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Pre-Filled Syringes
27 January - 28 January 2014
Pre-Filled Syringes

SAE Media Group are extremely proud to present their 6th annual Pre-filled Syringes 14' meeting due to be held on the 27 & 28 January 2014. With one of the most established European market leaders on this subject and the huge successes of our previous meetings, we will provide another great forum for new advances in this field.

Pre-filled syringes are continuing to make huge roadways in the applications of new therapeutic drugs, there are a number of challenges that must be overcome. Formulation and drug interactions with container material, filling equipment and drug stability are consistent problems. Allow PFS 14' to show you how these challenges are overcome and provide a range of answers through case studies exactly how your PFS can operate at its full capability. 

 


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.

FEATURED SPEAKERS

Advait Badkar

Advait Badkar

Group Leader - Senior Principal Scientist, Pfizer
Joel Richard

Joel Richard

Vice President, IPSEN
Robert Schnepf

Robert Schnepf

Molecule Leader , MPD CoE, Merck KGaA
Yuh Fun Maa

Yuh Fun Maa

Pharmaceutical Processing & Technology Development, Genentech

Adam Woolley

Senior Toxicologist & Consultant, ForthTox Limited
Adam Woolley

Advait Badkar

Group Leader - Senior Principal Scientist, Pfizer
Advait Badkar

Alexander Jaksch

Director, Marketing & Commercial Development, Safety, BD Medical
Alexander Jaksch

Andreas Kerschbaumer

Project Manager pre-filled Syringes, Fresenius Kabi Austria G M B H
Andreas Kerschbaumer

Anil-Kumar Busimi

Product Manager, SCHOTT AG
Anil-Kumar Busimi

Bobbijo Redler

Principal Scientist, Merck & Co.
Bobbijo Redler

Christian Siegmund

Head of Liquid and Pre-Filled Syringes, Hoffmann La Roche Ltd
Christian Siegmund

Christina Janssen-Otten

Director - Pre Filled Syringes, West Pharmaceutical Services
Christina Janssen-Otten

David Woolley

Director of In Silico Toxicology, ForthTox Limited
David Woolley

Delphine Brissaud

R&D Senior Scientist, bd medical pharmaceutical systems
Delphine  Brissaud

Don Naugler

Director of Global Sales and Marketing, VJ Electronix
Don Naugler

Don Rogers

Principal, CP Partners Inc.
Don Rogers

Jason Creasey

Head of Extractables & Leachables Team, GlaxoSmithKline
Jason Creasey

Joan Malmstrøm

Specalist, Novo Nordisk A/S
Joan Malmstrøm

Joel Richard

Vice President, IPSEN
Joel Richard

Khalil Razvi

Consultant Gynecological Oncologist, Southend University Hospital
Khalil Razvi

Martin Dearden

Corporate Microbiologist, UCB
Martin Dearden

Michael Schuler

Director Product and Process Development, Schreiner MediPharm
Michael Schuler

Patrick Garidel

Associate Director Protein Science, Boehringer Ingelheim
Patrick Garidel

Reinhard Scheller

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

Robert Schnepf

Molecule Leader , MPD CoE, Merck KGaA
Robert Schnepf

Roberto DePaz

Formulation and Process Development Scientist, Medimmune Inc
Roberto  DePaz

Sandrine Comola

Europe Product Manager, bd medical pharmaceutical systems
Sandrine Comola

Vikas Jaitely

Senior Pharmaceutical Assessor, MHRA
Vikas Jaitely

Yuh Fun Maa

Pharmaceutical Processing & Technology Development, Genentech
Yuh Fun Maa

Conference agenda

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8:30

Registration & Coffee

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9:00

Welcome and introductions to E&L

 

·         What exactly are they?
·         The guidance available currently

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9:20

Material Selection

 

·         What are the effects of differing materials
·         Analysis

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10:10

E&L analysis including novel case study

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11:00

Morning tea

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11:20

Testing on E&L

 

·         The current limits to testing
·         Methods of testing

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12:30

Conclusions and close of workshop

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13:30

Registration and coffee

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13:45

Welcome and Introductions

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14:00

Context and Background

 

·       Pressures driving creation of LVIs
·       Advantages over current parenteral systems

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14:20

Market Overview

 

·       Examination of some of the leading products in the public domain
·       Predicate devices

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15:30

Coffee and networking Break

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15:50

Technical and Human Factors

 

·         Primary containers
·         Manufacturing
·         Human Factors and Industrial Design

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16:40

Guidance and Predicate devices

 

·         Key performance markers
·         Appropriate standards
·         Defining or choosing your device

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17:10

Summary and Questions

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17:30

Close of workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Advait Badkar

Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer

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9:10

Quality by design in the manufacture of pre-filled syringes

Advait Badkar

Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer

PFS and quality by design assessment
Component preparation focus – PFS manufacturing
Operations and risk assessment review
Design and implementation for understanding parameters in PFS

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9:40

Merck case study – Introduction of a prefilled diluents syringe for preparation of a complex product

Robert Schnepf

Robert Schnepf, Molecule Leader , MPD CoE, Merck KGaA

  • Common and uncommon technical challenges
  • End user voices are key to develop the right product
  • Case study
  • clock

    10:10

    Panel Discussion – Extended Q&A

  • Opportunities for speakers to further clarify presentations
  • Raise discussions on related topics
  • Potential road blocks’
  • Case study
  • Adam Woolley

    Adam Woolley, Senior Toxicologist & Consultant, ForthTox Limited

    Advait Badkar

    Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer

    clock

    10:50

    Morning Coffee

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    11:10

    Improve medication safety in Hospital Care environment with Polymer Prefillable Syringes in combination with syringe pumps

     

    ·         Latest developments on polymer PFS
    ·         Recent roadblocks
    ·         Case study

    Anil-Kumar Busimi

    Anil-Kumar Busimi, Product Manager, SCHOTT AG

    Andreas Kerschbaumer

    Andreas Kerschbaumer, Project Manager pre-filled Syringes, Fresenius Kabi Austria G M B H

    clock

    11:50

    Leachables and safety considerations in Pre-filled syringes and cartridges: Impact on drug product quality and safety profile for biologics

    Joel Richard

    Joel Richard, Vice President, IPSEN

  • Sources and types of E&L in PFS and cartridges
  • Interactions of drug product with primary packaging and processing equipment
  • Regulatory guidance
  • Case study: Impact on product quality and safety profile
  • Interaction on safety profile
  • clock

    12:30

    X-ray Inspection of Syringes and Auto-Injectors

    •         Insight into manufacture quality issues
    •         How you can use X-ray inspection to measure internal tolerances, feed into production process control and analyse field returns
    •         Benefits of inspection through sterile packaging
     

    Don Rogers

    Don Rogers, Principal, CP Partners Inc.

    Don Naugler

    Don Naugler, Director of Global Sales and Marketing, VJ Electronix

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    13:10

    Networking Lunch

    clock

    14:10

    Toxicological evaluation of extractables and leachables with reference to ICH M7

  • The regulatory context of evaluation
  • Endpoints of interest – especially genotoxicity
  • Techniques for evaluation
  • Interpretation of the results and risk assessment including thresholds of concern
  • Adam Woolley

    Adam Woolley, Senior Toxicologist & Consultant, ForthTox Limited

    David Woolley

    David Woolley, Director of In Silico Toxicology, ForthTox Limited

    clock

    14:40

    Introducing « simulated studies » during the development of large volume plastic PFS and components

  • Large volume plastic PFS  – a new solution development for large volume drugs infused with pump syringes in Acute Care
  • Defining simulated studies during PFS development
  • Case study : BD Sterifill Advance™ 50ml
     
  • Sandrine Comola

    Sandrine Comola, Europe Product Manager, bd medical pharmaceutical systems

    Delphine  Brissaud

    Delphine Brissaud, R&D Senior Scientist, bd medical pharmaceutical systems

    clock

    15:20

    Afternoon Tea

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    15:40

    Challenges for Visual Inspection

    Martin Dearden

    Martin Dearden, Corporate Microbiologist, UCB

     

     

     

     

    • “Essential” challenges
    • Auto system challenges
    • Territory specific challenges

    clock

    16:10

    Techniques & processes for assessing the risk posed from leachables in pre-filled syringes

    Jason Creasey

    Jason Creasey, Head of Extractables & Leachables Team, GlaxoSmithKline

  • Appropriate risk assessment process for studying potential leachables
  • Consideration of all potential sources of leachables including manufacturing systems and container closure
  • Choosing the correct analytical methods for study
  • GSK case study
  • clock

    16:40

    Development of HCLF Biologics in Pre-Filled Syringes

    Patrick Garidel

    Patrick Garidel, Associate Director Protein Science, Boehringer Ingelheim

  • Challenges for the development of HCLF biologics from downstream to drug product
  • Interactions with primary packaging
  • Stability issues during manufacturing
  • Medical application and considerations
  • clock

    17:20

    Ovarian cancer diagnostics – A novel point of care device using Pre-filled syringes in the operating room

    Khalil Razvi

    Khalil Razvi, Consultant Gynecological Oncologist, Southend University Hospital

  • Current status in Ovarian Cancer diagnostics
  • Tumour marker discovery in ovarian cyst fluid
  • Development of a point of care device using pre-filled syringes to diagnose ovarian cancer in the operating room
  • Case study
  • clock

    18:00

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Jason Creasey

    Jason Creasey, Head of Extractables & Leachables Team, GlaxoSmithKline

    clock

    9:10

    PFS filling of high-concentration mAb formulations – Parameter investigation and optimasation using small-scale filler

    Yuh Fun Maa

    Yuh Fun Maa, Pharmaceutical Processing & Technology Development, Genentech

  • Technical details of of syringe filling are rarely published – particularly high concentration/ viscosity formulation
  • Reveal design details of a bench top syringe filling unit
  • Identification and optimisation of critical process parameters
  • Apply leaning to practical filling operations
  • Case study
  • clock

    9:50

    Understanding the risks and impact of offering both a prefilled syringes and a vial/stopper image

    Bobbijo Redler

    Bobbijo Redler, Principal Scientist, Merck & Co.

  • Drivers for offering both images
  • Considerations for materials selection
  • Impact to E&L study design when offering both images
  • clock

    10:30

    Incorporating human factors and patient centric design into a novel safety device

    Alexander Jaksch

    Alexander Jaksch, Director, Marketing & Commercial Development, Safety, BD Medical

  • Today, Injectable drugs in prefilled syringes require injection devices - how to choose the right one
  • A clinically proven safety device has been adapted for the self-administration market
  • Manual Injection control vs. automated injection support
  • clock

    11:10

    Morning Coffee

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    11:30

    Latest trends in PFS labelling – Smart and multi-functional solutions

    Michael Schuler

    Michael Schuler, Director Product and Process Development, Schreiner MediPharm

  • Label-integrated needlestick prevention: a unique answer to the EU Directive 2010/32/EU
  • Low migration labels: challenges of COC/COP materials
  • The next generation: interactive solutions to improve patient safety
  • clock

    12:10

    Introduction to Medical Grade Cyclo Olefin Polymers (COP) for Pre-Filled Syringes

    Reinhard Scheller

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

  • Key properties and features of COP - ZEONEX/ZEONOR
  • Protein Adsorption study with BSA, Insulin
  • Optical and Mechanical properties after exposure to gamma, steam, EOG and cryogenic temperature
  • Moisture/gas barrier data
  • Residual metal and outgas data
  • clock

    12:40

    Silicone oil in prefilled syringes determined by NMR spectroscopy

    Joan Malmstrøm

    Joan Malmstrøm, Specalist, Novo Nordisk A/S

  • Comparison of NMR data with MFI
  • Quantitative aspect of 1H-NMR spectroscopy
  • Method for determination and quantitation of Si-oil
  • clock

    13:10

    Networking Lunch

    clock

    14:10

    Next Generation of Plungers for Prefilled Syringes – the Ideal Combination for Self-Injection Devices

    Christina Janssen-Otten

    Christina Janssen-Otten, Director - Pre Filled Syringes, West Pharmaceutical Services

  • Newly designed syringe components are increasingly important in auto injectors
  • Newly developed plunger design developed under QbD aspects
  • Explination of developments of technologies into the design
  • Results presented on in-house functional performance of new plunger
  • clock

    14:40

    Implementation and start up of a pre-filled syringe isolator filling machine

    Christian Siegmund

    Christian Siegmund, Head of Liquid and Pre-Filled Syringes, Hoffmann La Roche Ltd

  • Challenges during start up
  • Minimization of scratches
  • Integrated AIM (automated inspection machine)
  • clock

    15:10

    Next generation Pre-filled Syringes

    Roberto  DePaz

    Roberto DePaz, Formulation and Process Development Scientist, Medimmune Inc

  • Advantages of pre-filled syringe presentations
  • Challenges developing pre-filled syringe presentations
  • Cross-linked silicone coating technology
  • Glass strengthening technology
  • clock

    15:50

    Afternoon Tea

    clock

    16:30

    Prefilled syringes: Understanding the regulatory challenges

    Vikas Jaitely

    Vikas Jaitely, Senior Pharmaceutical Assessor, MHRA

    • Prefilled syringe regulated as a medicinal product or a medical device in EU (definitions and examples)

    • Regulatory pathways and data expected in the registration dossier

    • Usability studies –Human factor engineering

    • Case studies

    clock

    17:10

    Panel Discussion – Extended Q&A

  • Opportunities for speakers to further clarify presentations
  • Raise discussions on related topics
  • Potential road blocks’
  • Case study
  • Jason Creasey

    Jason Creasey, Head of Extractables & Leachables Team, GlaxoSmithKline

    Bobbijo Redler

    Bobbijo Redler, Principal Scientist, Merck & Co.

    clock

    17:50

    Chairman’s Closing Remarks and Close of Day Two


    Group Leader - Senior Principal Scientist
    Pfizer
    Corporate Microbiologist
    UCB
    Associate Director Protein Science
    Boehringer Ingelheim
    Consultant Gynecological Oncologist
    Southend University Hospital
    Pharmaceutical Processing & Technology Development
    Genentech
    Principal Scientist
    Merck & Co.
    Director, Marketing & Commercial Development, Safety
    BD Medical
    Specalist
    Novo Nordisk A/S
    Director - Pre Filled Syringes
    West Pharmaceutical Services
    Head of Liquid and Pre-Filled Syringes
    Hoffmann La Roche Ltd
    Molecule Leader , MPD CoE
    Merck KGaA
    Formulation and Process Development Scientist
    Medimmune Inc
    Senior Pharmaceutical Assessor
    MHRA
    Director of In Silico Toxicology
    ForthTox Limited
    R&D Senior Scientist
    bd medical pharmaceutical systems
    Project Manager pre-filled Syringes
    Fresenius Kabi Austria G M B H
    Commercial Manager Cyclo Olefin Polymers - COP
    Zeon Europe GmbH
    Head of Extractables & Leachables Team
    GlaxoSmithKline
    Senior Toxicologist & Consultant
    ForthTox Limited
    Product Manager
    SCHOTT AG
    Director Product and Process Development
    Schreiner MediPharm
    Vice President
    IPSEN
    Director of Global Sales and Marketing
    VJ Electronix
    Principal
    CP Partners Inc.
    Europe Product Manager
    bd medical pharmaceutical systems

    Workshops

    Extractables & Leachables

    Extractables & Leachables

    Marriott Regents Park
    29 January 2014
    London, United Kingdom

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

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    Sponsor Manual

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    Delegate Prospectus

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    Marriott Regents Park

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    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, 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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