SMi Group's PreFilled Syringes Americas conference & exhibition

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Europe's leading Prefilled Syringes event is coming to the USA in 2014


  • 1. 4, London20 TH RE RE A D GI G N EC ST I D 20 STE SA EM ER B 14 R V BE Y A BY N 28 E $ R 2 D SA TH 300 013 VE FEB $1 RUA 00 RYP-114_5__ 21/11/2013 11:59 Page 3A wise choice of location and an intelligently designed program of expert speakers promises to bring together the leading minds and influencers mapping the future of the prefilled syringes sector. Guy Furness, Proprietor & Publisher, ONdrugDelivery MagazineSMi present the 8th conference and exhibition in its world leading series...Floor 0BS, UKerence pricerence priceVAILABLE Fee $2398.00 $1799.00 $599.00Pre-Filled Syringes Americas Development, manufacture and regulation of pre-filled syringe and injector devicesRenaissance Woodbridge Hotel, Iselin, New Jersey, USA$1598.00 $999.00 $599.0031ST MARCH - 1ST APRIL2014KEY SPEAKERS INCLUDE: Scott Brown, Device Development Lead, Merck Alexei Goraltchouk, Senior Manager, Operations, Regeneron Stephen Barat, Senior Director, Toxicology and Operations, Forest Laboratories Steven Projan, SVP, MedImmune* Martin Dearden, Chief Corporate Microbiologist, UCB Thomas Osterberg, Senior Manager, Biologics, Pfizer Inc Greg Sacha, Senior Research Scientist, Baxter Christian Siegmund, Head of Prefilled Syringes and liquid vials, Roche Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA Senior Executive1198.80 accesstions, TotalWHY ATTEND THIS EVENT: 3 days of presentations, panel discussions and interactive workshops. Return to your business with the information and contacts to make the right decisions for your products Focus sessions on biologics, manufacturing, polymers and extractables and leachables 20+ expert speakers from throughout the PFS and device ecosystem 85+ key decision makers, influencers and innovation drivers attending from the most relevant and sought after organisations in pre-filled syringes Network with delegates from the leading Biotechnology and Pharmaceutical businesses globally during the series of networking breaks, lunches and networking evenings designed to help conversation flow Hands on exhibition to help you evaluate the leading solutions in the marketplace and meet the thought leaders who developed them598.80 499.00, by one of e. Bookings of payment2R 8AU*stcPLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPEX cardAccelerating the regulatory approval of your pre-filled product: Insight into combination product approvalstomers and here 2nd April 2014, Iselin, New Jersey, USAWorkshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA Senior Executive, and Mr. Sall, Principal Consultant, ParExel 8.30am - 12.30pmSponsored REGISTER BY 20TH DECEMBER 2013 AND SAVE $300 / REGISTER BY 28TH FEBRUARY 2014 AND SAVE $100 Register online or call +448709090711 to speak to an account executive

2. P-114_5__ 21/11/2013 11:59 Page 4Pre-Filled Syringes Americaswww.pfsamericas.Day One | Monday 31st March 2014 8.30Registration & Coffee2.009.00Chairman's Opening Remarks Alexei Goraltchouk, Senior Manager, Operations RegeneronIntroduction to Medical grade Cyclo Olefin Polymers (COP) Key properties of current Medical grade Cycloolefin polymer (COP) Regulatory Status Bio-Compatibility and Protein Adsorption study9.109.5010.40KEYNOTE ADDRESS: Avoiding the pitfalls of device development What to look out for when developing your delivery device The 5 reasons product fail How can you plan to mitigate the risk of product failures Scott Brown, Device Development Lead, Merck Effect of Gamma/EB/Steam sterilization Introduction of new product Toshiro Katayama, Product Manager, Zeon Chemicals 2.40productsHEADLINE PANEL: Developments in pre filled syringes and injection devices PANEL What are key aspects driving the exponential growth of the market? Which challenges need to be worked out to continue expansion? Whats next for pre filled syringes, where will the growth come from? Steven Projan, SVP, MedImmune (STC) Lloyd Fishman, President, High Peaks Partners LLC Michael Dudley, CEO, Artemes Technologies Moderator: Cliff Mintz, Associate Editor, Life Science Leader Morning refreshments and networking in the exhibition areaDEVELOPING YOUR COMBINATION PRODUCTS OR INJECTABLE DEVICEPanel: Developing delivery systems for biological Overcoming viscosity and needle size challengesPANEL How can you ensure E&L are within acceptable limits? Seeking efficient FDA approval for RA and other drug products When should you develop your own solution and when should you work with a partner? Dr Thomas Osterberg, Senior Manager, Biologics, Pfizer Martin Dearden, Corporate Microbiologist, UCB William Lambert, Fellow, Drug Delivery and Device Development, MedImmune Moderator: Cliff Mintz, Associate Editor, Life Science Leader 3.30Afternoon refreshments and networking in the exhibition area4.00Pre-filled syringe manufacturing, a review of processes and challenges11.1011.5012.30Foreign Particulate Matter and Siliconization Testing rap.ID and Foreign Particulate Matter Identification Siliconization Process Spray on vs. Emulsion Silicone Control Methods Historical and Actual Layer Explorer Technology and Case Studies Oliver Valet, President, rap.ID Next generation Pre-Filled Syringes: How are electronic auto injectors changing the market? Trends in electronic injectors and how they compare to pre-filled syringes What are the key procurement challenges that category managers will face How these differ from conventional Pre Filled Syringe challenges Chanderkanth Gautam, Senior Research Analyst, Beroe Inc Geetha Vaithyanathan, Domain Lead, Beroe Inc Networking Lunch held in the exhibition area New challenges with COP and COC containers How to effectively reduce particle contamination Whens the right time in product development to decide on delivery systems? Greg Sacha, Senior Research Scientist, Baxter 4.40Cutting edge developments in pre filled syringe design soon to be ready for testing How are advances in syringe design going to open the market for new applications in PFS Developments in 2 chamber syringes capable of mixing powders and liquids Advances in large polymer syringes with the capacity to administer of nutritional gels Michael Spigarelli, Professor of Internal Medicine, Pediatrics and Pharmacy, University of Utah School of Medicine5.20Chairman's Closing Remarks and Close of Day OneRegister online at: Alternatively fax your registr Official Platinum Media PartnerSponsored by rap.ID Particle Systems GmbH rap.ID Particle Systems provides compliant solutions for the control of silicone and other lubricants thickness and distribution in pre-filled syringes. rap.ID also offers contract testing services providing particles identification and root cause analysis. rap.IDs good particle ID equipment reveals enumeration as well as the chemical structure and elements of microparticles. This becoming a standard in the identification of foreign particulate matter with a unique speed and power of distinction. Zeon Europe GmbH Achieve glass-like transparency and excellent long-term stability with protein- and peptidebased drugs by using ZEONEX. ZEONEX cyclo-oleflin polymers, break-resistant plastics designed for critical pharmaceutical packaging applications including vials, pre-filled syringes, and blister packaging. ZEONEX COP is an ultra-clean plastic that does not contain additives or components that leach-out over time. Additionally, for protein-based drugs, common proteins show low adsorption onto ZEONEX containers as compared to other plastics. For more information, visit or email zeonex@zeonchemicals.comOfficial Leading Media Partner 3. P-114_5__ 21/11/2013 11:59 Page 5Pre-Filled Syringes AmericasHALF-DA WDay Two | Tuesday 1st April & Coffee12.00Networking Lunch held in the exhibition areapolymer OVERCOMING MANUFACTURING CHALLENGES OF PRE-FILLED SYRINGES AND INJECTOR DEVICESREGULATORY SESSIONS: HOW YOU CAN ENSURE EFFICIENT APPROVAL 9.00Chairman's Opening Remarks Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior1.30Cambridge Judge Business Schools New drugs that require large injections: Why are bolus injectorsManaging the safety assessment of leachables for pre-filledare required?syringe drug productsvolume injectionsleachables.developmentassessment of leachables Example devices and their properties Unilife, BD, West, Ratio, How to approach the qualification of leachables andhen shouldSteadyMed etc.considerations needed during development and life-cycleTom Oakley, Director of Drug Delivery Device Development,management.Springboard Working examples to illustrate approach and key principles. Stephen Barat, Senior Director, Toxicology and Operations, Forest2.10LaboratoriesCase Study: Benefits and challenges of pre-filled syringe isolator filling machines Latest updates on how to overcome challenges9.40Getting to market: Regulatory perspective Minimization of product errors and scratches Defining a pre-filled syringe as a product or device and itson area Overcoming the challenges of machine start upsimpact on regulatory approval Methods of inspection: Visual and automated machines Roadmap to approval for PFSs and auto injectorsChristian Siegmund, Head of Prefilled Syringes and liquid vials, Insight into the FDAs current thoughtss andExecutive2.50Afternoon refreshments and networking in the exhibition areaProgramme 9.00 Reg 9.3010.10Morning refreshments and networking in the exhibition area3.20Developing your fill and finish production linesIntro9.45Ses devSes Upcoming trends in fill and finish functionality Considerations to gain international regulatory approval Adhering to visual inspection guidelines10.30 Considerations to make when developing your manufacturing10.40n soon to Considerations for international export markets11.00CofMartin Dearden, Chief Corporate Microbiol