SMi Group's 6th annual Pre-Filled Syringes conference & exhibition is already Europe's leading event. This year it will be better than ever. Check out the programme.

1. Top-Ranked Speaker Faculty Includes...
Event’s Highlights Include:
• 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
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 29th January 2014, Marriott Regents Park London, UK
Leachables and Extractables
Hosted by: Andrew Fieldon, Senior Consultant, Smithers Rapra
8.30am - 12.30pm
Large Volume Injectors – Technologies, Strategies
and Guidance
Hosted by: Stephen Augustyn Head of Mechanical Engineering, Team Consulting
1.30pm - 5.30pm
• Advait Badkar, Associate Research Fellow, Technolgy Lead,
Pfizer
• Jason Creasy, Head of Extractables & Leachables Team,
GlaxoSmithKline
• Bobbijo Redler, Principal Scientist, Merck & Co.
• Joel Richards, Director, Ipsen
• Christian Siegmund, Head of Prefilled Syringes and Liquid Vials,
Hoffmann La Roche Ltd
• Yuh-Fun Maa, Principal Engineer, Genentech
• Robert Schnepf, Molecule Leader, MPD CoE, Merck & Co.
• Joan Malstrøm, Specalist, Novo Nordisk A/S
“The meeting improves each year and should become a fixed date
on the calendar for anyone interested in Pre-Filled Syringes.”
Senior Director, Pharma Representative
SMi presents Europe’s Leading Event with 6 Years of Excellence
27th - 28th
JAN
2014Marriott Regents Park Hotel, London, UK
Future applications for safer drug delivery
Pre-Filled Syringes
BO
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BY
30TH
SEPTEM
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£300
BO
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BY
31STO
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£100
Sponsored by
www.pre-filled-syringes.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUPS DISCOUNTS AVAILABLE
SPECIAL £999 FOR FIRST 25 PHARMA COMPANIES

2. Register online at: www.pre-filled-syringes.com • Alternatively fax
Pre-Filled Syringes
Day One | Monday 27 January 2014 www.pre-filled
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer
PRE-FILLED PATIENT SAFETY AND QUALITY BY DESIGN
9.10 Quality by design in the manufacture of pre-filled syringes
• PFS and quality by design assessment
• Component preparation focus – PFS manufacturing
• Operations and risk assessment review
• Design and implementation for understanding parameters in
PFS
Advait Badkar, Associate Research Fellow, Technolgy Lead, Pfizer
9.50 Merck case study – Introduction of a prefilled diluents syringe for
preparation of a complex product
• Common and uncommon technical challenges
• End user voices are key to develop the right product
• Case study
Robert Schnepf, Molecule Leader, MPD CoE, Merck & Co.
10.30 Panel Discussion – Specific considerations for PFS development
•Start up of increased speed filling lines
•FDA regulations on PFS controls
•Operations and risk assessment
•Case study
Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer
Adam Woolley, CEO, ForthTox
11.10 Morning Coffee
11.40 Improve medication safety in Hospital Care environment with
Polymer Prefillable Syringes in combination with syringe pumps
• Design requirements for COC prefillable syringe to be used in
combination with syringe pumps
• Infusion performance due to pump specific system design
• Project challenges and the solutions found within the Fresenius
Kabi AG and SCHOTT AG partnership
• Latest developments on polymer PFS
• Recent roadblocks
• Case study
Anil-Kumar Busimi, Head of Global Product Management
Syringe Business, Schott
Andreas Kerschbaumer, Manager, Fresenius Kabi
CONTAINER INTEGRITY AND SAFETY CONSIDERATIONS WITH LEACHABLES
12.20 Leachables and safety considerations in Pre-filled syringes and
cartridges: Impact on drug product quality and safety profile for
biologics
• 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
Joël Richard, Vice President Peptides, Ipsen
1.00 Networking Lunch
2.00 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, CEO and
David Woolley, Consultant, ForthTox
2.40 Session reserved for BD
Nicolas Morais, Product Manager, Europe, Prefillable Syringes,
BD Medical
3.20 Afternoon Tea
4.00 Techniques & processes for assessing the risk posed from
leachables in pre-filled syringes
• 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
Jason Creasy, Head of Extractables & Leachables Team,
GlaxoSmithKline
4.40 Development of HCLF Biologics in Pre-Filled Syringes
• Challenges for the development of HCLF biologics from
downstream to drug product
• Interactions with primary packaging
• Stability issues during manufacturing
• Medical application and considerations
Patrick Garidel, Associate Director Protein Science,
Boehringer Ingelheim
5.20 Ovarian cancer diagnostics – A novel point of care device using
Pre-filled syringes in the operating room
• 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
Khalil Razvi, Consultant, Southend NHS Trust
6.00 Chairman's Closing Remarks and Close of Day One
Who should attend?
The Heads, VPs, Team Leaders, Consultants and Scientists involved in:
• Pre-Filled Syringes
• Drug Safety
• Medical Devices
• Drug Delivery Systems
• Packaging & Labelling
• R&D
• Extractables & Leachables
• Drug Formulation
• Clinical Trials
• Bioprocessing
• Sterile Manufacturing
• Quality Assurance

3. Want to know how you can get involved?
Interested in promoting your services to this market?
Contact Julia Rotar, SMi Marketing on +44 (0) 207 827 6088, or email: jrotar@smi-online.co.uk
your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Day Two | Tuesday 28 January 2014d-syringes.com
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Jason Creasy, Head of Extractables & Leachables Team,
GlaxoSmithKline
THE NEXT GENERATION OF PRE-FILLED SYRINGES
9.10 PFS filling of high-concentration mAb formulations – Parameter
investigation and optimasation using small-scale filler
• 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
Yuh-Fun Maa, Principal Engineer, Genentech
9.50 Understanding the risks and impact of offering both a prefilled
syringes and a vial/stopper image
• Drivers for offering both images
• Considerations for materials selection
• Impact to E&L study design when offering both images
Bobbijo Redler, Principal Scientist, Merck & Co.
10.30 Incorporating human factors and patient centric design into a
novel safety device
• 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
Alexander Jaksch, Director, Marketing & Commercial
Development, Safety, BD Medical
11.10 Morning Coffee
11.30 Introduction to Medical Grade Cyclo Olefin Polymers (COP) for
Pre-Filled Syringes
• 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
Reinhard Scheller, Commercial Manager Cyclo Olefin Polymers
- COP, Zeon Europe GmbH
12.10 Silicone oil in prefilled syringes determined by NMR spectroscopy
• Comparison of NMR data with MFI
• Quantitative aspect of 1H-NMR spectroscopy
• Method for determination and quantitation of Si-oil
Joan Malmstrøm, Specialist Peptide Characterisation, Diabetes,
Novo Nordisk A/S
12.50 Networking Lunch
1.50 Next Generation of Plungers for Prefilled Syringes – the Ideal
Combination for Self-Injection Devices
• 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
Christina Janssen-Otten, TCS Manager Europe,
West Pharmaceutical Services
PRE-FILLED UPDATES AND MANUFACTURING TRENDS IN
PRE-FILLED SYRINGES
2.30 Implementation and start up of a pre-filled syringe isolator
filling machine
• Challenges during start up
• Minimization of scratches
• Integrated AIM (automated inspection machine)
Christian Siegmund, Head of Prefilled Syringes and Liquid Vials,
Hoffmann La Roche Ltd
3.10 Next generation Pre-filled Syringes
• Advantages of pre-filled syringe presentations
• Challenges developing pre-filled syringe presentations
• Cross-linked silicone coating technology
• Glass strengthening technology
Roja Narwal, Scientist I, MedImmune
3.50 Afternoon Tea
4.30 Regulatory perspective and case studies
• Recent regulatory developments;
• Interpretation of analytical results;
• Useability and patient factors;
• Regulatory case studies
Brij Patel, CEO, RegExcel Consulting Ltd
5.10 Panel Discussion – Extended Q&A
• Potential problems with leachables as they stand
• Opportunities for speakers to further clarify presentations
• Potential road blocks’
• Case study
Jason Creasy, Head of Extractables & Leachables Team,
GlaxoSmithKline
Bobbijo Redler, Principal Scientist, Merck & Co.
5.50 Chairman’s Closing Remarks and Close of Day Two

4. POST-CONFERENCE WORKSHOP A
9.00am - 12.30pm I Wednesday 29th January 2014 I Marriott Regents Park, London, UK
Leachables and Extractables
Hosted by: Andrew Fieldon, Senior Consultant, Smithers Rapra
Overview of workshop:
It is becoming increasingly clear that for many research applications that
Three Dimensional (3D) cell culture and cell based assay approaches offer
huge advantages over the more conventional 2D cell culture and assay
models. This workshop will provide an overview of the very latest 3D cell based
assay and culture technologies and techniques for use in biomedical
research and drug discovery and the key application areas for these
technologies with a focus on HTS and HCS.
• To gain an insight into the issues surrounding this new area of research
• The opportunity of discussing issues and ideas and sharing experiences
with other scientists
• Networking opportunities with peer scientists working in the same area
Key learning include:
• Analyse current regulatory guidance and strategy management
• Share insight with experienced specialists in the fields of leachables
• and extractables
• Learn about relevant cases studies in analysis and selection
• Develop solutions to challenges in the field
About your wokshop leader:
Dr Andrew Feilden joined Smithers Rapra as a principal consultant in June
2011. He is specialising in extractable and leachable testing and the selection
and assessment of materials for medical and pharmaceutical applications.
For the previous 12 years he was at AstraZeneca, leading their extractable
and leachable testing. He has been working in the field of trace analysis using
hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst
at AstraZeneca he was an active member of industry working groups, the
IPAC-RS container closure group and he was the co-chair of ELSIE material
group. Andrew gained a degree and D.Phil from York University.
About Smithers Rapra
Smithers Rapra, part of the Smithers Group of companies, has been
recognized as a world leading rubber and plastics consultancy
delivering a comprehensive and strictly independent service since
its establishment over 90 years ago. These services have been
tailored to support the medical device and pharmaceutical
industries where polymers are widely used. Much of our work for this
sector is in the field of Extractables and Leachables testing for drug
delivery devices, immediate packaging and bioprocess
equipment, however we are also able to support the development
of medical and drug delivery devices and, where required,
comprehensive failure diagnosis.
Programme
8.30 Registration and coffee
9.00 Welcome and introductions to E&L
• What exactly are they?
• The guidance available currently
9:20 Material Selection
• What are the effects of differing materials
• Analysis
10:10 E&L analysis including novel case stud
11:00 Morning tea
11:20 Testing on E&L
• The current limits to testing
• Methods of testing
12:30 Conclusions and close of workshop
POST-CONFERENCE WORKSHOP B
1.30pm - 5.30pm I Wednesday 29th January 2014 I Marriott Regents Park, London, UK
Large Volume Injectors –
Technologies, Strategies
and Guidance
Hosted by: Stephen Augustyn, Head of Mechanical Engineering,
Team Consulting
Overview of workshop:
Chronic conditions and the rise of biological drugs with large volume
payloads are driving pharmaceutical companies and device
manufacturers to develop Large Volume Injectors (LVI). This workshop
will examine the pressures driving the creation of LVIs, the advantages
they offer over traditional parenteral delivery systems and some
guidance to help companies select or develop a device for their own
application.
Key learning include:
• To understand what makes LVIs different from current parenteral
systems
• To gain an overview of the devices currently being presented from
different device and pharmaceutical companies
• To better understand the standards that will affect LVIs
• For insight into the technical and user challenges associated with
these products
About your wokshop leader:
Stephen is responsible for the delivery of Team’s capability in device
engineering and has over twelve years’ experience in medical
devices. Since joining Team Consulting five years ago, Stephen has
been responsible for the management and delivery of a wide variety
of medical and surgical products. In addition to his work at Team,
Stephen is a member of the TC84 ISO committee responsible for
defining new standards for injection devices.
About Team Consulting Ltd
Team Consulting work globally for companies in the life science
industries, and we're acknowledged experts in medical and drug
delivery device development. To date, Team has helped clients to
develop over 20 injection devices and has worked for many of the
world’s leading pharma and device firms, including six of the 10
largest pharmaceutical companies.
Programme
1.30 Registration and coffee
1.45 Welcome and Introductions
2.00 Context and Background
• Pressures driving creation of LVIs
• Advantages over current parenteral systems
2.20 Market Overview
• Examination of some of the leading products
in the public domain
• Predicate devices
3.30 Coffee and networking Break
3.50 Technical and Human Factors
• Primary containers
• Manufacturing
• Human Factors and Industrial Design
4.40 Guidance and Predicate devices
• Key performance markers
• Appropriate standards
• Defining or choosing your device
5.10 Summary and Questions
5.30 Close of workshop
In asscociation with
In asscociation with

5. BD Medical Pharmaceutical Systems is a worldwide leader in supplying the
pharmaceutical industry with quality drug delivery systems and safety-
engineered devices. Our cutting-edge delivery systems are customizable to
meet patient needs, are market tested and are manufactured to meet the
high quality standards that our customers expect. BD Medical -
Pharmaceutical Systems provides a comprehensive range of prefillable
injection systems using clinically proven products that help deliver enhanced
drug or end-user benefits and results, and access to information and
distribution networks worldwide. For years we have also been one of the most
active promoters of healthcare worker safety. www.bd.com
SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of glass
tubing and primary packaging for the pharmaceutical industry. We provide
our customers quality solutions while meeting their highest demands with our
material expertise, specialized analytical lab services, and a broad product
portfolio; including syringes, cartridges, vials, and ampoules made of glass and
COC polymer. With our extensive production network of glass tubing and
pharmaceutical packaging, we offer safe supply and local service. Our state-
of-the-art production facilities and our products comply with the highest
international quality standards for pharmaceutical needs.
www.schott.com/pharmaceutical_systems
West works side-by-side with its healthcare partners from concept to the
patient, designing and manufacturing packaging, diagnostic and delivery
systems that promote the efficiency, reliability and safety of their products.
Every day, West is leading the way with cutting-edge technologies and quality
systems, a thorough understanding of global regulatory compliance, and an
unmatched and growing knowledge base of relevant pharmaceutical
product testing, development and packaging. Based in Exton, Pa., West
supports its customers from sales, manufacturing, customer service and
research and development facilities in North and South America, Europe, Asia
and Australia. www.westpharma.com
Zeon Europe GmbH is the European marketing/sales organisation of ZEON
CORPORATION, Japan. Based on unique C4 and C5 extraction technologies
Zeon developed an integrated production system and is striving to create new
products and business areas by utilizing these core technologies. As part of
specialty materials business Zeon produces Cyclo-Olefin Polymers (COP) under
the tradenames ZEONEX®
and ZEONOR®
. www.zeon.eu www.zeonex.com
Sponsored by
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First 25 Pharmaceutical Companies
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PRE-FILLED SYRINGES 2014
Conference: Monday 27th & Tuesday 28th January 2014, Marriott Regents Park Hotel, London, UK Workshop: Wednesday 29th January 2014, London
4 WAYS TO REGISTER
ONLINE www.pre-filled-syringes.com