training course quality management in pharma and … · an integrated course for the pharmaceutical...

Netherlands Centre for Post-Academic Education in Pharmacy

Broederplein 39 T + 31(0)30-30 40 1003703 CD Zeist F + 31(0)30 30 40 109www.paofarmacie.nl E [email protected]

MODULES

M1 Quality management, the role of the Qualified Person

M2 Drug development from Quality by Design to clinical studies: an integrated course for the pharmaceutical industry and hospital pharmacy

M3 Sterile manufacturing: a thorough discussion on sterility assurance challenges

M4 Quality and safety for the manufacturing of biopharmaceuticals: from cell line development to downstream processing and formulation

Training course Quality Management in Pharma and Biotech 2016



MONDAY, 29 FEBRUARY 2016Themes: The role and legal obligations of the Qualified PersonIntroduction to current concepts in Quality Management09.00 Welcome and Introduction VivienMoffat09.30 Responsibilities of the Qualified Person (QP) : Interna-

tional regulations Current views from the Inspectorate Mieke van der Meulen10.30 Break10.45 Responsibilities of the Qualified Person (QP) for batch re-

lease of commercial and Investigational products (IMPs) Mieke van der Meulen11.30 The role and duties of the Qualified Person in Pharma-

ceutical Quality Management and the supply of medi-cines to the European Community

Marijke Pubben12.30 Lunch13.30 The role and duties of the Qualified Person in Pharma-

ceutical Quality Management and the supply of medi-cines to the European Community (continued)

Marijke Pubben14.30 Case study addressing the issues facing the QP in an

integrated approach to Quality Assurance in a pharma-ceutical environment

MarijkePubbenandVivienMoffat14.15 Presentations and discussions16.00 Break16.30 Good Distribution Practice: the new EU requirements

and the role of the Responsible Person Reikert Bruinink18.00 Dinner

TUESDAY, 1 MARCH 2016Theme: Quality management and maintaining compliance in the current Quality environment08.30 Quality systems: Deviation management Mirjam te Koppele

10.00 Compliance, change control and audits Jolande Schoemaker11.00 Break11.15 Case study: in compliance or not in compliance ? Jolande Schoemaker12.30 Lunch13.30 Active pharmaceutical Ingredients (APIs) and the QP

Declaration Desiree Vendrig14.30 Introduction to the case study ’Creatis and BODL 2000’ Dominique Mudde15.00 Case study: preparation for an inspection of the manu-

facturing of the antidepressant ‘BODL 2000’ Dominique Mudde16.45 Break17.00 The fight against counterfeit medicines : the new falsi-

fied medicines directive and securing the supply chain for patients

Jean-Michel Guirado18.00 Dinner19.30 Introduction to the workshop : the real world PedroTetteroo,VivienMoffatandEricvanWensveen

WEDNESDAY, 2 MARCH 2016Theme: Operating effectively as a QP in the complex world of pharmaceutical manufacturing09.00 “The international QP” Tesh Patel09.45 Break10.00 Continuation of the lecture and discussions10.45 Break11.00 Experiences from a QP in industry EricvanWensveen And in a hospital pharmacy Katja van Rij12.30 Lunch13.30 Workshop: the real world PedroTetteroo,MirjamteKoppele,VivienMoffat, andEricvanWensveen15.30 Lessons from the workshop16.00 Evaluation of the course and concluding remarks VivienMoffat16.30 Close

Quality management, the role of the qualified personPROGRAM MODULE 129 February - 2 March 2016Hotel Bergse Bossen, Driebergen, the Netherlands



COURSE LEADERDr. V.L.C. MoffatAmgen BV, Breda, the Netherlands

LECTURERSDrs. R. BruininkHealth Care Inspectorate (IGZ), Utrecht, the Netherlands

Ir. J-M. GuiradoAmgen BV, Breda, the Netherlands

Drs. M.A. te KoppeleNovartis Pharma BV, Arnhem, the Netherlands

Drs. M. van der MeulenHealth Care Inspectorate (IGZ), Utrecht, the Netherlands

D.M. MuddeHAL Allergy, Leiden, the Netherlands

Dr. T.K. PatelAstellasPharmaEuropeLtd.,Staines,UnitedKingdom

Drs. M.M.G. PubbenMMG Pubben Consulting 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

Dr. P.A.T. TetterooTetteroo Coaching & Consulting, Oegstgeest, the Netherlands Drs. D. VendrigTEVAPharmaceuticals,Haarlem,theNetherlands

Drs. E. van WensveenCovidien, Petten, the Netherlands

GENERAL INFORMATIONAll the information on registration, cost and starting dates can be found on the page “General Information” and is also avail-able on the website of www.paofarmacie.nl

select course Quality Management

> Quality management, the role ofthequalifiedperson

Faculty



MONDAY, 30 MAY 2016Theme: Medicinal chemistry, pharmaceu-tical formulations, large scale production10.00 Welcome and introduction ErikFrijlinkandLeodeLeede10.15 Introduction of the case study: antidepressant BODL 2000 - the profile of BODL 2000; R&D

steps and R&D data - registration of BODL 2000; role

of RA department - the quality of the registration

dossier for BODL 2000 - Good Regulatory Practice (GRP)

and the quality of the company Leo de Leede11.30 Medicinal chemistry: quality in

lead finding and lead optimization JacWijkmans12.30 Lunch14.00 Quality requirements from

process chemistry to large scale production

Michel Guillaume15.15 Pharmaceutical formulations - the development of drug

products - quality management and cGMP

in pharmaceutical development - small scale production - from small scale to large scale ErikFrijlink18.00 Dinner

TUESDAY, 31 MAY 2016Theme: Quality by Design in industry and hospital pharmacy, GMP applied09.00 Objectives of the day, focus on GMP

Jan-Jaap Scherpbier09.15 Quality part of registration dossier Jan-Jaap Scherpbier09.30 From R&D to production - Quality by Design - PAT and PCT in industry and

hospital pharmacy ErikFrijlink11.30 Total Quality Management ob-

tained by Quality by Design - real life examples in industry Saskia Sturm12.30 Lunch13.30 Case study BODL 2000: GMP/

Quality: - deviations and changes during

manufacturing of clinical supplies - impurity profile drug substance - specifications and batch analysis

data - deviations during commercial

manufacturing Jan-JaapScherpbierandErikFrijlink15.15 Group presentations Wrap up of the case17.00 Drug development in Dutch hospital pharmacies to be decided18.00 Dinner

WEDNESDAY, 1 JUNE 2016Theme: Pre-clinical development, GLP ap-plied, personal skills08.30 Objectives of the day, focus on GLP Ineke Jonker-Hoogerkamp08.45 Introduction to GLP Chris Mitchell09.00 Pharmacokinetics and pharma-

codynamics (PK/PD) in industrial practice

Peter Vis10.30 Toxicology, BODL 2000 in focus Eric de Waal12.00 Lunch13.00 Case study BODL 2000: GLP and

regulatory aspects of pharma-cokinetics, pharmacodynamics and toxicological studies:

- action steps for the preparation and execution of the toxicologi-cal study to guarantee that it will be a GLP compliant study

- is there a need for additional re-quirements from GLP perspec-tive for a multi-site study ?

- are additional data from tox studies required for registration of BODL 2000 ?

Ineke Jonker-Hoogerkamp and Chris Mitchell

14.30 Group presentations Wrap up of the case study15.30 View points from the inspectorate to be decided 16.15 Workshop skills required in drug

development Real life example: mix-up in a wallet ErikFrijlinkandLeodeLeede16.30 Role 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

ErikFrijlinkandLeodeLeede19.00 Dinner

An integrated course for the pharmaceuti-cal industry and hospital pharmacyDrug development from quality by design to clinical studiesPROGRAM MODULE 230 May - 2 June 2016Hotel Bergse Bossen, Driebergen, the Netherlands



THURSDAY, 2 JUNE 2016Theme: Clinical development, GCP applied

08.30 Objectives of the day, focus on GCP Eveline Krijger and Lisette Vromans09.00 Clinical development Phase I Principles, clinical study documents, requirements for

a Phase I clinic, clinical pharmacology, types of Phase I studies

Leo de Leede10.00 Clinical development Phase II and III - clinical development plan - regulatory requirements clinical trials - issues (design, submissions, conduct) - investigator initiated studies (including case study) Petra Matthijsse

12.15 Lunch13.30 Reflection to the lectures and the case study14.00 Case study BODL 2000: GCP and clinical development

program - possible deficiencies in the clinical program - outline for a clinical trial - possible deficiencies in the informed consent - audit report EvelineKrijgerandLisetteVromans15.30 Group presentations Wrap up of the case study16.00 Evaluation of the course and learned lessons ErikFrijlink17.00 Close

COURSE LEADERSProf. dr. H.W. FrijlinkGroningenUniversityInstituteforDrugExploration(GUIDE),Dept.ofPharmaceutical Technology and Biopharmacy, the Netherlands

Dr. L.G.J. de LeedeExelionBio-PharmaceuticalConsultancyBV,Waddinxveen,theNetherlands

LECTURERSProf. dr. J.H. BeijnenNKI and Slotervaart Hospital, Amsterdam, the Netherlands

Dr. M. GuillaumeJanssen Pharmaceutica NV, Beerse, Belgium

Dr. A. Jonker-HoogerkampGenzymeEurope,Naarden,theNetherlands

Ir. E. KrijgerMerck, Sharp & Dohme, Oss, the Netherlands

Drs. P.C. MatthijsseTrialFormSupport,Berghem,theNetherlands

C. Mitchell, BScWilResearch,‘s-Hertogenbosch,theNetherlands

Dr. A. RietveldHealth Care Inspectorate (IGZ), Utrecht, the Netherlands

Drs. J.J. ScherpbierSonsbeek Pharma Consultancy BV, Arnhem, the Netherlands

Drs. S.E. SturmMerck, Sharp & Dohme BV, Haarlem, the Netherlands

Mr. P. VisJanssen Pharmaceutica NV, Beerse, Belgium

Ms. E.W.M. VromansMerck, Sharp & Dohme, Oss, the Netherlands

Dr. E.J. de WaalJanssen Pharmaceutica NV, Beerse, Belgium

Dr. J.C.H.M. WijkmansGriffinDiscoveries,Amsterdam,theNetherlands

GENERAL INFORMATIONAll the information on registration, cost and starting dates can be found on the page “General Information” and is also availa-ble on the website of www.paofarmacie.nl select course Quality Management.

Faculty

> An integrated course for the pharmaceutical industry and hospital pharmacy



MONDAY, 3 OCTOBER 2015Theme: Microbiology and sterility: execution and control09.30 Welcome and outline of the course Jos Mathôt09.45 Biology of microorganisms Implications for pharmaceutical production and quality control Speakertobeconfirmed10.45 Sterile manufacturing: a philosophy on design and control Jos Mathôt12.30 Lunch13.30 Environmental monitoring: - which sterility risks to be recognized and how to mitigate - which methods are available? - what are the results, how to evaluate and to thrend them - which actions to take in case of adverse resuts Marco Rijnbeek15.00 Case study Environmental monitoring: Marco Rijnbeek16.00 Sterilization methods: steam, dry heat Exercises for steam Douwe Hoekstra17.30 Film: Parenteral production at MedImmune, Nijmegen Marco Rutten18.00 Dinner19.30 The gowning procedure Marco Rutten

TUESDAY, 4 OCTOBER 2016Theme: Water systems and parenteral productionSterility assurance in practice08.30 Pharmaceutical water systems FrankvanEde10.00 Environmental monitoring: water monitoring Marco Rijnbeek11.00 Cleaning and desinfection Marco Rijnbeek12.30 Lunch

13.30 Sterilization methods: Filtration and alternative methods Douwe Hoekstra14.30 Case studies: Sterility Assurance in practice - selection of formulation and process - combination of production and QC activities - isolator application in unclassified environment - validation of visual inspection - environmental monitoring trend - start-up after power failure - HEPA filter failure - requirements for vial capping - Fungal contamination in clean room Jos Mathôt16.00 Presentations of the case study results / Evaluation18.00 Dinner

WEDNESDAY, 5 OCTOBER 2016Theme: Validation and qualification of processes and personnelThe role of the QP09.00 Validation of aseptic processes - introduction - technologies - qualification - validation - case studies aseptic processing Jos van der Lubbe11.30 Validation of analytical methods - introduction - validation - specifications Jos van der Lubbe12.15 Operator Qualification - introduction - training - case studies analytical methods and operator qualification Jos van der Lubbe13.00 Lunch14.00 Workshop: the role of the QP in assuring the quality of

sterile pharmaceuticals René Maassen16.00 Evaluation of the course Jos Mathôt16.30 Close

Sterile manufacturing: a thorough discussion on sterility assurance challengesPROGRAM MODULE 33 - 5 October 2016Hotel Bergse Bossen, Driebergen, the Netherlands



COURSE LEADERDrs. J.H.A. MathôtGEHealthcareBV,Eindhoven,theNetherlands

LECTURERSIng. F.H. van EdePharmaEngineering&Consulting(PEC),Drunen,theNetherlands

Ir. D. HoekstraGEHealthcareBV,Eindhoven,theNetherlands

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

Ing. M. RijnbeekPROXYLaboratoriesBV,Dept.MicroSafeLaboratories,Leiden,the Netherlands

M. RuttenMedImmune Pharma BV (Astra Zeneca), Nijmegen, the Netherlands GENERAL INFORMATIONAll the information on registration, cost and starting dates can be found on the page “General Information” and is also availa-ble on the website of www.paofarmacie.nlselect course Quality Management

> Sterile manufacturing: a thorough discussion on sterility assurance challenges

Faculty



MONDAY, 21 NOVEMBER 2016Theme: Cell line development, upstream and downstream09.30 Welcome Aad van de Leur09.45 Introduction to biotechnology: applications and ele-

ments of the biotechnological production process, qual-ity and regulatory aspects

Aad van de Leur11.00 Upstream process development for biopharmaceutical

products: different expression systems and unit operations WoutvanGrunsven12.30 Lunch13.30 Cell line development and cell bank preparation Theory and case study - Genetics: gene of interest; description of the starting

strain(s) or cell line(s); preparation and description of the product strain or cell line; genetic stability during storage of cell bank and during production.

- Cell Bank system: preparation and description of the Master Cell Bank (MCB); testing / in-process controls; protocol for preparation of subsequent Working Cell Bank (WCB).

Nienke Vriezen17.00 Purification survey of unit operations and process integration Marcel Ottens18.30 Dinner

TUESDAY, 22 NOVEMBER 2016Theme: The practice09.00 Design of an industrial process for purification of biologicals MichelEppink10.15 Development, tech transfer and commercial production

of monoclonal antibodies by cell culture Part 1: Introduction: Development and production of

monoclonal antibodies: Criticality (CQA’s, CPP’s, CMA’s)

12.30 Lunch13.30 Part 2: Specification settings: Case Study 1; Technology transfer and Process validation15.00 Part 3: Process fit to plant and Platform technology: Case Study 2; Changes, deviations and CAPA’s in manufacturing Linda Bus-Jacobs and Diana van der Graaf-Harris18.00 Pathogen safety Olaf Stamm19.30 Dinner WEDNESDAY, 23 NOVEMBER 2016Theme: Quality issues09.00 Protein analytics of biopharmaceuticals: relevant assays

and their principles Peter Verhaert10.00 Critical attributes and comparability studies Corne Stroop11.45 Quality attributes of ATMP’s as therapeutic drugs Arno Vulto12.45 Lunch14.00 Biosimilars: a new class of licensed biotech products Arnold Vulto15.15 Immunogenicity and formulation of biopharmaceuticals WimJiskoot16.15 Evaluation of the course Aad van de Leur16.30 Close

Quality and safety for the manufactu-ring of biopharmaceuticals:

From cell line development to downstream process-ing and formulationPROGRAM MODULE 421 - 23 November 2016Hotel Bergse Bossen, Driebergen, the Netherlands



COURSE LEADERDrs. A.C.A.J. van de LeurSynthon Biopharmaceuticals BV, Nijmegen, the Netherlands

LECTURERSL. Bus-Jacobs, MSc, PDEngJanssen Biologics BV, Leiden, the Netherlands

Prof. dr. M.H.M. EppinkSynthon Biopharmaceuticals 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 BV, Oss, the Netherlands

Prof. dr. W. JiskootLeiden/Amsterdam Center for Drug Research (LACDR), Leiden, the Netherlands

Dr. ir. M. OttensDelftUniversityofTechnology,Dept.ofBiotechnology,theNetherlands

Dr. O. StammCharlesRiverBiopharmaceuticalServicesGmbH,Erkrath,Germany Dr. C.J.M. StroopMerck, Sharp & Dohme BV, Oss, the Netherlands

Prof. dr. P.D.E.M. VerhaertDelftUniversityofTechnology,Dept.ofBiotechnology,theNetherlands

Dr. N. VriezenSynthon Biopharmaceuticals BV, Nijmegen, the Netherlands

Prof. dr. A.G. VultoErasmusMC,Rotterdam,theNetherlands

GENERAL INFORMATIONAll the information on registration, cost and starting dates can be found on the page “General Information” and is also availa-ble on the website of www.paofarmacie.nlselect course Quality Management

Faculty

>Fromcelllinedevelopmentto downstream processing and formulation



PROGRAM-/EXAMINATION COMMITTEE

Prof. dr. W. Jiskoot (chairman)Leiden/Amsterdam Centre for Drug Research (LACDR), Leiden, the Netherlands

Dr. ir. J.L.M. van der Lubbe (vice chairman)Pharming Technologies BV, Leiden, the Netherlands

Prof. dr. H.W. FrijlinkGroningenUniversityInstituteforDrugExploration(GUIDE),Dept.ofPharmaceuticalTechnologyandBiopharmacy,Groningen,the Netherlands

Dr. L.G.J. de LeedeExelionBio-PharmaceuticalConsultancyBV,Waddinxveen,the Netherlands

Drs. A.C.A.J. van de LeurSynthon Biopharmaceuticals BV, Nijmegen, the Netherlands

Drs. J. MathôtGEHealthcare,Eindhoven,theNetherlands

Dr. V.L.C. Moffat

Prof. dr. P.D.E.M. VerhaertDelft University of Technology,Dept.ofBiotechnology,Delft,theNetherlands

SCIENTIFIC ADVISORY BOARDHonorary Members

Prof. dr. D.D. BreimerFormerlyRectorMagnificus,LeidenUniversity,theNetherlands

Prof. dr. ir. G.W.K. van DedemFormerlyDiosynth,Oss,theNetherlands

Drs. P.H. VreeFormerlyChairmanNationalPharmacopoeiaAuthority,the Netherlands

Dr. M. van der WaartFormerlyOrganon/ScheringPlough,Oss,theNetherlands

SCIENTIFIC ADVISORY BOARDMembers

Prof. dr. H.J. de Jong (chairman) Formerly:LeidenUniversity,theNetherlands,ServierR&D,Courbe-voie,France,andEuropeanPharmacopoeia,Strasbourg,France

J. BroersenAspen Oss BV, Oss, the Netherlands

Dr. P.H.H. Le BrunApotheek Haagse Ziekenhuizen, Den Haag, the Netherlands

Prof. dr. M. DanhofLeiden/Amsterdam Center for Drug Research(LACDR), Leiden University, the Netherlands

Dr. M.H. Dearden

Drs. E. Ligtenberg AbbottHealthcareProductsBV,Weesp,theNetherlands

Drs. M.M. van der MeulenHealth Care Inspectorate (IGZ), Den Haag, the Netherlands

Dr. M. MoesterHealth Care Inspectorate (IGZ), Den Haag, the Netherlands

Drs. M.M.G. PubbenMMG Pubben Consulting BV, Haarlem, the Netherlands

Dr. A. RietveldHealth Care Inspectorate (IGZ), Utrecht, the Netherlands

Dr. R. SantingSinensis Life Sciences BV, Leiden, the Netherlands

Drs. T. VeenbaasApotheek Albert Schweitzerziekenhuis, Dordrecht, the Netherlands

Prof. dr. H. VromansUtrecht University, Pharmaceutical Sciences, Utrecht, the Netherlands

Dr. J. van ZutvenMSD, Oss, the Netherlands

Committee and board



PARTNERSHIPThe Netherlands Centre for Post-Academic Education in Phar-macy (PAOFarmacie) is a professional partnership between Pharmaceutical Sciences at Utrecht University (UU), the faculty of Medical Sciences of the University of Groningen (RuG), the Royal Dutch Pharmacists Association (KNMP), the Association of Dutch industrial Pharmacists (NIA) and the Dutch Association of Hospital Pharmacists (NVZA). The Board and Scientific Board of PAOFarmacie are formed by representatives of this professional partnership.

BOARDRepresentatives of state universities and pharmaceutical asso-ciations form the board of PAOFarmacie. The board is responsi-ble for policy, finance and personnel.

Prof. dr. A. de Boer chairmanProf. dr. B. Wilffert secretaryDrs. A.J. van der Werff chairmanoffinanceDr. C. Oussoren board memberDrs. M.J.G. van de Lustgraaaf-Wielens board memberDr. F.G.A. Jansman board member

ADVISORY BOARDMembers of the Advisory Board (PAR) are linked to national universities and pharmaceutical associations. Their aim is to further develop the curriculum of PAOFarmacie. In the PAR members of science and practice meet. They propose new top-ics for further training, continue development of existing topics and guarantee the scientific quality.

Prof. dr. J.J. de Gier chairman (RuG)Prof. dr. A.C.G. Egberts (NVZA)Dr. B. Koch (PUOZ)Drs. A. Heersche (UU)Dr. H. Buurma (KNMP)Dr. B.J.F. van den Bemt(NVPF)Prof. dr. K. Taxis (RuG)Dr. F.J. van de Vaart (KNMP)Drs. A. Nooij (KNMP)Ms. A. Hildebrand (StRIA / NIA)M.C. Hessels (VJA)

CHIEFEXECUTIVEOFFICERSharonSchouten-TjinATsoi,PharmDNetherlandsCentreforPost-AcademicEducationinPharmacy

THE ISO STANDARDPAOFarmacie is certified to the ISO standard since 2009

PAOFarmacie offers Post-Academic Education in Pharmacy



Module 1 Quality Management, the role of the Qualified Person29February–2March2016Module 2 Drug development from Quality by Design to clinical studies: an integrated course for the pharmaceuticalindustry and hospital pharmacy30May–2June2016Module 3 Sterile manufacturing: a thorough discussion onsterility assurance challenges3–5October2016Module 4 Quality and safety for the manufacturing of biophar-maceuticals: from cell line development to downstream proces-sing and formulation21–23November2016

AIMThe course offers an integrated approach on quality manage-ment in the pharmaceutical, biotechnological, medical device in-dustries and hospitals to safeguard the quality of their products. Expert knowledge and real life case studies are combined and presented and coached by professionals from Industry, Univer-sities and Health Care Inspectorates. The training is interactive.

TARGET GROUPS- Professionals in pharmaceutical, biotechnological and medical

device industries- Professionals in institutions and Contract Research Organisati-

ons (CRO’s)- Hospital pharmacists- Postgraduate studentsFor (young) professionals in Research and Development, Pro-duction, Packaging, Quality Control and Quality Assurance or Regulatory Affairs, who are dealing with the complexity of quality systems, it is important to have an overview of these systems in order to improve quality management in their own environment.

CERTIFICATES & DIPLOMAYou can select individual course modules best suited to comple-ment your education or experience. After attending a module, you will receive a certificate for attendance. In addition, the participants are offered the possibility to complete the modules through an examination. The examination sessions will be sche-duled twice per year. In combination with a university degree in e.g. pharmacy, biology, chemistry or engineering, and with industrial experience, successful completion of the modules of the training course forms a good starting point to apply for Qualified Person (QP) status.

ACCREDITATIONFor hospital pharmacists in the Netherlands: accreditati-on-hours are requested for each course module attended.

ORGANISATIONThe training course is organized by Netherlands Centre for Post-Academic Education in Pharmacy: www.paofarmacie.nlIn close collaboration with:- Leiden/Amsterdam Center for Drug Research (LACDR):

www.lacdr.nl- Groningen University Institute for Drug Exploration (GUIDE):

www.rug.nl/guide- Biotechnology Studies Delft Leiden (BSDL):

www.bsdl-edu.bt.tudelft.nl- Top Institute Pharma: www.tipharma.com- European Federation of Pharmaceutical Sciences (EUFEPS):

www.eufeps.org- International Pharmaceutical Federation (FIP):

www.industrialpharmacy.org

WHERE?All modules are organized in :Hotel Bergse Bossen, Driebergen, the NetherlandsTraaij 2993971 GM DRIEBERGENT +31 (0)343 528150E [email protected]

STANDARD COURSE FEEThe standard fee of Module 1, 3 and 4 is € 1700,00 excl. 21% VAT.The standard fee of Module 2 is € 2100,00 excl. 21% VAT.The fee includes hotel accomodation, course notes, drinks, lunches and dinners. In the event of cancellation we refere to the general terms of condition of PAOFarmacie (www.paofarmacie.nl).

REDUCED COURSE FEEUpon subscription by the same person for the modules 1, 2, 3 and 4, the total fee is € 5760,00 excl. 21% VAT.For PhD-students and and PDeng-trainees a limited number of fellowships (25% of the standard fee) is available. To apply, send a copy of your registration as a PhD-student or PDEng-trainee to [email protected]

REGISTRATIONFor registration, please submit your application on-line viawww.paofarmacie.nlselect course Quality Management

INFORMATIONPAOFarmacie, Zeist, the NetherlandsT: +31 (0)30 3040100E: [email protected]

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training course quality management in pharma and … · an integrated course for the pharmaceutical...

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