3rd Pre-filled
   Syringes
  Innovative solutions for injection devices and parenteral packaging systems

   25th - 27th Oc...
Conference Introduction
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Pre-Conference Interactive Workshop
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Day 1
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Day 2
                                                                                                       3rd Pre-fille...
Registration Form
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3rd Pre Filled Syringes (2010)

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  1. 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. 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 U 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. 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. 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. 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. 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 ad Standard Prices Location: SG Conference Centre B 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 EC1V 2TT City Road Promotional Literature Distribution UK Distribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £174.83 Total: £1173.83 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/pfs Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: 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 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or Methods of payment after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places Payment must be made in sterling between conferences. However, if you cannot attend the conference, you may make a substitution/name By Mail: Complete and return your signed registration form together with your cheque payable change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organisation and are not transferable between to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK countries. Please note that discounted delegates places at a visiongain event are non refundable. By Fax: Complete and fax your signed registration form with your credit card details Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the to +44 (0) 20 7549 9932 customer by credit card prior to the changes being made. By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or By Bank Transfer: expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. Barclays Bank Sort Code: 20-71-64 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Piccadilly Branch Account No: 6038 7118 Protection Act 1988. Your personal information contained in this form may be used to update you on 48 Regent Street Swift Code: BARC GB22 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you London W1B 5RA, UK IBAN: GB80 BARC 20716460387118 wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Please debit my credit card: EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Access MasterCard Visa American Express Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. Card number: This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Signature: Unable to attend Cardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£96.25 Total:£646.25 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/pfs

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