2019 PDA EUROPE The Universe of Pre-filled Syringes and Injection Devices CALL FOR ABSTRACTS CONNECTING PEOPLE SCIENCE AND REGULATION 22-23 OCTOBER 2019 GOTHENBURG, SWEDEN PRE-CONFERENCE WORKSHOPS: 21 OCTOBER CONFERENCE & EXHIBITION: 22-23 OCTOBER EDUCATION & TRAINING: 24-25 OCTOBER ABSTRACT SUBMISSION DEADLINE 29 MARCH 2019
CONFERENCE OVERVIEW Dear Colleagues, We would like to invite you to submit a paper or poster abstract for presentation at the 2019 The Universe of Pre-filled Syringes and Injection Devices, 22-23 October 2019 in Gothenburg / Sweden. Paper abstracts and posters must be non-commercial in nature, describing new developments or work that significantly contributes to the body of knowledge relating to Pre-filled Syringes and Injection Devices. The Program Planning Committee will review all proposals carefully and consider podium presentations. We look forward to receiving your topic proposal! Sincerely, the Co-Chairs Thomas Schoenknecht, PhD, SHL Group Mathias Romacker, PhD, Pfizer Call for Abstracts Topics areas of interest will include but are not limited 1. REGULATORY TRENDS Emerging Markets Global Inspections New Guidances European Medical Device Regulation Implementation Life Cycle Management, ICH Q12, ISO Standards Development Combination Products Usability Studies Continuous improvement and regulatory requirements Drug Safety / Anti-Counterfeiting Improved compliance due to new device / technology 2 2. DEVELOPMENT (Holistic) Design Approaches for Affinity/Usability/Manufacturability Formulation / container / device / functionality / usability Interchangeable filling systems Decision / selection process of application systems Container Closure Issues, Integrity & Testing Challenges with different products: monoclonal antibodies / vaccines / biosimilars / freeze-drying High viscosity, shear force sensitive formulations, oxygen sensitive formulations Bubble formation, head-space, gas formation Large Volume Injections Platform approaches Accelerating Market Access Injection Tolerability, needle shape, injection site reactions, leakage Primary and secondary packaging considerations Moving from IV to SC Delivery why do it and how Electrical and motorized sub-systems for devices Medical Device Test & Release Methods 3. MANUFACTURING Equipment and new technologies Upscaling and technology transfer Total product quality Zero defect challenges, improved technologies Visual inspection vs. automated inspection Manufacturing Flexibility (high speed fill-finish as well as small batches for clinical trials) Latest Developments in Aseptic Manufacturing Fill-finish and Assembly Equipment Primary and secondary packaging considerations Labelling Track and trace, serialization Single unit identification, smart labelling Automation Lyophilization in syringes and cartridges Contract services / best practices Component preparation and sterilization methods Sterile component assembly in an aseptic core Siliconization of components, siliconeoil-free systems Device Complaint Management during clinical phase and post-launch 4. ADVANCES IN COMPONENTS, APPLICATION SYSTEMS AND DEVICES New materials New designs, forms, customization Autoinjectors and pens Syringe and cartridges components Combination Products Pump systems and wearables Patch injection / on-body delivery systems Needle-free injections /micro-needles / intradermal injections Needle shapes, handling & preparation Cell & gene therapy / medicinal products and device needs
INFORMATION SCIENTIFIC PROGRAM PLANNING COMMITTEE Thomas Schoenknecht, SHL-Group, Chair Mathias Romacker, Pfizer, Chair Frank Bamberg, Hoffmann - La Roche Theresa Bankston, BD Markus Bauss, SHL-Connect Sherri Biondi, Medimmune Nicolas Brandes, West William Dierick, Terumo Olivia Henderson, Amgen Laurent Jeanmart, GSK Philippe Lauwers, Terumo Hanns-Christian Mahler, Lonza Manfred Maeder, Novartis Brigitte Reutter-Härle, Vetter Thomas Seiffer, Bausch + Ströbel Ian Thompson, Ypsomed Karthik Vaideeswaran, Eli Lilly Falk Klar, PDA Europe Sylvia Becker, Programs & Events PDA Europe VENUE The Swedish Exhibition & Congress Centre Gothia Towers Hotel Mässans Gata 24 41294 Gothenburg, Sweden to the following 5. SMART DEVICES, SMART PACKAGING AND DIGITAL HEALTH APPLICATIONS Medical Internet Of Things (IOT) Platforms Data Analytics and Artificial Intelligence New Service Models Roadmap for implementation of new technologies Application of novel technologies in clinical research and commercialization Big Data, data mining, the transparent patient and personal data protection Linking patient to manufacturing Optimizing patient on-boarding Recycling/Waste Management of Smart/Electronic Devices Blockchain in Pharma linking manufacturing, supply chain & patient benefit through new technologies 6. HOSPITAL NEEDS Access to medicines, specific needs in application devices, packaging, delivery Human factors, usability, handling, functionality Patient-led device design From compounding to patient Novel interaction between patients and general practitioner Safety, accidental needle stick prevention 7. BUSINESS DEVELOPMENT AND MARKETING Marketing trends for pre-filled syringes and application systems Technology/cost/competitive advantage Alliance Management; successful cooperation b/w pharma/pharma, pharma/supplier, multiple parties Assessing the value proposition of device innovation 8. REIMBURSEMENT / PAYER ASPECTS First Hand Experience, Patient Speaker Advanced Therapies / Personalized Medicine Outcomes-based Reimbursement Biosimilars Launch what comes next? 3
PDA Scientific Poster Presentation Exhibit your Work To join our scientific poster session, please send a printable PDF file according to the following specifications: Canvas size to work on: 84,1 cm x 118,9 cm (33,1 x 46,8 in) portrait format Slug / Bleed: 2 mm (0,0787 in) Images: 120dpi (low) - 150dpi (high) depending on size. All Images color Profile ISO Coated v2 (ECI) Deadline: 6 September 2019 118,9 cm (46,8 in) 84,1 cm (33,1 in) All posters will be printed by PDA and displayed as part of the exhibition. Poster Display is included in the regular conference registration fee. Please send your file and poster title to Nadjeschda Gomez-Stahl gomez@pda.org.
SUBMISSION PROCESS THE ONLINE PROCESS ASKS YOU TO PROVIDE THE FOLLOWING INFORMATION: - TITLE - PRESENTER S NAME - PRESENTER S BIOGRAPHY (APPROX. 100 WORDS) - ADDITIONAL SPEAKERS* - E-MAIL ADDRESS OF THE PRESENTER - KEY OBJECTIVES OF YOUR TOPIC - 2-3 PARAGRAPH ABSTRACT, SUMMARIZING THE TOPIC Commercial abstracts for papers or posters cannot be considered. All submitted abstracts will be reviewed by the Program Committee for acceptance. Upon review by the Program Committee, PDA Europe will advise each submitter of the status of the paper for presentation in writing. PDA Europe will provide one complimentary registration per podium presentation. *Additional speakers and poster presenters are required to pay one full conference registration fee. Please click or scan the QR Code to submit your abstract. Deadlines Abstracts of Papers for Presentation: 29 March 2019 Poster abstracts: 6 September 2019 https://goo.gl/dzm5hp Please submit your abstract and required information online. If you have any further questions, please do not hesitate to contact programs-europe@pda.org Attention Exhibitors PDA is seeking vendors who provide products / services in support of this conference. Space is limited and is on a first-come, first-serve basis. To reserve your space, please contact Nadjeschda Gomez-Stahl, gomez@pda.org or via telephone +49 30 436 55 08 23. 5
The Universe of Pre-filled Syringes and Injection Devices Reg Form Page 1 22-23 October Gothenburg Sweden This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. Your registration is only complete upon filling in and submitting both pages of this form. 1 Registration EARLY BIRD DISCOUNT Book by 25 Aug 2019 to receive 200 off the conference fee only All fees given in Euro, excluding VAT (25 %) 22-23 October Conference only Conference Fee The Universe of Pre-filled Syringes and Injection Devices PDA Member 1995 Nonmember 2295 Early Bird 900 Regulatory/Academic 1000 Poster Presenter please mark here (written approval required, conference fee applies) 21 October One-Day Workshop Workshop Fee Innovating the Journey from Manufacturing to the Patient All Participants 795 21 October One-Day Workshop Workshop Fee Innovative Drug Delivery Sytems / Combination Products All Participants 795 21 October One-Day Workshop Workshop Fee Impact of Pre-filled Syringe Packaging Components for Biopharmaceuticals All Participants 795 24-25 October Two-Day Training Course Training Course Fee Test Methods for Pre-Filled Syringe Systems All Participants 1595 24-25 October Two-Day Training Course Training Course Fee Extractables and Leachables All Participants 1595 24-25 October Two-Day Training Course Training Course Fee Container Closure Integrity Testing All Participants 1595 Your consent is important. We manage your personal data responsibly. For more information, please visit pda.org/privacy-policy RESPONSE REQUIRED By checking the box(es) below, I consent to: My contact information (name, company, job title, city, state, country) being printed on the attendee list distributed at the event. PDA recording and/or photographing me and using those recordings and/or photographs in future PDA promotional and marketing materials. PDA sending me promotional information via email. PDA sending me promotional information via post The fee includes event documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate. Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies). Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5 th registration free. For more information on group discounts please contact Antje Petzholdt at petzholdt@pda.org. Other discounts cannot be applied. Discount for Exhibiting Companies Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1545 per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount). 6
Reg Form Page 2 The Universe of Pre-filled Syringes and Injection Devices This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing. 22-23 October Gothenburg Sweden 3 WAYS TO REGISTER 2 1 2 3 Your Contact Information online: FAX: +49 30 436 55 08-66 Email: registration-europe@pda.org If this form is an update to a previously submitted form, please check here. Mr. Ms. Dr. Nonmember I want to become a PDA Member. Name (Last, First, MI) PDA Member ID Number Job Title Company Department Mailing Address City Postal Code Country Email Business Phone Fax Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.) 3 Information about Visa Matters All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.) Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). Payment Options 4 By Bank Transfer Beneficiary: PDA Europe ggmbh IBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBER Bank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany By Credit Card American Express MasterCard VISA For your credit card information safety: Please send your details by fax only (+49 30 436 55 08-66) or register online. Purchase Order Purchase Order Number Billing Address: Same as contact information address above. If not, please send your billing address to: petzholdt@pda.org Your Company VAT I.D.: This number starts by your country code with two characters (example: PDA Europe s country code starts with: DE followed by the number) PDA Europe VAT I.D.: DE254459362 Your registration is only complete upon filling in and submitting both pages of this form. Date Mandatory Signature CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A payment confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of 100 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 3 September 2019 you will receive a full refund minus a 150 excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at registration-europe@pda.org or fax to +49 30 436 55 08-66. 7
2 0 1 8 P D A E U R O P E E V E N T S 15-16 October Pharmaceutical Microbiology Berlin, Germany 23-24 October Visual Inspection Forum Berlin, Germany 6-7 November Outsourcing & Supply Chain - A 360 View Seville, Spain 22 November Project Management in the Pharmaceutical Industry Berlin, Germany 27-28 November Pharmaceutical Freeze Drying Technology Seville, Spain 27-28 November 11 th Workshop on Monoclonal Antibodies Seville, Spain 11 December Annex 1 Workshop Berlin, Germany 2 0 1 9 P D A E U R O P E E V E N T S 19-20 March Parenteral Packaging Venice, Italy 16-17 May Pharmacopoeia Geneva, Switzerland 4-5 June Advanced Therapy Medicinal Products Vilnius, Lithuania 25-26 June 4 th PDA Europe Annual Meeting Amsterdam, The Netherlands 3-4 September BioManufacturing tbc Subject to change For latest info: europe.pda.org Shortlist 28 Sep 2018 Events with additional Education Program. More information europe.pda.org Connecting People, Science and Regulation General Information PDA Europe ggmbh Am Borsigturm 60 13507 Berlin, Germany Tel: +49 30 4365508-0 Fax: +49 30 4365508-66 info-europe@pda.org europe. pda.org