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SMi's Pre-Filled Syringes Americas is the 8th in SMi’s world leading series of PFS conferences. In April 2014 over 100 delegates from the world’s leading Pharmaceutical and Biotechnology businesses will meet in New Jersey to discuss the latest developments in the pre-filled syringe marketplace.

With unit sales of 3.59 billion predicted in 2015, pre-filled syringes form one of the fastest growing markets in healthcare. The companies that will thrive in this marketplace will be those able to deliver products to market with the shortest lead times and longest shelf life.
Pre-Filled Syringes Americas is the western hemisphere's industry forum. The world’s biopharmaceutical companies will be gathering to discuss how the latest developments in drug stabilisation and material interactions are reshaping the drug delivery industry.

Find out how to navigate the regulatory roadmap and deliver your product to market through efficient supply chain management with 3 days of interactive presentations, panels, networking sessions and workshops.
 

Dear visitor, here you can download the list of attending companies for our upcoming Pre-Filled Syringes Conference. This document will be updated on a weekly basis

Check our exclusive infographic“Industry Survey Results: What are industry professionals saying about the future of pre-filled syringes”

We asked leading industry experts their thoughts on the challenges that the industry faces today and the opportunities for this rapidly expanding sector, ahead of Pre-Filled Syringes 2014.

3 days of presentations, panel discussions and interactive
workshops. Return to your business with the information and
contacts to make the right decisions for your products
• Focus sessions on biologics, manufacturing, polymers and
extractables and leachables
• 20+ expert speakers from throughout the PFS and device ecosystem
• 100+ key decision makers, influencers and innovation drivers
attending from the most relevant and sought after organisations in
pre-filled syringes
• Network with delegates from the leading Biotechnology and
Pharmaceutical businesses globally during the series of networking
breaks, lunches and networking evenings designed to help
conversation flow
• Hands on exhibition to help you evaluate the leading solutions in the
marketplace and meet the thought leaders who developed them

Whether you currently have a pre-filled syringe or device product in development, on the market are evaluating the landscape. This event will provide the information and contacts to help you make the informed decisions that benefit you and your business, accelerate development and help facilitate a smooth regulatory approval process.

 

Companies previously attending SMi Pre-Filled Syringe Conferences include: 

3P innovation Ltd; Abott GmbH & Co. KG; Aguettant Ltd; Amgros I/s; Amri Inc; Barts and the London NHS Trust; Baxter BioPharma Solutions; Bayer Pharma; Bayer Pharma AG; BD Medical - Pharmaceutical; BHR NHS Trust; Bioneer AS; Boehringer Ingelheim; Bosch PackagingTechnology; Cambridge Enterprise; Cobra Biologics; Covidien; Datwyler Ltd; Datwyler Pharma Packaging; Dyax Corp; First Group Healthcare; Forest Laboratories; Hoffmann La Roche Ltd; Honeywell; Hospira Inc; Injector; KOMAX Group; Laboratoire Aguettant; Manchester Royal Infirmary; MedImmune; MHRA; NanoSight Ltd; Nottingham University; Novartis A G; Novo Nordisk; Novo Nordisk A/s; Optima Pharma; Optimal Strategix; Owen Mumford; Patheon Italia S.p.A.; Patheon Italia SpA; Pfizer; Phillips - Medisize; PLIVA; Portsmouth Hospitals N H S Trust; rap.ID Particle Systems GmbH; Rexam; Roche Pharmaceuticals; Safety Syringes; Sandos Slovenia; Sandoz; Sanofi-Aventis; SCHOTT AG; Schreiner MediPharm; Stelmi; Team Consulting; University of Cambridge; University of Copenhagen; Vesdo Ltd; Vetter Pharma International GmbH; West Pharmaceutical Services; Xoma L L C; Zeon; Zogenix, Inc.;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Alexei Goraltchouk

Alexei Goraltchouk , Associate Director, Operations, Regeneron

9:10 KEYNOTE ADDRESS: Avoiding the pitfalls of device development

Scott Brown

Scott Brown, Device Development Lead, Merck & Co Inc

               What to look out for when developing your delivery device
               The 5 reasons product fail
               How can you plan to mitigate the risk of product failures
 

 

9:50 HEADLINE PANEL: Developments in pre filled syringes and injection devices

  • What are key aspects driving the exponential growth of the market?
  • Which challenges need to be worked out to continue expansion?
  • What’s next for pre filled syringes, where will the growth come from?

     

  • Cliff Mintz

    Cliff Mintz, Senior Writer/Correspondent, Life Science Leader

    Lloyd  Fishman

    Lloyd Fishman, President, High Peaks Partners

    Paul Roussel

    Paul Roussel, Senior Scientist, MedImmune

    10:40 Morning refreshments and networking in the exhibition area

    11:10 Foreign Particulate Matter and Siliconization Testing

    Oliver Valet

    Oliver Valet, Co-Founder, rap.ID Particle Systems GmbH

    •rap.ID and Foreign Particulate Matter Identification

    •Siliconization Process – Spray on vs. Emulsion •Silicone Control Methods – Historical and Actual

    •Layer Explorer – Technology and Case Studies

    11:50 Next generation Pre Filled Syringes: How are electronic auto injectors changing the market?

    Chanderkanth  Gautham

    Chanderkanth Gautham, Senior Research Analyst, Beroe Inc

    ·          Trends in electronic injectors and how they compare to pre filled syringes

    ·          What are the key procurement challenges that category managers will face

    ·          How these differ from conventional Pre Filled Syringe challenges

     

    12:30 Networking lunch held in the exhibition area

    14:00 Introduction to Medical grade Cyclo Olefin Polymers (COP)

    Toshiro Katayama

    Toshiro Katayama, Product Manager, Zeon Chemicals L.P.

    ·Key properties of current Medical grade Cycloolefin polymer (COP)

    ·Regulatory Status ·Bio-Compatibility and Protein Adsorption study

    ·Effect of Gamma/EB/Steam sterilization

    ·Introduction of new product

    14:40 Panel: Developing delivery systems for biological products

             Overcoming viscosity and needle size challenges

             How can you ensure E&L are within acceptable limits?

             Seeking efficient FDA approval for RA and other drug products

             When should you develop your own solution and when should you work with a partner?

     

    Cliff Mintz

    Cliff Mintz, Senior Writer/Correspondent, Life Science Leader

    Martin Dearden

    Martin Dearden, Corporate Microbiologist, UCB

    15:30 Pre-filled syringe manufacturing, a review of processes and challenges

    Gregory Sacha

    Gregory Sacha, Senior Research Scientist, Baxter Healthcare Corporation

    ·          New challenges with COP and COC containers

    ·          How to effectively reduce particle contamination

    ·          When’s the right time in product development to decide on delivery systems?

     

    16:10 Chairman’s Closing Remarks

    16:15 Evening Reception and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

    9:10 Sterilization Solution for Prefilled Syringes

    David Opie

    David Opie , PhD SVP, Noxilizer Inc

    . Overview of current and emerging sterilization solutions for prefilled syringes
    . Benefits and limitations of available technologies
    . Case study on prefilled syringe sterilization with nitrogen dioxide (NO2) gas
    . Addressing safety concerns for prefilled syringe drug products

    9:50 Getting to market: Regulatory perspective

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

    ·          Defining a pre-filled syringe as a product or device and its impact on regulatory approval

    ·          Roadmap to approval for PFS’s and auto injectors

    ·          Insight into the FDA’s current thoughts

     

    10:30 Refreshments and networking in the exhibition area

    11:00 Managing the safety assessment of leachables for pre-filled syringe drug products

    Stephen Barat

    Stephen Barat, Senior Director, Toxicology and Operations, Forest Laboratories

             Current trends in the safety assessment of extractables and leachables.

             The use of scientifically-justified threshold levels in the safety assessment of leachables

             How to approach the qualification of leachables and considerations needed during development and life-cycle management.

             Working examples to illustrate approach and key principles.

     

    11:40 Managing your toxicological evaluation of extractables and leachables

    Adam Woolley

    Adam Woolley, Senior Toxicologist & Consultant, ForthTox Limited

    · The regulatory context of evaluation and it's impact on product design
    · Endpoints of interest – especially genotoxicity
    · Evaluation of techniques
    · Results and risk assessment interpretation: Thresholds of concern

    12:20 Networking lunch held in the exhibition area

    13:20 The market and technologies for large volume (‘bolus’) injections

    Tom  Oakley

    Tom Oakley, Director of Drug Delivery Device Development, Springboard

    ·          Findings from study conducted in conjunction with the Cambridge Judge Business School

    ·          New drugs that require large injections: Why are bolus injectors are required?

    ·          The limitations of autoinjectors and infusion pumps for large volume injections

    ·          Why a new class of device, the bolus injector, is under development

    ·          Example devices and their properties– Unilife, BD, West, Ratio, SteadyMed etc.

     

    14:00 Aseptic Transfer of Pre-Sterilized Syringes

    Mike McGown

    Mike McGown, Regional Sales Manager, Bosch Packaging Technology

  • Nested syringe handling techniques
  • Nested syringe transfer into sterile filling core
  • Technology options for the filling and closing of nested syringes

     

  • 14:40 Afternoon refreshments and networking in the exhibition area

    15:10 Overcoming inspection challenges in manufacturing

    Martin Dearden

    Martin Dearden, Corporate Microbiologist, UCB

    • Essential challenges in particle inspection
    • Auto system challenges
    • Re-inspection - friend or foe
    • Territory specific challenges
    • Total Rejects-sub batch inspection
     

     

    15:50 Panel: Future trends in the pre filled syringes and medical devices

                   Delivery technology, business and operational needs from the drug-makers perspective

                   Usability, user preference, and learning from patient feedback

                   The next generation of needs, as opposed to the next generation technology

     

    Martin Dearden

    Martin Dearden, Corporate Microbiologist, UCB

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

    Bernard  Ettinger

    Bernard Ettinger , Manager, Manufacturing, Medical Devices, Regeneron Pharmaceuitcals Inc

    16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alexei Goraltchouk

    Alexei Goraltchouk

    Associate Director, Operations, Regeneron
    Cliff Mintz

    Cliff Mintz

    Senior Writer/Correspondent, Life Science Leader
    Ravi S. Harapanhalli

    Ravi S. Harapanhalli

    Vice President and Former FDA Senior Executive, Parexel International
    Scott Brown

    Scott Brown

    Device Development Lead, Merck & Co Inc
    Stephen Barat

    Stephen Barat

    Senior Director, Toxicology and Operations, Forest Laboratories
    Toshiro Katayama

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.

    Adam Woolley

    Senior Toxicologist & Consultant, ForthTox Limited
    Adam Woolley

    Alexei Goraltchouk

    Associate Director, Operations, Regeneron
    Alexei Goraltchouk

    Bernard Ettinger

    Manager, Manufacturing, Medical Devices, Regeneron Pharmaceuitcals Inc
    Bernard  Ettinger

    Chanderkanth Gautham

    Senior Research Analyst, Beroe Inc
    Chanderkanth  Gautham

    Cliff Mintz

    Senior Writer/Correspondent, Life Science Leader
    Cliff Mintz

    David Opie

    PhD SVP, Noxilizer Inc
    David Opie

    Gregory Sacha

    Senior Research Scientist, Baxter Healthcare Corporation
    Gregory Sacha

    Gregory Sacha

    Senior Research Scientist, Baxter Healthcare Corporation
    Gregory Sacha

    Lloyd Fishman

    President, High Peaks Partners
    Lloyd  Fishman

    Martin Dearden

    Corporate Microbiologist, UCB
    Martin Dearden

    Mike McGown

    Regional Sales Manager, Bosch Packaging Technology
    Mike McGown

    Oliver Valet

    Co-Founder, rap.ID Particle Systems GmbH
    Oliver Valet

    Paul Roussel

    Senior Scientist, MedImmune
    Paul Roussel

    Ravi S. Harapanhalli

    Vice President and Former FDA Senior Executive, Parexel International
    Ravi S. Harapanhalli

    Scott Brown

    Device Development Lead, Merck & Co Inc
    Scott Brown

    Stephen Barat

    Senior Director, Toxicology and Operations, Forest Laboratories
    Stephen Barat

    Stephen Barat

    Senior Director, Toxicology and Operations, Forest Laboratories
    Stephen Barat

    Tom Oakley

    Director of Drug Delivery Device Development, Springboard
    Tom  Oakley

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.
    Toshiro Katayama

    Pre-Filled Syringes Americas 2014 – List of attending companies

    Download

    Whitepaper: REACH and RoHS – Medical Device. 2013 - Provided by: Beroe

    Download

    EXCLUSIVE INFOGRAPHIC Industry Survey Results: What are industry professionals saying about the future of pre-filled syringes

    Download

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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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