SMi Group's Pre-Filled Syringes Conference & Exhibition


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SMi Group's 6th annual Pre-Filled Syringes conference & exhibition is already Europe's leading event. This year it will be better than ever. Check out the programme.

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SMi Group's Pre-Filled Syringes Conference & Exhibition

  1. 1. Top-Ranked Speaker Faculty Includes... Event’s Highlights Include: • An Ipsen case study in the sources and types of E&L and regulatory guidance on interaction safety profiles • Merck case study on a prefilled diluents syringe • Genentech focus on next generation PFS - high concentration mAb formulations and other biologics revealing design details on bench top syringe filling units • Novel uses for PFS - Point of care device case study showing usage in Ovarian Cancer diagnostics • Important regulatory updates - FDA regulations on device controls and new cGMP rules for combination products PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 29th January 2014, Marriott Regents Park London, UK Leachables and Extractables Hosted by: Andrew Fieldon, Senior Consultant, Smithers Rapra 8.30am - 12.30pm Large Volume Injectors – Technologies, Strategies and Guidance Hosted by: Stephen Augustyn Head of Mechanical Engineering, Team Consulting 1.30pm - 5.30pm • Advait Badkar, Associate Research Fellow, Technolgy Lead, Pfizer • Jason Creasy, Head of Extractables & Leachables Team, GlaxoSmithKline • Bobbijo Redler, Principal Scientist, Merck & Co. • Joel Richards, Director, Ipsen • Christian Siegmund, Head of Prefilled Syringes and Liquid Vials, Hoffmann La Roche Ltd • Yuh-Fun Maa, Principal Engineer, Genentech • Robert Schnepf, Molecule Leader, MPD CoE, Merck & Co. • Joan Malstrøm, Specalist, Novo Nordisk A/S “The meeting improves each year and should become a fixed date on the calendar for anyone interested in Pre-Filled Syringes.” Senior Director, Pharma Representative SMi presents Europe’s Leading Event with 6 Years of Excellence 27th - 28th JAN 2014Marriott Regents Park Hotel, London, UK Future applications for safer drug delivery Pre-Filled Syringes BO O K BY 30TH SEPTEM BER A N D SA VE £300 BO O K BY 31STO C TO BER A N D SA VE £100 Sponsored by Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUPS DISCOUNTS AVAILABLE SPECIAL £999 FOR FIRST 25 PHARMA COMPANIES
  2. 2. Register online at: • Alternatively fax Pre-Filled Syringes Day One | Monday 27 January 2014 www.pre-filled 8.30 Registration & Coffee 9.00 Chairman's Opening Remarks Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer PRE-FILLED PATIENT SAFETY AND QUALITY BY DESIGN 9.10 Quality by design in the manufacture of pre-filled syringes • PFS and quality by design assessment • Component preparation focus – PFS manufacturing • Operations and risk assessment review • Design and implementation for understanding parameters in PFS Advait Badkar, Associate Research Fellow, Technolgy Lead, Pfizer 9.50 Merck case study – Introduction of a prefilled diluents syringe for preparation of a complex product • Common and uncommon technical challenges • End user voices are key to develop the right product • Case study Robert Schnepf, Molecule Leader, MPD CoE, Merck & Co. 10.30 Panel Discussion – Specific considerations for PFS development •Start up of increased speed filling lines •FDA regulations on PFS controls •Operations and risk assessment •Case study Advait Badkar, Group Leader - Senior Principal Scientist, Pfizer Adam Woolley, CEO, ForthTox 11.10 Morning Coffee 11.40 Improve medication safety in Hospital Care environment with Polymer Prefillable Syringes in combination with syringe pumps • Design requirements for COC prefillable syringe to be used in combination with syringe pumps • Infusion performance due to pump specific system design • Project challenges and the solutions found within the Fresenius Kabi AG and SCHOTT AG partnership • Latest developments on polymer PFS • Recent roadblocks • Case study Anil-Kumar Busimi, Head of Global Product Management Syringe Business, Schott Andreas Kerschbaumer, Manager, Fresenius Kabi CONTAINER INTEGRITY AND SAFETY CONSIDERATIONS WITH LEACHABLES 12.20 Leachables and safety considerations in Pre-filled syringes and cartridges: Impact on drug product quality and safety profile for biologics • Sources and types of E&L in PFS and cartridges • Interactions of drug product with primary packaging and processing equipment • Regulatory guidance • Case study: Impact on product quality and safety profile • Interaction on safety profile Joël Richard, Vice President Peptides, Ipsen 1.00 Networking Lunch 2.00 Toxicological evaluation of extractables and leachables with reference to ICH M7 • The regulatory context of evaluation • Endpoints of interest – especially genotoxicity • Techniques for evaluation • Interpretation of the results and risk assessment including thresholds of concern Adam Woolley, CEO and David Woolley, Consultant, ForthTox 2.40 Session reserved for BD Nicolas Morais, Product Manager, Europe, Prefillable Syringes, BD Medical 3.20 Afternoon Tea 4.00 Techniques & processes for assessing the risk posed from leachables in pre-filled syringes • Appropriate risk assessment process for studying potential leachables • Consideration of all potential sources of leachables including manufacturing systems and container closure • Choosing the correct analytical methods for study • GSK case study Jason Creasy, Head of Extractables & Leachables Team, GlaxoSmithKline 4.40 Development of HCLF Biologics in Pre-Filled Syringes • Challenges for the development of HCLF biologics from downstream to drug product • Interactions with primary packaging • Stability issues during manufacturing • Medical application and considerations Patrick Garidel, Associate Director Protein Science, Boehringer Ingelheim 5.20 Ovarian cancer diagnostics – A novel point of care device using Pre-filled syringes in the operating room • Current status in Ovarian Cancer diagnostics • Tumour marker discovery in ovarian cyst fluid • Development of a point of care device using pre-filled syringes to diagnose ovarian cancer in the operating room • Case study Khalil Razvi, Consultant, Southend NHS Trust 6.00 Chairman's Closing Remarks and Close of Day One Who should attend? The Heads, VPs, Team Leaders, Consultants and Scientists involved in: • Pre-Filled Syringes • Drug Safety • Medical Devices • Drug Delivery Systems • Packaging & Labelling • R&D • Extractables & Leachables • Drug Formulation • Clinical Trials • Bioprocessing • Sterile Manufacturing • Quality Assurance
  3. 3. 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: your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Day Two | Tuesday 28 January 8.30 Registration & Coffee 9.00 Chairman's Opening Remarks Jason Creasy, Head of Extractables & Leachables Team, GlaxoSmithKline THE NEXT GENERATION OF PRE-FILLED SYRINGES 9.10 PFS filling of high-concentration mAb formulations – Parameter investigation and optimasation using small-scale filler • Technical details of of syringe filling are rarely published – particularly high concentration/ viscosity formulation • Reveal design details of a bench top syringe filling unit • Identification and optimisation of critical process parameters • Apply leaning to practical filling operations • Case study Yuh-Fun Maa, Principal Engineer, Genentech 9.50 Understanding the risks and impact of offering both a prefilled syringes and a vial/stopper image • Drivers for offering both images • Considerations for materials selection • Impact to E&L study design when offering both images Bobbijo Redler, Principal Scientist, Merck & Co. 10.30 Incorporating human factors and patient centric design into a novel safety device • Today, Injectable drugs in prefilled syringes require injection devices - how to choose the right one • A clinically proven safety device has been adapted for the self-administration market • Manual Injection control vs. automated injection support Alexander Jaksch, Director, Marketing & Commercial Development, Safety, BD Medical 11.10 Morning Coffee 11.30 Introduction to Medical Grade Cyclo Olefin Polymers (COP) for Pre-Filled Syringes • Key properties and features of COP - ZEONEX/ZEONOR • Protein Adsorption study with BSA, Insulin • Optical and Mechanical properties after exposure to gamma, steam, EOG and cryogenic temperature • Moisture/gas barrier data • Residual metal and outgas data Reinhard Scheller, Commercial Manager Cyclo Olefin Polymers - COP, Zeon Europe GmbH 12.10 Silicone oil in prefilled syringes determined by NMR spectroscopy • Comparison of NMR data with MFI • Quantitative aspect of 1H-NMR spectroscopy • Method for determination and quantitation of Si-oil Joan Malmstrøm, Specialist Peptide Characterisation, Diabetes, Novo Nordisk A/S 12.50 Networking Lunch 1.50 Next Generation of Plungers for Prefilled Syringes – the Ideal Combination for Self-Injection Devices • Newly designed syringe components are increasingly important in auto injectors • Newly developed plunger design developed under QbD aspects • Explination of developments of technologies into the design • Results presented on in-house functional performance of new plunger Christina Janssen-Otten, TCS Manager Europe, West Pharmaceutical Services PRE-FILLED UPDATES AND MANUFACTURING TRENDS IN PRE-FILLED SYRINGES 2.30 Implementation and start up of a pre-filled syringe isolator filling machine • Challenges during start up • Minimization of scratches • Integrated AIM (automated inspection machine) Christian Siegmund, Head of Prefilled Syringes and Liquid Vials, Hoffmann La Roche Ltd 3.10 Next generation Pre-filled Syringes • Advantages of pre-filled syringe presentations • Challenges developing pre-filled syringe presentations • Cross-linked silicone coating technology • Glass strengthening technology Roja Narwal, Scientist I, MedImmune 3.50 Afternoon Tea 4.30 Regulatory perspective and case studies • Recent regulatory developments; • Interpretation of analytical results; • Useability and patient factors; • Regulatory case studies Brij Patel, CEO, RegExcel Consulting Ltd 5.10 Panel Discussion – Extended Q&A • Potential problems with leachables as they stand • Opportunities for speakers to further clarify presentations • Potential road blocks’ • Case study Jason Creasy, Head of Extractables & Leachables Team, GlaxoSmithKline Bobbijo Redler, Principal Scientist, Merck & Co. 5.50 Chairman’s Closing Remarks and Close of Day Two
  4. 4. POST-CONFERENCE WORKSHOP A 9.00am - 12.30pm I Wednesday 29th January 2014 I Marriott Regents Park, London, UK Leachables and Extractables Hosted by: Andrew Fieldon, Senior Consultant, Smithers Rapra Overview of workshop: It is becoming increasingly clear that for many research applications that Three Dimensional (3D) cell culture and cell based assay approaches offer huge advantages over the more conventional 2D cell culture and assay models. This workshop will provide an overview of the very latest 3D cell based assay and culture technologies and techniques for use in biomedical research and drug discovery and the key application areas for these technologies with a focus on HTS and HCS. • To gain an insight into the issues surrounding this new area of research • The opportunity of discussing issues and ideas and sharing experiences with other scientists • Networking opportunities with peer scientists working in the same area Key learning include: • Analyse current regulatory guidance and strategy management • Share insight with experienced specialists in the fields of leachables • and extractables • Learn about relevant cases studies in analysis and selection • Develop solutions to challenges in the field About your wokshop leader: Dr Andrew Feilden joined Smithers Rapra as a principal consultant in June 2011. He is specialising in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. For the previous 12 years he was at AstraZeneca, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University. About Smithers Rapra Smithers Rapra, part of the Smithers Group of companies, has been recognized as a world leading rubber and plastics consultancy delivering a comprehensive and strictly independent service since its establishment over 90 years ago. These services have been tailored to support the medical device and pharmaceutical industries where polymers are widely used. Much of our work for this sector is in the field of Extractables and Leachables testing for drug delivery devices, immediate packaging and bioprocess equipment, however we are also able to support the development of medical and drug delivery devices and, where required, comprehensive failure diagnosis. Programme 8.30 Registration and coffee 9.00 Welcome and introductions to E&L • What exactly are they? • The guidance available currently 9:20 Material Selection • What are the effects of differing materials • Analysis 10:10 E&L analysis including novel case stud 11:00 Morning tea 11:20 Testing on E&L • The current limits to testing • Methods of testing 12:30 Conclusions and close of workshop POST-CONFERENCE WORKSHOP B 1.30pm - 5.30pm I Wednesday 29th January 2014 I Marriott Regents Park, London, UK Large Volume Injectors – Technologies, Strategies and Guidance Hosted by: Stephen Augustyn, Head of Mechanical Engineering, Team Consulting Overview of workshop: Chronic conditions and the rise of biological drugs with large volume payloads are driving pharmaceutical companies and device manufacturers to develop Large Volume Injectors (LVI). This workshop will examine the pressures driving the creation of LVIs, the advantages they offer over traditional parenteral delivery systems and some guidance to help companies select or develop a device for their own application. Key learning include: • To understand what makes LVIs different from current parenteral systems • To gain an overview of the devices currently being presented from different device and pharmaceutical companies • To better understand the standards that will affect LVIs • For insight into the technical and user challenges associated with these products About your wokshop leader: Stephen is responsible for the delivery of Team’s capability in device engineering and has over twelve years’ experience in medical devices. Since joining Team Consulting five years ago, Stephen has been responsible for the management and delivery of a wide variety of medical and surgical products. In addition to his work at Team, Stephen is a member of the TC84 ISO committee responsible for defining new standards for injection devices. About Team Consulting Ltd Team Consulting work globally for companies in the life science industries, and we're acknowledged experts in medical and drug delivery device development. To date, Team has helped clients to develop over 20 injection devices and has worked for many of the world’s leading pharma and device firms, including six of the 10 largest pharmaceutical companies. Programme 1.30 Registration and coffee 1.45 Welcome and Introductions 2.00 Context and Background • Pressures driving creation of LVIs • Advantages over current parenteral systems 2.20 Market Overview • Examination of some of the leading products in the public domain • Predicate devices 3.30 Coffee and networking Break 3.50 Technical and Human Factors • Primary containers • Manufacturing • Human Factors and Industrial Design 4.40 Guidance and Predicate devices • Key performance markers • Appropriate standards • Defining or choosing your device 5.10 Summary and Questions 5.30 Close of workshop In asscociation with In asscociation with
  5. 5. BD Medical Pharmaceutical Systems is a worldwide leader in supplying the pharmaceutical industry with quality drug delivery systems and safety- engineered devices. Our cutting-edge delivery systems are customizable to meet patient needs, are market tested and are manufactured to meet the high quality standards that our customers expect. BD Medical - Pharmaceutical Systems provides a comprehensive range of prefillable injection systems using clinically proven products that help deliver enhanced drug or end-user benefits and results, and access to information and distribution networks worldwide. For years we have also been one of the most active promoters of healthcare worker safety. SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of glass tubing and primary packaging for the pharmaceutical industry. We provide our customers quality solutions while meeting their highest demands with our material expertise, specialized analytical lab services, and a broad product portfolio; including syringes, cartridges, vials, and ampoules made of glass and COC polymer. With our extensive production network of glass tubing and pharmaceutical packaging, we offer safe supply and local service. Our state- of-the-art production facilities and our products comply with the highest international quality standards for pharmaceutical needs. West works side-by-side with its healthcare partners from concept to the patient, designing and manufacturing packaging, diagnostic and delivery systems that promote the efficiency, reliability and safety of their products. Every day, West is leading the way with cutting-edge technologies and quality systems, a thorough understanding of global regulatory compliance, and an unmatched and growing knowledge base of relevant pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers from sales, manufacturing, customer service and research and development facilities in North and South America, Europe, Asia and Australia. Zeon Europe GmbH is the European marketing/sales organisation of ZEON CORPORATION, Japan. Based on unique C4 and C5 extraction technologies Zeon developed an integrated production system and is striving to create new products and business areas by utilizing these core technologies. As part of specialty materials business Zeon produces Cyclo-Olefin Polymers (COP) under the tradenames ZEONEX® and ZEONOR® . Sponsored by SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement 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. 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: Official Platinum Media Partner Official Leading Media Partner Media Partners
  6. 6. 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 If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at 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 providedocumentationinthesecircumstances.Wecannotacceptcancellationsofordersplaced forDocumentationortheDocumentPortalasthesearereproducedspecificallytoorder.Ifwehave 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 Act1998andwemayusethistocontactyoubytelephone,fax,postoremailtotellyouaboutother productsandservices.Unlessyoutickhere□ wemayalsoshareyourdatawiththirdpartiesoffering 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 the attached letter. Unique Reference Number Our Reference LVP-093 Terms and Conditions of Booking DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: 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 must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-093 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: □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. 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): DOCUMENTATION 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) PAYMENT VENUE Marriott Regents Park Hotel, 128 King Henry's Road, London, NW3 3ST □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: or fax +44 (0) 870 9090 712 □ Book by 30th September to receive a £300 discount off the conference price □ Book by 31st October to receive a £100 discount off the conference price EARLY BIRD DISCOUNT VAT VAT at 20% is charged on the attendance fees for all delegates. VAT is also 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: ______________________________________ CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE I would like to attend: (Please tick as appropriate) Fee Total □ Conference & 2 Workshops £2697.00 + VAT £3236.40 □ Conference & 1 Workshop £2098.00 + VAT £2517.60 □ Conference only £1499.00 + VAT £1798.80 □ 1 Workshop only £599.00 + VAT £718.80 □ 2 Workshops only £1198.00 + VAT £1437.60 Workshop A □ Workshop B □ First 25 Pharmaceutical Companies □ Conference only LIMITED AVAILABILITY £999.00 + VAT £1198.80 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 The Conference fee includes refreshments, lunch, conference papers and CD ROM containing all of the presentations. PRE-FILLED SYRINGES 2014 Conference: Monday 27th & Tuesday 28th January 2014, Marriott Regents Park Hotel, London, UK Workshop: Wednesday 29th January 2014, London 4 WAYS TO REGISTER ONLINE