SyllabusoftheCertificateProgram

ClinicalResearchandRegulatoryAffairs

Effective:October12,2011

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 2
Content

1. ModularStructureoftheProgram.............................................................................................3
2. AbouttheCourseDescriptions...................................................................................................3
2.1. Personell.............................................................................................................................3
2.1.1. Authors...................................................................................................................3
2.1.2. CourseLeaders.......................................................................................................3
2.1.3. Tutors.....................................................................................................................3
2.2. TeachingForms...................................................................................................................4
2.2.1. IndividualStudy......................................................................................................4
2.2.2. OnlineStudy...........................................................................................................4
2.2.3. InclassStudy.........................................................................................................4
2.3. FurtherInformation............................................................................................................4
3. DetailoftheCourses..................................................................................................................5


SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 3
ThissyllabuscontainsdetailsregardingthecoursesofthecertificateprogramClinicalResearchandRegu
latoryAffairs.Italsostipulatestherequirementsandmethodsofassessement.
1. ModularStructureoftheProgram
Eachcourseintheprogramisattributed5creditpoints.Uponsuccessfullycompletingacoursestudents
receivethecreditpointsattributedtothemoduleinaccordancewiththeEuropeanCreditTransferSys
tem(ECTS).Acourseissuccessfullycompletedwhenallofthepartialexaminationassignmentsinthe
coursehavebeensuccessfullycompleted.

Allcoursesaredesignedtosuitspecificgroupsofprofessionsandcurrentdemands.Thisorientationis
achievedbytheselectionofcoursecontentwithregardtothejobmarket,andbythepreparationofsuch
contentforuseincontinuingeducationwithspecificteachingandlearningformats.

2. AbouttheCourseDescriptions
2.1. Personell
2.1.1. Authors
TheauthorsofthestudybookletstakeacentralpositionamongtheteachersatDUWbecausethestudy
bookletsareconsideredastutorialsinprint.Incoordinationwiththeprogramdirectorandwithrefer
encetothehighstandardsofscientificqualityauthorsdidactiallydesignedstudybookletswhicharecon
tinuouslyupdatedifnecessary.Theauthorsinvolvedinthiscertificateprogramareexpertsoftheprofes
sionalfield.
2.1.2. CourseLeaders
Courseleadersdesignthephasesofinclassstudywithparticularfocusonthedevelopmentandenlarge
mentofprofessionalcompetencies.Theyaimatenablingstudentstoapplyheirnewlyacquired
knowledgetopracticalsituations,developadequatestrateiesofactionandimprovethenecessaryskills.
Thecourseleadersinvolvedinthiscertificateprogramareexpertsoftheprofessionalfield.
2.1.3. Tutors
Inconjunctionwiththeprogrammanager,tutorssupportthestudentswithrespecttoallquestionsrelat
edtothesubjectmatterofthisprogram.Thisincludescomprehensivefeedbackonthehomeworksub
mittedbythestudentsaswellascounselingbybothtelephoneandemail.Tutorsareinvolvedinthe
learningcommunityontheDUWonlincecampusastheydesignonlineunits,superviseforumactivities,
commentonstudentspostings,andofferacademicsupport.

Etutorsmoderateandcommentallstudentscontributioninthecontextoftheonlineunit.Theyarestu
dentsmaincontactastheypromptdiscussions,askforfeedback,andanswertoparticularneedofthe
students.

Alltutorsinvolvedinthiscertificateprogramareexpertsoftheprofessionalfield.

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 4
2.2. TeachingForms
Eachcoursepromotesproblembasedlearning.Inadditiontocommunicatingandassimilatingknowledge,
eachcoursefocusesonthecooperative,progressivetreatmentofpracticalproblemsinrelationtothe
subjectmatterofthecourseofstudy.Theselectionoftheexercisesandassignmentsiscloselyoriented
afterthestudentsdaytodayprofessionalpractice.Studentsareexplicitlyencouragedtointegratetheir
priorprofessionalexperienceandtheirexistingknowledgeinthelearningprocess.Thislearningmethodis
adaptedtotherequirementsofadulteducation.Problemorientedlearningisconductedmainlyduring
theinclassphases.
Thecontent,organization,anddidacticmethodsoftheteachingandlearningprocessesintheindividual
studyphases,onlineunit,andinclassunitsarecoordinatedandinterwoven.
2.2.1. IndividualStudy
Withrespecttotheindividualstudyphases,studentsreceivestudymaterials.Selectedexercises,case
studiesandassignmentsensurethestudentslearningprogressandsupportthemintransferringtheir
newknowledgeintotheirprofessionalpractice.
2.2.2. OnlineStudy
Duringonlinestudyphase,theteachingandlearningprocessestakeplacethroughtheOnlineCampus.By
focusingoncollaborative,practicallyorientedlearning,theinteractiveonlineunitsreproducetheincreas
inglyprojectorientedprofessionalworld.Theonlineunitsupplementstheinclasssessions.
2.2.3. InclassStudy
Theinclassphasesjuxtaposegroupassignmentsandapplicationexerciseswithinputorientedlectures.
Theyfocusonpersonalandsocialskillsthatarerelevanttoprofessionalpractice,andprovideasafeenvi
ronmentforstudentstotraintheseskillsinrelationtospecificpracticalexamples.Givingandreceiving
feedbackinregardtocompletedassignmentsisanessentialelementoftheseapplicationorientedlearn
ingformats.

2.3. FurtherInformation
InformationregardingthetopicWorkload:HoursperActivity:
Thehoursmentionedcontaintransfertostudentsworkplace.
Thehoursmentionedwithrespecttoinclassstudycomprisepreparationandfollowup.Thetime
studentswillactuallybepresentismentionedundertheheadingDurationinthesyllabus.

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 5
3. DetailoftheCourses
Overview

NameoftheProgram ClinicalResearchandRegulatoryAffairs
ProgramNumber 108001
ProgramCode CRRA
Structure Course1:IntroductionandFundamentals(5ECTS)
Course2:ClinicalTrialOperations(5ECTS)
Course3:StrategicClinicalDevelopmentandBestPractice(5ECTS)
ProgramDirector Dr.FerdinandHundt,FFPM (RCP)
ContactwithDUW Dr.RoswithaGrassl, roswitha.grasssl@duwberlin.de
Authors Dr.GudrunBusch
JanCarlsenMD,FESC
Dr.AlexandraGruber
SusanneHastrupM.Sc.
Dr.ReinhardNibler
Dr.ThorstenRuppert
Dr.ThomasTrilling
Dr.AxelF.Wenzel
Content Thecertificateprogramprovidesathoroughintroductiontothesigna
turefieldsandtheirinterrelationship.Itfoucesesontherespective
requirementsofbothconductingclinicalresearchandtheapplication
andmaintenanceofamarketingauthorization.Inaddition,manage
mentaspectsofbothfieldsareconsideredasstudentswilldiscussthe
positioningandmarketingofmedicinalproductsintheEUaswellasin
theU.S.market.
LearningOutcome Aftercompletingthecertificateprogramstudentsareableto:
1) Contributetoadevelopmentplan,meetingtherequirements
withregardtomarketingauthorizationofanewlydevelopedme
dicinalproductandwithrespecttothemaintenanceofmarketing
authorizationthroughouttheenitirelifecycleofamedicinal
product;
2) Assessthevariousoptionsregardingtheplanningandconducting
ofclinicalresearch;
3) Editandcorrectlypresenttheresultsofclinicalresearchinstudy
reportsandregulatorydossiers;
4) Recognizepossibilitiesandrisksduringtheclinicaldevelopment
ofamedicinalproduct,assesstheconsequenceswithrespectto
marketingoftheproduct,andtimelysuggesttheappropriate
courseofaction.
Methods IndividualStudy
OnlineStudy
InclassStudy
NumberofECTS 15ECTS
Workload:HoursperActivity IndividualStudy:300hours
OnlineStudy:45hours
InclassStudy:105hours

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 6

ExaminationFormatsandWeight AssessmentCourse1(20%)
AssessmentCourse2(40%)
AssessmentCourse3(40%)
CourseUse Inparts, constituentofthemastersdegreeprogramDrugResearch
andManagement
Frequency Quarterly
CourseDuration Asageneralrule:18 weeks (3 daysinclass)
CourseLanguage English

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 7

CourseTitle Course 1:IntroductionandFundamentals

CourseCode KINAFU
CourseDirector Dr.FerdinandHundt,FFPM(RCP)
Contact Dr.RoswithaGrassl,roswitha.grasssl@duwberlin.de
Authors Dr.GudrunBusch
JanCarlsenMD,FESC
SusanneHastrupM.Sc.
Dr.ThorstenRuppert
Dr.ThomasTrilling
Dr.AxelF.Wenzel
Content IntroductiontoClinicalTrialsandRegulatoryAffairs
Fundamentalsof:
Clinicaldevelopmentofnewmedicinalproducts
Regulatoryrequirementswithrespecttoclinicaldevelopment
Labelingofpharmaceuticalproductswithregardtotheproduct
claim
Positioningandmarketingofamedicinalproduct
FundamentalsofClinicalTrials
Fundamentalsandspecificaspectsofclinicalresearch(ICH
prinicples,phasesofclinicalresearch,clinicaldevelopmentplan)
Studydesignandstudyreports
Keydocuments(InvestigatorsBrochure,IND,IMPD,StudyProto
col,PatientInformation/InformedConsent)
Transparencyissues
Qualityassuranceofclinicalresearch
FundamentalofRegulatoryAffairs
Basicsofmarketingauthorizationofpharmaceuticalproductsinthe
EUandtheU.S.,inparticular:
Competentauthorities
Regulations
Process
LearningOutcomes Aftercompletingthecoursestudentsareableto:
1) Elucidatedthesignificanceofdataobtainedinclinicaltrialsand
regulatoryrequirementswithrespecttoprofitablemarketingof
amedinicalproduct;
2) Explaintheimportanceofaclosecollaborationofexpertsfor
clinicalresearch,marketingauthorization,andmarketingduring
productdevelopmentandrecognizetheirprofessionalinterrela
tionship;
3) Assemblealldocumentsnecessarytoplanaclinicaltrial,to
applyforitsauthorizationandtoconductitaswellassassessist
qualityandtranparency;
4) Selecttheappropriatestudydesignwithregardtovariousis
sues;
5) Explaintheregulationinthecontextofthemarketingauthoriza
tionofamedicinalproductintheEUandintheU.S.andalign
developmentstrategiesaccordingly.
Methods IndividualStudy
InclassStudy
Prerequisites None(programentryrequirements)
NumberofECTS 5ECTS

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 8

Workload:HoursperActivity IndividualStudy:105hours
InclassStudy:45hours
ExaminationFormatsandWeight Homework:ICRRADxx(33%)
InclassAssessment(67%)
CourseUse Inparts, constituentofthemastersdegreeprogramDrugResearch
andManagement
Frequency Quarterly
CourseDuration Asageneralrule:8weeks(1day inclass)
StudyBooklets IntroductiontoClinicalTrialsandRegulatoryAffairs(ICRRAD)
FundamentalsofClinicalTrials(CLIFUD)
FundamentalsofRegulatoryAffairs(FUNRAD)
OnlineUnit None
InclassUnit SelectedIssuesofClinicalTrialsandRegulatoryAffairs(SICRRAD)
CourseLanguage English

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 9

CourseTitle Course 2:ClinicalTrialOperations

CourseCode KCTROP
CourseDirector Dr.FerdinandHundt,FFPM(RCP)
Contact Dr.RoswithaGrassl,roswitha.grasssl@duwberlin.de
Authors JanCarlsenMD,FESC
Dr.ReinhardNibler
Dr.ThorstenRuppert
Dr.AxelF.Wenzel
Content AuthorizationandManagementofClinicalTrials
Regulatoryrequirementswithrespecttotheauthorizationof
clinicalresearch(process,competentauthorities,ethicscommit
tees)
Contractresearchinstitutions,studysiteselection
Logisticsofclinicalresearchandstudyprotocol
GCP,datamanagement,anddocumentation
AppliedBiostatistics
Basicsofstatisticsinthepharmaceuticalindustry
Statisticalanalysisplan,studyreports
ICHprinciples
Evidencebasedmedicine
DrugSafety
Responsibility,tasks,andprocessesinpharmacovigilance
Requirementswithrespecttoassessment,reporting,anddocu
mentationofrisksrelatedtopharmaceuticalproductsinthecon
textofclinicaldevelopment
Requirementswithrespecttoassessment,reporting,anddocu
mentationofrisksrelatedtopharmaceuticalproductsaftertheir
launch(PSUR)
Implementationofmeasurestoestablishdrugsafety
QualityAssurance
Qualitystandardsinclinicaltrials
Internalandextermalauditswhy,how,andwhere?
LearningOutcomes Aftercompletingthecoursestudentsareableto:
1) Describetheregulationswhichapplytoclinicaltrials;
2) Namethecompetentauthoritiesfortheauthorizationandsuper
visionofclinicalresearchbothintheEUandtheU.S.andtransfer
theseprovisiontoselectedpractiaclacases;
3) Decideonfundamentalmethodsofbiostatisticstoconductclinical
trials,analyzetheirresultsandapplythisknowledgetoselected
examples;
4) Interpretbothstudyresultsandclinicalparametersandassess
theirrelevancewithrespecttothetherapeuticgoalandmarkeing
authorization;
5) Elucidatethebasicprinciples,regulations,andmethodsofphar
macovigilanceandapplythemtopracticalexamples;
6) Criticallyreflectonselectedexampleswithrespecttoresponsi
bilites,tasks,andprocesses;
7) Evaluatetheconductingandtheresultsofclinicaltrialswithre
gardtothequalityrequirementsofthecompetentauthorities.

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 10

Methods IndividualStudy
OnlineStudy
InclassStudy
Prerequisites None(programentryrequirements)
NumberofECTS 5ECTS
Workload:HoursperActivity IndividualStudy:75hours
OnlineStudy:45hours
InclassStudy:30hours
ExaminationFormatsandWeight OnlineAssessment(33%)
Homework(CLIAMDxx)(33%)
InclassAssessment(33%)
CourseUse Inparts, constituentofthemastersdegreeprogramDrugResearch
andManagement
Frequency Quarterly
CourseDuration Asageneralrule:12weeks(1 dayinclass)
StudyBooklets AuthorizationandManagementofClinicalTrials(CLIAMD)
DrugSafety(DSAFED)
OnlineUnit AppliedBiostatistics(OBSTATD)
InclassUnit QualityAssuranceofClinicalTrials(SQACTRD)
CourseLanguage English

SyllabusCertificateProgramClinicalResearchandRegulatoryAffairs12.October2011 11

CourseTitle Course 3:StrategicClinicalDevelopmentandBestPractice

CourseCode KSCDBP
CourseDirector Dr.FerdinandHundt,FFPM(RCP)
Contact Dr.RoswithaGrassl,roswitha.grasssl@duwberlin.de
Authors Dr.GudrunBusch
Dr.AlexandraGruber
Dr.AxelF.Wenzel
Content ProductClassificationandBorderlines
Productdevelopmentstrategiesinthepharmaceuticalindustry
Thestrategicpotentialofborderlineproducts
Selectedborderlines(medinicalproducts,medicinaldevices,cos
meticproducts,neutraceuticals)
RegulatoryDossierandLabeling
Dossier(CTD/eCTD)
Safetyinformation
SmPC(SummaryofProductCharacteristics)
BasicsofPharmabusinessandPharmamarketing
Marketingstrategiesandperspectives
Reponsibilitiesofproduct/marketingmanagement
Process,planning,andtoolsofmarketing
Conceptofmarketanalysis(SWOTanalysis,breakevenanalysis)
Customerfocusedmarketing,communicationstrategies
LearningOutcomes Aftercompletingthecoursestudentsareableto:
1) Describethecharacteristicsofborderlineproductsanddemon
stratetheirstrategicpotential;
2) Assemblethedocumentsrequiredtoapplyformarketingau
thorizationandassesstheirqualityandappropriatenesswith
respecttotheintendedlabeling;
3) Maintainthesedocumentsandfurtherdevelopthem;
4) Takethefundamentalprinciplesofpharmamarketingintoac
countwhenintroducingapharmaceuticalproducttothemarket
orpositioningsuchaproduct.
Methods IndividualStudy
InclassStudy
Prerequisites None(programentryrequirements)
NumberofECTS 5ECTS
Workload:HoursperActivity IndividualStudy:120hours
InclassStudy:30hours
ExaminationFormatsandWeight InclassAssessment(50%)
Paper(50%)
CourseUse Inparts, constituentofthemastersdegreeprogramDrugResearch
andManagement
Frequency Quarterly
CourseDuration Asageneralrule:8weeks (1day inclass)
StudyBooklets ProductClassificationandBorderlines(BORDED)
RegulatoryDossierandLabeling(RDLABD)
BasicsofPharmabusinessandPharmamarketing(PHMARD)
OnlineUnit none
InclassUnit BestPracticeofClinicalTrialsandRegulatoryAffairs(SBPCRA)
CourseLanguage English