This document summarizes an upcoming conference on pre-filled syringes in Europe. The two-day conference will feature presentations and discussions on pre-filled syringe formulations, filling and finishing processes, primary and secondary packaging developments, regulatory compliance, and patient safety approaches. It will also include two post-conference workshops on self-injection devices and safety issues within pre-filled syringes. Key industry leaders and experts will speak on topics such as biologics formulations, extractables and leachables, facility design strategies, and regulatory trends. The conference aims to explore challenges and solutions for pre-filled syringe development and commercialization.

1. "Brilliant. Complicated technology explained well”
Teva Pharmaceuticals
SMi PRESENTS THE 5TH ANNUAL Early
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PRE-FILLED SYRINGES 0
EUROPE'S LEADING PRE-FILLED SYRINGES EVENT
28TH - 29TH JANUARY 2013 | COPTHORNE TARA HOTEL, LONDON, UK
KEY SPEAKERS INCLUDE: KEY REASONS TO ATTEND:
• Advait Badkar, Associate Research Fellow, Explore the challenges for the development of HCLF biologics with
Pfizer key industry professionals
• Karoline Bechtold-Peters, Head, Clinical Consider the effects of leachables and extractables and evaluating
Manufacturing, Roche interactions between formulation and containers
• Patrick Garidel, Head of Pharmaceutical Basic
Development, Boehringer-Ingelheim Develop your understanding of regulatory compliance from
• Carston Worsoe, Principal Scientist, Novo pharmaceutical companies and the MHRA
Nordisk Hear from leading healthcare professionals on the growing use of
• Jasdeep Singh, Head of Pharmacy pre-filled syringes at the patient ‘front line’
Manufacturing, Royal London Hospital
• Richard Hart, Pharma Partner Executive, Streamline the filling and closing process by exploring facility design
Baxter Healthcare strategies and syringe development line techniques
• Violeta Gabrijelcic, Head Global Discuss the latest in vendor procurement and outsourcing strategies
Pharmaceutical and Device Development,
Sandoz Network with and learn from key industry professionals, leading
• Morag Bratby, Pharmaceutical Assessor, academics and healthcare representatives
MHRA
PLUS TWO INTERACTIVE POST CONFERENCE WORKSHOPS
Workshop A: The Future of Self-injection: Workshop B: Safety Issues
Where do we want to be? within Pre-filled Syringes
8.30am - 12.30pm 1.30pm - 5.30pm
30th January 2013, Copthorne Tara Hotel, London, UK 30th January 2013, Copthorne Tara Hotel, London, UK
Workshop Leaders: Martin Bontoft, Head of Design Workshop Leaders:
Research and Julian Dixon, Director of Human Factors, Simon Cohen, Director, Innovate UK
Team Consulting
NEW FOR 2013: EVENING DINNER AT THE GILGAMESH RESTAURANT
Sponsored by
www.pre-filled-syringes.com
Register online or alternatively fax your registration to
+44 (0) 870 9090 712 or call +44 (0) 870 9090 711

2. DAY ONE | MONDAY 28TH JANUARY 2013 Very informative with a great mix of speakers“ Sanofi-Aventis
8.30 REGISTRATION & COFFEE 14.10 Q & A Discussion with the Morning Session Speakers
9.00 Chairman's opening remarks 14.30 AFTERNOON TEA
Advait Badkar, Associate Research Fellow, Pfizer
PRIMARY PACKAGING DEVELOPMENTS
PRE-FILLED SYRINGE FORMULATIONS
14.50 Daikyo Crystal Zenith® Prefillable
9.10 Development Considerations for Biologics as Pre-Filled syringe Systems: A Superior Containment
Syringe Products: A QbD approach Alternative over Glass Syringes
• Quality Attributes for Pre-filled syringe products that are • The unique properties of Daikyo Crystal
of concern Zentih prefillable syringe systems
• Component Selection and Risk Assessment • Discussion into the associated processing requirements
• Co-development with Component Manufacture to fill and finish these unique systems
• Taking these lessons and making immediate • Exponential advantages for the safety and stability of high
improvements value biopharmaceutical drug products
Advait Badkar, Associate Research Fellow, Pfizer Nicolas Brandes, Director Strategic Marketing Daikyo Crystal
Zenith Products, West Pharma
9.50 PFS Developments for Biotechs
• Prefilled syringe market overview 15.30 Interactions between formulation components and container
• Patient, regulatory and operational • Reducing extractables and leachables in pre-filled syringes
excellence trends for the biotech by collaborations with packaging design
• Injectable market • Interactions with primary packaging
• Development of new biotech prefillable systems answering • Techniques for inspection
unmet needs • Differences between interactions in glass and plastic
Nicolas Morais, Product Manager, Europe, Prefillable syringes
Syringes, BD Medical Sandipan Sinha, Prinicpal Scientist, Pfizer
10.30 MORNING COFFEE 16.00 Proven Glass Coding Technology allows
for full Traceability in Production and the
11.00 Extractables and Leachable investigations and Supply Chain
documentation for pre-filled syringes • Total visibility of the manufacturing process
• Risk assessment for extractables and leachabes in PFS through batch record/ pedigree on item level
• Optimal study for PFS - extractable, simulated or leachable • Preventing of mix-ups between production lots even of
study ? unlabeled containers
• Experiences with glass vs. plastic PFS • Method to support filling lines clearing after product change
• Case studies on extractables and leachables in PFS systems • Identifying a single item in the after sales supply chain to
Carsten Worsoe, Principal Scientist, Novo Nordisk authenticate its original provenance to fight against product
piracy.
11.40 Development of pre-filled syringes for high concentrated Carmen Heiter, Product Management, Syringes, Schott
liquid protein formulations
• Challenges for the development of HCLF biologics 16.40 Primary container developments; Glass V Plastic
• Interactions with primary packaging • Developments in glass syringes; stability and permeability
• Stability issues • Advanced processing and inspections of glass containers
• New manufacturing techniques of polymer based containers
• Medical requirements and application
• Filling capability of polymer syringes
Patrick Garidel, Associate Director Protein Science,
Moderator:
Boehringer Ingelheim
Martin Bontoft, Head of Design Research, Team Consulting
12.20 NETWORKING LUNCH Panelist:
Patrick Garidel, Associate Director Protein Science,
13.40 Leachables and Extractables in Pre-Filled Syringes Boehringer Ingelheim and Advait Badkar, Associate Research
• Review of current guidance available
Fellow, Pfizer
• Reducing, monitoring and controlling interactions
• Non-invasive methods of detection 17.10 Chairman’s Closing Remarks
• Effects of material selections
• Performing controlled extraction studies 19.00 Evening Reception and Dinner
All attendees and speakers are invited
Stephen Barat, Senior Director, Toxicology and Operations, to join us for a formal dinner. Transport
Forest Laboratories will be provided at 19.00 from the conference hotel
New for 2013: Evening Dinner at the Gilgamesh Restaurant
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 contempory 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.
Register online at www.pre-filled-syringes.com • Alternatively fa

3. "Very interesting perspectives on PFS changes” Abbott
8.30 REGISTRATION & COFFEE 14.30 Safety Devices for Self-injection Drugs
DAY TWO | TUESDAY 29TH JANUARY 2013
• Safety devices as a primary choice
9.00 Chairman’s Opening Remarks to be added to pre-filled syringes to
Patrick Garidel, Associate Director Protein Science,
Boehringer Ingelheim meet anit-needlestick legislation around
the globe
FILLING, FINISHING & FACILITY DESIGN • Currently a growing number of biotech drugs in pharma’s
pipeline that require self-injection device to satisfy patients’
9.10 Challenges and solutions in fill and finishing lines
• The importance of flexibility in filling operations needs and handle new drug properties eg. Higher viscosities
• Potential strategies to reduce costs and speed up processes • How was the design of a clinically proven safety device
• Dual-chamber syringes adapted to meet those new requirements
• Meeting deadline, budget and quality requirements
Tobias Posset, Head of Production Support, Roche Alexander Jaksch, VP of Business Development and
Marketing, Safety Syringes, Inc
9.40 Secondary Packaging; Hero or villain of the
PFS world? An overview to PFS Secondary 15.10 Reducing contamination and medical
Packaging machinery errors with PFS in the acute care
• Relationship to filling lines environment and address the need for
• Current status of secondary packaging machinery compatibility with syringe pumps
• Current issues for the handling of filled syringes • BD response: New generation of polymer large size PFS
• Relationship to tertiary packaging • Presentation of the solution: superior Materials (CCP
Dale Charlton, Business Development Director, Optima
&rubber), innovation with patented luer lock
10.20 MORNING COFFEE • Seamless transition by design: acceptance in syringe pumps
• Technical performance and pumps requirements: tests on
10.50 Validation and Qualification of a cRABS Clinical Supplies Line gliding, clinical study on product performance
• Review of restricted access barrier systems
• Obtaining a higher level of assurance for aseptic filling • Human Factors: Preliminary results of the clinical study on
compared to cleanroom processes user acceptance figures and product preference
• Industrial scale production lines • Platform for new generation of plastic products at BD, for
• Combination filling stations
Karoline Bechtold-Peters, Head, Clinical Manufacturing, Roche applications in other therapeutical classes
Dragana Cvijanovic, Product Manager, BD Medical
11.20 Silicone layer control thickness and
protein aggregation in prefilled syringes 15.50 AFTERNOON TEA
• Linking the influence of siliconisation
parameters and the silicone agglomeration REGULATORY & COMMERCIALISATION TRENDS
behaviour of the protein based drug
• Enabling the understanding of the siliconization process in 16.10 Regulatory Aspects of Pre filled Syringes in Europe
order to minimize silicone induced issues for development • Pre-filled syringe: medicinal product or medical device
and manufacturing • Borderline Examples
• Considering issues related to the interaction of silicone oil • Auto-injectors
and protein based formulations
• Investigating these interactions by image directed particle • Module 3: Quality - including special focus on the
Raman spectroscopic analysis equipment (SPE) Manufacturing Process, Container Closure aspects
Oliver Valet, Managing Director, rap.ID GmbH • Agency feedback: Licensing
• the Regulatory Horizon
12.00 Q & A Discussion with Filling and Finishing Session Speakers
• Future MAA trends: Rapid Micro Methods
12.20 NETWORKING LUNCH Morag Bratby, Pharmaceutical Assessor, MHRA
DEVICE DESIGN AND PATIENT SAFETY APPROACHES 16.40 Pre-filled Syringes: An NHS Perspective
• Manufacturing of pre-filled syringes as ‘specials’
13.30 Formulation and Pre-filled Syringe Development for • Problems at the coal face – how can we overcome then?
Biosimilars - Sandoz Experience • Patient perspectives
• What are the common obstacles in development?
• Specifics in biosimilar syringe development • Lessons pharma can learn from the NHS
• Focus on Sandoz Case Studies Jasdeep Singh, Head of Pharmacy Manufacturing, Royal
Violeta Gabrijelcic, Head Global Pharmaceutical and Device London Hospital
Development, Sandoz
17.10 Manufacturing pre-filled syringes with a contract
14.00 The role of pre-filled syringes in patient safety manufacturing partner.
• Current trends in parenteral therapy • Finding and selecting a partner
• Intravenous medication safety
• New international recommendations and regulations • Contracting for success
• Overcoming challenges
• Advantages of pre-filled syringes
• Achieving excellent outcomes
• Barriers to the introduction of pre-filled syringes
Richard Hart, Pharma Partner Executive, Baxter Healthcare
David Whitaker, Consultant Anaesthetist, Manchester Royal
Infirmary 17.40 Chairman’s Closing Remarks and End of Day Two
Official Media Partner Supported by
Want to know how to get involved? Interested in promoting your services to this market?
Contact Margaret Mugema on +44 (0) 207 827 6072 or email: mmugema@smi-online.co.uk
ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

4. PLUS TWO INTERACTIVE POST–CONFERENCE WORKSHOPS
WEDNESDAY 30TH JANUARY 2013, COPTHORNE TARA HOTEL, LONDON, UK
Workshop A: Workshop B:
The Future of Self-injection: Safety Issues within
Where do we want to be? Pre-filled Syringes
Innovate UK
8.30am - 12.30pm 1.30pm - 5.30pm
Workshop Leader: Martin Bontoft, Head of Design Research Workshop Leader: Simon Cohen, Director, Innovate UK
and Julian Dixon, Director of Human Factors, Team Consulting
Overview Overview
We have seen an explosion of attention to human factors (HF) in This unique masterclass will focus on the latest developments in
drug delivery device development. This has been the era of patient safety in Pre-Filled Syringe development and will provide
usability, marked by a focus on the effectiveness and safety of an insight into alternative forms of risk. Led by the expertise and
devices in the hands of users. By focusing on case studies from experience of Simon Cohen, Director at Innovate UK this
adjacent fields, this interactive workshop will discuss and workshop will present attendees with an in-depth view into the
showcase the new methods and mindset that need to adopted in risks associated with Pre-Filled Syringes and evaluating needle
order to meet our ambitions for self-injection. stick injury and splash risk.
Timetable Timetable
8.30 Registration & Coffee 13.30 Registration & Coffee
9.00 Welcome & Introductions 14.00 Welcome & Introductions
9.15 The landscape and current trends in self-injection 14.10 Overview into Needle Stick Injury Risk
• Current needle safety devices that are available
9.45 How to ‘do’ human factors engineering in line with • Comparing Automated and Table-Top Devices
regulatory requirements
14.45 Evaluating alternative forms of risk
10.15 Beyond validation: desirability, advocacy, adherence • Case Study Focus Session
10.45 Mindsets and methodologies for researching the 15.45 Afternoon Tea
patient experience 16.00 Investigation into Splatter Risk for Pre-Filled Syringes
11.15 Morning Coffee • Developing splatter trials
• Discussing Chemical and Cross-Infection Hazards
11.30 The customer journey: the path to participation 17.00 Discussion Session
12.00 What constraints have we imposed on our user appeal 17.30 Close of Workshop
aspirations by the technology we’ve selected?
12.30 End of Workshop About Simon Cohen, Director, Innovate UK
Simon has worked both in the NHS and private practice
specialising in the prevention and treatment of sports injury
About Team Consulting: through gait analysis and biomechanics. He joined Pfizer
We are recognised globally as experts in the design and working as an NHS liaison specialist before continuing his
development of medical devices. That’s all we do and we are career in The Pharmaceutical Sector in various sales, marketing
and NHS liaison roles. Simon is one of the founders of Innovate
proud of this focus. It enables us to deliver real insight and
UK Ltd, alongside a number of working Doctors and an
expertise to our clients.Commercially successful products need international lawyer. The aim for the company is to provide a
to be safe, easy to use and ultimately make people better. Our service to both The Pharmaceutical Industry and the NHS in
clients like our approach, which combines design, human quick turn round innovative device solutions. Their ability to turn
factors, science and engineering from inspiration right through a basic idea into a finished prototype within a two-week period
to industrialisation. has won them a number of key customers within the sector, and
has continued to grow their portfolio of innovative solutions. In
particular, within the safety market, in this field. Simon has also
worked as a support for lobby groups within The European
Parliament.
New for 2012: SMi Event Communities
SMi Group is a global events business specialising in business to share, engage and network. The SMi Event Communities will
business conferences, workshops and masterclasses. build and expand your experience beyond the conference,
workshop or Masterclass you attend. Not just another "social
We successfully create and run 250 events every year across 6 network”, SMi’s Event Communities have been specifically
sectors including Defence and Security, Energy and Utilities, designed around the needs of our delegates, speakers and
Finance and Pharmaceuticals. We believe in bringing together sponsors, allowing all of our clients to foster longer term
the most knowledgeable experts from across the globe in each relationships with all of the other attendees beyond the three
sector to learn, engage, share and network be it in London, day event for year round engagement.
Paris or Singapore.
To take part all you need to do is register for this event.
To further enhance the SMi experience, we have launched our
very own SMi Event Communities. These will be exclusive, SMi Group Communities
private and secure communities in which our clients will learn, Learn Engage Share Network

5. European Pre-Filled Syringes
2013 Sponsors
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
OPTIMA pharma with the long established brands of inova, Kugler, Klee and Metall + Plastic
isolation technology offer a comprehensive, cutting-edge range of products and services in
pharmaceutical fill / finish. This includes the filling and packaging of pharmaceutical liquids and
powders in syringes, vials, infusion bottles etc., as well as freeze drying systems and automatic
loading / unloading systems. Turnkey production and packaging lines for medical / pharmaceutical
products and project management of such complex projects complete with global production /
service capabilities compliments the portfolio and offering from OPTIMA pharma. www.optima-
pharma.com
rap.ID provides compliant solutions for the control of silicone and other lubricants (i.e. thickness
and distribution) in pre-filled syringes. rap.ID also offers services providing foreign particle
identification. Latest invention is the SPE metal.ID+raman.ID. With this tool any user identifies
foreign particulate matter with a unique speed and high power of recognition. www.rap-id.com
Safety Syringes, Inc. (SSI) has established itself as the market leader in safety devices for prefilled
glass syringes and the preferred partner of the world’s leading pharmaceutical companies. With a
strong core competency in needlestick safety devices for prefilled glass syringes, SSI will continue
to lead the expanding prefilled syringe market with solutions that reduce the costs of meeting
increasingly stringent anti-needlestick legislation. www.safetysyringes.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, ampoules, and
special articles made of glass and COC polymer. With four glass tubing production sites and
seventeen sites for pharmaceutical packaging spread over four continents, 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
West Pharmaceutical Services is a global leader in providing solutions for injectable drug
administration. The products West makes and the services the company provides help improve
health care for people around the globe.West’s innovative system, device and component solutions
help improve the safety and administration of injectable drugs. West’s proprietary materials
science, formulation research and manufacturing technologies advance the quality, therapeutic
value, development speed and rapid market availability of pharmaceuticals, biologics and
vaccines. West’s customers include the world’s leading pharmaceutical, biopharmaceutical and
medical device companies. West supports its customers with sales, manufacturing, customer
support and research and development from 50 locations in North and South America, Europe,
Asia and Australia. www.westpharma.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to
complement your company's marketing strategy. Should you wish to join the increasing number
of companies benefiting from sponsoring our conferences please call: Alia Malick,
SMi Sponsorship on +44 (0)20 7827 6168 or email: amalick@smi-online.co.uk
www.pre-filled-syringes.com
FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,
PHONE on +44 (0) 870 9090 711 Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

6. EUROPEAN PRE-FILLED SYRINGES
MONDAY 28TH & TUESDAY 29TH JANUARY 2013, COPTHORNE TARA HOTEL, LONDON, UK WORKSHOPS: WEDNESDAY 30TH JANUARY, 2013, LONDON
4 WAYS TO REGISTER
www.pre-filled-syringes.com
FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,
PHONE on +44 (0) 870 9090 711 Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
EARLY BIRD □ Book by 28th September 2012 to receive a £300 off the conference price
DISCOUNT □ Book by 31st October 2012 to receive a £100 off the conference price
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