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 : info@paofarmacie.nl

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:info@paofarmacie.nlwww.paofarmacie.nlwww.bsdl-edu.bt.tudelft.nl/TrainingCourse

General inForMaTion