Home
overview

SMi 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.

Pre-filled 2014 will offer the latest in regulatory updates from MHRA and FDA bodies - held in combination with a panel discussion to open discussion to the floor. As a special highlight for 2014 we will be bringing exclusive news on autoinjector technologies and how it is being actively applied with biologics as well as small molecules. Practical case studies will be submitted associated with the potential pitfalls of practical applications in manufacture and how to avoid these hurdles. Practical approaches to drug stabilisation and maintaining container integrity.
 

  • An Ipsen case study in the sources and types of E&L and regulatory guidance on interaction safety profiles
  • Merck case study on a prefilled diluents syringe
  • Genentech focus on next generation PFS - high concentration mAb formulations and other biologics revealing design details on bench top syringe filling units
  • Novel uses for PFS - Point of care device case study showing usage in Ovarian Cancer diagnostics
  • Important regulatory updates - FDA regulations on device controls and new cGMP rules for combination products
   

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

Advait Badkar

Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer

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

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
  • 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

    10:50 Morning Coffee

    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

    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
  • 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

    13:10 Networking Lunch

    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

    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

    15:20 Afternoon Tea

    15:40 Challenges for Visual Inspection

    Martin Dearden

    Martin Dearden, Corporate Microbiologist, UCB

     

     

     

     

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

    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
  • 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
  • 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
  • 18:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Jason Creasey

    Jason Creasey, Head of Extractables & Leachables Team, GlaxoSmithKline

    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
  • 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
  • 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
  • 11:10 Morning Coffee

    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
  • 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
  • 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
  • 13:10 Networking Lunch

    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
  • 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)
  • 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
  • 15:50 Afternoon Tea

    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

    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.

    17:50 Chairman’s Closing Remarks and Close of Day Two

    +

    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

    Workshops

    Extractables & Leachables
    Workshop

    Extractables & Leachables

    Marriott Regents Park
    29th January 2014
    London, United Kingdom

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

    Download

    Sponsor Manual

    Download

    Delegate Prospectus

    Download

    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.

    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.