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After the overwhelming success of our 2012 conference, SMi are proud to present Europe's leading Pre-Filled Syringes event. Building on the success of our previous event, this 5th annual event promises to be bigger and better! This exciting event will present itself as a perfect forum for learning about new advances in the field, providing attendees with the latest information on technological and regulatory updates from key industry professionals. 

The 2013 event will include senior industry representatives presenting on their own experiences and referring to case studies, success stories and failures, this event promises to be a unique forum for problem-solving debate and idea-sharing discussion.

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

This market-leading event will bring together senior representatives from all over the parenteral community to share knowledge and discuss the latest developments in the field.

Testimonials from our successful 2012 event:

"Brilliant. Complicated technology explained well” - Teva Pharmaceuticals

“Very informative with a great mix of speakers“ - Sanofi-Aventis

"Very interesting perspective of PFS changes” - Abbott

"Great presentations on interesting technologies” - Medimmune 

 

  • Consider strategies to achieve success in delivery device development
  • Examine novel technologies in filling, closing and secondary packaging
  • Hear from leading healthcare professionals on the growing use of pre-filled syringes in the public sector
  • Evaluate combination product design and development techniques
  • Develop your understanding of leachables and extractables and interactions between formulation components and containers
  • Analyse all phases of facility design and understand the requirements of pre-filled syringes development lines
  • Network with and learn from key industry professionals, leading academics and healthcare representatives
  • Discuss the latest in regulatory and commercialisation considerations

SMi's Event Communities

SMi Group is a global events business specialising in business to business conferences, workshops and masterclasses.
We successfully create and run 250 events every year across 6 sectors including Defence and Security, Energy and Utilities, Finance and Pharmaceuticals. We believe in bringing together the most knowledgeable experts from across the globe in each sector to learn, engage, share and network be it in London, Paris or Singapore.

To further enhance the SMi experience, we have launched our very own SMi Event Communities. These will be exclusive, private and secure communities in which our clients will learn, share, engage and network. The SMi Event Communities will build and expand your experience beyond the conference, workshop or Masterclass you attend. Not just another "social network”, SMi’s Event Communities have been specifically designed around the needs of our delegates, speakers and sponsors, allowing all of our clients to foster longer term relationships with all of the other attendees beyond the three day event for year round engagement.

To take part all you need to do is register for this event.

SMi Group Communities
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New for 2013 - Evening Reception and Dinner
SMi Group invites you to join them for a post conference dinner reception following the end of the first day. Dinner will be held at Gilgamesh Restaurant and Bar where you will have the extended opportunity to network with industry professionals. Jump aboard a traditional red London bus at the hotel at 7.00pm for a real London experience. Leave Pre-Filled Syringes 2013 having forged new working relationships and strengthened your current ones.

The Gilgamesh Restaurant and Bar combines history with elements of contemporary design and modern art to make one of the most visually stunning venues in central London. In the Babylon Bar you will experience some of the finest pan-Asian cuisine prepared by award winning chefs. Dine, drink and socialize in jaw dropping surrounds. A truly unforgettable experience.
 

SMi's 5th annual Pre-Filled Syringes Conference will build on the success of our previous events and bring together a unique mix of senior executives from the industry, academia and the public sector and will provide an unrivalled forum for problem-solving discussion and debate.
Last year's attendees included senior representatives from companies including:
 

• Abbott Laboratories
• Adelphi (Tubes) Ltd
• Amgen
• Astech Projects
• Barts and the London NHS Trust
• Baxter BioPharma Solutions
• Bayer Pharma
• BD Medical - Pharmaceutical Systems
• BHR NHS Trust
• Bioneer A/S
• Bone Support A B
• Bosch PackagingTechnology
• Bristol-Myers Squibb Pharmaceuticals Ltd
• Britannia Pharmaceuticals
• Capa Valve
• Catalent
• Central Manchester Foundation Trust
• Corium International Inc
• Datwyler Pharma Packaging
• Development Syrategy
• ESL & Network
• F.Hoffmann-La Roche
• F.Hoffmann-La Roche
• FDA
• Ferring Pharmaceuticals A/S
• Forteq Healthcare
• Genentech
• Gerresheimer Group Gmbh
• Hospira Zagreb
• Induchem Components Ltd
• InnoScan
• Innovate UK
• Ith Pharma
• Komax Systems
• Laboratoire Aguettant
• Lilly
• Manchester Royal Infirmary
• MedImmune
• Merial Sas
• MGlas AG
• MHRA
• NHS Plymouth
• Nipro Glass Americas
• Novartis International AG
• Optima Pharma
• Overlook Industries, Inc.
• Owen Mumford Ltd
• Pan American Health Organization
• Patheon Italia S P A
• Pfizer
• Pharmacy Manufacturing Unit, Portsmouth Hospitals
• R+E Automationstechnik GmbH
• Rexam
• Roche Pharmaceuticals
• Roselabs Group
• Safety Syringes
• Sandoz Biopharmaceuticals
• Schott Schweiz A G
• Specialty Coating Systems, Inc
• Stelmi
• Teva Pharmaceuticals
• West Pharmaceutical Services
• Zeon Europe GmbH


 


 

This event is unmissable for professionals in departments such as; 

  • 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

Advait Badkar PhD.

Advait Badkar PhD., Associate Research Fellow- Technology Lead, Pfizer Inc

9:10 Pre-filled syringe developments for biotechs

Nicolas Morais

Nicolas Morais, Product Manager, BD Medical - Pharmaceutical

• Prefilled syringe market overview
• Patient, regulatory and operational excellence trends for the biotech
• Injectable market
• Development of new biotech prefillable systems answering unmet needs

9:50 Development considerations for biologics as pre-filled syringe products: A QbD approach

Advait Badkar PhD.

Advait Badkar PhD., Associate Research Fellow- Technology Lead, Pfizer Inc

• 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

10:30 Morning Coffee

11:00 Development of pre-filled syringes for high concentrated liquid protein formulations

Patrick Garidel

Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation

• Challenges for the development of HCLF biologics
• Interactions with primary packaging
• Stability issues
• Medical requirements and application

11:40 Extractables and Leachable investigations and documentation for pre-filled syringes

Carsten Worsoe

Carsten Worsoe, Principal Scientist, Novo Nordisk

• Risk assessment for extractables and leachabes in PFS
• Optimal study for PFS - extractable, simulated or leachable study ?
• Experiences with glass vs. plastic PFS
• Case studies on extractables and leachables in PFS systems

12:20 Networking Lunch

13:40 Formulation and Pre-filled Syringe Development for Biosimilars - Sandoz Experience

Violeta Gabrijelcic

Violeta Gabrijelcic, Head Global Pharmaceutical & Device Development, Sandoz

14:15 Safety Assessment of Leachables from Container Closure Systems – Pre-Filled Syringes

Stephen Barat

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

•    Overview of the needs for safety evaluation of leachables
•    Outline of the approaches taken for toxicological assessment of leachables
•    Considerations to take during development
•    Working examples of safety assessments for pre-filled syringe drug products 

14:40 Daikyo Crystal Zenith® Prefillable syringe Systems: A Superior Containment Alternative over Glass Syringes

Nicolas Brandes

Nicolas Brandes, Manager CZ European Business Development, West Pharmaceutical Services

• The unique properties of Daikyo Crystal Zentih prefillable syringe systems
• Discussion into the associated processing requirements to fill and finish these unique systems
• Exponential advantages for the safety and stability of high value biopharmaceutical drug products

15:20 Development of a simple and inexpensive Dual-Chamber Syringe

Daniel Bar-Shalom

Daniel Bar-Shalom, Associate Professor, University of Copenhagen

  • Enabling direct Lyophilization in the device and sealing under vaccum
  • Air free filling of solvent and air-free dissolution of the API in the solvent
  • Comparison of COC against Glass
  • Simultaneous freeze drying of 2 or more APIs while keeping them separated
  • 15:50 Afternoon Tea

    16:10 Laser Coding for Glass Syringes

    • Total visibility of the manufacturing process through batch record/ pedigree on item level
    • Preventing of mix-ups between production lots even of unlabeled containers
    • Method to support filling lines clearing after product change
    • Identifying a single item in the after sales supply chain to authenticate its original provenance to fight against product piracy

    Anil-Kumar Busimi

    Anil-Kumar Busimi, Product Manager, SCHOTT AG

    Sergej Toedtli

    Sergej Toedtli, CEO, Vesdo Ltd

    16:50 Primary container developments; Glass V Plastic

    • Developments in glass syringes; stability and permeability
    • Advanced processing and inspections of glass containers
    • New manufacturing techniques of polymer based containers
    • Filling capability of polymer syringes

    Martin Bontoft

    Martin Bontoft, Head of Design Research, Team Consulting

    Patrick Garidel

    Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation

    Advait Badkar PhD.

    Advait Badkar PhD., Associate Research Fellow- Technology Lead, Pfizer Inc

    17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Patrick Garidel

    Patrick Garidel, Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation

    9:10 The future of ampoules: are they superseded by pre-filled syringes for all drugs, even generics

    Dan Wheeler

    Dan Wheeler, Lecturer in Anaesthesia, University of Cambridge

    • Preparation of drugs at the bedside vs. pre-filled syringes
    • Problems with drug infusion on Intensive Care
    • Errors and delays during preparation of drug solutions

    9:50 Secondary Packaging; Hero or villain of the PFS world? An overview to PFS Secondary Packaging machinery

    Dale Charlton

    Dale Charlton, Business Development Director, Optima Pharma

    • Relationship to filling lines
    • Current status of secondary packaging machinery
    • Current issues for the handling of filled syringes
    • Relationship to tertiary packaging

    10:20 Morning Coffee

    10:50 Validation and Qualification of a cRABS Clinical Supplies Line

    Mathias Misiek

    Mathias Misiek, Group Leader, Clinical Manufacturing, Roche Pharmaceuticals

    • Review of restricted access barrier systems
    • Obtaining a higher level of assurance for aseptic filling
    compared to cleanroom processes
    • Industrial scale production lines
    • Combination filling stations

    11:20 Silicone layer control thickness and protein aggregation in pre-filled syringes

    Oliver K. Valet

    Oliver K. Valet, Managing director, rap.ID Particle Systems GmbH

    • Linking the influence of siliconisation parameters and the silicone agglomeration behaviour of the protein based drug
    • Enabling the understanding of the siliconization process in order to minimize silicone induced issues for development and manufacturing
    • Considering issues related to the interaction of silicone oil and protein based formulations
    • Investigating these interactions by image directed particle Raman spectroscopic analysis equipment (SPE)

    12:00 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

    12:35 Networking Lunch

    13:50 Safety Devices for Self-injection Drugs

    Alexander Jaksch

    Alexander Jaksch, VP Business Development & Marketing, Safety Syringes

    • Safety devices as a primary choice to be added to pre-filled syringes to meet anit-needlestick legislation around the globe
    • Currently a growing number of biotech drugs in pharma’s pipeline that require self-injection device to satisfy patients’ needs and handle new drug properties eg. Higher viscosities
    • How was the design of a clinically proven safety device adapted to meet those new requirements?

    14:30 Reducing contamination and medical errors with PFS in the acute care environment and address the need for compatibility with syringe pumps

    Dragana Cvijanovic

    Dragana Cvijanovic, Product Manager, BD Medical - Pharmaceutical

    15:10 Label-integrated needlestick prevention system for pre-filled syringes: A unique approach

    Frank Janssen

    Frank Janssen, Global Key Account Manager, Schreiner MediPharm

  • The caregivers’ and patients’ perspective – simple handling
  • The pharmaceutical companies’ perspective – easy processing
  • Environmental and supply chain impacts – minimized volume
  • Safety and reliability in healthcare practice – effective protection
  • 15:50 Afternoon Tea

    16:10 Regulatory Aspects of Pre filled Syringes in Europe

    Morag Bratby

    Morag Bratby, Pharmaceutical Assessor, MHRA

    • Pre-filled syringe: medicinal product or medical device
    • Borderline Examples
    • Auto-injectors
    • Module 3: Quality - including special focus on the Manufacturing Process, Container Closure aspects
    • Agency feedback: Licensing
    • the Regulatory Horizon
    • Future MAA trends: Rapid Micro Methods

    16:40 Pre-filled Syringes: An NHS Perspective

    Jasdeep Singh

    Jasdeep Singh, Head of PMU, Barts and the London NHS Trust

    • Manufacturing of pre-filled syringes as ‘specials’
    • Problems at the coal face – how can we overcome then?
    • Patient perspectives
    • Lessons pharma can learn from the NHS

    17:10 Manufacturing pre-filled syringes with a contract manufacturing partner

    Richard  Hart

    Richard Hart, Pharma Partner Executive, Baxter

    • Finding and selecting a partner
    • Contracting for success
    • Overcoming challenges
    • Achieving excellent outcomes

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

    +

    FEATURED SPEAKERS

    Advait Badkar PhD.

    Advait Badkar PhD.

    Associate Research Fellow- Technology Lead, Pfizer Inc
    Patrick Garidel

    Patrick Garidel

    Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation

    Advait Badkar PhD.

    Associate Research Fellow- Technology Lead, Pfizer Inc
    Advait Badkar PhD.

    Alexander Jaksch

    VP Business Development & Marketing, Safety Syringes
    Alexander Jaksch

    Anil-Kumar Busimi

    Product Manager, SCHOTT AG
    Anil-Kumar Busimi

    Carsten Worsoe

    Principal Scientist, Novo Nordisk
    Carsten Worsoe

    Dale Charlton

    Business Development Director, Optima Pharma
    Dale Charlton

    Dan Wheeler

    Lecturer in Anaesthesia, University of Cambridge
    Dan Wheeler

    Daniel Bar-Shalom

    Associate Professor, University of Copenhagen
    Daniel Bar-Shalom

    David Whitaker

    Consultant Anaesthetist, Manchester Royal Infirmary
    David Whitaker

    Dragana Cvijanovic

    Product Manager, BD Medical - Pharmaceutical
    Dragana Cvijanovic

    Frank Janssen

    Global Key Account Manager, Schreiner MediPharm
    Frank Janssen

    Jasdeep Singh

    Head of PMU, Barts and the London NHS Trust
    Jasdeep Singh

    Martin Bontoft

    Head of Design Research, Team Consulting
    Martin Bontoft

    Mathias Misiek

    Group Leader, Clinical Manufacturing, Roche Pharmaceuticals
    Mathias Misiek

    Morag Bratby

    Pharmaceutical Assessor, MHRA
    Morag Bratby

    Nicolas Brandes

    Manager CZ European Business Development, West Pharmaceutical Services
    Nicolas Brandes

    Nicolas Morais

    Product Manager, BD Medical - Pharmaceutical
    Nicolas Morais

    Oliver K. Valet

    Managing director, rap.ID Particle Systems GmbH
    Oliver K. Valet

    Patrick Garidel

    Head of Pharmaceutical Basic Development, Boehringer Ingelheim Corporation
    Patrick Garidel

    Richard Hart

    Pharma Partner Executive, Baxter
    Richard  Hart

    Sergej Toedtli

    CEO, Vesdo Ltd
    Sergej Toedtli

    Stephen Barat

    Senior Director, Toxicology and Operations, Forest Laboratories
    Stephen Barat

    Violeta Gabrijelcic

    Head Global Pharmaceutical & Device Development, Sandoz
    Violeta Gabrijelcic

    Workshops

    The Future of Self-Injection; Where do you want to be?
    Workshop

    The Future of Self-Injection; Where do you want to be?

    Copthorne Tara Hotel
    30th January 2013
    London, United Kingdom

    Safety Issues within Pre-Filled Syringes
    Workshop

    Safety Issues within Pre-Filled Syringes

    Copthorne Tara Hotel
    30th January 2013
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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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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