Husserl_Ideas_Crisis of Philosophy_Introduction to

Husserl_Ideas_Crisis of Philosophy_Introduction to

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  • mémoire
  • cours magistral - matière potentielle : by brentano
  • dissertation
Husserl Ideas : General Introduction to Pure Phenomenology (1913) Husserl, Edmund. Ideas : General Introduction to Pure Phenomenology, Translated by W. R. Boyce Gibson. London, New York: Collier,Macmillan, 1962. bibliographical information from: Intersubjectivity Info: Chapter 6 The Phenomenological Reductions Chapter 9 Noesis and Noema Chapter 12 Phenomenology of the Reason Phenomenology: A Science of Consciousness Edmund Husserl (1859-1938) German Studied Mathematics, physics and philosophy, but was intrigued by astronomy and optics.
  • existence of the real world
  • father of the phenomenology movement
  • own mindset with regard to the rigors of phenomenal reduction
  • own world
  • phenomenological reduction
  • phenomenology
  • consciousness
  • world

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Course5.1Nonclinicalsafetyassessment: Strategies,ethics&protocols
2327January2012UniversityofVeterinaryMedicineVienna
HomeAssignment(CaseStudiesandCoursequestions)th Tobecompletedbythe9March2012
Nonclinicalsafetyassessment:Strategies,ethics&protocols:Keyquestionstobetackledbythecourse
¾Regulatoryrequirementscoveringconductandtimingofnonclinicalstudies¾Invitroandinvivononclinicalstudytypes¾Nonclinicalsafetystrategiesandprinciplesofprotocoldesign¾Biomarkersandtoxicologyendpoints¾Safetyimplicationsoftargetchoice¾Safetyassessmentofbiologics,MABEL,highriskproducts,andstemcells¾Ethics,includingroleofethicalcommittees¾Firstinhumandoseconsiderations¾Regulatoryrequirementsandnonclinicalsafetyaspectsofveterinarymedicinalproducts
Introduction “Nonclinicalsafetyassessment:Strategies,ethics&protocols”isacourseofDomain5 (Course5.1)ofthenewEuropeanMastersdegreeforAdvancedSafetySciencesfor MedicinesdesignedbySafeSciMETaspartoftheEuropeanInnovativeMedicines Initative(IMI).Maintopicsofthiscoursearestrategiesfortheselectionofcandidatesandthedesign ofnonclinicalprogrammes.Themanyregulatoryandscientificaspectsofthesafety assessmentofcandidatecompounds(includingbiologics,MABELandhighriskproducts) withintheframeworkofnonclinicalstudieswillbepresented.WhyjointhecourseinNonclinicalsafetyassessment:Strategies,ethicsandprotocols?Thecourse“Nonclinicalsafetyassessment:Strategies,ethicsandprotocols”presentskeylecturesreferringtotheknowledgeandunderstandingofthelegalrequirements andhowsafetyscienceandtoxicologyfitsintomodernnonclinicaldrugresearchand development.Itgivesinsightintothestrategies,chronology,andprojectplansopreclinicalsafetypharmacologyandtoxicologystudiesincludinganoverviewo experimentaldesigns,therelevanceandpredictabilityofanimalmodels,the3R´s,and ethicalaspects.Also,thesafetyassessmentofspecialproductclassesincluding veterinarymedicinalproductsiscovered.Thiscourseisofsignificanceforall professionalsfromindustry,academia,andregulatoryagenciesworkinginthefieldo candidateidentificationandthenonsafetyassessmentofdrugsincludingthosealready onthemarket.CourseObjectivesThiscourseconsistsof5dayswithlecturesandcaseworkattheUniversityofVeterinaryMedicineViennafollowedbyaweekathomededicatedtoanindividualassignment. Thus,thetotalcoursewillprovidetheparticipantswithacomprehensiveoverviewofthe stepsinanonclinicalsafetyprogrammeandinterrelationshipwithothercomponentso drugdiscoveryanddevelopmentcoveredbytheremainderoftheSafeSciMETprogramme.Keyareascoveredbythiscourse¾Regulatoryrequirementsbehindnonclinicalsafetytesting¾Investigativetoxicologyandpathology¾Experimentaldesignandapplicationofthe3R´s¾Translationfromnonclinicaltofirstinhumanstudies¾Specialapproachesandspecialproducts¾Theroleofnonclinicalsafetyassessmentindrugdevelopment
TargetGroup
SafeSciMETstudents,academicsandworkersinthepharmaceuticalindustryandregulatoryauthoritieswhoneedabroadcomprehensiveunderstandingofthedrugdevelopmentprocesswithparticularemphasisonsafety.LearningoutcomesThiscoursewillprovideparticipantswithacomprehensiveoverviewofnonclinicalsafetyassessmentfocussingonstrategies,protocols,experimentaldesign,andtheroleofethicalcommittees.Morespecifically,participantswillbeabletounderstand:RegulatoryrequirementsanddesignstrategiesfornonclinicalsafetyprogrammesProtocoldesignsofthefullrangeofnonclinicalsafetystudiesSpeciesselection,ethicaldesign,applicationofthe3R´s,andpredictivityofsafetystudiesTargetorgantoxicityanddifferencesbetweenadverseandadaptiveresponsesTherelationshipbetweenthenonclinicalsafetyandclinicalprogrammesSafetyassessmentofpharmatherapeuticsandbiotherapeuticsThecurrentstateofnonclinicalsafetytestingincludingspecialstudiesSafetyassessmentofalltherapeuticagentsincludingbiologics,highriskproducts,alreadyauthorizedproducts,veterinaryproductsandbeabletoreviewandassesssafetydata.
. TypicalbuildingsonthecampusoftheUniversityofVeterinaryMedicineVienna
CourseProgrammeTheSyllabusAsyllabuscontaininganintroductorychapter,lecturehandouts,listofabbreviations, definitionsandreadingmaterialswillbeprovidedbythecourseleader14dayspriortothe course.Thematerialforthehomeassignmentwillbeprovidedduringthefirstweekofthe course.
AssessmentTheassessmentisbasedona2hourwrittenexaminationonthelastdayofthecourseandon theevaluationofthehomeassessment.
Type
Assessors(s)ExamaidsCourseadministrator:
Thepurposeoftheexaminationistotestthattheexamineehasabroadknowledgeandcomprehensionoftheroleofnonclinicalsafetyassessmentindrugdevelopment.Theweightinggiventotopicstestedwillreflecttheweightingsgiventothetopicsinteachingthecourse:Nonclinical55%Experimentaldesign15%Translational25%Clinical5%Forthenonclinicalcomponent25%willbeawardedforunderstandingofthecoreframework(acutetoxicity,chronictoxicity,genotoxicity,carcinogenicty,andreproductivetoxicity).CourseDirectorsAllwrittenexamaidsareallowed.Univ.Prof.Dr.IvoSchmerold,InstituteofPharmacology,UniversityofVeterinaryMedicineVienna,Veterinärplatz1,A1210Vienna,Austria.Phone:+431250772900(direct)+431250772901(secretary)ivo.schmerold@vetmeduni.ac.at
PracticalInformationCourseCredits:3ECTScreditsLevel:Master’slevel(secondcyclehighereducation)CourseDates:2327January2012Location:UniversityofVeterinaryMedicineVienna,Veterinärplatz1,A1210Vienna,AustriaTeachingmethods:Lectures,caseworkgroupdiscussions,presentationsanddiscussions.Inordertoemphasizetheflowoftheprocess,thecourseistoalargeextentbasedontheuseofcasesinbothlecturesandassignments.StudentWorkload:Preparation:15hoursCourse:38hoursAssignment:35hoursExamination:2hoursTotal:90hoursCourseFee:2,500Euro—750Euro(dependantoncategoryofstudent)(pleasevisitwww.SafeSciMET.eu.Howtoapplyformoreinformation)Applicationdeadline:23rdDecember2011CourseCapacity:36ParticipantsLanguage:TheofficiallanguageofthecourseisEnglish.NosimultaneoustranslationswillbeprovidedCoursenotes:Completecoursenotes,exceptforthetextbooks,willbeavailableforalltheparticipants.CavagnaroJ.(2008):PreclinicalSafetyEvaluationofBiopharmaceuticals:AScienceBasedApproachtoFacilitatingClinicalTrials”.JohnWiley&SonsLtd.(UK).CavallaD.(1997):ModernStrategyforPreclinicalPharmaceuticalR&D:TowardstheVirtualResearchCompany.JohnWiley&SonsLtd.(UK).Courseaccreditation:ThecoursemeetsthecriteriaforContinuousProfessionalDevelopment(CPD)diplomas,anditwillbepartofa(forthcomingEuropean)MastersofadvancedSafetySciencesdegree.Moreinformationcanbeobtainedthroughourwebsite:http://www.SafeSciMET.eu
CourseLeaders n.n.IvoSchmerold,UniversityofVeterinaryMedicineVienna,InstituteofPharmacology,AustriaLecturers PhilipBentleyNovartis, USA MichelDoubovetzkySanofiAventis, FRPaulDuffyAstrazeneca, UKJeanCharlesGautierSanofiAventis, FRJohannesH.HarlemanAstrazeneca, UKCharlesHumfreyAstrazeneca, UKEvaMariaMuchitschBaxter, ATNigelRoomeSanofiAventis, FRSallyRobinsonAstrazeneca, UKIvoSchmeroldUniversityofVeterinaryMedicineVienna, ATJenniferSimsNovartis, CHMargitSpatzeneggerBaxter, ATChristelvandenEedePfizer, BEElisabethWeberSeibersdorfLaborGmbH, ATSilvioWuschkoSeibersdorfLaborGmbH, ATEvaMariaZebedinMedicalUniversityofVienna,ATTheUniversityofVeterinaryMedicineViennaislocatedin“Floridsdorf”,anurbandistrictinthenorthernpartofVienna.
REGISTRATIONPleasevisitwww.safescimet.eu toregister.Onthehomepage,pleasegotoHowtopplyandsignup:ForMScofAdvancedSafetyCourses ForContinuingProfessionalDevelopment(CPD) ForSinglecourses
Youwillbenotifiedthatyourregistration hasbeenreceived
TheclosingdatetoregisterforthiscourseisDecember 23rd 2011
Pleasenotethatthenumberof participantsislimitedto36. Itishighlyadvisabletosendinyourregistrationformassoonaspossible.Registrationwillbemadeonafirstcomefirstservedbasis.
TRANSPORTThecoursetakesplaceinViennaat theUniversityofVeterinaryMedicineVienna,Veterinärplatz1,A1210Vienna;locatedapprox.25kmfromtheairport.
ACCOMMODATIONHotelscanbearrangedindividuallyviahttp://www.booking.com/Wien
CANCELLATIONth Cancellationofapreregisteredstudentispossible,uponwrittennoticeby10January2012.BeforethatdatetheCoursefeewillberefundedexceptforanadministrativefeeofEUR75,.Afterthatdate,norefundscanbemadeforcancellations.