Husserl_Ideas_Crisis of Philosophy_Introduction to

Toxi_2

Description

• 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

Sujets

• Mémoire
• Dissertation
• Study
• Gibson
• Edmund Husserl
• Consciousness
• Phenomenology
• Movement
• Réduction
• Existence
• Regard

Informations

• Publié par: undre
• Nombre de lectures: 28
• Langue: English

Extrait

Course5.1Non‐clinicalsafetyassessment: Strategies,ethics&protocols

23‐27January2012 UniversityofVeterinaryMedicineVienna

HomeAssignment(CaseStudiesandCoursequestions) th Tobecompletedbythe9 March2012

Non‐clinicalsafetyassessment:Strategies,ethics& protocols: Keyquestionstobetackledbythecourse

¾Regulatoryrequirementscoveringconductandtimingof nonclinicalstudies ¾Invitroandinvivononclinicalstudytypes ¾Nonclinicalsafetystrategiesandprinciplesofprotocol design ¾Biomarkersandtoxicologyendpoints ¾Safetyimplicationsoftargetchoice ¾Safetyassessmentofbiologics,MABEL,highrisk products,andstemcells ¾Ethics,includingroleofethicalcommittees ¾Firstinhumandoseconsiderations ¾Regulatoryrequirementsandnonclinicalsafetyaspects ofveterinarymedicinalproducts

Introduction “Non‐clinicalsafetyassessment:Strategies,ethics&protocols”isacourseofDomain5 (Course5.1)ofthenewEuropeanMastersdegreeforAdvancedSafetySciencesfor MedicinesdesignedbySafeSciMETaspartoftheEuropeanInnovativeMedicines Initative(IMI). Maintopicsofthiscoursearestrategiesfortheselectionofcandidatesandthedesign ofnonclinicalprogrammes.Themanyregulatoryandscientificaspectsofthesafety assessmentofcandidatecompounds(includingbiologics,MABELandhighriskproducts) withintheframeworkofnonclinicalstudieswillbepresented. WhyjointhecourseinNon‐clinicalsafety assessment:Strategies,ethicsandprotocols? Thecourse“Non‐clinicalsafetyassessment:Strategies,ethicsandprotocols”presents keylecturesreferringtotheknowledgeandunderstandingofthelegalrequirements andhowsafetyscienceandtoxicologyfitsintomodernnonclinicaldrugresearchand development.Itgivesinsightintothestrategies,chronology,andprojectplanso preclinicalsafetypharmacologyandtoxicologystudiesincludinganoverviewo experimentaldesigns,therelevanceandpredictabilityofanimalmodels,the3R´s,and ethicalaspects.Also,thesafetyassessmentofspecialproductclassesincluding veterinarymedicinalproductsiscovered.Thiscourseisofsignificanceforall professionalsfromindustry,academia,andregulatoryagenciesworkinginthefieldo candidateidentificationandthenonsafetyassessmentofdrugsincludingthosealready onthemarket. CourseObjectives Thiscourseconsistsof5dayswithlecturesandcaseworkattheUniversityofVeterinary MedicineViennafollowedbyaweekathomededicatedtoanindividualassignment. Thus,thetotalcoursewillprovidetheparticipantswithacomprehensiveoverviewofthe stepsinanonclinicalsafetyprogrammeandinterrelationshipwithothercomponentso drugdiscoveryanddevelopmentcoveredbytheremainderoftheSafeSciMET programme. Keyareascoveredbythiscourse ¾Regulatoryrequirementsbehindnonclinicalsafetytesting ¾Investigativetoxicologyandpathology ¾Experimentaldesignandapplicationofthe3R´s ¾Translationfromnonclinicaltofirstinhumanstudies ¾Specialapproachesandspecialproducts ¾Theroleofnonclinicalsafetyassessmentindrugdevelopment

TargetGroup

SafeSciMETstudents,academicsandworkersinthepharmaceuticalindustryandregulatory authoritieswhoneedabroadcomprehensiveunderstandingofthedrugdevelopmentprocess withparticularemphasisonsafety. Learningoutcomes Thiscoursewillprovideparticipantswithacomprehensiveoverviewofnonclinicalsafety assessmentfocussingonstrategies,protocols,experimentaldesign,andtheroleofethical committees. Morespecifically,participantswillbeabletounderstand: •Regulatoryrequirementsanddesignstrategiesfornonclinicalsafety programmes •Protocoldesignsofthefullrangeofnonclinicalsafetystudies •Speciesselection,ethicaldesign,applicationofthe3R´s,and predictivityofsafetystudies •Targetorgantoxicityanddifferencesbetweenadverseandadaptive responses •Therelationshipbetweenthenonclinicalsafetyandclinical programmes •Safetyassessmentofpharmatherapeuticsandbiotherapeutics •Thecurrentstateofnonclinicalsafetytestingincludingspecial studies •Safetyassessmentofalltherapeuticagentsincludingbiologics,high riskproducts,alreadyauthorizedproducts,veterinaryproductsand beabletoreviewandassesssafetydata.

. TypicalbuildingsonthecampusoftheUniversityofVeterinaryMedicineVienna

CourseProgramme TheSyllabus Asyllabuscontaininganintroductorychapter,lecturehandouts,listofabbreviations, definitionsandreadingmaterialswillbeprovidedbythecourseleader14dayspriortothe course.Thematerialforthehomeassignmentwillbeprovidedduringthefirstweekofthe course.

Assessment Theassessmentisbasedona2‐hourwrittenexaminationonthelastdayofthecourseandon theevaluationofthehomeassessment.

Type

Assessors(s) Examaids Courseadministrator:

Thepurposeoftheexaminationistotestthat theexamineehasabroadknowledgeand comprehensionoftheroleofnonclinical safetyassessmentindrugdevelopment.The weightinggiventotopicstestedwillreflectthe weightingsgiventothetopicsinteachingthe course: Non‐clinical55% Experimentaldesign15% Translational25% Clinical5% Forthenonclinicalcomponent25%willbe awardedforunderstandingofthecore framework(acutetoxicity,chronictoxicity, genotoxicity,carcinogenicty,andreproductive toxicity). CourseDirectors Allwrittenexamaidsareallowed. Univ.Prof.Dr.IvoSchmerold,Instituteof Pharmacology,UniversityofVeterinary MedicineVienna,Veterinärplatz1, A‐1210Vienna,Austria. Phone:[phone](direct) [phone](secretary) [e-mail]

PracticalInformation CourseCredits:3ECTScredits Level:Master’slevel(secondcyclehighereducation) CourseDates:23‐27January2012 Location:UniversityofVeterinaryMedicineVienna,Veterinärplatz1, A‐1210Vienna,Austria Teachingmethods:Lectures,caseworkgroupdiscussions,presentationsand discussions.Inordertoemphasizetheflowoftheprocess, thecourseistoalargeextentbasedontheuseofcasesin bothlecturesandassignments. StudentWorkload:Preparation:15hours Course:38hours Assignment:35hours Examination:2hours Total:90hours CourseFee:2,500Euro—750Euro(dependantoncategoryofstudent) (pleasevisitwww.SafeSciMET.eu.Howtoapplyformore information) Applicationdeadline:23rdDecember2011 CourseCapacity:36Participants Language:TheofficiallanguageofthecourseisEnglish.No simultaneoustranslationswillbeprovided Coursenotes:Completecoursenotes,exceptforthetextbooks,willbe availableforalltheparticipants. CavagnaroJ.(2008):PreclinicalSafetyEvaluationof Biopharmaceuticals:AScience‐BasedApproachto FacilitatingClinicalTrials”.JohnWiley&SonsLtd.(UK). CavallaD.(1997):ModernStrategyforPreclinical PharmaceuticalR&D:TowardstheVirtualResearch Company.JohnWiley&SonsLtd.(UK). Courseaccreditation:ThecoursemeetsthecriteriaforContinuousProfessional Development(CPD)diplomas,anditwillbepartofa (forthcomingEuropean)MastersofadvancedSafety Sciencesdegree. Moreinformationcanbeobtainedthroughourwebsite: http://www.SafeSciMET.eu

CourseLeaders n.n. IvoSchmerold,UniversityofVeterinaryMedicineVienna,Institute ofPharmacology,Austria Lecturers PhilipBentleyNovartis, USA MichelDoubovetzkySanofi‐Aventis, FR PaulDuffyAstrazeneca, UK Jean‐CharlesGautierSanofi‐Aventis, FR JohannesH.HarlemanAstrazeneca, UK CharlesHumfreyAstrazeneca, UK EvaMariaMuchitschBaxter, AT NigelRoomeSanofi‐Aventis, FR SallyRobinsonAstrazeneca, UK IvoSchmeroldUniversityofVeterinaryMedicineVienna, AT JenniferSimsNovartis, CH MargitSpatzeneggerBaxter, AT ChristelvandenEedePfizer, BE ElisabethWeberSeibersdorfLaborGmbH, AT SilvioWuschkoSeibersdorfLaborGmbH, AT EvaMariaZebedinMedicalUniversityofVienna, AT TheUniversityofVeterinaryMedicineViennaislocatedin “Floridsdorf”,anurbandistrictinthenorthernpartofVienna.

REGISTRATION Pleasevisit www.safescimet.eu toregister.Onthehomepage,pleasegotoHowto pplyandsignup: ForMScofAdvancedSafetyCourses ForContinuingProfessionalDevelopment(CPD) ForSinglecourses

Youwillbenotifiedthatyourregistration hasbeenreceived

TheclosingdatetoregisterforthiscourseisDecember 23rd 2011

Pleasenotethatthenumberof participantsislimitedto36. Itishighlyadvisableto sendinyourregistrationformassoonaspossible.Registrationwillbemadeonafirst comefirstservedbasis.

TRANSPORT ThecoursetakesplaceinViennaat theUniversityofVeterinaryMedicine Vienna,Veterinärplatz1,A‐1210Vienna;locatedapprox.25kmfromthe airport.

ACCOMMODATION Hotelscanbearrangedindividuallyviahttp://www.booking.com/Wien

CANCELLATION th Cancellationofapre‐registeredstudentispossible,uponwrittennoticeby10 January2012.BeforethatdatetheCoursefeewillberefundedexceptforan administrativefeeofEUR75,‐.Afterthatdate,norefundscanbemadefor cancellations.