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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
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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.
4 www.unige.ch/formcont/cours/drug-dvp
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
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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
6 www.unige.ch/formcont/cours/drug-dvp
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.
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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.
8 www.unige.ch/formcont/cours/drug-dvp
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
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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
10 www.unige.ch/formcont/cours/drug-dvp
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
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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
12 www.unige.ch/formcont/cours/drug-dvp
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
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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
14 www.unige.ch/formcont/cours/drug-dvp
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.
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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