This document provides information about an upcoming conference on pre-filled syringes. It outlines the conference details including dates, location, key speakers from companies like Merck Serono and AstraZeneca. It also lists media partners, sponsors, and exhibitors. The document discusses the growing market for pre-filled syringes and challenges in the industry. It promotes the conference as a chance to learn about new developments, network, and address issues like drug compatibility and manufacturing processes. A pre-conference workshop on legal issues is also advertised.

1. 3rd Pre-filled
Syringes
Innovative solutions for injection devices and parenteral packaging systems
25th - 27th October 2010, BSG Conference Centre, London, UK BOOK NOW!
Key Speakers
Todd Stephens, Global Marketing Director, Merck Serono
Stefan Sundström, Director, Sterile Aseptic Manufacturing, Engineering and Maintenance,
Technical Lead Sterile Process Systems, AstraZeneca
Ian Thompson, Director of Business Development, Ypsomed
Klaus Ullherr, Product Manager, Packaging Technology, Robert Bosch Packaging
Jim Spolyar, Sales and Technical Director, Skan US
Gabriele Peron, Marketing Manager, Stevanato Group - Glass Division
Thomas Zelmer, Director, Groninger
Sterling Kline, Director of Project Development, Integrated Project Services
Shawn Kinney, Chief Executive Officer, Hyaluron
Elliot Lawrence, Associate Director of Regulatory Affairs, ERA Consulting
Daniel Wheeler, Lecturer in Anaesthesia, University of Cambridge
Andrew Longworth, General Manager, KÖRBER MEDIPAK UK & RoI
Pre-conference Workshop, Monday 25th October, 2010
Legal updates concerning pre-filled syringes
Led by: Alex Denoon, Partner, Lawford Davies Denoon, London
Erik Vollebregt, Of Counsel, Greenberg Traurig LLP, Amsterdam
Mathias Klümper, Partner, Lützeler und Partner, Rechtsanwälte, Düsseldorf
Associate Sponsor
Organised By
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pfs

2. Conference Introduction
3rd Pre-filled Syringes
25th - 27th October 2010, London UK
With more injectable biological drugs in use than ever, the pre- Associate Sponsor:
filled syringes market will sustain its inexorable growth, with total Nuova Ompi produces glass tubing containers for pharmaceutical
revenues of $6bn by 20251. and cosmetic use. Standard production from neutral glass includes
vials (penicillin and insulin, screw neck, pilfer-proof, blow back, pill),
Dear Colleague,
cartridges (pen and dental cartridges), syringes (bulk and sterile) and ampoules. Ompi
re-filled syringe and autoinjection devices remain the primary methods for
P supplies prefillable syringes EZ-fill™ clean, sterile and packaged in nested tubs. Nuova
parenteral drug delivery, from oncology to autoimmune diseases. Soaring annual Ompi has started to supply vials EZ-fill™ clean, sterile and ready to fill offering the market
growth rates topping 10% will continue as stakeholders move towards the greater the advantages of the EZ-fill™ concept for other major container types, including vials
accuracy, safety and convenience afforded by pre-filled devices. However, challenges
and cartridges. This allows clients to continue the trend of delegating services to partner
and threats continue to bedevil manufacturers, including siliconisation, stability and suppliers while improving operational efficiency.
bioavailability issues.
For further information please visit: www.ompi.it or www.ez-fill.com
isiongain is proud to present its 3rd Pre-filled Syringes conference, with keynote
V
presentations from the market’s main players. Case studies and interactive discussions Media Partners:
will address new developments in manufacturing, quality control, regulation,
inspection, and use. Act now to register your participation amongst the industry’s PharmiWeb.com is the leading industry-sponsored portal for the
finest for three intensive days of learning, networking and business opportunities.
pharmaceutical sector. Supported by most of the leading pharmaceutical
corporations, PharmiWeb.com provides dynamic real-time news, features, events listings
Whether your interests lie in drug formulation, sterile manufacturing and international jobs to industry professionals across Europe and the US.
or strategic partnering, attending this conference will enable you to: For further information please email: corporate@pharmiweb.com
• Overcome challenges arising from silicon-drug solution interaction BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
• roubleshoot heavy-metal induced drug precipitation and microbiological
T It is based and located in Warsaw, Poland. Biotechnology World was
contamination founded in 2007 to provide the world’s biotech and pharma information and market to
• mprove dosing accuracy and enhance patient compliance with next-generation
I make it universally accessible and useful for scientific and business processes. Its first step
electronic devices to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
• Learn about novel pre-filled syringes for biotech products and auto injector devices
allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
companies completed internet public relations, publication and marketing solutions. One
• nderstand pre-filled syringe processing with RABS, isolators, E-beam and
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of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma
alternatives
Sector in Europe to global biotechnology, pharmaceutical and life science activities.
• Examine factors and recent developments in processing syringe nests For further information please visit www.biotechnology-europe.com
• Analyse new developments in COC, COP, glass, and elastometric components
Future Pharmaceuticals has forged powerful relationships with key
Driving the Industry Forward | www.futurepharmaus.com
• Offset the impact of extractables and leachables on product performance
• ssess the impact of new post-market surveillance regulations on pre-filled medical
A industry leaders to provide a platform for successful brand recognition,
devices and for senior decision-makers to have the means to procure and plan implementation
strategies based on the topics covered. Positioned to be an authoritative resource within
• Develop new strategies to remain competitive
top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals
• btain the latest market analysis, and meet manufacturers showcasing their leading
O magazine is geared to create a deep penetration into a highly targeted and responsive
products audience, bridging the gap between the industries’ top issues and the solutions top-tier
I look forward to meeting you at the conference vendors can provide.
Best regards For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical news, comment,
contracts, services, jobs and events and is home to InPharmjobs.com,
Pharmafile and Pharmafocus.
John Shah For further information please visit: www.In-Pharm.com
Conference Producer
Pharma Connections Worldwide® is the leading professional business
networking website focused in the Pharmaceutical, Biotechnology
and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere
content coupled with the right clientele in order to facilitate business development
Who should attend opportunities among industry professionals responsible for making key decisions in a
global marketplace.
Presidents, Chief Executives, Chief Scientific Officers, Chief Operating For further information please visit www.pharmaconnections.com
Officers, Vice Presidents, Heads, Directors, Clinicians, Principal Scientists,
Managers, Project/Team Leaders in:
• Packaging and labelling
• Vaccine, antibody and protein manufacturing Sponsorship and exhibition opportunities:
• Product design This event offers a unique opportunity to meet and do business with some
• Technical support of the key players in the pharmaceutical and biotech industries. If you have a
• Drug product process development service or product to promote, you can do so at this event by:
• Drug device process development
• Hosting a networking drinks reception
• Formulation sciences
• Safe medication practice • Taking an exhibition space at the conference
• Drug discovery & delivery • Advertising in the delegate documentation pack
• Clinical product resourcing • Providing branded bags, pens, gifts, etc.
• Supply outsourcing If you would like more information on the range of sponsorship or exhibition
• Contract manufacturing and management
possibilities for visiongain's 3rd Pre-filled Syringes Conference, please contact us:
• Process development
• Strategic alliances Ronald Magali, +44 (0)20 7549 9934
• Investment and venture capital ronald.magali@visiongainglobal.com
Visiongain, (2010). Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025. Pp. 44-80
1

3. Pre-Conference Interactive Workshop
3rd Pre-filled Syringes
Monday 25th October 2010
Legal updates concerning pre-filled syringes
Led by: Alex Denoon, Partner, Lawford Davies Denoon, London Timings: 9:30 - 10:00 Coffee & Registration
0
Erik Vollebregt, Of Counsel, Greenberg Traurig LLP, Amsterdam 10:00 - 17:00 Workshop
Dr. Mathias Klümper, Partner, Lützeler und Partner, Rechtsanwälte, Düsseldorf T
iming includes lunch and refreshment breaks
About the workshop: About the workshop leaders:
The session will overview the legal and regulatory issues applicable to Alexander Denoon
pre-filled syringes and some of the more pressing or challenges concerns
Alex has both a science degree (human genetics) and a law degree. He
regarding their sale and use. These will include: qualified as a solicitor (in Australia) in 1995. Alex spent more than five
years in- house, including as general counsel and company secretary of
• Product liability Biotech Australia.
• Reuse Alex advises clients in relation to the development of strategies for the protection,
defence and commercialisation of intellectual property. This involves the development
• ontrol of supply and distribution chains (including parallel imports,
C of strategies and the drafting of a wide array of commercial agreements from licences to
pharmacovigilance and post marketing surveillance) joint ventures. Alex also advises in relation to the regulation of pharmaceuticals, medical
devices and advanced therapy medicinal products.
• A regulatory overview
Alex has a breadth of international experience structuring, negotiating and drafting
commercial agreements. Both as a corporate advisor and as in house counsel.
About visiongain: LDD (www.lawforddaviesdenoon.com) was established to focus on advising clients in
Visiongain is a specialist business information company focused on providing cutting edge the Life Sciences sector – namely the pharmaceutical, medical devices, reproductive
products and services across the Pharmaceutical/Biotech, Telecommunications, Defence and regenerative medicine industries. Together we bring more than 25 years experience
and Finance sectors, which include reports, conferences, online daily news and offline
advising clients in the sector. Our particular areas of legal expertise include regulatory
news analysis and bespoke consultancy. With a commitment to innovation and excellence, matters, compliance programmes, public law and judicial review, intellectual property,
visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing
commercial contracts and due diligence.
the right information at the right time to facilitate the commercial decision-making process. Our
pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for Erik Vollebregt
the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, Erik’s practice focuses on (medical) technology, marketing, healthcare
in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences and life sciences. He has broad experience both in litigation and in
address the hottest commercial, regulatory and technical topics and provide an ideal forum for transactional work in these areas, as well as in the application of anti-
debate and networking for pharmaceutical professionals from around the world. trust law to high technology and pharmaceutical products.
For further information, please visit: www.visiongain.com
Mathias Klümper
Mathias worked as a lawyer and core member of the industry group
Pre-Filled Syringes and Related Systems: “Healthcare, Life Sciences and Chemicals” at the Düsseldorf office of
World Market Outlook 2010-2025 Clifford Chance from 2004 until 2008.
He advised clients from the pharmaceutical, medical device and
Newly published report - order your copy NOW
biotechnology industry in all regulatory matters. He focussed on advising clients on
The report will examine the following areas in detail: healthcare fraud and abuse prevention (business compliance) and the implementation of
• Analysis of the prospects for pre-filled syringe devices: predicted employee guidelines and processes.
revenues, by therapeutic category and leading brands
He does not only know the perspective of a lawyer but also obtained a comprehensive
• Sales forecasts for the global market and leading markets insight into the in-house perspective within two client secondments in the European legal
• Evolutions in this area for ease of use, safety, product stability and department of an international medical device company in Switzerland and a German
patient compliance pharmaceutical company.
• Legislative aspect as one of the most important drivers of demand He is author of a number of publications on regulatory themes relating to
for pre-filled injection technology and products
pharmaceuticals and medical devices as well as co-author of the “Handbuch des
• Drivers, restraints, competition and opportunities influencing the Arzneimittelrechts” (textbook on pharmaceutical law, in prep.).
pre-filled injection devices industry and market
Furthermore, he holds lectures and speeches on current subjects from the pharmaceutical
To order this important report visit: www.visiongain.com and medical device area.
or email: sara.peerun@visiongain.com

4. Day 1
3rd Pre-filled Syringes
Tuesday 26th October 2010
09:00 Registration and refreshments 14:00 Microbiological and particulate contamination risks
in the manufacture of parenterals
09:30 Opening address from the Chair • Elucidating contaminant dispersion routes when producing parenterals
• Risk-based methods to evaluate contamination risks
09:40 Technology advances and market trends for
auto-injectors • ethods for calculating contamination risks (to determine viability and
M
non-viability)
• User benefits
tefan Sundström
S
• Creating and protecting market share Director, Sterile Aseptic Manufacturing, Engineering and Maintenance,
Technical Lead Sterile Process Systems
• A new generation of device and compromises in device design
AstraZeneca
• Future opportunities
an Thompson
I
14:40 Pre-filled syringe processing with RABS, isolators,
Director of Business Development
Ypsomed e-beam & alternatives
• Isolator technology with latest E-Beam design features
10:20 Achieving extra high quality production of glass • Comparison of RABS vs Isolators
primary packaging: building a manufacturing
• Expansion of the areas of application of syringe technology
concept flow based on a streamlined process
im Spolyar
J
• OMPI case study / optimised process Sales and Technical Director
• efining criteria for excellence in glass containers for pharmaceutical
D Skan US
products
• uccessfully managing critical aspects (particle control, high tolerances,
S
15:20 Afternoon refreshments
contact free, silicon, traceability)
abriele Peron
G
Marketing Manager 15:40 Minimising the risk of sterility breach from
Stevanato Group - Glass Division stopper movement
• Intra-syringe gas bubble movement permits breach of product sterility
10:40 Opportunities and challenges for novel primary drug
containers in autoinjectors • etermining the maximum allowable gas bubble for a given syringe
D
and stopper combination using a risk based approach
• nalysis of suitability and weaknesses of current syringe platforms for use
A
in autoinjectors hawn Kinney
S
Chief Executive Officer
• pportunities and challenges for cyclic olefins in novel primary drug
O Hyaluron
containers for autoinjectors
• One approach: Oval’s novel primary drug containment technology
atthew Young
M
Chief Executive Officer
Oval Medical Technologies 16:20 Panel discussion: Improving performance and
reliability in pre-filled devices- where are we and
11:00 Morning refreshments what are the prospects for the future?
T
opics discussed will include overcoming siliconisation and drug
11:20 Preserving form and functionality when dealing precipitation, how materials science can aid primary packaging design,
maintaining sterility and ensuring stability.
with sensitive molecules
• nderstanding product-packaging interactions to reduce denaturation
U
and aggregation
• Recovery challenges for high concentration formulations
17:00 Closing remarks from the chair
• Avoiding product loss through effective monitoring
12:00 Negating the effects of heavy metal contamination
on product stability
• Effects of tungsten and iron on product behaviour in solution 17:10 Networking drinks
Take your discussions further and build new
• Considerations when dealing with high concentration formulations
relationships in a relaxed and informal setting.
• Strategies to optimise colloidal stability
12:40 Networking lunch
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010

5. Day 2
3rd Pre-filled Syringes
Wednesday 27th October 2010
09:00 Registration and refreshments 12:30 Developments in the secondary packaging of
pre-filled syringes
• Identify the principal requirements of a package for pre-filled syringes
09:30 Opening address from the Chair • Identify two alternative methods of packaging pre-filled syringes
• Identify features and benefits of both systems
• Identify future trends in the packaging of pre-filled syringes
09:40 Stopper insertion methodology and
shelf-life longevity ndrew Longworth
A
General Manager
• High-speed filling equipment and online stopper insertion KÖRBER MEDIPAK UK & RoI
• Online high-speed filling and offline vacuum stoppering
• Eliminating stopper movement
12:50 Networking lunch
homas Zelmer
T
Director
Groninger
14:10 Next generation injection devices for high-cost,
long-term medications
10:10 Why we need pre-filled syringes (but might • Improving compliance to injectable therapies- a ongoing challenge
not be getting them...)
• Easypod: an empowering, patient-friendly option
• Drawing up drug solutions is fraught with risks to patients
• Applications to growth hormone, multiple sclerosis and fertility treatments
• Mistakes are common and medication errors are frequent
odd Stephens
T
• re-filled syringes address many, but by no means all, of
P Global Marketing Director
these issues Merck Serono
• eports of the death of the ampoule may have been greatly
R
exaggerated...
aniel Wheeler
D 14:50 Best practices on current and future demands
Lecturer in Anaesthesia on finishing
University of Cambridge
• Validating unit operations
• Ensuring resilience during transportation
10:50 Morning refreshments • Maintaining photostability to preserve product quality
11:10 The impact of advanced aseptic technology 15:30 Afternoon refreshments
on facility design
• Harmonisation of EU and FDA guidance for room classifications
• Isolators versus RABS risk and cost impact 15:50 Regulatory issues versus requirements for biological
medicinal products in pre-filled syringes
• Recent case studies
• Overview of the regulatory requirements and guidelines
terling Kline
S
• Data package required
Director of Project Development
Integrated Project Services • Case studies: potential issues to consider
lliot Lawrence
E
Associate Director of Regulatory Affairs
11:50 Future oriented processing of nested syringes ERA Consulting
• XS 5100 high-performance machine with output of up to 600 syringes
F
per minute
• nnovative line concept for fully automated processing of pre-sterilized,
I 16:30 Chair’s closing remarks
pre-filled nested syringes
• Integrated automatic bag and tub openers
laus Ullherr
K 16:40 End of conference
Product Manager, Packaging Technology
Robert Bosch Packaging

6. Registration Form
3rd Pre-filled Syringes
25th - 27th October 2010, London UK
Angel
For multiple bookings Pentonville Road
Photocopy this form Conf. code VG 3rd Pre-filled Syringes
C
Ci
ty
Ro
25th - 27th October 2010
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Standard Prices
Location: SG Conference Centre
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Conference and workshop Fee: £1699 VAT: £297.33 Total: £1996.33 Old Street
Address:
Conference only Fee: £1299 VAT: £227.33 Total: £1526.33 Old Street
226-236 City Road
Workshop only Fee: £599 VAT: £104.83 Total: £703.83 London
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Tel: +44(0) 20 7336 6100
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Visiongain Ltd
Address: BSG House
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General information
Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United
Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City
Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503,
Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
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