visual inspection of components
  • Glass vs. plastic syringes
  • Proteins and primary packaging
  • 9:50 Turnkey, or not turnkey, that is the questions? A practical (supplier's) guide to the design and implementation of a PFS and packaging line

    Dale Charlton

    Dale Charlton, Business Development Director, Optima Pharma

  • Design and process considerations eg. workflow, containment, turnkey or stand-alone
  • Line speed
  • Filling & closing technology
  • Secondary packaging
  • 10:30 Morning Coffee

    10:50 RFID - a novel technology to offer additional benefits to the customer

    Torsten Kneuß

    Torsten Kneuß, Operations Manager, Bayer Pharma

  • Brief overview of RFID in healthcare
  • Case study; increase of patient safety and process improvements with RFID
  • Case study; interaction with injection devices
  • Challenges - from technical and non-technical perspectives
  • Possible fields of application of RFID and portfolio evaluation
  • 11:30 A global approach to creating innovative value in parenteral packaging

    Juan Cerdan-Diaz

    Juan Cerdan-Diaz, Director R&D and Technical Services, Nipro

    Leveraging the new global organization
    Using different backgrounds/expertise/cultures/glass formulation research
    Improving glass making and glass products/services to meet market needs (as collected on the market, trends, requirements): design, chemical durability, mechanical strength, services, AP, packaging automation, vision
    Building a partnership approach to commercial relations with customers with the patient in mind – value-chain approach
    Wide product scope: Vials, ampoules, pre-filled syringes

    12:10 Prefilled syringes at the front line of the NHS launch challenges with a pre-filled injection device

    Frank Ellwood

    Frank Ellwood, CT Superintendent, NHS Plymouth

  • Use of prefilled syringes with Computed Tomography scanner and iodinated contrast media
  • Injection via pump injector devices
  • The clinical task, including safety and quality issues
  • Advantages of prefilled syringes and desired future development
  • 12:50 Networking Lunch

    14:00 KEYNOTE ADDRESS: Extractables and leachables in prefilled syringes

    Ingrid Markovic

    Ingrid Markovic, Expert Review Scientist , FDA

    14:40 Hazard shift; replacing needle stick injury risk with splatter risk

    Simon Cohen

    Simon Cohen, Director, Innovate UK

  • Needle stick prevention legislation in Europe comes into force in 2013
  • We need to ensure that by reducing needle stick injury risk, we are not replacing it with other risks
  • Splatter trials looking at a range of table activated devices have shown that these devices may cause a chemical and cross infection hazard
  • 15:20 KEYNOTE ADDRESS: Transactional to intergrated contractor partnership: a prefilled syringe commercialization strategy

    Raul  Soikes

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

  • Partnership's strategic potential and scope
  • Mutual benefits
  • Business model novelty
  • Partnership's long term viability
  • 16:00 Afternoon Tea

    16:20 New perspectives for biotech drug delivery

    Nicolas  Morais

    Nicolas Morais, Product Manager, Europe, BD Medical - Pharmaceutical Systems

  • Prefilled syringe market overview
  • Patient, regulatory and operational excellence trends for the biotech
  • Injectable market
  • Development of new biotech prefillable systems answering unmet needs
  • 17:00 Managing post-launch challenges with a pre-flled injection device

    Aaron Chesterman

    Aaron Chesterman, Device Development Engineer, Genentech

    17:40 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    An in-depth approach to leachables and extractables
    Workshop

    An in-depth approach to leachables and extractables

    Marriott Hotel Regents Park
    17th January 2012
    London, United Kingdom

    The processes and pitfalls when developing an autoinjector
    Workshop

    The processes and pitfalls when developing an autoinjector

    Marriott Hotel Regents Park
    20th January 2012
    London, United Kingdom

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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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.

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    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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