Pre-Filled Syringes West Coast · in terms of content and attendance as the pre-fi lled syringe...
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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, astraZeneca Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals 08.30 Registration & Coffee 09.00 Co-chairs opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, astraZeneca Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals 13.10 Networking Lunch PLATFORM APPROACHES AND DEVICE DEVELOPMENT INNOVATIONS OPENING ADDRESS 09.10 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 Ronald Forster, Executive Director, amgen Kesley E. gallagher, Director of External Engagement, Combination Products, amgen 09.45 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 10.25 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 11.00 Morning Coffee Sponsored by 11.30 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. 12.10 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 12.45 Networking Lunch 13.10 Networking Lunch IMPRovINg hUMaN FaCToRS FoR ENhaNCED PaTIENT CENTRICITy – PaRT 1 13.45 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, Head of Human Factors Engineering, genentech 14.20 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, astraZeneca 14.55 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. 15.30 afternoon Tea Sponsored by 13.10 Networking Lunch A REGULATORY OUTLOOK PANEL DISCUSSION 16.00 Future Regulatory Trends • The European Medical Device Regulation • The emerging market in China • Brexit and how it will affect the device industry • Regulatory strategies for wearables, software-based medical devices and integrated devices Panel Moderator: Ronald Forster, Executive Director, amgen Panelists: Natalie abts, Head of Human Factors Engineering, genentech gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co Kesley E. gallagher, Director of External Engagement, Combination Products, amgen Robert Schultheis, President, ZebraSci inc. 16.35 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 17.10 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 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 www.asdevents.com - www.asdevents.com/event.asp?id=20281
Transcript of Pre-Filled Syringes West Coast · in terms of content and attendance as the pre-fi lled syringe...
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
Overthepastdecade,pre-filledsyringevenueshavegrownsignificantlyin terms of content and attendance as the pre-filled syringe marketandpharmaceutical interest inpre-filledsyringecontinuestogrow.Theprefilledsyringemarketisprojectedtogrowanadditional10.5%by2024with continually increasing number of drug products being developed andadministeredviaprefilledsyringe.
Prefilledsyringeoffersmanyuniquebenefitsandcanbeeasilyintegratedwithindrugdeliverydevicesforpatientself-administration.Theseproductshave undoubtedly improved the lives of countless patients and caregivers whoadministerthemedicationbutarenotwithoutchallenges.Assuch,asan 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, andscientificbreakthroughs.
Themeetingwillallowfortheface-to-faceconvergenceofsubjectmatterexperts, thought leaders, researchers, and manufacturers in disciplines related to thedevelopmentofprefilled syringesandother therapeuticdelivery products, and thereby provide a tremendous opportunity for meaningfuldiscourse.
We look forward to seeing you there!
Michael Song, Senior Manager, Dosage Form Design and Development, astraZeneca
Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals
08.30 Registration & Coffee
09.00 Co-chairs opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, astraZeneca Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals
13.10 Networking LunchPLAtFORm APPROACHES AND DEVICE DEVELOPmENt INNOVAtIONS
OPENING ADDRESS09.10 Platform approach for combination products and devices
• HFEassessmentconsiderations• Challengesinbiocompatibility• Thebalancebetweenvolumeandviscosity• ThefutureoftheplatformapproachfordevicesRonald Forster, Executive Director, amgen Kesley E. gallagher, Director of External Engagement, Combination Products, amgen
09.45 Elastomeric Components: Supporting Next generation Drug Delivery Systems• HowcaninnovationinelastomericcomponentssupportPFS&
next generation drug delivery systems?• HowcanasuppliersmanufacturingnetworksupportPFS&next
generation drug delivery systems?• Whatcanwelearnfromotherindustriesandapplyittofuture
innovations and support drug delivery innovations? Douglas Cusato, Director of Medical Rubber Business, Sumitomo Rubber North america
10.25 Innovative application of Computer aided Engineering in Development of Pharmaceutical Packaging• Simulationleddesign• Devicemechanismoptimization• Containerclosureintegrityatvariousshippingcondition• InjectionPhysiologyLin Li, Senior Consultant Engineer, Eli Lilly and Company
11.00 Morning Coffee Sponsored by
11.30 Multilayer plastic syringe with excellent oxygen and Uv barrier• ExcellentoxygenandUVbarriercontributetostabilityof
biologics• Optimizedsilicone-oilcontributestopreventingprotein
aggregation• Extremelylowlevelsofextractablescontributetostabilityof
biologics • Developmentofstakedneedlesyringes hiroki hasegawa, Researcher, Mitsubishi gas Chemical Company, Inc.
12.10 Development of user-centric requirements for pre-fi lled syringes and injection devices• Reviewofuser-centricdevicecharacteristics• Generatinguser-relevantdesigninputrequirements• Applyingaplatformapproachtouser-centricdevicesDiane Doughty, Senior Scientist, MedImmune
12.45 Networking Lunch
13.10 Networking LunchIMPRovINg hUMaN FaCToRS FoR ENhaNCED PaTIENT CENTRICITy – PaRT 1
13.45 human Factors guidelines for Mobile health applications• Backgroundondevelopmentprocess• Guidelinescontentreview• Detailsondevelopmentandapplicationofusabilityguidelines• PracticalwaystoapplyguidelinestodevelopmentNatalie abts, Head of Human Factors Engineering, genentech
14.20 Digital health, considerations when developing digital connectivity solutions • Exploretheuseofwirelesscommunicationsystemsbeyond
Bluetooth• Exploreadvantagesanddisadvantagesbetweenusingadd-onvs.add-in
• Howmuchdataisenoughdata• Regulatoryconsiderationsandchallenges Michael Song, Senior Manager, Dosage Form Design and Development, astraZeneca
14.55 FDa Training Decay Research Initiative – Is a 1-hour training decay long enough for summative usability testing?• Identifydifferencesindecaybetweendevicetypes• Theeffectsofaccelerateddecay• Assessingthetask-trainingdecaycurveprofiles• IdentifygeneralizabledetailedtrainingdecaycurvesShannon Clark, Principal, UserWise, Inc.
15.30 afternoon Tea Sponsored by
13.10 Networking LunchA REGULAtORY OUtLOOK
PANEL DISCUSSION16.00 Future Regulatory Trends
• TheEuropeanMedicalDeviceRegulation• TheemergingmarketinChina• Brexitandhowitwillaffectthedeviceindustry• Regulatorystrategiesforwearables,software-basedmedical
devices and integrated devicesPanel Moderator: Ronald Forster, Executive Director, amgen Panelists: Natalie abts, Head of Human Factors Engineering, genentech gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co Kesley E. gallagher, Director of External Engagement, Combination Products, amgenRobert Schultheis, President, ZebraSci inc.
16.35 overview of EU MDR specifi c to safety• OverviewofrequirementsforEUMDR• Discussnewrequirementsforpost-marketsurveillance• Integrationofpost-marketsurveillanceactivitieswithrisk
management and clinical evaluation gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co
17.10 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
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 leadersin the exhibition area
www.asdevents.com - www.asdevents.com/event.asp?id=20281
Pre-Filled Syringes West Coast Day TWo | TUESDay 4Th JUNE 2019
Register online at www.prefilled-syringes-westcoast.com
08.30 Registration & Coffee
09.00 Co-chairs opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, astraZeneca Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals
IMPRovINg hUMaN FaCToRS FoR ENhaNCED PaTIENT CENTRICITy – PaRT 2
OPENING ADDRESS09.10 Digital health applications
• Mobileapplicationsthatsupportdrugdelivery• Thebenefitsofdigitalhealthandpatientcompliance• Userinterfacedevelopments• Advancesinconnectivity Ed Israelski, Consultant – Technical Advisor on Human Factors, Retired Director Human Factors, abbvie
09.45 human Factors Submission Expectations: a CDRh perspective• GeneraloverviewoftheCDRH2016humanfactorsguidance
document• Bestpractices,includingcurrentreviewstatistics• CaseStudiescomparingCDRHmedicaldeviceand
combination product HF submissionsRita Lin, Human Factors Reviewer, FDA
10.20 Pain perception and injection devices: could pain be assessed through non-human person trials in early stage device development?• Painperceptionkeydriversduringinjection• CanastudyonNHPevaluatepainassociatedtoinjection?• ApplicationofNHPmodelontestingcustomizationandtechnicalimprovementsoninjectiondevicestolimitpain
Severine Duband, Global Category Manager, Nemera
11.00 Morning Coffee Sponsored by
11.30 human Factor considerations for pre-filled syringes• Newproductdesignanddevelopment• Approachingaregulatorysubmission• Advancementsinhumanfactorsforpre-filledsyringes• Considerationsforpatientcentricity Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals
12.05 Prefilled syringes + safety devices = fun with users• Anoverviewofadd-onsafetyaccessories• Ingeniouswayssafetyaccessoriesareused• Tipsandtricksforproperinstructions
valerie Fenster, Director of Insights and Human Factors,Kaleidoscope Innovation
PANEL DISCUSSION12.45 Improving patient centricity through digital health
• Optimisinguserinterfacetools• Howtoimprovepatientcompliance• Overcomingcybersecuritychallenges• ThebenefitsofdigitalhealthandpatientcomplianceModerator: Ed Israelski, Consultant – Technical Advisor on Human Factors, Retired Director Human Factors, abbviePanel Members: Lin Li, Senior Consultant Engineer, Eli LillyDiane Doughty, Senior Scientist, MedImmune Michael Song, Senior Manager, Dosage Form Design and Development, astraZeneca
13.20 Networking Lunch
FORmULAtION AND CONtAINmENt CONSIDERAtIONS
14.20 viscosity Challenges for Design and Development of Combination products for Subcutaneous administration • Combinationproducts(i.e.,accessorizedprefilledsyringesandautoinjector)forSCadministrationhavedifferentrequirementsfor maximum viscosity to meet the device functionality (i.e.glideforce&injectiontime)criteria
• Proteinformulationsmayshowshearthinningbehaviour(i.e.decreaseinviscosityasshearrateincreases),therebyimpacting device functionality
• Viscositylimitforcombinationproductswassignificantlyhigherdue to shear thinning observed for protein formulations
Swapnil Pansare, Scientist, Dosage Form Design and Development, MedImmune
14.55 Technical updates in Cyclo olefin Polymer (CoP) – a Case Study• KeyPropertiesofCOP• Casestudy:BiologicsformulationforCOPsyringeoptimized
to eliminating use of surfactant• Casestudy:StudyonProteinadsorption/aggregation
– COP vs glass• Casestudy:Studyondelaminationwithglasssyringe
vs COP syringe• LeachabledataonCOPsyringeswithvariouschemicals Toshiro Katayama, Product Manager, Speciality Plastics, Zeon Chemicals L.P
15.35 Impact of silicone oil free polymer syringes on therapeutic proteins• Advantagesanddisadvantagesofglassandpolymersyringes• Long-termproteinstabilityforpolymersystems• Oxygenpermeationofpolymersyringes• Nitrogenfilledpouchesforpolymersyringestorage Benjamin Werner, Scientist, Pharmaceutical Development Biologicals, Boehringer Ingelheim
16.10 afternoon Tea Sponsored by
16.40 Drug Product Development Considerations for Subcutaneous Delivery of Proteins• Thereareanumberofconsiderationswhendeveloping
protein drug products for subcutaneous delivery, this talk will highlight some common considerations: - Managingtheviscosityofliquidformulationsforhigh
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
17.15 Understanding and Controlling the Risk of Protein aggregation in Siliconized Pre-Filled Syringes• Biologicsproducts,packagedinpre-filledsyringes,can
sometimes show physical instability due to the silicone oil used tolubricatethesyringebarrel.
• Thefollowingwillbereviewed:- Nature of the interaction between proteins and silicone oil- Common approaches for mitigating the risk of silicone oil-
induced instabilityLori Burton, Senior Principal Scientist, Bristol-Myers Squibb
17.50 Co-Chair’s Closing Remarks and Close of Day Two
Network with industry and pharma leadersin the exhibition area
www.asdevents.com - www.asdevents.com/event.asp?id=20281
Workshop Leader: Shannon Clark, Principal,
UserWise, Inc.
The Secrets to Uncovering and addressing Design Flaws BEFoRE Usability Testing
Programme8.30 Registration and Coffee
9.00 opening remarks and introductions
9.10 Principles of Design•Whataretheguidingprinciplesofdesigning
a new medical product or selecting a drug delivery device for your new drug?
•HowdoIconductanexpertreviewtouncoverdesignflawsevenbeforeenteringintousabilitytesting?
9.50 good vs. Bad Design•StudynumerousexamplesofGoodvs.Bad
Design and start training delegates to see the patternsofgoodvs.baddesign
•Reviewtheprinciplesofcomparativeexpertreviews - How do I select the best drug delivery platform for my product?
•Reviewtheprinciplesofinformaluseerroranalysis,IEC62366PCAtaskanalysis,anduse-related risk analysis to uncover use errors
10.30 Morning Coffee and Networking Break
11.00 Interactive Expert Reviews•Delegateswillbepresentedwithdifferentreal-
life medical product prototypes and concepts, and they’ll be tasked with conducting an expert review
•Discusstheprinciplesofidentifyingwhethertheproductis“optimized”andreadyfortesting
11.40 Closing Remarks from Workshop Leader
12.00 End of Workshop
Workshop overviewWorkshop attendees will learn
1. Principles of design that are key for developing medical products or selecting drug deliverydevices for new drugs, and
2. Best practices for how to conduct an expertreview touncoverdesignflawsevenbeforeenteringintousabilitytesting.
A review will be presented on numerous examples of Good vs. Bad Design and delegates will betrained on how to best select the drug delivery platform for a specific product as well as useprinciplesof informaluseerroranalysis, IEC62366PCA 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 attendUncoveringdesignflawslateinthedevelopmentcycle can be costly and catastrophic to meeting amedicalproduct’scommercializationdeadline.Workshop attendees will learn how to uncover use errors early in the design process to avoid unacceptable use errors surfacing during late stageusabilitytesting.
about the workshop leadersShannon 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. Theconsultants at UserWise conduct usability testing for a variety of medical devices ranging
from surgical robots to home-use injectionplatforms. UserWise consultants also performsafety assessments to comply with U.S. andinternational 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.ShannonisadditionallyaCertifiedProfessionalIndustrial Engineer, holds two patents, and has writtenandpublishedthreebooks.
about the organisationUserWise is a team of Human Factors Engineers dedicated to designing best-in class medical products, packaging, and labelling. Withexperiencerangingfromhome-useinjectablesand diagnostics to robotic surgery platforms, our consultants successfully navigate medical device and combination product regulations via usability testing, use-related riskanalysis,andcompliancedocumentation.www.userwiseconsulting.com
HALF-DAY POSt-CONFERENCE WORKSHOP AWEDNESDay 5Th JUNE 2019 | 08.30 - 12.00 hyaTT REgENCy MISSIoN Bay, SaN DIEgo, Ca, USa
alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
•RAUMEDICINC•Regeneron•Shire•SmithersRapra•Steri-Tek•StevanatoGroupS.p.A•SubcujectApS•SuttonsCreekInc•TerumoCorporation•UserWise,Inc.•W.L.Gore&Associates,Inc.•WestPharmaceuticals
Services Inc•Worrell•XerisPharmaceuticals•Zebrasciinc•ZEONCorporation
Workshop Leaders: Rita Lin, Human Factors Reviewer, FDA
Natalie abts, Head of Human Factors Engineering, genentech
Developing a human Factors validation Plan with Consideration for the Digital health Marketplace
Programme13.00 Registration & Morning Coffee
13.30 opening remarks and introductions
13.40 overview of human Factors guidance Documents•ReviewFDAhumanfactorsguidance
Applying Human Factors and Usability Engineering to Medical Devices
•ReviewXcertiamHealthAppGuidelinesanddiscussrelevancetopre-filledsyringeindustry
•Discusscurrentdirectionsandchallengeswithpre-filledsyringesfromregulatoryandindustryperspectives
14.20 Case Study Introduction•Casestudyproductoverview–testingapre-filledsyringeutilizingBluetoothtocommunicate with an accompanying app
•Discussionofriskanalysisandriskconsiderations for this type of product
•Preliminarydiscussionandreviewofproductdocumentation
15.00 afternoon Tea
15.30 validation Study Planning•Discusskeycomponentsofagoodvalidation
study design•FDAperspectiveoncommonproblemswith
validation plans•Industryperspectiveonproblem-solvingfordifficult-to-testproducts
16.10 Creating a Study Plan•Worktimetocreateavalidationstudyplan
for the device introduced during Session 2•Teamreportoutofstudyplans•Discussionoflessonslearnedfrom
the exercise
16.50 Closing Remarks
17.00 End of Workshop
Workshop overviewThis workshop will provide an overview of human factors validation strategies that companies should consider as the pre-filled syringe marketincreasinglytakesondigitalhealthcomponents.Acasestudyofapre-filledsyringewithconnectiontoamobileappwillbeutilizedthroughoutthecourseto demonstrate the concepts under discussion andhelpparticipantsworkthroughastudyplan.The workshop aims to generate discussion around challenges, lessons learned, and future directions for human factors considerations regarding similar products.
Why you should attend•Hearregulatoryandindustryperspectivesonstudydesignforpre-filledsyringes
•UnderstandcurrentFDAthinkingonhumanfactors submissions
•Discussconsiderationsforproductsincorporating digital health
about the workshop leadersRita Lin joined the U.S. Foodand Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and RadiologicalHealth(CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes,respiratory and anesthesia care, and digital health apps. She has been involved inproviding edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongstothers.
Rita previously worked in the orthopedic devices industry with experience in qualityassurance(QA)andresearch&development(R&D). Her responsibilities included leadingmajor design change projects, conductingempathic interviews, performing verificationand validation testing and risk management, and implementing manufacturing process changesinPuertoRico.
Rita earned her B.S. andM.S. in biomedicalengineering and global health from Duke University.
Natalie abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior
to joining Genentech, Natalie worked inmedical device consulting for seven years with the National Center for Human Factors inHealthcare.Nataliehasspecializedexperiencein planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds amaster’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored byDr.Ben-TzionKarsh.
HALF-DAY POSt-CONFERENCE WORKSHOP BWEDNESDay 5Th JUNE 2019 | 13.00 - 17.00 hyaTT REgENCy MISSIoN Bay, SaN DIEgo, Ca, USa
www.asdevents.com - www.asdevents.com/event.asp?id=20281
