SMi Group's Prefilled Syringes West Coast 2019 conference
1 like142 views
This document provides information about a half-day post-conference workshop on June 5th, 2019 in San Diego, CA on identifying and addressing design flaws in medical devices before usability testing. The workshop will be led by Shannon Clark and will teach attendees principles of design, how to differentiate good and bad design through examples, and how to conduct expert reviews to uncover usability issues. Attendees will get hands-on experience reviewing prototypes and concepts to evaluate if they are optimized before testing. The workshop aims to help attendees learn how to identify design flaws early in the development process.
SMi Group's Prefilled Syringes West Coast 2019 conference
- 1. PLUS ONE INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP WEDNESDAY 5TH JUNE 2019, HYATT REGENCY MISSION BAY, SAN DIEGO, CA, USA www.prefilled-syringes-westcoast.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUP DISCOUNTS AVAILABLE SPONSORED BY SMi Group Presents the 4th Annual Conference and Exhibition… Hyatt Regency Mission Bay, San Diego, CA, USA CONFERENCE: 3RD - 4TH JUNE 2019WORKSHOP: 5TH Pre-Filled Syringes West Coast Assessing Device Development Strategies and Regulation for Enhanced Innovation The Secrets to Uncovering and Addressing Design Flaws BEFORE Usability Testing Workshop Leader: Shannon Clark, Principal, UserWise, Inc. 08.30 - 12.00 SMi Pharma @SMiPharm #smipfsusa CO-CHAIRS FOR 2019: • Michael Song, Senior Manager, Dosage Form Design and Development, MedImmune • Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals LEADING PHARMACEUTICAL SPEAKERS: • Bejamin Werner, Scientist, Pharmaceutical Development Biologicals, Boehringer Ingelheim • Diane Doughty, Senior Scientist, MedImmune • Ed Israelski, Consultant - Technical Advisor on Human Factors, Retired Director Human Factors, AbbVie • Jason E. Fernandez, Senior Scientist, Protein Pharmaceutical Development, Biogen • Lin Li, Senior Consultant Engineer, Eli Lilly and Company • Lori Burton, Senior Principal Scientist, Bristol-Myers Squibb • Ronald Forster, Director Process Development, Amgen • Swapnil Pansare, Scientist, Dosage Form Design and Development, MedImmune NEW FOR 2019: • Explore the latest innovations in digital technology, enhancing the patient experience through mobile applications, software-based medical devices and advances in connectivity • Navigate through the recent updates in the PFS regulatory environment with an FDA perspective and industry perspectives as well as a panel discussion forecasting the future trends • Assess on emerging approaches to device development from leading pharmaceutical companies including Eli Lilly, Amgen and MedImmune • Delve into the latest research and case studies exploring the key challenges in formulation for combination products BOOK BY 28TH FEBRUARY AND SAVE $400 BOOK BY 29TH MARCH AND SAVE $200 BOOK BY THE 30TH APRIL AND SAVE $100
- 2. LETTER FROM THE CHAIRS: Dear Participants, It is with great pleasure and delight that we welcome each of you to SMi’s 2019 Pre-Filled Syringe West Coast conference in San Diego, California Over the past decade, pre-filled syringe venues have grown significantly in terms of content and attendance as the pre-filled syringe market and pharmaceutical interest in pre-filled syringe continues to grow. The prefilled syringe market is projected to grow an additional 10.5% by 2024 with continually increasing number of drug products being developed and administered via prefilled syringe. Prefilled syringe offers many unique benefits and can be easily integrated within drug delivery devices for patient self-administration. These products have undoubtedly improved the lives of countless patients and caregivers who administer the medication but are not without challenges. As such, as an industry, we have a duty to further develop and evolve these products to meet and/or exceed the needs of our patients and improve upon therapeutic options through the sharing of lessons learned, experiences, and scientific breakthroughs. The meeting will allow for the face-to-face convergence of subject matter experts, thought leaders, researchers, and manufacturers in disciplines related to the development of prefilled syringes and other therapeutic delivery products, and thereby provide a tremendous opportunity for meaningful discourse. We look forward to seeing you there! Michael Song, Senior Manager, Dosage Form Design and Development, MedImmune Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals 08.30 Registration & Coffee 08.50 Co-chairs Opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, MedImmune Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals 13.10 Networking LunchPLATFORM APPROACHES AND DEVICE DEVELOPMENT INNOVATIONS OPENING ADDRESS 09.00 Platform approach for combination products and devices • HFE assessment considerations • Challenges in biocompatibility • The balance between volume and viscosity • The future of the platform approach for devices Ron Forster, Executive Director, Amgen 09.35 Elastomeric Components: Supporting Next Generation Drug Delivery Systems • How can innovation in elastomeric components support PFS & next generation drug delivery systems? • How can a suppliers manufacturing network support PFS & next generation drug delivery systems? • What can we learn from other industries and apply it to future innovations and support drug delivery innovations? Douglas Cusato, Director of Medical Rubber Business, Sumitomo Rubber North America 10.15 Innovative Application of Computer Aided Engineering in Development of Pharmaceutical Packaging • Simulation led design • Device mechanism optimization • Container closure integrity at various shipping condition • Injection Physiology Lin Li, Senior Consultant Engineer, Eli Lilly and Company 10.50 Morning Coffee Sponsored by 11.20 Multilayer plastic syringe with excellent oxygen and UV barrier • Excellent oxygen and UV barrier contribute to stability of biologics • Optimized silicone-oil contributes to preventing protein aggregation • Extremely low levels of extractables contribute to stability of biologics • Development of staked needle syringes Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc. 12.00 Development of user-centric requirements for pre-filled syringes and injection devices • Review of user-centric device characteristics • Generating user-relevant design input requirements • Applying a platform approach to user-centric devices Diane Doughty, Senior Scientist, MedImmune 12.35 Networking Lunch 13.10 Networking LunchIMPROVING HUMAN FACTORS FOR ENHANCED PATIENT CENTRICITY – PART 1 13.35 Human Factors Guidelines for Mobile Health Applications • Background on development process • Guidelines content review • Details on development and application of usability guidelines • Practical ways to apply guidelines to development Natalie Abts, Senior Program Manager, Usability Services, National Center for Human Factors in Health Care, MedStar Health 14.10 Digital Health, considerations when developing digital connectivity solutions • Explore the use of wireless communication systems beyond Bluetooth • Explore advantages and disadvantages between using add-on vs. add-in • How much data is enough data • Regulatory considerations and challenges Michael Song, Senior Manager, Dosage Form Design and Development, MedImmune 14.45 FDA Training Decay Research Initiative – Is a 1-hour training decay long enough for summative usability testing? • Identify differences in decay between device types • The effects of accelerated decay • Assessing the task-training decay curve profiles • Identify generalizable detailed training decay curves Shannon Clark, Principal, UserWise, Inc. 15.20 Afternoon Tea Sponsored by 13.10 Networking LunchA REGULATORY OUTLOOK PANEL DISCUSSION 15.50 Future Regulatory Trends • The European Medical Device Regulation • The emerging market in China • Brexit and how it will effect the device industry • Regulatory strategies for wearables, software-based medical devices and integrated devices Moderator: Ronald Forster, Director Process Development, Amgen Panel Members: Natalie Abts, Senior Program Manager, Usability Services, National Center for Human Factors in Health Care, MedStar Health Gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co 16.25 Overview of EU MDR specific to safety • Overview of requirements for EU MDR • Discuss new requirements for post-market surveillance • Integration of post-market surveillance activities with risk management and clinical evaluation Gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co 17.00 Co-Chair’s Closing Remarks and Close of Day One 18.00 - 20.00 End of Day One Dinner Hosted by Sponsors Limited availability - Only available to pharma companies Pre-Filled Syringes West Coast DAY ONE | MONDAY 3RD JUNE 2019 www.prefilled-syringes-westcoast.com Register online at www.prefilled-syringes-westcoast.com Engage with top pharma scientists and engineers in our PFS focused conference Hear the very latest plans for drug-delivery development in the injectables industry Network with industry and pharma leaders in the exhibition area
- 3. Pre-Filled Syringes West Coast DAY TWO | TUESDAY 4TH JUNE 2019 www.prefilled-syringes-westcoast.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 08.30 Registration & Coffee 08.50 Co-chairs Opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, MedImmune Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals IMPROVING HUMAN FACTORS FOR ENHANCED PATIENT CENTRICITY – PART 2 OPENING ADDRESS 09.00 Digital health applications • Mobile applications that support drug delivery • The benefits of digital health and patient compliance • User interface developments • Advances in connectivity Ed Israelski, Consultant – Technical Advisor on Human Factors, Retired Director Human Factors, AbbVie 09.35 Pain perception and injection devices: could pain be assessed through non-human person trials in early stage device development? • Pain perception key drivers during injection • Can a study on NHP evaluate pain associated to injection? • Application of NHP model on testing customization and technical improvements on injection devices to limit pain Severine Duband, Global Category Manager, Nemera 10.10 Human Factor considerations for pre-filled syringes • New product design and development • Approaching a regulatory submission • Advancements in human factors for pre-filled syringes • Considerations for patient centricity Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals 10.45 Morning Coffee Sponsored by 11.15 Session reserved for Kaleidoscope Innovation Speaker details to be confirmed PANEL DISCUSSION 11.55 Improving patient centricity through digital health • Optimising user interface tools • How to improve patient compliance • Overcoming cyber security challenges • The benefits of digital health and patient compliance Moderator: Ed Israelski, Consultant – Technical Advisor on Human Factors, Retired Director Human Factors, AbbVie Panel Members: Lin Li, Senior Consultant Engineer, Eli Lilly Diane Doughty, Senior Scientist, MedImmune FORMULATION AND CONTAINMENT CONSIDERATIONS 12.30 Viscosity Challenges for Design and Development of Combination products for Subcutaneous Administration • Combination products (i.e., accessorized prefilled syringes and autoinjector) for SC administration have different requirements for maximum viscosity to meet the device functionality (i.e. glide force & injection time) criteria • Protein formulations may show shear thinning behaviour (i.e. decrease in viscosity as shear rate increases), thereby impacting device functionality • Viscosity limit for combination products was significantly higher due to shear thinning observed for protein formulations Swapnil Pansare, Scientist, Dosage Form Design and Development, MedImmune 13.05 Networking Lunch 14.05 Technical updates in Cyclo Olefin Polymer (COP) – A Case Study • Key Properties of COP • Case study: Biologics formulation for COP syringe optimized to eliminating use of surfactant • Case study: Study on Protein adsorption/aggregation – COP vs glass • Case study: Study on delamination with glass syringe vs COP syringe • Leachable data on COP syringes with various chemicals Toshiro Katayama, Product Manager, Speciality Plastics, Zeon Chemicals L.P 14.45 Impact of silicone oil free polymer syringes on therapeutic proteins • Advantages and disadvantages of glass and polymer syringes • Long-term protein stability for polymer systems • Oxygen permeation of polymer syringes • Nitrogen filled pouches for polymer syringe storage Bejamin Werner, Scientist, Pharmaceutical Development Biologicals, Boehringer Ingelheim 15.20 Afternoon Tea Sponsored by 15.50 Drug Product Development Considerations for Subcutaneous Delivery of Proteins • There are a number of considerations when developing protein drug products for subcutaneous delivery, this talk will highlight some common considerations: - Managing the viscosity of liquid formulations for high concentration products - Drug product manufacturing parameter development for SC administered products - Managing subcutaneous primary container compatibility and interactions with protein formulations for SC delivery Jason E. Fernandez, Senior Scientist, Protein Pharmaceutical Development, Biogen 16.25 Understanding and Controlling the Risk of Protein Aggregation in Siliconized Pre-Filled Syringes • Biologics products, packaged in pre-filled syringes, can sometimes show physical instability due to the silicone oil used to lubricate the syringe barrel • The nature of the interaction between proteins and silicone oil will be reviewed • The common approaches for understanding and mitigating this risk Lori Burton, Senior Principal Scientist, Bristol-Myers Squibb 17.00 Co-Chair’s Closing Remarks and Close of Day Two SMI’S UPCOMING EVENTS IN THE PRE-FILLED SYRINGES SERIES: PRE-FILLED SYRINGES EAST COAST 8TH-9TH APRIL 2019, BOSTON, USA INJECTABLE DRUG DELIVERY 15TH-16TH MAY 2019, LONDON, UK • Advanced Molding Technologies • Aegerion Pharmaceuticals • Ajinomoto Althea, Inc. • Allergan • Almac Group • Amgen • Antares Pharma • Aptar Pharma • Baxter Healthcare • BCM Group LLC • BioMarin • Connecticut Spring & Stamping • Credence MedSystems • Dexcom • Execution Metrics, Inc • Ferring Pharmaceuticals • Fresenius-Kabi • Genentech • Gilead Sciences • Glenmark Pharmaceuticals • Harro Hofliger Verpackungsmaschinen GmbH • Inovio Pharmaceuticals • iO Lifesciences • Ionis Pharmaceuticals • MedImmune • Medizap • Medtronic • Mitsubishi Gas Chemical Company • Nemera • Nipro PharmaPackaging • Novartis • NOVO Engineering, Inc. • One World DMG • Owen Mumford • Pfenex • RAUMEDIC INC • Regeneron • Shire • Smithers Rapra • Steri-Tek • Stevanato Group S.p.A • Subcuject ApS • Suttons Creek Inc • Terumo Corporation • UserWise, Inc. • W. L. Gore & Associates, Inc. • West Pharmaceuticals Services Inc • Worrell • Xeris Pharmaceuticals • Zebrasci inc • ZEON Corporation PRE-FILLED SYRINGES WEST COAST ATTENDEE LIST
- 4. Workshop Leader: Shannon Clark, Principal, UserWise, Inc. The Secrets to Uncovering and Addressing Design Flaws BEFORE Usability Testing Programme 8.30 Registration and Coffee 9.00 Opening remarks and introductions 9.10 Principles of Design • What are the guiding principles of designing a new medical product or selecting a drug delivery device for your new drug? • How do I conduct an expert review to uncover design flaws even before entering into usability testing? 9.50 Good vs. Bad Design • Study numerous examples of Good vs. Bad Design and start training delegates to see the patterns of good vs. bad design • Review the principles of comparative expert reviews - How do I select the best drug delivery platform for my product? • Review the principles of informal use error analysis, IEC 62366 PCA task analysis, and use- related risk analysis to uncover use errors 10.30 Morning Coffee and Networking Break 11.00 Interactive Expert Reviews • Delegates will be presented with different real- life medical product prototypes and concepts, and they’ll be tasked with conducting an expert review • Discuss the principles of identifying whether the product is “optimized” and ready for testing 11.40 Closing Remarks from Workshop Leader 12.00 End of Workshop Workshop Overview Workshop attendees will learn 1. Principles of design that are key for developing medical products or selecting drug delivery devices for new drugs, and 2. Best practices for how to conduct an expert review to uncover design flaws even before entering into usability testing. A review will be presented on numerous examples of Good vs. Bad Design and delegates will be trained on how to best select the drug delivery platform for a specific product as well as use principles of informal use error analysis, IEC 62366 PCA task analysis, and use-related risk analysis to uncover use errors that could negatively impact usability testing results and ultimate product success. Why you should attend Uncovering design flaws late in the development cycle can be costly and catastrophic to meeting a medical product’s commercialization deadline. Workshop attendees will learn how to uncover use errors early in the design process to avoid unacceptable use errors surfacing during late stage usability testing. About the workshop leaders Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors. Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books. About the organisation UserWise is a team of Human Factors Engineers dedicated to designing best-in class medical products, packaging, and labelling. With experience ranging from home-use injectables and diagnostics to robotic surgery platforms, our consultants successfully navigate medical device and combination product regulations via usability testing, use-related risk analysis, and compliance documentation. www.userwiseconsulting.com HALF-DAY POST-CONFERENCE WORKSHOP A WEDNESDAY 5TH JUNE 2019 | 08.30 - 12.00 HYATT REGENCY MISSION BAY, SAN DIEGO, CA, USA Register online at www.prefilled-syringes-westcoast.com MARKETING OPPORTUNITIES Want to know how you can get involved? Interested in promoting your services to this market? Contact Jinna Sidhu, SMi Marketing on +44 (0) 207 827 6088 or email: [email protected] SUPPORTED BYOFFICIAL MEDIA PARTNERS Pre-Filled Syringes West Coast - Past Attendee Breakdown Breakdown by Job Function 110+Industry professionals from Europe and beyond 8+Dedicated hours of networking Breakdown by Geo-Split USA 77% Europe 10% United Kingdom 7% Asia Pacific 6% C-level 9% Vice President 3% Director 17% Product Manager 15% Senior Engineer 13% Senior Device Manager 6% Senior Principal Scientist 11% Supply Chain Manager 1% Quality Assurance 4% Packaging Expert 3% Regulatory Affairs 2% Business Development Manager 16% Attendee Testimonials: “ The conference did a good job of bridging the gap between drug/bio and device knowledge”
- 5. PROUDLY SPONSORED BY: SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you 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. Should you wish to join the increasing number of companies benefiting from sponsoring our conference please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected] Pre-Filled Syringes West Coast www.prefilled-syringes-westcoast.com Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms (vials, ampoules, pre-filled syringes, auto-injector pens) includes: • Pack design and prototype generation • Labeling, assembly and secondary packaging • Complex kit assembly • Temperature sensitive storage • Serialization Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner. www.almacgroup.com Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. www.aptar.com/pharma Harro Höfliger is located in Southern Germany with over 1250 employees. With an extensive portfolio of technical platforms, Harro Höfliger offers customer specific, special solutions for growing market segments, innovative products and new drug delivery systems. Its technology platforms and turnkey system solutions are always precisely tailored to the needs of the customer. This 100% customer focus and a high level of innovation have earned the company a leading market position. With a worldwide sales and service network. A member of Excellence United. www.hoefliger.com Founded in 1989, Kaleidoscope Innovation is a full-service, insights, design and development firm. Offering consultancy-style and onsite services, Kaleidoscope Innovation helps business partners solve challenges through: Insights & Human Factors, Industrial Design & User Experience, Engineering, Visualization and Software Development. Kaleidoscope Innovation has ISO 13485:2016 certification and IEC 60601 compliant. www.kascope.com Lonstroff is a partner that offers all services related to elastomeric solutions from a single source. We advise our customers not only in the new development and optimization of materials, but also in their applications and in value analysis. Thanks to our experience, we are also able to provide valuable support with the registration and approval of the products. www.lonstroff.com Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs. www.mgc.co.jp/eng/products/abd/oxycapt.html Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology & generics industries.Nemeraalwaysputspatientsfirst,providingservicesandproductsforseveralkeydeliveryroutes:Parenteral,Ophthalmic,Nasal,Buccal,Auricular, Inhalation, Dermal/Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: - Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. - Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations. www.nemera.net Plastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment. www.plasticingenuity.com Since our founding in 1909 as the first modern rubber factory in Japan, we at Sumitomo Rubber Industries have strived to produce advanced, environmentally friendly products based on the latest innovations in rubber technology. Within the medical rubber group, we are focused on providing the highest quality products, and ultimately dedicated to improving the lives of people around the world. Utilizing the latest in material and process innovations and our global manufacturing footprint, our team members work diligently to ensure we deliver consistent high performing products and provide strong assurance of supply. http://hybrid.srigroup.co.jp/en/products/cleanrubber/ ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. www.zeonex.com With over 160 years of expertise in materials and components testing, ZwickRoell delivers intelligent materials testing solutions for the medical industry, including drug delivery testing systems for syringes and cartridges, autoinjectors, and pen injectors. Our qualification services help ensure compliance to your industry’s stringent testing requirements. www.zwickroell.com Register online at www.prefilled-syringes-westcoast.com SMi PHARMACEUTICAL EVENT PLANNER 2019 FEBRUARY 2019 Parallel Trade 5th - 6th February 2019, London, UK 3D Cell Culture 20th - 21st February 2019, London, UK RNA Therapeutics 20th - 21st February 2019, London, UK MARCH 2019 Superbugs & Superdrugs 18th - 19th March 2019, London, UK Drug Discovery Chemistry 18th - 19th March 2019, London, UK APRIL 2019 Adaptive Designs 1st - 2nd April 2019, London, UK Pre-Filled Syringes East Coast 8th - 9th April 2019, Boston, USA Pharmaceutical Microbiology East Coast 10th - 11th April 2019, Boston, USA MAY 2019 Pain Therapeutics 13th - 14th May 2019, London, UK Highly Potent Active Pharmaceutical Ingredients 13th - 14th May 2019, London, UK Injectable Drug Delivery 15th - 16th May 2019, London, UK JUNE 2019 Prefilled Syringes West Coast 3rd - 4th June 2019, San Diego, USA Lyophilisation 3rd - 4th June 2019, London, UK Pharmaceutical Microbiology West Coast 5th - 6th June 2019, San Diego, USA SEPTEMBER 2019 Biosimilars & Biobetters 25th - 26th September 2019, London, UK OCTOBER 2019 Orphan Drugs 15th - 16th October 2019, London, UK NOVEMBER 2019 Ophthalmic Drugs 18th - 19th November 2019, London, UK
- 6. PRE-FILLED SYRINGES WEST COAST 2019 Conference: Monday 3rd & Tuesday 4th June 2019, Hyatt Regency Mission Bay, San Diego, CA, USA Workshop: Wednesday 5th June 2019, Hyatt Regency Mission Bay, San Diego, CA, USA 4 WAYS TO REGISTER www.prefilled-syringes-westcoast.com If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email [email protected] EARLY BIRD DISCOUNT □ Book by 28th February to receive $400 off the conference price □ Book by 29th March to receive $200 off the conference price □ Book by 30th April to receive $100 off the conference price Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-290 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment: □ UK BACS Account Name: SMi (Group) Ltd □ Wire Transfer Sort Code: 30-00-09, Account: 11775391 Lloyds TSB Bank Plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 11775391 IBAN GB75 LOYD 3000 0911 7753 91 □ Cheque We can only accept US Dollar Cheques drawn on a US Bank □ Credit Card □ Visa □ MasterCard □ American Express SMi Group will apply surcharges to commercial cards Please tick here □ if the card provided is not a commercial card Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. Card Billing Address (If different from above): PAYMENT 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. ______________________________________________________________________________________ VAT I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) DOCUMENTATION CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee □ Conference & Workshop $2498.00 □ Conference only $1999.00 □ Workshop only $499.00 □ Evening Dinner - Limited availability, only available to pharmaceutical companies PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees $1598 + VAT $1917.60 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference. Unique Reference Number Our Reference LVP-290 Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: If you would like to continue to receive email updates about our events, please tick □ Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: 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. Privacy policy / Opt Out: For full details on our privacy policy please go to http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out Terms and Conditions of Booking DELEGATE DETAILS VENUE Hyatt Regency, Mission Bay, San Diego, CA, USA □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: [email protected] or fax +44 (0) 870 9090 712 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, Ground Floor, India House, 45 Curlew Street, London SE1 2ND