Career Opportunities For Pharma and Pharma Management Graduates
Training Course QualiTy ManageMenT in PharMa and … Management in... · 11.00 Case study: in...
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Training Course QualiTy ManageMenT in PharMa and BioTeCh2012
Quality Management, the role of the Qualified PersonDrug development from Quality by Design to clinical studies : an integrated course for the pharmaceutical industry and hospital pharmacySterile manufacturingQuality and safety for the manufacturing of biopharmaceuticals : from cell line development to downstream processing and formulation
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MonDay, 6 February 2012
Themes: The role and legal obligations of the Qualified Person Introduction to current concepts in Quality Management
09.15Welcome and introduction VivienMoffat09.30responsibilities of the Qualified Person (QP) : international regulations Current views from the inspectorate HansSmallenbroek10.15The role and duties of the Qualified Person in Pharmaceutical Quality Management and the supply of medicines to the european Community MarijkePubben12.00lunch13.00Case study addressing the issues facing the QP in an integrated approach to Quality assurance in a pharmaceutical environment SaskiaSturmandMarijkePubben14.15Presentations and discussions15.00Validation principles in the pharmaceutical industry SaskiaSturm16.15Case study : risk management VincentCoolenandJanDamm17.45social drink and dinner
TueSDay, 7 February 2012
Theme: Maintaining compliance in the current Quality environment
09.00Quality systems SueMann10.00Compliance, change control and audits JolandeSchoemaker11.00Case study: in compliance or not in compliance ? JolandeSchoemaker12.30lunch13.30The role of the QP in the manufacture of active Pharmaceutical ingredients (aPis) and finished products for investigational purposes (iMPs) Speakertobeannounced14.30introduction to the case study ’Creatis and Bodl 2000’ DominiqueMuddeandCarinHuibers
ProGraM 6 - 8 February 2012 H o t e l B e r g s e B o s s e n , D r i e b e r g e n , t h e N e t h e r l a n d s
QualiTy ManageMenT, The role of The Qualified Person
15.00 Case study : preparation for an inspection of the manufacturing of the antidepressant Bodl 2000 DominiqueMuddeandCarinHuibers17.00 The fight against counterfeit medicines : the new falsified medicines directive and securing the supply chain for patients Jean-MichelGuirado18.00 dinner19.30 introduction to the workshop : the real world PedroTetteroo,VivienMoffatandMirjamteKoppele
WeDneSDay, 8 February 2012
Theme: Operating effectively as a QP in the complex world of pharmaceutical manufacturing
09.00 “The international QP” TeshPatel11.00 experiences from a QP in industry: EricvanWensveen in a hospital pharmacy: KatjavanRij12.30 lunch13.30 Workshop: the real world PedroTetteroo,MirjamteKoppele,VivienMoffat, EricvanWensveenandKatjavanRij15.30 lessons from the workshop16.00 evaluation of the course and concluding remarks VivienMoffat16.15 farewell drink
TraininG CourSe QualiTy ManaGeMenT in PharMa anD bioTeCh
CourSe leaDerDr. V.l.C. MoffatAmgen BV, Breda, the Netherlands
leCTurerSV.P. Coolen, MScTebodin, Eindhoven, the Netherlands
Dr. J.b.l. DammPharmSupport BV, Oss, the Netherlands
J-M. GuiradoAmgen BV, Breda, the Netherlands
Drs. C.M. huibers Janssen Biologics BV, Leiden, the Netherlands
Drs. M.a. te KoppeleMedImmune Pharma BV, Nijmegen, the Netherlands
S. MannSue Mann Consulting Ltd (SMC), Newnham, Hook, United Kingdom
D.M. Mudde, M.biotechHAL Allergy, Leiden, the Netherlands
Dr. T.K. PatelAstellas Pharma Europe Ltd., Staines, United Kingdom
Drs. M.M.G. PubbenMerck, Sharp & Dohme BV, Haarlem, the Netherlands
Drs. C.M. van rijClinical Pharmacy, UMC St Radboud, Nijmegen, the Netherlands
Drs. T.J. SchoemakerSchoemaker Consultancy, Nieuw-Dordrecht, the Netherlands
Drs. a.J. SmallenbroekHealthCareInspectorate,DenHaag,theNetherlands
Drs. S.e. SturmMerck, Sharp & Dohme BV, Haarlem, the Netherlands
Dr. P.a.T. TetterooTetteroo Coaching & Consulting, Oegstgeest, the Netherlands
Drs. e. van WensveenCovidien, Petten, the Netherlands
General inForMaTionAlltheinformationonregistration,costandstartingdatescanbefoundonthepage“GeneralInformation”andisalsoavailableonthewebsiteofwww.paofarmacie.nlselectcourseQuality Management
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DRUG DE VELOPMENT FROM QUALIT Y BY DESIGN TO CLINIC AL STUDIES:
an inTegraTed Course for The PharMaCeuTiCal indusTry and hosPiTal PharMaCy
MonDay, 16 aPril 2012
Theme: Medicinal chemistry, pharmaceutical formulations, large scale production
10.00Welcome and introduction ErikFrijlinkandLeodeLeede10.15introduction of the case study: antidepressant Bodl 2000 - theprofileofBODL2000;R&DstepsandR&Ddata - registrationofBODL2000;roleofRAdepartment - thequalityoftheregistrationdossierforBODL2000 - GoodRegulatoryPractice(GRP)andthequalityofthecompany LeodeLeede11.30Medicinal chemistry: quality in lead finding and lead optimization JacWijkmans12.30lunch14.00Quality requirements from process chemistry to large scale production MichelGuillaume15.00Pharmaceutical formulations - thedevelopmentofdrugproducts - qualitymanagementandcGMPin pharmaceuticaldevelopment - smallscaleproduction - fromsmallscaletolargescale ErikFrijlink 18.00social drink and dinner
TueSDay, 17 aPril 2012
Theme: Quality by Design in industry and hospital pharmacy, GMP applied
09.00 objectives of the day, focus on gMP: Jan-JaapScherpbier09.15 Quality part of registration dossier FransMetsers09.30from r&d to production - QualitybyDesign - PATandPCTinindustryandhospitalpharmacy ErikFrijlink 11.30 Total Quality Management obtained by Quality by design - reallifeexamplesinindustry BenvanBeek12.30lunch
13.30Case study Bodl 2000: gMP/Quality: - deviationsandchangesduringmanufacturingof clinicalsupplies - impurityprofiledrugsubstance - specificationsandbatchanalysisdata - deviationsduringcommercialmanufacturing Jan-JaapScherpbierandFransMetsers15.15group presentations Wrap up of the case17.00The development of oncolytic drug products: the slotervaart case JosBeijnen 18.00social drink and dinner
WeDneSDay, 18 aPril 2012
Theme: Pre-clinical development, GLP applied, personal skills
08.30objectives of the day, focus on glP InekeJonker-Hoogerkamp08.45introduction to glP ChrisMitchell09.00Pharmacokinetics and pharmacodynamics (PK/Pd) in industrial practice PeterVis10.30Toxicology, Bodl 2000 in focus EricdeWaal12.00lunch13.00Case study Bodl 2000: glP and regula-
tory aspects of pharmacokinetics, pharmacodynamics and toxicological studies:
- actionstepsforthepreparationandexecutionofthe toxicologicalstudytoguaranteethatitwillbeaGLP compliantstudy - isthereaneedforadditionalrequirementsfromGLP perspectiveforamulti-sitestudy? - areadditionaldatafromtoxstudiesrequired forregistrationofBODL2000? InekeJonker-HoogerkampandChrisMitchell14.30group presentations Wrap up of the case study15.30events occurring in industry and hospital pharmacy, not appreciated by inspectors discussion AnnieRietveld
16.15Workshop skills required in drug development real life example: mix-up in a wallet AnnieRietveld,ErikFrijlinkandLeodeLeede16.30role play by acting as company experts and authorities experts: representative from r&d (and site) management, the QP, head of pharmaceutical development, clinical production and packaging, head of clinical development and head of quality control AnnieRietveld,ErikFrijlinkandLeodeLeede19.00dinner
ThurSDay, 19 aPril 2012
Theme: Clinical development, GCP applied
08.30objectives of the day, focus on CP LuukPromesandLisetteVromans09.00Clinical development Phase i Principles, clinical study documents, requirements for a Phase i clinic, clinical pharmacology, types of Phase i studies LeodeLeede10.45Clinical development Phase ii and iii - clinicaldevelopmentplan - regulatoryrequirementsclinicaltrials - issues(design,submissions,conduct) - investigatorinitiatedstudies(includingcasestudy) PetraMatthijsse12.15lunch13.30reflection to the lectures and the case study 14.00Case study Bodl 2000 : gCP and clinical development program - possibledeficienciesintheclinicalprogram - outlineforaclinicaltrial - possibledeficienciesintheinformedconsent - auditreport LuukPromesandLisetteVromans15.30group presentations Wrap up of the case study16.00evaluation of the course and learned lessons ErikFrijlinkandLeodeLeede17.00farewell drink
ProGraM 16 - 19 april 2012 H o t e l B e r g s e B o s s e n , D r i e b e r g e n , t h e N e t h e r l a n d s
TraininG CourSe QualiTy ManaGeMenT in PharMa anD bioTeCh
CourSe leaDerSProf.dr. h.W. FrijlinkGroningen University Institute for Drug Exploration (GUIDE), Dept. of Pharmaceutical Technology and Biopharmacy, the Netherlands
Dr. l.G.J. de leedeExelion Bio-Pharmaceutical Consultancy BV, Waddinxveen, the Netherlands
leCTurerSDrs. b.D. van beekMerck, Sharp & Dohme, Haarlem, the Netherlands
Prof.dr. J.h. beijnenNKI and Slotervaart Hospital, Amsterdam, the Netherlands
Dr. M. GuillaumeJanssen, Beerse, Belgium
Dr. a. Jonker-hoogerkampXendo BV, Leiden, the Netherlands
Drs. P.C. MatthijsseTrial Form Support, Berghem, the Netherlands
ing. F.a.a.J. Metsers Merck, Sharp & Dohme, Oss, the Netherlands
C. Mitchell, bScNOTOX BV, ‘s-Hertogenbosch, the Netherlands
Drs. l.W. PromesMerck, Sharp & Dohme, Oss, the Netherlands
Dr. a. rietveldHealth Care Inspectorate, Utrecht, the Netherlands
Drs. J.J. ScherpbierMerck, Sharp & Dohme, Oss, the Netherlands
P. VisJanssen, Beerse, Belgium
Ms. e.W.M. VromansMerck, Sharp & Dohme, Oss, the Netherlands
Dr.E.J.deWaalJanssen, Beerse, Belgium
Dr. J.C.h.M. WijkmansFormerly, Merck, Sharp & Dohme, Oss, the Netherlands
General inForMaTionAlltheinformationonregistration,costandstartingdatescanbefoundonthepage“GeneralInformation”andisalsoavailableonthewebsiteofwww.paofarmacie.nlselectcourseQuality Management
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8 – 10 october 2012
MonDay, 8 oCTober 2012
Theme: Microbiology
09.30Welcome and outline of the course HansvanDoorne09.45Biology of microorganisms implications for pharmaceutical production and quality control HansvanDoorne10.45sterile manufacturing: a philosophy on design and control JosMathôt12.30lunch13.30environmental monitoring methods: - whataretherisksweneedtorecognizeandwhichmethods areavailable? - whataretheresultsweobtain,howtoevaluatethem,howto recognizetherisksandhowtomitigatethem - introductiontothecasestudy KlausHaberer15.30heat sterilization exercises HansvanDoorne17.30 film: Parenteral production at Medimmune, nijmegen MirjamteKoppele18.00social drink and dinner19.30The gowning procedure MirjamteKoppele
TueSDay, 9 oCTober 2012
Theme: Water systems and parenteral production Sterility assurance in practice
08.30Case study: environmental monitoring methods KlausHaberer10.00Pharmaceutical water systems FrankvanEde11.30environmental monitoring methods: -watermonitoring KlausHaberer12.30lunch13.30Membrane filtration HansvanDoorne
14.30Case studies: sterility assurance in practice - selectionofformulationandprocess - combinationofproductionandQCactivities - isolatorapplicationinunclassifiedenvironment - validationofvisualinspection - environmentalmonitoringtrend - start-upafterpowerfailure - HEPAfilterfailure - newrequirementsforvialcapping JosMathôt16.00Presentations of the case study results evaluation18.00social drink and dinner
WeDneSDay, 10 oCTober 2012
Theme: Validation and qualification of processes and personnel The role of the QP
09.00Validation of aseptic processes - introduction - technologies - qualification - validation - casestudiesasepticprocessing JosvanderLubbe11.30Validation of analytical methods - introduction - validation - specifications JosvanderLubbe12.15operator Qualification - introduction - training - casestudiesanalyticalmethodsandoperatorqualification JosvanderLubbe13.00lunch14.00Workshop: the role of the QP in assuring the quality of sterile pharmaceuticals RenéMaassen16.00evaluation of the course HansvanDoorne16.30farewell drink
sTerile ManufaCTuring
ProGraMH o t e l B e r g s e B o s s e n , D r i e b e r g e n , t h e N e t h e r l a n d s
TraininG CourSe QualiTy ManaGeMenT in PharMa anD bioTeCh
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CourSe leaDerDr.ir. h. van DoorneGroningen University Institute for Drug Exploration (GUIDE), Dept. of Pharmaceutical Technology and Biopharmacy, the Netherlands
leCTurerSing. F.h. van edePharma Engineering & Consulting (PEC), Drunen, the Netherlands
Dr. K. habererCompliance, Advice and Services in Microbiology GmbH, Frankfurt, Germany
Drs. M.a. te KoppeleMedImmune Pharma BV, Nijmegen, the Netherlands
Dr.ir. J.l.M. van der lubbePharming Technologies BV, Leiden, the Netherlands
Drs. r.h.l.M. MaassenPharmaceutical Consultancy Services, PCS, Haastrecht, the Netherlands
General inForMaTionAlltheinformationonregistration,costandstartingdatescanbefoundonthepage“GeneralInformation”andisalsoavailableonthewebsiteofwww.paofarmacie.nlselectcourseQuality Management
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QUALITY AND SAFETY FOR THE MANUFACTURING OF BIOPHARMACEUTICALS:
froM Cell line deVeloPMenT To doWnsTreaM ProCessing and forMulaTion
MonDay, 26 noVeMber 2012
Theme: Cell line development, upstream and downstream
09.30Welcome AadvandeLeur09.45introduction to biotechnology: applications and elements of the biotechnological production process, quality and regulatory aspects AadvandeLeur11.00upstream process development for biopharmaceutical products: different expression systems and unit operations WoutvanGrunsven12.30lunch13.30Cell line development and cell bank preparation Theory and case study Genetics:geneofinterest;descriptionofthestartingstrain(s)orcellline(s);preparationand descriptionoftheproductstrainorcellline;geneticstabilityduringstorageofcellbankandduring production. CellBanksystem:preparationanddescriptionoftheMasterCellBank(MCB);testing/in-process controls;protocolforpreparationofsubsequentWorkingCellBank(WCB) NienkeVriezen17.00Purification survey of unit operations and process integration MarcelOttens18.30dinner
TueSDay, 27 noVeMber 2012
Theme: The practice
09.00design of an industrial process for purification of biologicals MichelEppink10.15development, tech transfer and commercial production of monoclonal antibodies: theory and case studies - Theuseofplatformtechnology12.30lunch - Criticalqualityattributesandcriticalprocessparameters - Specsettingandtheconsequencesforroutinemanufacturing - Casestudy1 - Technologytransferandprocessvalidation - Pre-approvalinspections - ProcessFittoPlant - Casestudy2 - Changes,deviationsandCAPAsinmanufacturing - ProcessExcellenceforcontinuouscostreduction LindaBus-Jacobs,DianavanderGraaf-HarrisandMaaikePoppema18.00Viral safety KlausKellings19.30dinner
ProGraMH o t e l B e r g s e B o s s e n , D r i e b e r g e n , t h e N e t h e r l a n d s
26–28November2012
WeDneSDay, 28 noVeMber 2012
Theme: Quality issues
09.00Protein analytics of biopharmaceuticals: relevant assays and their principles MartijnPinkseandPeterVerhaert10.00Critical attributes and comparability studies PrathimaAcharya11.15specific quality issues around aTMPs ArnoldVulto12.15lunch14.00Biosimilars ArnoldVulto15.15immunogenicity and formulation of biopharmaceuticals WimJiskoot16.15evaluation of the course AadvandeLeur16.30farewell drink
TraininG CourSe QualiTy ManaGeMenT in PharMa anD bioTeCh
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CourSe leaDer Drs. a.C.a.J. van de leurSynthon BV, Nijmegen, the Netherlands
leCTurerSDr. P.S. acharyaKBI Biopharma Inc., Durham, North Carolina, USA
l. bus-Jacobs, MSc, PDengJanssen Biologics BV, Leiden, the Netherlands
Dr. M.h.M. eppinkSynthon BV, Nijmegen, the Netherlands
D.M. van der Graaf-harris, M.biotech, PhDJanssen Biologics BV, Leiden, the Netherlands
Dr. W.M.J. van GrunsvenMerck, Sharp & Dohme, Oss, the Netherlands
Prof.dr. W. JiskootLeiden/Amsterdam Center for Drug Research (LACDR), Leiden, the Netherlands
Dr. K. KellingsCharles River Biopharmaceutical Services GmbH, Erkrath, Germany
Dr.ir. M. ottensDelft University of Technology, Dept. of Biotechnology, the Netherlands
Dr. M.W.h. PinkseDelft University of Technology, Dept. of Biotechnology, the Netherlands
M. Poppema MSc, PDengJanssen Biologics BV, Leiden, the Netherlands
Prof.dr. P.D.e.M. VerhaertDelft University of Technology, Dept. of Biotechnology, the Netherlands
Dr. n. VriezenSynthon BV, Nijmegen, the Netherlands
Prof.dr. a.G. VultoErasmus MC, Rotterdam, the Netherlands
General inForMaTionAlltheinformationonregistration,costandstartingdatescanbefoundonthepage“GeneralInformation”andisalsoavailableonthewebsiteofwww.paofarmacie.nlselectcourseQuality Management
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CoMMiTTee anD boarD
ProGraM-/exaMinaTion CoMMiTTee
Prof.dr. W. Jiskoot (chairman)Leiden/AmsterdamCentreforDrugResearch(LACDR),Leiden,theNetherlands
Dr. J.l.M. van der lubbe (vice chairman)PharmingTechnologiesBV,Leiden,theNetherlands
Dr.ir. h. van DoorneFormerlyGroningenUniversityInstituteforDrugExploration(GUIDE),Dept.ofPharmaceuticalTechnologyandBiopharmacy,theNetherlands
Prof.dr. h.W. FrijlinkGroningenUniversityInstituteforDrugExploration(GUIDE),Dept.ofPharmaceuticalTechnologyandBiopharmacy,theNetherlands
Dr. l.G.J. de leedeExelionBio-PharmaceuticalConsultancyBV,Waddinxveen,theNetherlands
Drs. a.C.a.J. van de leurSynthonBV,Nijmegen,theNetherlands
Dr. V.l.C. MoffatAmgenBV,Breda,theNetherlands
Prof.dr. P.D.e.M. VerhaertDelftUniversityofTechnology,Dept.ofBiotechnology,theNetherlands
SCienTiFiC aDViSory boarD
honorary Members
Prof.dr. D.D. breimerFormerlyRectorMagnificus,LeidenUniversity,theNetherlands
Prof.dr.ir. G.W.K. van Dedem FormerlyDiosynth,Oss,theNetherlands
Drs. P.h. VreeFormerlyChairmanNationalPharmacopoeiaAuthority,theNetherlands
Dr. M. van der Waart FormerlyScheringPlough,Oss,theNetherlands
SCienTiFiC aDViSory boarD
Members
Prof.dr. h.J. de Jong (chairman)FormerlyLeidenUniversity,theNetherlands,Servier,R&D,Courbevoie,France,andEuropeanPharmacopoeia,Strasbourg,France
Prof.dr. M. DanhofLeiden/AmsterdamCenterforDrugResearch(LACDR),LeidenUniversity,theNetherlands
Dr. M.h. DeardenUCBS.A.,Brainel-Alleud,Belgium
Drs. e.W. de FlinesGenzymeEuropeBV,Naarden,theNetherlands
Drs. J.M.M. hansenHealthCareInspectorate,DenHaag,theNetherlands
Dr. P.h.h. le brunApotheekHaagseZiekenhuizen,DenHaag,theNetherlands
Drs. M.M.G. PubbenMerckSharp&DohmeBV,Haarlem,theNetherlands
Dr. a. rietveldHealthCareInspectorate,Utrecht,theNetherlands
Dr. a.P. SamMerckSharp&DohmeBV,Oss,theNetherlandsandFIP’sIndustrialPharmacySection
Drs. a.J. SmallenbroekHealthCareInspectorate,DenHaag,theNetherlands
Prof.dr. h. VromansUtrechtUniversity,PharmaceuticalSciences,Utrecht,theNetherlands
PaoFarMaCie netherlands Centre for Post-academic education in Pharmaceutical sciences
PAOFarmacieoffersPostAcademicEducationinPharmaceuticalSciences
ChieF exeCuTiVe oFFiCerSharonSchoutenTjinATsoiPharmDandCEOoftheNetherlandsCentreforPostAcademicEducationinPharmaceuticalSciences.
ParTnerShiPTheNetherlandsCentreforPostAcademicEducationinPharmaceuticalSciences(PAOFarmacie)isaprofessionalpartnershipbetweenPharmaceuticalSciencesatUtrechtUniversity(UU), ThefacultyofMedicalSciencesoftheUniversityofGroningen(RuG), theRoyalDutchPharmacistsAssociation(KNMP),theAssociationofDutchindustrialPharmacists(NIA)andtheDutchAssociationofHospitalPharmacists(NVZA).TheBoardandScientificBoardofPAOFarmacieareformedbyrepresentativesofthisprofessionalpartnership.
boarDRepresentativesofstateuniversitiesandpharmaceuticalassociationsformtheboardofPAOFarmacie.Theboardisresponsibleforpolicy,financeandpersonnel.Prof.dr.A.deBoerchairmanDr.F.MoolenaarsecretaryDrs.R.J.WolterschairmanoffinanceProf.dr.A.F.A.M.SchobbenboardmemberDrs.R.DessingboardmemberDrs.M.M.Tjoengboardmember
SCienTiFiC aDViSory boarD MembersoftheScientificAdvisoryBoard(WAR)arelinkedtonationaluniversitiesandpharmaceuticalassociations.TheiraimistofurtherdevelopthecurriculumofPAOFarmacie.IntheWARmembersofscienceandpracticemeet.Theyproposenewtopicsforfurthertraining,continuedevelopmentofexistingtopicsandguaranteethescientificquality.Prof.dr.J.J.deGierchairman,representingtheRuGProf.dr.A.C.G.EgbertsrepresentingtheNVZADrs.J.A.M.WesselsrepresentingthePostAcademicEducationforHospitalPharmacists(PUOZ)Dr.T.SchalekamprepresentingtheUUDr.H.BuurmarepresentingtheDirectorofstudiesfortheKNMPDrs.B.J.F.vandenBemtrepresentingtheDutchAssociationofPoliclinicPharmacy(NVPF)Dr.K.TaxisrepresentingtheRuGDr.F.J.vandeVaartrepresentingKNMPDrs.A.NooijrepresentingtheKNMPMs.A.HildebrandrepresentingtheAssociationforRegistrationofIndustrialPharmacists(StRIA/NIA)
The iso sTandardPAOFarmacieiscertifiedtotheISOstandardsince2009ISO9001
M1 Quality Management, the role of the Qualified Person 6 – 8 February 2012
M2 drug development from Quality by design to clinical studies: an integrated course for the pharmaceutical industry and hospital pharmacy
16 – 19 April 2012M3 sterile manufacturing
8 – 10 October 2012M4 Quality and safety for the manufacturing of biopharmaceuticals: from cell line development to downstream processing and formulation
26 – 28 November 2012
aiMThecourseoffersanintegratedapproachonqualitymanagementinthepharmaceutical,biotechnological,medicaldeviceindustriesandhospitalstosafeguardthequalityoftheirproducts.
ExpertknowledgeandreallifecasestudiesarecombinedandpresentedandcoachedbyprofessionalsfromIndustry,UniversitiesandHealthCareInspectorates.Thetrainingisinteractive.
TarGeT GrouPS - Professionalsinpharmaceutical,biotechnologicalandmedicaldeviceindustries - ProfessionalsininstitutionsandContractResearchOrganisations(CRO’s) - Hospitalpharmacists - PostgraduatestudentsFor(young)professionalsinResearchandDevelopment,Production,Packaging,QualityControlandQualityAssuranceorRegulatoryAffairs,whoaredealingwiththecomplexityofqualitysystems,itisimportanttohaveanoverviewofthesesystemsinordertoimprovequalitymanagementintheirownenvironment.
CerTiFiCaTeS & DiPloMaYoucanselectindividualcoursemodulesbestsuitedtocomplementyoureducationorexperience.Afterattendingamodule,youwillreceiveacertificateforattendance.
Inaddition,theparticipantsareofferedthepossibilitytocompletethemodulesthroughanexamination.Theexaminationsessionsarefreeofchargeandwillbescheduledinconsultationwiththeparticipants.
Incombinationwithauniversitydegreeine.g.pharmacy,biology,chemistryorengineering,andwithindustrialexperience,successfulcompletionofthemodulesofthetrainingcourseformsagoodstartingpointtoapplyforQualifiedPerson(QP)status.
aCCreDiTaTionForhospitalpharmacistsintheNetherlands:20accreditation-hoursforeachcoursemoduleattended.
PAOFARMACIE Netherlands Centre for Post Academic Education in Pharmaceutical Sciences since 2001
adress: Sorbonnelaan 16, Utrecht • PO Box: 80082, 3508 TB Utrecht • antwoordnummer 57511, 3507 WB Utrecht
phone: +31 (0)30 - 253 69 75 • fax +31 (0)30 - 253 69 29 • www.paofarmacie.nl • e-mail : [email protected]
orGaniSaTion ThetrainingcourseisorganizedbyNetherlandsCentreforPost-AcademicEducationinPharmaceuticalSciences:www.paofarmacie.nlinclosecollaborationwith: - Leiden/AmsterdamCenterforDrugResearch(LACDR):www.lacdr.nl - GroningenUniversityInstituteforDrugExploration(GUIDE):www.rug.nl/guide - BiotechnologyStudiesDelftLeiden(BSDL):www.bsdl-edu.bt.tudelft.nl - TopInstitutePharma:www.tipharma.com - EuropeanFederationofPharmaceuticalSciences(EUFEPS):www.eufeps.org - InternationalPharmaceuticalFederation(FIP):www.industrialpharmacy.org
Where? Allmodulesareorganizedin:HotelBergseBossen,Driebergen,theNetherlandsTraaij2993971GMDRIEBERGENT+31343528150Einfo@bergsebossen.nlwww.bergsebossen.nl
STanDarD CourSe Fee ThestandardfeeofModule1,3and4is€1500,00excl.19%VAT.ThestandardfeeofModule2is€1900,00excl.19%VAT.Thefeeincludeshotelaccomodation,coursenotes,drinks,lunchesanddinners.IntheeventofcancellationwereferetothegeneraltermsofconditionofPAOfarmacie(www.paofarmacie.nl).
reDuCeD CourSe Fee Uponsubscriptionbythesamepersonforthemodules1,2,3and4,thetotalfeeis€4.125,00excl.19%VAT.ForPhD-studentsalimitednumberoffellowships(50%ofthestandardfee)isavailable.ForPDeng-traineesalsoalimitednumberoffellowship(25%ofthestandardfee).
Toapply,sendacopyofyourregistrationasaPhD-studentorPDEng-traineetoinfo@paofarmacie.nl
reGiSTraTionForregistration,pleasesubmityourapplicationon–lineviawww.paofarmacie.nl selectcourseQualityManagement
inForMaTion PAOFarmacie, Utrecht, The NetherlandsT:+31302536975E:[email protected]/TrainingCourse
General inForMaTion