mas master of advanced studies maîtrise universitaire d

www.unige.ch/formcont/cours/drug-dvp 1

MAS Master of Advanced StudiesMaîtrise universitaire d'études avancées

Drug Discovery and Clinical Development

August 2020 > June 2021

CRC Centre de

Recherche

Clinique

2 www.unige.ch/formcont/cours/drug-dvp

Programme Directors¡Prof. Jules Desmeules,HeadoftheClinicalTrialUnit,Clinical

ResearchCenter(CRC),UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva

¡Dr François Curtin,PD,MedicalDirectorPersonalisedHealthProgrammes,SwissFederalInstituteofTechnologyinZürich(ETHZürich)&LectureratHospitalsofGeneva(UNIGE)

Coordinators¡Dr Catherine Deloche,ChiefOperatingOfficer,SolidDrug

Development,Geneva

¡Dr Françoise Lascombes,ExternalConsultant

¡Dr François Curtin,PD,MedicalDirectorPersonalisedHealthProgrammes,SwissFederalInstituteofTechnologyinZürich(ETHZürich)&LectureratHospitalsofGeneva(UNIGE)

¡Ms Camille Arni,AdministrativeAssistantoftheMAS,UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva


A catalyst for career success in drug discovery and development

The Master of Advanced Studies (MAS) in Drug Discovery andClinicalDevelopmentisaimedatprofessionalsfromtheacademia,pharmaceuticalindustry,biotechnologysector,andinternational

organizationswhowishtogainanin-depthunderstandingofdrugsandmedicaldevicesresearchanddevelopment(R&D).Theprogramcoverstheentiremedicalproductlifecycle–frommoleculetothemarketplaceand addresses the scientific, regulatory, and market requirements ofsuccessful product development. By providing essential knowledgeand understanding of this complex process, and by engaging instrong partnerships with industrials, regulatory experts and publicstakeholderstheprogramfacilitatesasmoothtransitiontoanenduringand productive career within a biotechnology firm, pharmaceuticalcompany, contract research or nonprofit organization or an academicinstitution.


Steering Committee¡Prof. Cem Gabay,DeanoftheFacultyofMedicine,Universityof

Geneva¡Prof. Arnaud Perrier,MedicalDirector,UniversityHospitalsof

Geneva¡Prof. Gerrit Borchard,HeadofBiopharmaceutics,Sectionof

PharmaceuticalSciences,FacultyofScience,UniversityofGeneva¡Dr Angèle Gayet-Ageron,CC,Lecturer,HeadoftheMethodological

SupportUnit,ClinicalResearchCentre(CRC),UniversityHospitalsofGeneva,FacultyofMedecine,UniversityofGeneva

¡Prof. Bernard Hirschel,President,CantonalCommissiononHumanResearchEthics,CantonofGeneva

¡Prof. Samia Hurst,Director,InstituteofEthics,HistoryandHumanities(iEH2),FacultyofMedicine,UniversityofGeneva

¡Prof. Jérôme Pugin,Vice-DeanoftheFacultyofMedicineandPresidentoftheClinicalResearchCenter(CRC),UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva


Scientific Committee¡Dr Emilie Alirol,ProjectLeader,GlobalAntibioticsResearchand

DevelopmentPartnership(GARDP),DrugsforNeglectedDiseasesinitiative(DNDi)

¡Dr Vanya Beltrami,Vice-President,HeadofManufacturing,Anergis,Lausanne

¡Dr Jocelyne Chabert,ClinicalResearchAssociate,ClinicalResearchCentre(CRC),UniversityHospitalsofGeneva,FacultyofMedicine,UniversityofGeneva

¡Dr Francois Curtin,PD,MedicalDirectorPersonalisedHealthProgrammes,SwissFederalInstituteofTechnologyinZürich(ETHZürich)&LectureratHospitalsofGeneva(UNIGE)

¡Dr Patricia Delaite,MedicalDirector,Geneva¡Dr Catherine Deloche,ChiefOperatingOfficer,SolidDrug

Development,Geneva¡Prof. Philippe Ducor,FacultyofLaw,UniversityofGeneva¡ Prof. Marc Froissart,ChiefMedicalDirectoroftheClinicalResearch

(CRC),CHUV-UNIL,Lausanne¡Dr Angèle Gayet-Ageron,CC,Lecturer,HeadoftheMethodological

SupportUnit,ClinicalResearchCentre(CRC),UniversityHospitalsofGeneva,FacultyofMedecine,UniversityofGeneva

¡Dr Françoise Lascombes,ExternalConsultant¡Prof. Hervé Porchet,Pharmaceuticalconsultant¡Dr Victoria Rollason,PharmD,DivisionofClinicalPharmacologyand

Toxicology,UniversityHospitalsofGenevaandFacultyofMedicine,UniversityofGeneva

¡Dr Gabriele Ackermann,ChiefScientificOfficeradinterim,TherapeuticAreaHeadCardiovascular,Renal&MetabolismTherapeuticAreaHeadRespiratory,NovartisPharmaSwitzerland


TargetMedicaldoctors,biologists,pharmacists,nurses,biochemistsandotherprofessionalsinvolved,orwishingtogainskillsandknowledge,inthefieldofdrugdiscoveryanddevelopment.

Objectives¡Toprovideessentialbusinessknowledgeofdrugandmedical

devicesclinicalresearchanddevelopment.¡Togivehealthprofessionalsthetoolstocomplywiththehighest

scientificandethicalstandardsinclinicalresearch.¡Toempowerphysiciansandhealthscientiststoleadclinicaltrials

withinhospitals,pharmaceuticalandbiotechnologycompanies.¡Toenablehealthprofessionalstogainastrategicvisionofdiscovery

andclinicaldevelopmentofdrugsandnavigatethecomplexitiesofbringingnewmedicinalproductstotheglobalmarket.

Skills and Competencies¡Understandthestakes,challengesandopportunitiesofdrug

discoveryanddevelopment.¡Masterthefundamentalscientificandethicalprinciplesofdrug

discoveryanddevelopment.¡GainknowledgeofGoodClinicalPractices(GCP)andofclinical

researchregulationsinSwitzerland,EuropeandtheUnitedStates.¡Learnhowtonavigateclinicaltrialauthorizationandmarketing

authorizationprocesses.¡Mastereffectiveprojectplanningandmanagementforclinicaltrials.¡Successfullymanagepartnershipswithpharmaceuticaland

biotechnologypartners.¡Understandtheissuesrelatedtoresearchsubjectprotection.¡Understandandtakeupthechallengesofnewtechnologiesand

personalizedmedicine.


Programme Structure¡12modulesoveroneyear(average24hoursofteachingpermodule)¡ Teaching:280hours¡ Dissertation:500hours¡ NumberofECTScredits:60¡ Somemodulesmaybeattendedindividually

Learning MethodsLectures,interactiveseminars,workshops,vocationaltraining.TeachingisinEnglishorinFrench.

DissertationStudentsshouldselectthedissertationsubjectfromalistproposedatthebeginingoftheacademicyear.

Diploma AwardedParticipantswhosuccessfullycompletetheprogrammewillbeawardedtheMasterofAdvancedStudiesinDrugDiscoveryandClinicalDevelopment/Maîtrise d'études avancées en découverte et développement clinique de médicamentsdeliveredbytheUniversityofGeneva.Itequatesto60ECTS(EuropeanCreditTransferandAccumulationSystem)credits.


Module 1 | Introduction to Clinical Development: Challenges and ProspectsAugust 31, September 1, 2, 2020Dr François Curtin, Dr Emilie Alirol¡Definitionofpharmaceuticaldevelopment:

purpose,playersandphases¡ Successandfailureindrugdiscoveryand

development¡ Fundamentalsofhealtheconomics¡ Intellectualproperty¡ Marketingstrategiesindrugdevelopment¡ Alternativemodelsofdrugdevelopment:Product

developmentpartnershipsandnot-for-profitentities

Module 2 | Principles and Methods of Clinical ResearchSeptember 28, 29 , 30, 2020Dr François Curtin, Dr Angèle Gayet-Ageron¡Developmentofresearchquestionsandchoiceof

endpoints¡ Studydesigns¡ Statisticalmethodsusedinclinicalresearch¡ PrinciplesofRandomizedControlledTrials(RCT)¡ Criticalreviewofpublications¡ Developmentofstudyprotocols¡ Choiceofendpoints¡ Samplesizecalculation¡ Interimanalysisplanning


Module 3 | Ethical and Legal AspectsOctober 26, 27, 28, 2020Prof. Samia Hurst, Prof. Philippe Ducor, Dr Brigitte Happ¡Clinicalresearchethics¡Informedconsentprocess¡Dataprotectionandconfidentiality¡PurposeandfunctionofresearchEthics

Committees(EC)¡Assessingrisksandbenefitstoresearch

participants¡Vulnerablepopulations¡Goodclinicalpractices¡LegalframeworkapplicableinSwitzerland,

EuropeandtheUnitedStatesfordrugs,medicaldeviceandnon-interventionaltrials

¡ClinicalTrialAgreements(CTA)andauthorshipissues¡Ethicalissuesinbiobanks

Module 4A 4B | Preclinical Pharmacology, Toxicology and Clinical Pharmacology

November 17, 18, 19, 2020Prof. Gerrit Borchard, Prof. Youssef Daali, Dr Catherine Deloche, Dr Marie Besson¡Basicsofpharmacology¡Safetyassessmentinpre-clinicalresearch¡Drugmetabolism¡InvestigationalMedicinalProductDossier(IMPD)

andInvestigatorBrochure(IB)¡Preclinicaldevelopmentforspecificindications

andtypeofproducts¡Populationphysiologicaly-basedpharmacokinetics¡Earlyphasesofclinicaldevelopment


Module 5 | Safety Management and Drug DevelopmentNovember 23, 24, 2020Dr Victoria Rollason, Dr François Curtin, Prof. Jules Desmeules¡Riskmanagementandsafetymonitoringduring

drugdevelopment¡Safetyassessment,documentationandreporting

duringclinicaltrials¡Pre-andpost-marketingpharmacovigilance¡RoleofDataandSafetyMonitoringBoards

(DSMB)

Module 6 | Medical Statistics and Trial MethodologiesDecember 14, 15, 16, 17, 2020Dr François Curtin, Dr David W Warne¡Statisticalprinciplesfordrugdevelopment:ICHE9¡ Distributions¡ Parametersestimators¡ Powercalculations¡ Clinicaltrialsdesigns:parallel,cross-over,

sequential,andadaptivedesigns¡ Developmentofstudyprotocols¡ Pharmaco-epidemiology


Module 7 | Clinical Trials Set-up and Conduct – Part 1 January 11, 12 , 13, 2021Dr Mariagrazia Di Marco, Dr Sandrine Charvat¡Scientific,strategicandsafetyconsiderationsin

clinicaltrialdesign¡ Budgetdevelopmentandresourceplanning¡ Investigatorsitesselection¡ RoleofCROsandexternalproviders¡ Clinicaltrialdocuments¡ StandardOperationProcedures(SOP)¡ SubmissiontoSwissEthicsCommittee(EC)and

SwissRegulatoryAuthorities(RA)

Module 8 | Clinical Trials Set-up and Conduct – Part 2February 1, 2 , 3, 2021Ms Jennifer Kealy, Ms Virginie Vidal¡Projectmanagementappliedtoclinicaltrials¡Recruitmentandretentionofstudysubjects¡Managementofrandomizationandblinding

systems¡Datacollectionanddatamanagement¡Managementofinvestigationalmedicinalproduct¡Documentsandrecords¡Monitoringofclinicalstudies¡Root-causeanalysis


Module 9 | Regulatory Consideration in Drug DevelopmentMarch 1, 2, 3, 2021Dr Brigitte Happ, Ms Marion Laumonier¡Roleandresponsibilitiesofregulatoryagencies¡ Internationalregulatoryenvironment¡ EU,Swiss,USLegislation¡ Earlyaccesstonewtherapeuticproducts¡ Life-cyclemanagement¡ Specialpopulations(orphan,paediatrics)¡ Antibioticdevelopment¡ Advancedtherapies¡ Invitrocompaniondiagnostics¡ Regulatorystrategiesandhealthagencies

interactions

Module 10 | Clinical Trials Close-out and ReportingApril 12, 13, 2021Me Gabriel Avigdor, Dr Mariagrazia Di Marco¡Clinicaltrialclose-outactivities¡ Datacleaninganddatabaselock¡ StatisticalAnalysisPlan(SAP)andresultreporting¡ Medicalwritingandclinicalstudyreport¡ SafetyreconciliationandMedDRAcoding¡ Medicaldevicesandclinicalrequirementsunder

MDR/IVDR¡ Clinicalinvestigationofmedicaldevicesand

submissionstoauthorities¡ Regulatoryaspectsofdigitalhealthandmedical

software¡ Medicaldevicevigilance


Module 11 | Audits and InspectionsMay 10, 11, 12, 2021Dr Isabelle Mercier, Dr Isabelle Semac¡Qualitymanagementsystems¡Audit¡Purposeandconductofregulatoryinspections¡Sitepreparationtoinspections

Module 12 | New Perspectives, Personalized Medicine and New TherapeuticsJune 14, 15, 16, 2021Prof. Caroline Samer, Dr Patricia Delaite¡Personalizedmedicinescopeanddefinition¡ Omicsandbigdata¡ Newrequirementsindrugdevelopment¡ Newtoolsandtechnologiesenablingkeypatient

benefit¡ Newtherapeuticapproachesbeingcurrently

developed


General InformationAdmission Criteria¡ Titleofphysician.¡ OrMaster’sorBachelor’sdegreeinLifeScienceortitledeemed

equivalent.¡ OrBachelor’sdegreefromaSwissUniversityofAppliedScience

plusaminimumof1yearprofessionalexperienceinclinicaldevelopment.

¡ GoodunderstandingofbothFrench(knowledgeequivalenttoB2Level)andEnglish(knowledgeequivalenttotheCambridgeFirstCertificate).

Thecandidateswhofollowtheprogrammeduringtheirworkingtimemustprovidewrittenauthorizationfromtheiremployer.

Application and DeadlineOnlineapplicationmaybesubmittedviathecoursewebsiteat:www.unige.ch/formcont/cours/drug-dvp¡ Candidatesshouldsendcopiesofrelevantuniversitydegrees,a

curriculumvitae,acoveringletter,tworeferencelettersandawrittenauthorizationfromtheiremployerbyJuly31,2020totheMASsecretariat([email protected]).

¡ Forindividualmodules,applicationshouldbesentatleastonemonthpriortothebeginningoftheselectedmodule.Prioritywillbegiventocandidatesapplyingforthemaster.

¡ TheMASisentirelypaperlessandstudentsareencouragedtobringtheirlaptopduringclasses.


Important NoteCandidatesarewarnedthatasignificantamountofself-studyisrequiredtocompletetheMAS,andthattheyareexpectedtogothroughpreparatoryworkbeforeeachmodule.Studentsshouldthusallowsufficienttimetostudyathome,inadditiontoattendingtheclassroomlectures.

Tuition Fee¡ CHF13,000.–fortheMAS¡ CHF1,500.–foranindividualmodule

AccreditationThecourseprogrammeisaccreditedby:¡ Swissethics¡ SwissAssociationofPharmaceuticalProfessionals(SwAPP)¡ SwissSocietyofClinicalPharmacologyandToxicology(SGKPT-SSPTC)¡ SwissInstituteforPostgraduateandContinuousMedicalEducation

(SWIF-ISFM)

Course LocationFondationLouisJeantet77routedeFlorissant-1208GenèveBus21and8:directionGenève-Eaux-Vives-Gare,orVeyrier-Douane,stopAubert

[email protected]/formcont/cours/drug-dvp

Centre for Continuing and Distance Education (CCDE)UniversityofGeneva| CH-1211 Geneva4

Tel:+41(0)223797833|[email protected]

www.unige.ch/formcont