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


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.


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


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


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.


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.


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


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)


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


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


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.


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