Working Paper Series A COMPREHENSIVE ECONOMIC IMPACT ANALYSIS OF ...

Working Paper Series A COMPREHENSIVE ECONOMIC IMPACT ANALYSIS OF ...

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CITY AND REGIONAL PLANNING Cornell University · 106 West Sibley Hall · Ithaca, New York 14853 Tel: (607) 255-4331 · Fax: (607) 255-1971 · Working Paper Series A COMPREHENSIVE ECONOMIC IMPACT ANALYSIS OF NATURAL GAS EXTRACTION IN THE MARCELLUS SHALE May 2011 This is one in a series of policy working papers, prepared by a group of researchers centered at Cornell University with support from the Park Foundation and the Heinz Endowments, to inform policy makers and citizens about key economic issues related to shale gas drilling and production.
  • longer period of time differs from the amount
  • boom
  • analysis of the geographic pattern of drilling
  • shale gas drilling
  • environmental protection
  • drilling
  • economic development
  • economic impact
  • production

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Course5.2Biomoleculanalysis:From methoddevelopmenttoclinic30January3February2012BioMolecularAnalysisGroup,FacultyofSciencesVUUniversity,Amsterdam,theNetherlandsHomeAssignment(CaseStudiesandCoursequestions)th Tobecompletedbythe16March2012
BiomolecularAnalysis:FromMethodDevelopmenttoClinic:
žBioanalyticsforsmallmolecules9FromsamplingtodatahandlingžBioanalyticsforbiopharmaceuticals9Differencestosmallmolecules9PK,PD9Immunogenicity9IntegratedbioanalyticalapproachžWorkinginaregulatedenvironmentžNoveldevelopmentsinbioanalytics
Introduction ThistrainingmoduleonintegratedbioanalyticsispartoftheEuropeanModular EducationSafeSciMETprogramme.Theprogrammeaimstoencompassthesafety,ethical,regulatoryandsocietalaspectsinallphasesofdrugdevelopment,with emphasisonintegrative,translationaland3Rs[replacement,reductionand refinement]aspectsofdrugsafetyassessment.Awelldesignedbioanalyticalstrategyisanimportantpillarforthedevelopmentofsafedrugs.Thiscourseaimsatthetranslationalaspectsoftransformingbasicbioanalyticalapproachestoreallifeclinical/industrialapplications.WhyjointhecourseinBiomolecularanalysis:Frommethoddevelopmenttoclinic?Thiscoursedealswithbiomolecularanalysis,andaimsatprovidinginsightand knowledgeonmostaspectsofmethoddevelopment,validation,andapplication.A uniquefeatureofthiscourseisinthefactthatthebioanalysisofbothsmallmoleculedrugsandbiopharmaceuticalsisdiscussed.Expertsfromthefieldwithhandsonexperiencewillbetheretoguideyouthroughthedifferentstepsandstrategieso methoddevelopment,optimization,validationandapplication.Methoddevelopmentis discussedfrombothanalytepropertyandapplicationperspective.CourseObjectivesThecourseconsistsoffivedaytraininginattheVUUniversityAmsterdam,theNetherlands.Therewillbelectureswhichcanbefreelyinterruptedforquestionsanddiscussion,andsessions dealingwithactualcasestudies.aweekofhomeassignments.Keyareascoveredbythiscourse¾Physicochemicalparametersatthebasisofmethoddevelopment¾Bioanalyticalstrategiesforsmallmolecules:sampling,samplepretreatment,separation,detection,validationanddatahandling.¾Generalconsiderationinbioanalyticalstrategiesforbiopharmaceuticals¾PK,PD,andbiomarkerassayformats¾Developmentofimmunogenicassaystrategies:background,assaystrategies,redictiveimmuno enicit
TargetGroup SafeSciMETstudents,academicsandworkersinthepharmaceuticalindustryandregulatoryauthoritieswhoneedabroadcomprehensiveunderstandingofthedrugdevelopmentprocesswithparticularemphasisonsafety.
LearningoutcomesThecoursewillenableattendees:ToevaluatestudiesinthebioanalyticalfieldTocommunicatewithexpertsinthefield.
Morespecifically,participantswillbeableto:¾Understandhowthephysicochemicalpropertiesoftheanalytesshouldbeusedinthemethoddevelopmentofbioanalyticalstrategiesforsmallmoleculedrugs.¾Haveabasicunderstandingofwidelyappliedtoolsforsamplepretreatment,separation,anddetectioninsmallmoleculebioanalysis.¾Definethebasicneedsforthedevelopmentofintegratedbioanalyticalmethodsforbiopharmaceuticals,involvingbothrecombinantproteinproductsand(monoclonal)antibodies.¾Haveabasicunderstandingofvalidationanddatahandlingissues.¾Criticallyassessanumberofrecentdevelopmentsinthefieldofbiomolecularanalysis.
CourseProgrammeTheSyllabusAsyllabuscontaininganintroductorychapter,lecturehandouts,listofabbreviations, definitionsandreadingmaterialswillbeavailableviaBlackboard14dayspriortothe courseandpaperhandoutswillbeprovidedbythecourseleaderonthefirstdayofthe course.Thematerialforthehomeassignmentwillbeprovidedduringthefirstweekofthe course.AssessmentTheassessmentisbasedona2hourwrittenexaminationonthelastdayofthecourseandontheevaluationofthehomeassessment
Type
Assessors(s)
ExamaidsCourseadministrator:
Thepurposeoftheexaminationistotestthattheexamineehasabroadknowledgeandcomprehensionofthedrugdevelopmentprocessasawhole.Thepercentageofitemsonthetestdevotedtoaparticulartopicwillroughlycorrespondtotheemphasisgiventhetopicinteachingofthecourse:ExperimentalDesign:30%Preclinical:30%Clinical:30%Translational:10%Prof.dr.WilfriedNiessen(public)Dr.ChristianHerling(EFPIA)Allwrittenexamaidsareallowed.Prof.dr.W.M.A.Niessen VUUniversityAmsterdamDivisionofBioMolecularAnalysisDeBoelelaan10831081HVAmsterdamEmail:w.m.a.niessen@vu.nlPhone:Iamaparttimer:useemail!Phone:+31205987544(Secr.)
PracticalInformation3ECTScrediCourseCredits:ts Level:Master’slevel(secondcyclehighereducation)CourseDates:30January3February2012Location:BioMolecularAnalysisGroupFacultyofSciences,VUUniversityDeBoelelaan10831081HVAmsterdam,theNetherlands Teachingmethods:Lectures,caseworkgroupdiscussions,presentationsanddiscussions.Inordertoemphasizetheflowoftheprocess,thecourseistoalargeextentbasedontheuseofcasesinbothlecturesandassignments.StudentWorkload:Preparation:12hoursCourse:38hoursAssignment:38Examination:2hoursTotal:90CourseFee:2,500Euro—750Euro(dependantoncategoryofstudent)(pleasevisitwww.SafeSciMET.eu.Howtoapplyformoreinformation)Applicationdeadline:30December2011CourseCapacity:30Language:TheofficiallanguageofthecourseisEnglish.NosimultaneoustranslationswillbeprovidedCoursenotes:Notes(literature)usedinthecourseCourseaccreditation:ThecoursemeetsthecriteriaforcontinuousprofessionalDevelopment(CPD)diplomas,anditwillbepartofa(forthcomingEuropean)MastersofadvancedSafetySciencesdegree.Moreinformationcanbeobtainedthroughourwebsite:http://www.SafeSciMET.eu
CourseLeaders Prof.Dr.WilfriedNiessen,VUUniversityAmsterdam,FacultyofSciences,DivisionofBioMolecularAnalysis,DeBoelelaan1083,1081HVAmsterdam,theNetherlandsDr.ChristianHerling,NovoNordisk,Copenhagen,Denmark
Lecturers WilfriedNiessenChristianHerlingSteenHonoréHanssenAnnetteZaarPeterLloydSebastianSpindeldreherHenkLingemanPascalEspie
VUUniversity,Amsterdam,NL NovoNordisk,Copenhagen,DKUniversityofCopenhagen,DKNovartis,Basle,CHNovartis,Basle,CHNovartis,Basle,CHVUUniversity,Amsterdam,NLNovartis,Basle,CH
REGISTRATIONPleasevisitwww.safescimet.eutoregister.Onthehomepage,pleasegotoHowtopplyandsignup:ForMScofAdvancedSafetyCourses ForContinuingProfessionalDevelopment(CPD) ForSinglecourses
Youwillbenotifiedthatyourregistrationhasbeenreceived
Theclosingdatetoregisterforthiscourseis30December 2011
Pleasenotethatthenumberof participantsislimitedto30. Itishighlyadvisabletosendinyourregistrationformassoonaspossible.Registrationwillbemadeonafirstcomefirstservedbasis
TRANSPORTThecoursetakesplaceattheVUUniversityinAmsterdam.TheUniversityisonly10minbytrainfromSchipholAirporttothe"AmsterdamZuid/WTC"station,followedbya5minwalk.InformationofhowthereachtheVUUniversitycanbefoundon:www.vu.nl/en/aboutvuamsterdam/contactinfocmdroute.index.sp
ACCOMMODATIONAmsterdamhasanexcellentbus,metro,trainandtramsystem,whichmeansthattheVUUniversityeasilycanbereachedfromthevarioushotelsinthecity.Hotelinformationcanbefoundonthefollowingwebsite:www.hotels.nl/amsterdam.
CANCELLATION3January2012.BeforethatdatetheCoursefeewillberefundedexceptforanadministrativefeeofEUR75,Afterthatdate,norefundscanbemadeforcancellations