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SMi is pleased to announce its third annual conference on Pre-Filled Syringes, due to take place in London on Wednesday 19th & Thursday 20th January 2011.

About the conference

The global pre-filled syringe market has seen rapid growth in recent years with the development of new treatments and formulations to treat a wide range of acute and chronic conditions.

The benefits of pre-filled syringes in increased patient compliance, market share and price premium are obvious - recent reports have estimated a total of 2 billion syringes being sold in 2009 with a total market size of up to US$2.5bn which is growing at 10-15% per year. Contributing to this growth are a number of factors including the rising number of injectable biotherapeutics, increasing patient/physician demands for convenient and safe containers, and spiralling healthcare costs which have led to a rising trend in drug self-administration and has introduced a range of naive users to parenteral drug delivery.

SMi's third annual conference on Pre-Filled Syringes will cover the current status of this industry and look beyond to the next generation of advanced injection devices in an interactive, case study led environment.

Get more from the conference - Join us for a drinks reception on day one, straight after the final presentation.  Network and socialise with the speakers and other delegates; ask questions, discuss ideas and plan partnerships over drinks and nibbles.

 

Source: ONdrugDELIVERY, 2009


Want to download the brochure?  Click here

Want to register your place? Click here

Sponsorship and exhibition opportunities available - Click here

Make a group booking and save - Click here

The conference will address:

  • 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
  • Commercialisation Perspectives - Case studies in successful pre-filled injection device commercialisation
  • Development & Manufacturing Considerations - PFS formulation, manufacturing considerations and inspection strategies
  • Networking - Share valuable experiences and network with key industry figures

 

SMi is pleased to announce:

Pre-Filled Syringes Asia
20th and 21st July 2011, Singapore

To register your interest in attending, speaking, sponsoring, workshop hosting or shaping the agenda, please click here.

 

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

 

  • Business Development
  • Chemistry, Manufacturing, Controls (CMC)
  • Commercial Operations
  • Contract Management and Partnering
  • Customer & Technical Support
  • 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
  • Safe Medication Practice

 Delegates at our previous Pre-Filled Syringes conference included representation from:

  • Abbott
  • Affymax
  • Amcor
  • Amgen
  • Astech Projects
  • BD Medical
  • Baxter Healthcare
  • Bayer Schering Pharma
  • Boehringer Ingelheim
  • Bone Support
  • Bosch Packaging Technology
  • Britannia Pharmaceuticals
  • Cambridge Consultants
  • Cilag
  • Codan France
  • Consort Medical
  • Europe Economics
  • F. Hoffmann-La Roche
  • Future Injection Technologies
  • Gedeon Richter
  • Genentech
  • Genus Pharmaceuticals
  • Gerresheimer Group
  • Glide Pharma
  • Helvoet Pharma
  • Hospira
  • Innoscan
  • Intelligent Hospital Systems
  • Ith Pharma
  • J&J Pharmaceutical Research
  • Laboratoire Aguettant
  • Medac
  • Merck Serono
  • MHRA
  • Mundipharma International
  • Novo Nordisk
  • Optima Group
  • Owen Mumford
  • Packaging Technologies & Inspection
  • Patheon UK
  • Pfizer
  • Roche Diagnostics
  • Samedan
  • Sanofi-Aventis
  • SCHOTT
  • SmartCells
  • Solvay Pharmaceuticals
  • Sueddeutsch Feinmechanik
  • Team Consulting
  • TRB Chemedica
  • UCB Pharma
  • University of Cambridge
  • University of Southampton
  • Vetter Pharma-Fertigung
  • Vygon
  • West Pharmaceutical Services
  • Ypsomed

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dan Wheeler

Dan Wheeler, Lecturer in Anaesthesia, University of Cambridge

9:10 Preparing for the future of advanced injection technologies

David Post

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

  • Injectable prefilled syringes global market sector analysis
  • Advances in technology and materials
  • Meeting the changing therapeutic demand drivers
  • Identifying the opportunities and formulating strategies for success
  • 9:50 New developments for drug delivery systems

    Nicolas  Morais

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

  • Regulatory guidelines and GMP framework updates
  • Meeting product critical quality attributes and consistent quality over time
  • Case study: Capitalising on new developments of processes, products and Operational Excellence aiming to lower the total cost of ownership
  • 10:30 Morning Coffee

    11:00 Prefilled generics - why they are badly needed

    Dan Wheeler

    Dan Wheeler, Lecturer in Anaesthesia, University of Cambridge

  • The imprecision of drawing up drugs from traditional glass ampoules
  • Variations in infusions prepared at the bedside - are they clinically acceptable?
  • Precision offered by industry is far greater than that even of satellite pharmacies
  • Presently very few generics are available in prefilled syringes; do we need to examine novel ways of making ampoules safer?
  • 11:40 Developing an innovative ready to fill staked needle syringe

    Horst Koller

    Horst Koller, Regulatory Affairs / Quality R&D PP, SCHOTT forma vitrum

  • Innovative principle to separate the drug from the closure system
  • Minimising interaction with other materials to improve the drug stability
  • Attaining high patient safety and satisfaction due to a unique design
  • 12:20 Networking Lunch

    13:20 Next generation of pre-filled syringes used in injection devices

    Joerg Sielemann

    Joerg Sielemann, Pharmaceutical & Device Development, F. Hoffmann - La Roche AG

  • Design considerations
  • Optimization of leachables and extractables
  • Process requirements (filling & finishing)
  • Quality challenges
  • Regulatory impact on component suppliers
  • 14:00 Moving an autoinjector from design concept to commercialisation

    Eric Faulkner

    Eric Faulkner, Associate Director, CMC Management and Strategic Supply Chain, Biogen Idec

  • Trends, developments and technology advancements
  • Strategic overview of autoinjector development
  • Integration of the prefilled syringe
  • Human Factors
  • Scale up considerations
  • Regulatory requirements
  • Lessons learnt
  • 14:40 Product impact study to support technology transfer to a commercial isolator enclosed filling line

    Samantha Somerlott

    Samantha Somerlott, Associate Scientist, Glaxosmithkline

    • Mimicking process conditions utilising the Aris test isolator
    • Analysing samples for critical quality attributes for up to 6 months' storage
    • Identifying operational range and control parameters for Isolator decontamination/de-aeration cycles, component prep and filling
     

    15:20 Afternoon Tea

    15:50 Regulatory considerations for the development of a diluent syringe for biologics

    Joerg Zuercher

    Joerg Zuercher, Packaging and Device Development Manager, Bayer Schering Pharma

  • Selection of the prefillable syringe system
  • Specification and measurement of system functionality
  • Extractables/Leachables evaluation
  • Preparation of submission
  • 16:30 Case Study: Development of a Conjugated Protein in a Dual Chamber Syringe

    Tamara Hodge

    Tamara Hodge, Scientist, Pharmaceutical R&D, Pfizer

  • Formulation considerations
  • Process challenges 
  • Importance of patient friendly primary packaging
  • 17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Suketu Desai

    Suketu Desai, Vice President, Biotechnology Operations, Cephalon Inc

    9:10 Manufacturing considerations for developing pre-filled syringes

    Edwin Chan

    Edwin Chan, Process Engineer, Late Stage Pharmaceutical & Processing Development, Genentech

  • Quality by design approaches in process development
  • Case Study #1: Correlation of needle gauge as a function of prefilled syringe physical performance
  • Case Study #2: Identifying dissolved gas issues in solution that may lead to low deliverable volume in prefilled syringes
  • 9:50 Pre-Filled syringe development - formulation, process to final combination product

    Suketu Desai

    Suketu Desai, Vice President, Biotechnology Operations, Cephalon Inc

  • Formulation consideration
  • Process consideration
  • Device - engineering, design and quality consideration
  • Inspection consideration
  • Regulatory consideration
  • 10:30 Morning Coffee

    11:00 Challenges in development of pre-filled syringes for biologicals

    Michael Adler

    Michael Adler, Head Late-Stage Pharmaceutical and Processing Development, F. Hoffmann-La Roche AG

  • High concentration/high viscosity formulations
  • Characterization of the subvisible particle population
  • Case study: Switching from a luer type syringe to a staked-in needle pre-filled syringe
  • 11:40 Case study: Enhancing the quality of PFS glass containers

    Alessandro Morandotti

    Alessandro Morandotti, R&D Department, Stevanato Group

  • Glass forming knowledge
  • Integrating dimensional and inspection control
  • Importance of production in a fully controlled environment
  • 12:20 Networking Lunch

    13:40 The ebb and flow of liquid dispensing for pharmaceutical applications

    Dale Charlton

    Dale Charlton, Business Development Director, Optima Pharma

  • Overview of different dispensing systems
  • Fit-for-purpose the right pump for the right 'solution'
  • The rise of disposable technology in fill / finish
  • 14:20 Challenges of manual visual inspection of pre-filled syringes

    Iris Metzmacher

    Iris Metzmacher, Associate Director of Visual Inspection, Boehringer Ingelheim

  • Special characteristics of visual inspection of pre-filled syringes
  • Handling of pre-filled syringes during manual visual inspection
  • Case study: Implementing a manual visual inspection procedure meeting Japanese market requirements
  • 15:00 Afternoon Tea

    15:30 Proof of sterility and Final Quality Declaration for pre-filled syringes by 100% inline foreign particle and leak detection

    Gerhard Schramm

    Gerhard Schramm, Sales Director, Wilco

    • Detection of both visible and non-visible foreign particles
    • CCI in-line leak testing
    • Combination of technologies for a FINAL QUALITY machine concept

    16:10 Automatic inspection strategies

    Gert Nielsen

    Gert Nielsen, Director, Chief Executive Officer, InnoScan

  • The ever expanding range of syringes, closures, materials and capacity requirements
  • Changes in inspection strategies
  • New methods for process flow, handling and inspection
  • 16:40 Q&A: What is the marketplace for pre-filled syringes?

    Suketu Desai

    Suketu Desai, Vice President, Biotechnology Operations, Cephalon Inc

  • Asian market: Future plans for pre-filled syringes
  • What are the requirements of international authorities
  • How can we minimize regulatory conflicts for launches in the future
  • What type of testing companies do for combination products?
  • 17:10 Chairman’s Closing Remarks and Close of Day Two

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