SMi Group's 2nd annual Prefilled Syringes America

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SMi Group's 2nd annual Prefilled Syringes America conference returns to New Jersey next April

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  • 1. "Excellent, informative and good quality"Delegate 2014SMi presents its 2nd annual conference and exhibition on...Pre-Filled SyringesAmerica27 - 28APRILAssessing the future of pre-filled syringes to improve innovationand device development2015 Renaissance Woodbridge Hotel, Iselin, New Jersey, USABUSINESS BENEFITS FOR 2015: LISTEN to keynote addresses from the leaders in humanfactors engineering with expert input on reachingcertain patient populations, considerations andcompliance in device design and how can we ensurethe drug product is administered safely and effectively LEARN about the critical issues surrounding safetyassessments of pre-filled syringes from extractablesand leachables to sterility and needle stick preventionrequirements NEW FOR 2015 ENHANCE your understanding of labelling and pricingconsiderations with the competitive market forbiosimilars set to storm with patent expiries due ASSESS the future of pre-filled syringes with case studyled presentations addressing the challenges facedwith parenteral packaging innovations and reviewingthe strategies needed to overcome the hurdles withimportance insights into autoinjectors and pens ADDRESS the use of lyophilisation in pre-filled syringes, isthis the future vision?CHAIRS FOR 2015:Ravi Harapanhalli,Vice President,ParExelWilliam Beierschmitt,Research Fellow, Drug Safety Researchand Development,Pfizer Inc.KEY SPEAKERS FOR 2015: Natalia Mazaeva, Usability Leader, Sanofi Stephen Barat, Executive Director, Forest Laboratories,a subsidiary of Actavis Ed Israelski, Director of Human Factors, AbbVie Scott Brown, Device Development Lead, Merck Li-Chun Tsou, Global Device Technical Director,AstraZeneca Pharmaceuticals Kiran Singh, Associate Director, Sandoz Michel Mikhail, Former Chief Regulatory Officer,Executive Vice President, Global Regulatory -Governmental Relations, Fresenius Kabi NV/SA Mark Tsai, Principal Engineer, Drug Delivery, JanssenPharmaceuticalsPlus many more...PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 29th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USAWill Drug Delivery in Coming Days be an Integral Part of DDM?Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team,Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative,Sponsored byAdvanced Delivery Systems to EnablePersonalised MedicinesWorkshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel andMr. Sall, Principal Consultant, ParExel8.30am 12.30pm- Diagnose, Deliver and Monitorwww.pfsamericas.comBeroe Inc.1.30pm 5.30pmBOOK BY 19TH DECEMBER AND SAVE $400 BOOK BY 30TH JANUARY AND SAVE $200BOOK BY 27TH FEBRUARY AND SAVE $100Register online or call +448709090711 to speak to an account executiveBOOK BY 19THDECEMBER TORECEIVE OURSPECIAL $999 RATEFOR PHARMACOMPANIES ONLY!BOOK BY19TH DECEMBERAND SAVE $400BOOK BY 30TH JANUARY200$FEBRUARYSAVE 100$AND 27TH SAVE BY BOOK AND @SMIPHARM#USAPFSSMI

2. Pharmaceutical industrys perspectives: Drug stability (minimize drug-syringe interactions bymitigating leachables and extractables, flakes (lamellae)or deposits, glass fragments, and lubricant particles) Syringe durability CostManufacturers perspectives: Simplified manufacturing/assembly processes to mitigatebatch variances Consider stringent sterilization and packaging processes Compliance of the mandatory "safety" PFSHealthcare industrys perspectives: Avoid needlestick injuries User-friendly Eco-friendly (minimum residual of medicine,recyclable device material)Patient's perspectives: User-friendly (convenience and safety in preparationand self-administration) Eco-friendly (minimum residual of medicine,recyclable device material) Price-friendlyPre-Filled Syringes AmericaDay One | Monday 27th April 20158.30 Registration & Coffee9.00 Chairs Opening RemarksWilliam Beierschmitt, Research Fellow, Drug Safety Research andDevelopment, Pfizer Inc.HUMAN FACTOR STUDIESOPENING ADDRESS9.10 The importance of the patient and how each individual differs Reviewing the patient populations and the needs of certainindividuals in device design How can we enhance products to ensure theyrespecifically designed for the patients needs? Evaluating the best outcome for the patients, whatfactors should be consideredEd Israelski, Director of Human Factors, AbbVie9.50 Success Criteria How can the FDAs requirements be met? Demonstrating safety and effectiveness in the hands of the user Reviewing the design requirements for validation purposes Are the customer requirements being met in design transfer? Post market surveillance What observations canbe made?Natalia Mazaeva, Sr. Usability Leader, Global Usabilityand Risk Management, Device Development, SanofiCASE STUDY10.30 End user needs and perspectives for device assemblyEnd User Needs and Perspectives are critical for final devicedelivery. This presentation will address the injectable devicetrends and flexibility required for an assembly machine to adaptto new market challenges while incorporating the HumanFactor. This presentation will also focus on recent Regulatoryupdates (11608) for Combination ProductsThe lecture will show: Injectable Device Trends Human Factor - Increased focus on safety, usability andhandling studies Flexible standardized platforms to handle customizedassembly of pens and auto-injectors Gentle handling of the filled glass container duringassembly of the device using proven liquid fill finishhandling technologyDena Flamm, Product Manager, Robert Bosch GmbH11.10 Morning CoffeeKEYNOTE ADDRESS11.40 Convenience and compliance: empower the userthrough good design Reducing concerns by the end user is critical, what steps canbe taken to increase patient satisfaction? Precision and safety go hand in hand, lets addressconsiderations to ensure the product designed is safe andeffective How do we ensure the patient receives the exactdose intended?Ben Bartfeld, Human Factors and Industrial DesignConsultant, Otsuka Pharmaceutical Companies12.20 What makes a pre-filled syringes ergonomic? Addressing the importance of human factor studiesin device development Assessing the possibilities to ensure the drug productis administered safely and effectively Working with clients concentrating on the designbased strategiesSaikrishna Garrepalli, Procurement ManagementRepresentative, Beroe Inc.1.00 BREAKOUT SESSION & OPPORTUNTY TO NETWORK PRE-LUNCH Are we seeing a growing trend in drug delivery beingadministered outside traditional medical settings? How can we ensure this is safe?Host: William Beierschmitt, Research Fellow, Drug SafetyResearch and Development, Pfizer Inc.1.30 Networking LunchCRITICAL ISSUES: SAFETY ASSESSMENT2.40 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products Background on leachables and pre-filled syringes Why safety assessment for leachables is necessary How to approach and conduct a leachable safetyevaluation Current best practice recommendations andexamplesStephen Barat, Executive Director, Forest Laboratories,a subsidiary of Actavis3.20 The Risk Assessment of Extractables - A Toxicological Window ofOpportunity Ensuring compatibility of the profile of the pre-filled syringe withthe biologic Avoiding changes in product quality Material selection and final assessment of leachablesWilliam Beierschmitt, Research Fellow, Drug SafetyResearch and Development, Pfizer Inc.4.00 Afternoon Tea4.30 CASE STUDYIdentifying incompatibility causes and challenges Assessing drug delivery studies and reflecting on theimpactof incompatibility Assessing the specific fit of LAV valves and specificissues surrounding prefilled syringe designKiran Singh, Associate Director, Sandoz GmbH5.10 Assessing the safety of needle devices Looking at the global demand of safety needledevices What necessary steps should be taken to ensurea successful safety pre-filled syringe Creative design of safety pre-filled syringesPei-Yang Phillip Hsu, Chief Executive Officer, SaferMedTechnologies Co. Ltd.5.50 ROUND TABLE DISCUSSION AND NETWORKING OPPORTUNITY Discussing the safety challenges surrounding pre-filledsyringesHost: Pei-Yang Phillip Hsu, Chief Executive Officer,SaferMed Technologies Co. Ltd6.30 Chair's Closing Remarks and Close of Day OneNEW FOR2015!NEW FOR2015!Register online at: www.pfsamericas.com Alternatively fax yo 3. Pre-Filled Syringes AmericaDay Two | Tuesday 28th April 20158.30 Registration & Coffee9.00 Chairs Opening RemarksRavi S. Harapanhalli, Vice President, ParExelENHANCING DEVICE DEVELOPMENTOPENING ADDRESS9.10 Getting to market: Regulatory perspective Defining a pre-filled syringe as a product or deviceand its impact on regulatory approval Insight into the FDAs current thoughtsRavi S. Harapanhalli, Vice President, ParExel,former FDA Senior Executive9.50 Biosimilars and Delivery Deviceshere we go! Patent expiries for biologics are creating a newcompetitive market for biosimilars in particularMonoclonal antibodies How to differentiate from the innovator with a device Factors to Review: e.g. Interchangeability studiesMichel Mikhail, Former Chief Regulatory Officer,Executive Vice President, Global Regulatory- Governmental Relations, Fresenius Kabi NV/SA10.30 Morning CoffeeCASE STUDY11.00 The partnership reviewed between a pharmaceutical companyand the manufacturer/supplier Overview of the relationship and how it was managedAn explanation on why the products have been developedPHARMA What worked(Existing Actions)Pharma companiessometimes use mono-layerplastic containersto prevent the belowproblems, but all ofthem dont haveenough oxygen barrier. What couldve beenimproved?(Existing Problems forGlass Container- Breakage- Heavy Weight- Difficulty of disposal- Protein Adsorption- Inorganic Extractable,etc. Moving forward, whatwould you have donedifferently?(Future actions)Some antioxidizingagent might be used forinjectable drugs.SUPPLIER What worked(Existing solutions bysuppliers)Some supplies providemono-layer plasticcontainers instead ofglass, but a

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