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

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SMi Group's PreFilled Syringes Americas conference & exhibition

  1. 1. 4, London 20 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 RY P-114_5__ 21/11/2013 11:59 Page 3 “A 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 Magazine SMi present the 8th conference and exhibition in its world leading series... Floor 0BS, UK erence price rence price VAILABLE Fee $2398.00 $1799.00 $599.00 Pre-Filled Syringes Americas Development, manufacture and regulation of pre-filled syringe and injector devices Renaissance Woodbridge Hotel, Iselin, New Jersey, USA $1598.00 $999.00 $599.00 31ST MARCH - 1ST APRIL 2014 KEY 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 Executive £1198.80 access tions, Total WHY 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 them £598.80 £499.00 , by one of e. Bookings of payment 2R 8AU *stc □□ PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP EX card Accelerating the regulatory approval of your pre-filled product: Insight into combination product approvals tomers and here ____________ Wednesday 2nd April 2014, Iselin, New Jersey, USA Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel, and Former FDA Senior Executive, and Mr. Sall, Principal Consultant, ParExel 8.30am - 12.30pm Sponsored by 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. 2. P-114_5__ 21/11/2013 11:59 Page 4 Pre-Filled Syringes Americas www.pfsamericas. Day One | Monday 31st March 2014 8.30 Registration & Coffee 2.00 9.00 Chairman's Opening Remarks Alexei Goraltchouk, Senior Manager, Operations Regeneron Introduction to Medical grade Cyclo Olefin Polymers (COP) • Key properties of current Medical grade Cycloolefin polymer (COP) • Regulatory Status • Bio-Compatibility and Protein Adsorption study 9.10 9.50 10.40 KEYNOTE 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 2.40 products HEADLINE 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? • What’s 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 area DEVELOPING YOUR COMBINATION PRODUCTS OR INJECTABLE DEVICE Panel: Developing delivery systems for biological • Overcoming viscosity and needle size challenges PANEL • 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 3.30 Afternoon refreshments and networking in the exhibition area 4.00 Pre-filled syringe manufacturing, a review of processes and challenges 11.10 11.50 12.30 Foreign 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 • When’s the right time in product development to decide on delivery systems? Greg Sacha, Senior Research Scientist, Baxter 4.40 Cutting 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 Medicine 5.20 Chairman's Closing Remarks and Close of Day One Register online at: • Alternatively fax your registr Official Platinum Media Partner Sponsored 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 Official Leading Media Partner
  3. 3. P-114_5__ 21/11/2013 11:59 Page 5 Pre-Filled Syringes Americas HALF-DA W Day Two | Tuesday 1st April 2014 Renaissanc (COP) 8.30 Registration & Coffee 12.00 Networking Lunch held in the exhibition area polymer OVERCOMING MANUFACTURING CHALLENGES OF PRE-FILLED SYRINGES AND INJECTOR DEVICES REGULATORY SESSIONS: HOW YOU CAN ENSURE EFFICIENT APPROVAL 9.00 Chairman's Opening Remarks Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior 1.30 Cambridge Judge Business School s • New drugs that require large injections: Why are bolus injectors Managing the safety assessment of leachables for pre-filled are required? syringe drug products volume injections leachables. development assessment of leachables • Example devices and their properties– Unilife, BD, West, Ratio, • How to approach the qualification of leachables and hen should SteadyMed etc. considerations needed during development and life-cycle Tom Oakley, Director of Drug Delivery Device Development, management. Springboard • Working examples to illustrate approach and key principles. Stephen Barat, Senior Director, Toxicology and Operations, Forest 2.10 Laboratories Case Study: Benefits and challenges of pre-filled syringe isolator filling machines • Latest updates on how to overcome challenges 9.40 Getting to market: Regulatory perspective • Minimization of product errors and scratches • Defining a pre-filled syringe as a product or device and its on area • Overcoming the challenges of machine start ups impact on regulatory approval • Methods of inspection: Visual and automated machines • Roadmap to approval for PFS’s and auto injectors Christian Siegmund, Head of Prefilled Syringes and liquid vials, • Insight into the FDA’s current thoughts s and Executive 2.50 Afternoon refreshments and networking in the exhibition area Programme 9.00 Reg 9.30 10.10 Morning refreshments and networking in the exhibition area 3.20 Developing your fill and finish production lines Intro 9.45 Ses dev Ses • Upcoming trends in fill and finish functionality Considerations to gain international regulatory approval • Adhering to visual inspection guidelines 10.30 • Considerations to make when developing your manufacturing 10.40 n soon to • Considerations for international export markets 11.00 Cof Martin Dearden, Chief Corporate Microbiologist, UCB 11.30 Ses reg Future trends in the pre filled syringes and medical devices 12.00 Ses thro 12.30 End facility • Overcoming the challenges of the Japanese market? the market • Planning for success in multiple regions 4.00 Brij Patel, CEO, RegExcel xing atrics and Why you sh • Accelera delivery s • Find out h product g • Assess the drug deliv • Develop managem • Understan Regulatio • Know how delivery d • Get to ap device d • Perform r assessme Roche Ravi S. Harapanhalli, Vice President, ParExel, former FDA Senior ecide on ty to Workshop o Run by one approval p Ravi Harap help you p help with a delays in ta • Why a new class of device, the bolus injector, is under • The use of scientifically-justified threshold levels in the safety g products ader • The limitations of autoinjectors and infusion pumps for large • Current trends in the safety assessment of extractables and PANEL Ravi S. Mr. The market and technologies for large volume (‘bolus’) injections • Findings from study conducted in conjunction with the Executive 9.10 Acceler your p com • Delivery technology, business and operational needs from the How should you manage your biological assessment of medical • Usability, user preference, and learning from patient feedback devices • The next generation of needs, as opposed to the next drug-makers perspective 11.20 • Safety evaluations of E&L About the w generation technology • Adhering to regulations in the EU and beyond Alexei Goraltchouk, Senior Manager, Operations Regeneron • Benefits and pit falls of different container materials Adam Wooley, CEO, ForthTox 4.40 Chairman’s Closing Remarks and Close of Day Two About the w y fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Supported by About ParE Over the significant e pharmace device ind of their pro treatments who need Massachus throughout and has ov
  4. 4. P-114_5__ 21/11/2013 12:00 Page 6 HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 2nd April 2014 8.30am - 12.30pm Renaissance Woodbridge, Iselin, New Jersey, USA Accelerating the regulatory approval of your pre-filled product : Insight into combination product approvals Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel Mr. Sall, Principal Consultant, ParExel ) injections e s injectors r large Workshop overview: Run by one of the US’s leading figures in regulatory approval processes and drug delivery systems, Dr. Ravi Harapanhalli. This industry leading workshop will help you plan for smooth regulatory approvals and help with avoiding pitfalls that can cause expensive delays in taking your product to market. er st, Ratio, ment, ge isolator nes d vials, n area Why you should attend: • Accelerate the time it takes to take your drug delivery system to market • Find out how to navigate new combination product guidelines • Assess the right time to start thinking about your drug delivery mechanism • Develop a strategy for product life cycle management by switching over to PFS • Understand how to apply the FDA Quality System Regulation to delivery device development • Know how to apply FDA Design Controls to delivery device development • Get to appreciate how to selection of a delivery device development partner • Perform risk analysis and Human Factors assessment Programme 9.00 Registration 9.30 Introductions and Opening Remarks 9.45 Session 1: Quality-by-Design in the development of drug delivery systems 10.30 Session 2: Regulatory pit falls to avoid 11.00 vices Coffee break 11.30 Session 3: New combination product regulations and how to comply with them 12.00 Session 4: How to accelerate approval through FDA 12.30 End of Workshop from the feedback xt neron About the workshop host Dr. Ravi Harapanhalli advises bio/pharmaceutical companies on CMC regulatory strategies and Qualityby-Design approaches to medicinal product development and flexible regulatory approaches. About the workshop co-leader Mr. Sall is a Principal Consultant with PAREXEL Consulting in Waltham, MA. PAREXEL provides clinical trial, clinical data management, medical and regulatory services to the pharmaceutical and medical device industries. About ParExel Over the past 30 years, ParExel has developed significant expertise to assist clients in the worldwide pharmaceutical, biotechnology and medical device industries with the development and launch of their products in order to bring safe and effective treatments to the global marketplace for the patients who need them. Headquartered near Boston, Massachusetts, ParExel operates over 77 locations throughout more than 51 countries around the world, and has over 14,400 employees.
  5. 5. P-114_5__ 21/11/2013 11:58 Page 1 SPONSORSHIP AND EXHIBITION OPPORTUNITIES Conferenc Imagine a room full of the highest level decision-makers from your target market... SMi offer sponsorship, advertising and branding packages, uniquely tailored to compliment your company's marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Expected audience at Pre-Filled Syringes Americas: Audience by Location ■ ■ North America Europe ■ ■ Asia Rest of World Audience by Sector ■ ■ Bio Tech /Pharma Pre-Filled Systems ■ ■ Pre-Filled Components Product Equipment SPONSORSHIP ENQUIRIES Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director on +44 (0) 20 7827 6168 or email: 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: If you
  6. 6. d nents ent PRE-FILLED SYRINGES AMERICAS Workshop: Wednesday 2nd April 2014, London 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK EARLY BIRD □ DISCOUNT □ Book by 20th December to receive a $300 discount off the conference price Book by 28th February to receive a $100 discount off the conference price CONFERENCE PRICES Unique Reference Number Our Reference LV P-114 DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: G RE Conference: Monday 31st March & Tuesday 1st April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA 20 TH RE A D GI N EC ST I D 20 STE S EM ER 14 R BY AV BE BY A N 28 E $ R 2 D P-114_5__ 21/11/2013 11:58 Page 2 GROUP DISCOUNTS AVAILABLE I would like to attend: (Please tick as appropriate) □ Conference & Workshop □ Conference Only □ Workshop Only Pharmaceutical Companies Rates: LIMITED AVAILABILITY □ Conference & Workshop □ Conference Only □ Workshop Only PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT Fee $2398.00 $1799.00 $599.00 $1598.00 $999.00 $599.00 £1198.80 Email: The conference fee includes refreshments, lunch, conference papers and access Company VAT Number: to the Document Portal containing all of the presentations. Address: DOCUMENTATION Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Unable to travel, but would like to watch the conference live, ask questions, participate as if you were in the room. Price Total Mobile: □ Access to the conference documentation Switchboard: Signature: Date: I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT Title: on the Document Portal £499.00 + VAT £499.00 (or only £300 if ordered with the Document Portal) □ The Conference Presentations - paper copy £598.80 £499.00 Forename: Surname: PAYMENT Email: Address (if different from above): Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-114 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: VENUE Renaissance Woodbridge Hotel, 515 U.S. Route 1, Iselin, NJ 08830 □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: or fax +44 (0) 870 9090 712 Terms and Conditions of Booking Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager or visit our website quoting the URN as detailed above your address on the attached letter. A/C Name SMI GROUP LTD Sort Code 300009, Account Number 11775391 CCY USD □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU IBAN GB75LOYD30000911775391 BIC LOYDGB21013 □ Cheque We can only accept cheques in US Dollars. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Card No: Cardholder’s Name: Signature: Workshop L Date: I agree to be bound by SMi's Terms and Conditions of Booking. Card Billing Address (If different from above): VAT VAT at 20% is charged on Document Portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here ______________________________________________________________________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at REGISTE