Download - DAS Diploma of Advanced Studies - UNIGE
www.unige.ch/formcont/cours/clinical-trials 1
DAS Diploma of Advanced StudiesDiplôme de formation continue
Management of Clinical TrialsGood Clinical Practice Implementation
and Quality Processes
September 2021 – May 2022
CRC Centre de
Recherche
Clinique
2 www.unige.ch/formcont/cours/clinical-trials
Programme Directors¡Prof. Jules Desmeules,HeadoftheDivisionofClinical
PharmacologyandToxicology,UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva
¡Dr François Curtin,MedicalDirectorPersonalisedHealthProgrammes,SwissFederalInstituteofTechnologyZürich&LectureratUniversityHospitalsofGeneva(UNIGE)
Coordinators¡Dr François Curtin,MedicalDirectorPersonalisedHealth
Programmes,SwissFederalInstituteofTechnologyZürich&LectureratUniversityHospitalsofGeneva(UNIGE)
¡Dr Catherine Deloche,ChiefOperatingOfficer,SolidDrugDevelopment,Geneva
¡Dr Françoise Lascombes,ExternalConsultant¡Ms Camille Arni,AdministrativeAssistantoftheDAS,Facultyof
Medicine,UniversityofGeneva
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An essential step for transitioningyour career to clinical research
Inthepasttwodecades,thenumberofClinicalTrialsconductedinSwitzerlandandworldwidehasvirtuallyexploded.Thistremendousincreasewenthandinhandwiththedevelopmentofcodes,
guidelinesandregulationsaimedatprotectinghumanresearchsubjects.StandardizationandstrengtheningofclinicalresearchregulationshaveledtothedevelopmentofarapidlygrowingeconomicsectorinwhichClinicalResearchAssociates,ClinicalResearchScientists,DataManagers,ClinicalResearchCoordinators,ClinicalTrialManagers,ClinicalResearchNursesandInvestigatorsarekeyplayers.
TheDiplomaofAdvancedStudies(DAS)inManagementofClinicalTrials–GoodClinicalPracticeImplementationandQualityProcessesprovidesatheoreticalandpracticalunderstandingofhowGoodClinicalPractice(GCP)principlesareshapingeachstepofaClinicalTrial,includingstudydesign,trialmanagementandconduct.
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Steering Committee¡Prof. Gerrit Borchard,HeadofBiopharmaceutics,Sectionof
PharmaceuticalSciences,FacultyofScience,UniversityofGeneva¡Prof. Cem Gabay,DeanoftheFacultyofMedicine,Universityof
Geneva¡Prof. Bernard Hirschel,President,CantonalCommissiononHuman
ResearchEthics,CantonofGeneva¡Prof. Samia Hurst,Director,InstituteofEthics,Historyand
Humanities(iEH2),FacultyofMedicine,UniversityofGeneva¡Prof. Angèle Gayet-Ageron,HeadoftheMethodologicalSupport
Unit,ClinicalResearchCentre(CRC),UniversityHospitalsofGeneva,FacultyofMedecine,UniversityofGeneva
¡Prof. Arnaud Perrier,MedicalDirector,UniversityHospitalsofGeneva
¡Prof. Jérôme Pugin,Vice-DeanoftheFacultyofMedicineandPresidentoftheClinicalResearchCenter(CRC),UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva
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Scientific Committee¡Dr Gabriele Ackermann,ChiefScientificOfficeradinterim,
TherapeuticAreaHeadCardiovascular,Renal&MetabolismTherapeuticAreaHeadRespiratory,NovartisPharmaSwitzerland
¡Dr Emilie Alirol,MedicinesforMalariaVenture,AssociateDirector,AccessandProductManagement
¡Dr Enrica Alteri,Pharmaceuticalconsultant,formerHeadofHumanMedicineR&DSupportDivision,EMA
¡Dr Vanya Beltrami,Vice-President,HeadofManufacturing,Anergis,Lausanne
¡Dr Jocelyne Chabert,ClinicalResearchAssociate,ClinicalResearchCentre(CRC),UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva
¡Dr Francois Curtin PD,MedicalDirectorPersonalisedHealthProgrammes,SwissFederalInstituteofTechnologyinZürich&LectureratHospitalsofGeneva(UNIGE)
¡Prof. Youssef Daali,HeadofthelaboratoryoftheDivisionofClinicalPharmacologyandToxicology,UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva
¡Dr Patricia Delaite,ChiefMedicalOfficer,Nouscom,Basel¡Dr Catherine Deloche,ChiefOperatingOfficer,SolidDrug
Development,Geneva¡Prof. Philippe Ducor,FacultyofLaw,UniversityofGeneva¡Prof. Marc Froissart,MedicalDirectoroftheClinicalResearch
Centre(CRC),CHUV-UNIL,Lausanne¡Prof. Angèle Gayet-Ageron,HeadoftheMethodologicalSupport
Unit,ClinicalResearchCentre(CRC),UniversityHospitalsofGeneva,FacultyofMedecine,UniversityofGeneva
¡Dr Françoise Lascombes,ExternalConsultant¡Prof. Hervé Porchet,Pharmaceuticalconsultant¡Dr Victoria Rollason,DivisionofClinicalPharmacologyand
Toxicology,UniversityHospitalsofGenevaandFacultyofMedicine,UniversityofGeneva
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Target AudienceMedicaldoctors,biologists,pharmacists,nurses,biochemistsandotherprofessionalsinvolved,orwishingtogainskillsandknowledge,inthefieldofclinicalresearch.
Topics¡Methodologyofclinicaltrials,datamanagementandanalysis.¡Ethicalprinciplesofclinicalresearch,regulationsapplicableto
clinicalresearchinSwitzerland,EuropeandUnitedStates.¡Projectmanagementandcoordinationinclinicalresearch.¡Qualitysystemsinclinicalresearch.¡Safetyaspectsofdrugdevelopment,pharmaco-vigilanceand
pharmaco-epidemiology.¡Drugdevelopmentandmarketingauthorizationprocess.¡MedicalDevicesdevelopment.
Skills and Competencies¡UnderstandanduseinarelevantcontextthedifferentClinicalTrial
designsandmethodologies.¡Befamiliarwithdrugdevelopmentandmarketingauthorization
processes.¡GainknowledgeofGCPandofclinicalresearchregulationsin
Switzerland,EuropeandtheUnitedStates.¡BecomeskilledatdevelopingCaseReportForm(CRF).¡Coordinatethedevelopmentofclinicaltrialprotocols.¡Mastereffectiveprojectplanningandmanagement.¡KnowhowtomanageapplicationsforEthicsCommittee(EC)and
RegulatoryAuthority(RA).¡UnderstandandimplementQualitySystemsusedinClinicalTrials.¡Understandtheissuesrelatedtoresearchsubjectprotection.
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Programme Structure9modulesoveroneyear(average24hoursofteachingpermodule)8h00-12h00/13h00-17h00|NumberofECTScredits:33|Eachmoduleissubjectedtoanevaluationinordertobeaccredited|Modules2to12maybeattendedindividually.
Learning MethodsLectures,interactiveseminars,workshops,vocationaltraining.TeachingisinEnglishorinFrench.
DissertationStudentsmaychoosebetween:¡Avocationaltraininginapharmaceuticalcompany,aClinical
ResearchOrganization(CRO)oraClinicalTrialUnitinaUniversityHospital(3-4months)followedbyareport.
¡ThedevelopmentofaClinicalTrialprotocoloraliteraturereviewanddissertation.
Diploma AwardedParticipantswhosuccessfullycompletetheprogrammewillbeawardedtheDiplomaofAdvancedStudies(DAS)inManagementofClinicalTrials–GoodClinicalPracticeImplementationandQualityProcesses/Diplôme de formation continue (DAS) en Gestion des essais cliniques – Mise en application des bonnes pratiques cliniques et processus qualitédeliveredbytheUniversityofGeneva.Itequatesto33ECTS(EuropeanCreditTransferandAccumulationSystem)credits.
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Module 2 | Principles and Methods of Clinical ResearchSeptember13,14,15,2021Prof. Angèle Gayet-Ageron, Dr François Curtin¡Developmentofresearchquestionsandchoiceof
endpoints¡Studydesigns¡Statisticalmethodsusedinclinicalresearch¡PrinciplesofRandomizedControlledTrials(RCT)¡Criticalreviewofpublications¡Developmentofstudyprotocols¡Choiceofendpoints¡Samplesizecalculation¡Interimanalysisplanning
Module 3 | Ethical and Legal AspectsOctober11,12,13,2021Prof. Samia Hurst, Prof. Philippe Ducor, Dr Brigitte Happ¡Clinicalresearchethics¡Informedconsentprocess¡Dataprotectionandconfidentiality¡PurposeandfunctionofresearchEthicsCommittees
(EC)¡Assessingrisksandbenefitstoresearchparticipants¡Vulnerablepopulations¡Goodclinicalpractices¡LegalframeworkapplicableinSwitzerland,Europe
andtheUnitedStatesfordrugs,medicaldeviceandnon-interventionaltrials
¡ClinicalTrialAgreements(CTA)andauthorshipissues¡Ethicalissuesinbiobanks
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Module 4A | Preclinical Pharmacology, Toxicology and Clinical Pharmacology
November23,2021Prof. Gerrit Borchard, Prof. Youssef Daali, Dr Catherine Deloche, Dr Marie Besson¡Pharmacodynamics¡Pharmacokinetics¡Toxicology¡Drugmetabolism¡InvestigationalMedicinalProductDossier(IMPD)and
InvestigatorBrochure(IB)
Module 5 | Safety Management in Drug DevelopmentDecember13,14,2021Dr Victoria Rollason, Dr François Curtin, Prof. Jules Desmeules¡Riskmanagementandsafetymonitoringduring
drugdevelopment¡Safetyassessment,documentationandreporting
duringclinicaltrials¡Pre-andpost-marketingpharmacovigilance¡RoleofDataandSafetyMonitoringBoards(DSMB)
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Module 7 | Clinical Trials Set-up and Conduct – Part 1January17,18,19,2022Dr Mariagrazia Di Marco, Dr Sandrine Charvat¡Scientific,strategicandsafetyconsiderationsin
clinicaltrialdesign¡Budgetdevelopmentandresourceplanning¡Investigatorsitesselection¡RoleofCROsandexternalproviders¡Clinicaltrialdocuments¡SubmissiontoSwissEthicsCommittee(EC)and
SwissRegulatoryAuthorities(RA)
Module 8 | Clinical Trials Set-up and Conduct – Part 2February21,22,23,2022Dr Françoise Lascombes, Ms Virginie Vidal¡Projectmanagementappliedtoclinicaltrials¡Recruitmentandretentionofstudysubjects¡Managementofrandomizationandblindingsystems¡Datacollectionanddatamanagement¡Managementofinvestigationalmedicinalproduct¡Documentsandrecords¡Monitoringofclinicalstudies¡Root-causeanalysis
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Module 10 | Clinical Trials Close-out and ReportingMarch14,2022Dr Mariagrazia Di Marco, Dr Françoise Lascombes¡Clinicaltrialclose-outactivities¡Datacleaninganddatabaselock¡StatisticalAnalysisPlanandresultreporting(SAP)¡Medicalwritingandclinicalstudyreport¡SafetyreconciliationandMedDRAcoding
Module 11 | Medical DevicesMarch15,16,2022Dr Mariagrazia Di Marco, Me Gabriel Avigdor¡Medicaldevices(MD)andnewEUregulations(MDR,
IVDR)¡Qualificationandclassification¡Clinicalinvestigationandclinicaltrialapplicationto
authorities¡Marketaccessstrategy¡ConformityassessmentandCEmarking¡Materiovigilance¡Digitalhealthandmedicalsoftware¡Combinationproducts
Module 12 | Audits and InspectionsMay16,17,18,2022Dr Isabelle Mercier, Dr Isabelle Semac¡Qualitymanagementsystems¡Audit¡Purposeandconductofregulatoryinspections¡Sitepreparationtoinspections
12 www.unige.ch/formcont/cours/clinical-trials
General InformationAdmission Criteria¡ Titleofphysician¡ OrMaster’sorBachelor’sdegreeinLifeScienceortitledeemed
equivalent¡ OrBachelor’sdegreefromaSwissUniversityofAppliedSciences
plusaminimumof1yearprofessionalexperienceinthefieldoftheDAS
¡ GoodunderstandingofbothFrench(knowledgeequivalenttoB2Level)andEnglish(knowledgeequivalenttotheCambridgeFirstCertificate)
Thecandidateswhofollowtheprogrammeduringtheirworkingtimemustprovidewrittenauthorizationfromtheiremployer.
Application and DeadlineOnlineapplicationmaybesubmittedviathecoursewebsiteat:www.unige.ch/formcont/cours/clinical-trials¡ Candidatesshouldsendcopiesofrelevantuniversitydegrees,a
CurriculumVitae,acoveringletter,tworeferencelettersandawrittenauthorizationfromtheiremployerbyJune30,2021totheDASsecretariat([email protected]).CandidatesshouldmentionintheircoverletteriftheywanttorealizeavocationaltrainingattheendoftheDAS.
¡ Forindividualmodules,applicationshouldbesentatleastonemonthpriortothebeginningoftheselectedmodule(2to12).PrioritywillbegiventocandidatesapplyingfortheDiploma.
¡ TheDASisentirelypaperlessandstudentsareencouragedtobringtheirlaptopduringclasses.
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Important NoteCandidatesarewarnedthatasignificantamountofself-studyisrequiredtocompletetheDAS,andthattheyareexpectedtogothroughpreparatoryworkbeforeeachmodule.Studentsshouldthusallowsufficienttimetostudyathome,inadditiontoattendingtheclassroomlectures.
Tuition Fee¡ CHF7,500.–fortheDiploma¡ CHF1,500.–foranindividualmodule
AccreditationThecourseprogrammeisaccreditedby:¡ Swissethics¡ SwissAssociationofPharmaceuticalProfessionals(SwAPP)¡ SwissSocietyofClinicalPharmacologyandToxicology(SGKPT-SSPTC)¡ SwissInstituteforPostgraduateandContinuousMedicalEducation
(SWIF-ISFM)
Course Location¡ FondationLouisJeantet(allmodules) 77routedeFlorissant–1208Genève Bus21and8–Genève-Eaux-Vives-Gare,orVeyrier-Douane,stopAubert¡ CMU(module3,salleAo4.2713) 1rueMichel-Servet–1211Genève4 Fromtrainstation,Bus1,3,5,7,stopClaparède
[email protected]/formcont/cours/clinical-trials
Centre for Continuing and Distance Education (CCDE)UniversityofGeneva| CH-1211 Geneva4
Tel:+41(0)223797833|[email protected]
www.unige.ch/formcont