TRAINING COURSE QUALITY MANAGEMENT IN PHARMA AND BIOTECH 2015

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1 TRAINING COURSE QUALITY MANAGEMENT IN PHARMA AND BIOTECH 2015 MODULES M1 M2 M3 M4 Quality management, the role of the Qualified Person Drug development from Quality by Design to clinical studies: an integrated course for the pharmaceutical industry and hospital pharmacy Sterile manufacturing: a thorough discussion on sterility assurance challenges Quality and safety for the manufacturing of biopharmaceuticals: from cell line development to downstream processing and formulation

2 TRAINING COURSE QUALITY MANAGEMENT IN PHARMA AND BIOTECH QUALITY MANAGEMENT, THE ROLE OF THE QUALIFIED PERSON PROGRAM 2-4 March 2015 Hotel Bergse Bossen, Driebergen, MONDAY, 2 MARCH 2015 Themes: The role and legal obligations of the Qualified Person Introduction to current concepts in Quality Management Welcome and Introduction Vivien Moffat Responsibilities of the Qualified Person (QP) : International regulations Current views from the Inspectorate Mieke van der Meulen Break Responsibilities of the Qualified Person (QP) for batch release of commercial and Investigational products (IMPs) Mieke van der Meulen The role and duties of the Qualified Person in Pharmaceutical Quality Management and the supply of medicines to the European Community Marijke Pubben The role and duties of the Qualified Person in Pharmaceutical Quality Management and the supply of medicines to the European Community (continued) Marijke Pubben Case study addressing the issues facing the QP in an integrated approach to Quality Assurance in a pharmaceutical environment Marijke Pubben and Vivien Moffat Presentations and discussions Break Good Distribution Practice: the new EU requirements and the role of the Responsible Person Reikert Bruinink Dinner TUESDAY, 3 MARCH 2015 Theme: Quality management and maintaining compliance in the current Quality environment Quality systems: Deviation management Mirjam te Koppele Compliance, change control and audits Jolande Schoemaker Break Case study: in compliance or not in compliance? Jolande Schoemaker Active pharmaceutical Ingredients (APIs) and the QP Declaration Desiree Vendrig Introduction to the case study Creatis and BODL 2000 Dominique Mudde Case study: preparation for an inspection of the manufacturing of the antidepressant BODL 2000 Dominique Mudde Break The fight against counterfeit medicines : the new falsified medicines directive and securing the supply chain for patients Jean-Michel Guirado Dinner Introduction to the workshop : the real world Pedro Tetteroo,Vivien Moffat and Eric van Wensveen WEDNESDAY, 4 MARCH 2015 Theme: Operating effectively as a QP in the complex world of pharmaceutical manufacturing The international QP Tesh Patel Break Continuation of the lecture and discussions Break Experiences from a QP in industry Eric van Wensveen and in a hospital pharmacy Katja van Rij Workshop: the real world Pedro Tetteroo, Mirjam te Koppele, Vivien Moffat, and Eric van Wensveen Lessons from the workshop Evaluation of the course and concluding remarks Vivien Moffat Close

3 M1 FACULTY COURSE LEADER Dr. V.L.C. Moffat Amgen BV, Breda, LECTURERS Drs. R. Bruinink Health Care Inspectorate (IGZ), Utrecht, Ir. J-M. Guirado Amgen BV, Breda, Drs. M.A. te Koppele Novartis Pharma BV, Arnhem, Drs. D. Vendrig TEVA Pharmaceuticals, Haarlem, Drs. E. van Wensveen Mallinckrodt Medical B.V., Petten, GENERAL INFORMATION All the information on registration, cost and starting dates can be found on the page General Information and is also available on the website of select course Quality Management Drs. M. van der Meulen Health Care Inspectorate (IGZ), Utrecht, D.M. Mudde HAL Allergy, Leiden, Dr. T.K. Patel Astellas Pharma Europe Ltd., Staines, United Kingdom Drs. M.M.G. Pubben MMG Pubben Consulting BV, Haarlem, Drs. C.M. van Rij Clinical Pharmacy, UMC St Radboud, Nijmegen, Drs. T.J. Schoemaker Schoemaker Consultancy, Nieuw-Dordrecht, Dr. P.A.T. Tetteroo Tetteroo Coaching & Consulting, Oegstgeest, photo from Synthon BV, Nijmegen

4 TRAINING COURSE QUALITY MANAGEMENT IN PHARMA AND BIOTECH DRUG DEVELOPMENT FROM QUALITY BY DESIGN TO CLINICAL STUDIES: AN INTEGRATED COURSE FOR THE PHARMACEUTICAL INDUSTRY AND HOSPITAL PHARMACY PROGRAM 1-4 June 2015 Hotel Bergse Bossen, Driebergen, MONDAY, 1 JUNE 2015 Theme: Medicinal chemistry, pharmaceutical formulations, large scale production Welcome and introduction Erik Frijlink and Leo de Leede Introduction of the case study: antidepressant BODL 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 Good Regulatory Practice (GRP) and the quality of the company Leo de Leede Medicinal chemistry: quality in lead finding and lead optimization Jac Wijkmans Quality requirements from process chemistry to large scale production Michel Guillaume Pharmaceutical formulations - the development of drug products - quality management and cgmp in pharmaceutical development - small scale production - from small scale to large scale Erik Frijlink Dinner TUESDAY, 2 JUNE 2015 Theme: Quality by Design in industry and hospital pharmacy, GMP applied Objectives of the day, focus on GMP: Jan-Jaap Scherpbier Quality part of registration dossier Jan-Jaap Scherpbier From R&D to production - Quality by Design - PAT and PCT in industry and hospital pharmacy Erik Frijlink Total Quality Management obtained by Quality by Design - real life examples in industry Saskia Sturm 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-Jaap Scherpbier and Erik Frijlink Group presentations Wrap up of the case The development of oncolytic drug products: the Slotervaart case Jos Beijnen Dinner WEDNESDAY, 3 JUNE 2015 Theme: Pre-clinical development, GLP applied, personal skills Objectives of the day, focus on GLP Ineke Jonker-Hoogerkamp Introduction to GLP Chris Mitchell Pharmacokinetics and pharmacodynamics (PK/PD) in industrial practice Peter Vis Toxicology, BODL 2000 in focus Eric de Waal Lunch Case study BODL 2000: GLP and regulatory aspects of pharmacokinetics, pharmacodynamics and toxicological studies: - action steps for the preparation and execution of the toxicological study to guarantee that it will be a GLP compliant study - is there a need for additional requirements from GLP perspective for a multi-site study? - are additional data from tox studies required for registration of BODL 2000? Ineke Jonker-Hoogerkamp and Chris Mitchell Group presentations Wrap up of the case study Events occurring in industry and hospital pharmacy, not appreciated by inspectors Annie Rietveld Workshop skills required in drug development Real life example: mix-up in a wallet Annie Rietveld, Erik Frijlink and Leo de Leede 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 Erik Frijlink and Leo de Leede Dinner THURSDAY, 4 JUNE 2015 Theme: Clinical development, GCP applied Objectives of the day, focus on GCP Eveline Krijger and Lisette Vromans Clinical development Phase I Principles, clinical study documents, requirements for a Phase I clinic, clinical pharmacology, types of Phase I studies Leo de Leede 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 Lunch Reflection to the lectures and the case study 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 Eveline Krijger and Lisette Vromans Group presentations Wrap up of the case study Evaluation of the course and learned lessons Erik Frijlink Close

5 M2 FACULTY COURSE LEADERS Prof.dr. H.W. Frijlink Groningen University Institute for Drug Exploration (GUIDE), Dept. of Pharmaceutical Technology and Biopharmacy, Dr. L.G.J. de Leede Exelion Bio-Pharmaceutical Consultancy BV, Waddinxveen, LECTURERS Prof.dr. J.H. Beijnen NKI and Slotervaart Hospital, Amsterdam, Dr. M. Guillaume Janssen Pharmaceutica NV, Beerse, Belgium Dr. A. Jonker-Hoogerkamp Genzyme Europe, Naarden, Ir. E. Krijger Merck, Sharp & Dohme, Oss, Drs. P.C. Matthijsse Trial Form Support, Berghem, C. Mitchell, BSc WilResearch, s-hertogenbosch, Health Care Inspectorate (IGZ), Utrecht, Drs. J.J. Scherpbier Sonsbeek Pharma Consultancy BV, Arnhem, Drs. S.E. Sturm Merck, Sharp & Dohme BV, Haarlem, Mr. P. Vis Janssen Pharmaceutica NV, Beerse, Belgium Ms. E.W.M. Vromans Merck, Sharp & Dohme, Oss, Dr. E.J. de Waal Janssen Pharmaceutica NV, Beerse, Belgium Dr. J.C.H.M. Wijkmans Griffin Discoveries, Amsterdam, GENERAL INFORMATION All the information on registration, cost and starting dates can be found on the page General Information and is also available on the website of select course Quality Management Dr. A. Rietveld

6 TRAINING COURSE QUALITY MANAGEMENT IN PHARMA AND BIOTECH STERILE MANUFACTURING: A THOROUGH DISCUSSION ON STERILITY ASSURANCE CHALLENGES PROGRAM 5 7 October 2015 Hotel Bergse Bossen, Driebergen, MONDAY, 5 OCTOBER 2015 Theme: Microbiology and sterility: execution and control Welcome and outline of the course Jos Mathôt Biology of microorganisms Implications for pharmaceutical production and quality control Speaker to be confirmed Sterile manufacturing: a philosophy on design and control Jos Mathôt 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 Rijnbeek Case study Environmental monitoring: Marco Rijnbeek Sterilization methods: steam, dry heat Exercises for steam Douwe Hoekstra Film: Parenteral production at MedImmune, Nijmegen Marco Rutten Dinner The gowning procedure Marco Rutten TUESDAY, 6 OCTOBER 2015 Theme: Water systems and parenteral production Sterility assurance in practice Pharmaceutical water systems Frank van Ede Environmental monitoring: water monitoring Marco Rijnbeek Cleaning and desinfection Marco Rijnbeek Sterilization methods: Filtration and alternative methods Douwe Hoekstra 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 Mathôt Presentations of the case study results Evaluation Dinner WEDNESDAY, 7 OCTOBER 2015 Theme: Validation and qualification of processes and personnel The role of the QP Validation of aseptic processes - introduction - technologies - qualification - validation - case studies aseptic processing Jos van der Lubbe Validation of analytical methods - introduction - validation - specifications Jos van der Lubbe Operator Qualification - introduction - training - case studies analytical methods and operator qualification Jos van der Lubbe Lunch Workshop: the role of the QP in assuring the quality of sterile pharmaceuticals René Maassen Evaluation of the course Jos Mathôt Close

7 M3 FACULTY COURSE LEADER Drs. J.H.A. Mathôt GE Healthcare BV, Eindhoven, LECTURERS Ing. F.H. van Ede Pharma Engineering & Consulting (PEC), Drunen, GENERAL INFORMATION All the information on registration, cost and starting dates can be found on the page General Information and is also available on the website of select course Quality Management Ir. D. Hoekstra GE Healthcare BV, Eindhoven, M. Rutten MedImmune Pharma BV (Astra Zeneca), Nijmegen, Dr.ir. J.L.M. van der Lubbe Pharming Technologies BV, Leiden, Drs. R.H.L.M. Maassen Pharmaceutical Consultancy Services, PCS, Haastrecht, Ing. M. Rijnbeek PROXY Laboratories BV, Dept. MicroSafe Laboratories, Leiden,

8 TRAINING COURSE QUALITY MANAGEMENT IN PHARMA AND BIOTECH QUALITY AND SAFETY FOR THE MANUFACTURING OF BIOPHARMACEUTICALS: FROM CELL LINE DEVELOPMENT TO DOWNSTREAM PROCESSING AND FORMULATION PROGRAM November 2015 Hotel Bergse Bossen, Driebergen, MONDAY, 23 NOVEMBER 2015 Theme: Cell line development, upstream and downstream Welcome Aad van de Leur Introduction to biotechnology: applications and elements of the biotechnological production process, quality and regulatory aspects Aad van de Leur Upstream process development for biopharmaceutical products: different expression systems and unit operations Wout van Grunsven 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 Vriezen Purification survey of unit operations and process integration Marcel Ottens Dinner WEDNESDAY, 25 NOVEMBER 2015 Theme: Quality issues Protein analytics of biopharmaceuticals: relevant assays and their principles Peter Verhaert Critical attributes and comparability studies Corne Stroop Quality attributes of ATMP s as therapeutic drugs Arno Vulto Lunch Biosimilars: a new class of licensed biotech products Arnold Vulto Immunogenicity and formulation of biopharmaceuticals Vera Brinks Evaluation of the course Aad van de Leur Close TUESDAY, 24 NOVEMBER 2015 Theme: The practice Design of an industrial process for purification of biologicals Michel Eppink 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) Part 2: Specification settings: Case Study 1; Technology transfer and Process validation 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-Harris Pathogen safety Olaf Stamm Dinner

9 M4 FACULTY COURSE LEADER Drs. A.C.A.J. van de Leur Synthon Biopharmaceuticals BV, Nijmegen, LECTURERS Dr. V. Brinks ProQR Therapeutics, Leiden, L. Bus-Jacobs, MSc, PDEng Janssen Biologics BV, Leiden, Prof. Dr. M.H.M. Eppink Synthon Biopharmaceuticals BV, Nijmegen, Dr. C.J.M. Stroop Merck, Sharp & Dohme BV, Oss, Prof.dr. P.D.E.M. Verhaert Delft University of Technology, Dept. of Biotechnology, Dr. N. Vriezen Synthon Biopharmaceuticals BV, Nijmegen, Prof.dr. A.G. Vulto Erasmus MC, Rotterdam, D.M. van der Graaf-Harris, M.Biotech, PhD Janssen Biologics BV, Leiden, Dr. W.M.J. van Grunsven Merck, Sharp & Dohme BV, Oss, Dr.ir. M. Ottens Delft University of Technology, Dept. of Biotechnology, Dr. O. Stamm Charles River Biopharmaceutical Services GmbH, Erkrath, Germany GENERAL INFORMATION All the information on registration, cost and starting dates can be found on the page General Information and is also available on the website of select course Quality Management

10 COMMITTEE AND BOARD PROGRAM-/EXAMINATION COMMITTEE Prof.dr. W. Jiskoot (chairman) Leiden/Amsterdam Centre for Drug Research (LACDR), Leiden, Dr. ir. J.L.M. van der Lubbe (vice chairman) Pharming Technologies BV, Leiden, Prof.dr. H.W. Frijlink Groningen University Institute for Drug Exploration (GUIDE), Dept. of Pharmaceutical Technology and Biopharmacy, Groningen, Dr. L.G.J. de Leede Exelion Bio-Pharmaceutical Consultancy BV, Waddinxveen, Drs. A.C.A.J. van de Leur Synthon Biopharmaceuticals BV, Nijmegen, Drs. J. Mathôt GE Healthcare, Eindhoven, Dr. V.L.C. Moffat Amgen BV, Breda, Prof. dr. P.D.E.M. Verhaert Delft University of Technology, Dept. of Biotechnology, Delft, SCIENTIFIC ADVISORY BOARD Honorary Members Prof. dr. D.D. Breimer Formerly Rector Magnificus, Leiden University, SCIENTIFIC ADVISORY BOARD Members Prof. dr. H.J. de Jong (chairman) Formerly: Leiden University,, Servier R&D, Courbevoie, France, and European Pharmacopoeia, Strasbourg, France Dr. P.H.H. Le Brun Apotheek Haagse Ziekenhuizen, Den Haag, Prof.dr. M. Danhof Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, Dr. M.H. Dearden Drs. E.W. de Flines Dr. M. Moester Health Care Inspectorate (IGZ), Den Haag, Drs. M.M.G. Pubben MMG Pubben Consulting BV, Haarlem, Dr. A. Rietveld Health Care Inspectorate (IGZ), Utrecht, Dr. A.P. Sam FIP s Industrial Pharmacy Section, Prof. dr. H. Vromans Utrecht University, Pharmaceutical Sciences, Utrecht, Prof.dr.ir. G.W.K. van Dedem Formerly Diosynth, Oss, Drs. P.H. Vree Formerly Chairman National Pharmacopoeia Authority, Dr. M. van der Waart Formerly Organon / Schering Plough, Oss,

11 PAOFARMACIE Netherlands Centre for Post-Academic Education in Pharmacy PAOFarmacie offers Post-Academic Education in Pharmacy CHIEF EXECUTIVE OFFICER Sharon Schouten-Tjin A Tsoi, Pharm D Netherlands Centre for Post-Academic Education in Pharmacy PARTNERSHIP The Netherlands Centre for Post-Academic Education in Pharmacy (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. BOARD Representatives of state universities and pharmaceutical associations form the board of PAOFarmacie. The board is responsible for policy, finance and personnel. Prof.dr. A. de Boer chairman Prof dr. B. Wilffert secretary Drs. R.J. Wolters chairman of finance Dr. T. Schalekamp board member Drs. R. Dessing board member Drs. M.M. Tjoeng board member ADVISORY BOARD Members 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 topics 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. C.F. Ebbelaar (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) THE ISO STANDARD PAOFarmacie is certified to the ISO standard since 2009 ISO9001

12 GENERAL INFORMATION M1 Quality Management, the role of the Qualified Person 2 4 March 2015 M2 Drug development from Quality by Design to clinical studies: an integrated course for the pharmaceutical industry and hospital pharmacy 1 4 June 2015 M3 Sterile manufacturing: a thorough discussion on sterility assurance challenges 5 7 October 2015 M4 Quality and safety for the manufacturing of biopharmaceuticals: from cell line development to downstream processing and formulation November 2015 AIM The course offers an integrated approach on quality management in the pharmaceutical, biotechnological, medical device industries 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, Universities and Health Care Inspectorates. The training is interactive. TARGET GROUPS - Professionals in pharmaceutical, biotechnological and medical device industries - Professionals in institutions and Contract Research Organisations (CRO s) - Hospital pharmacists - Postgraduate students For (young) professionals in Research and Development, Production, 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 & DIPLOMA You can select individual course modules best suited to complement 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 scheduled 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. ACCREDITATION For hospital pharmacists in : accreditation-hours are requested for each course module attended. ORGANISATION The training course is organized by Netherlands Centre for Post-Academic Education in Pharmacy: In close collaboration with: - Leiden/Amsterdam Center for Drug Research (LACDR): - Groningen University Institute for Drug Exploration (GUIDE): - Biotechnology Studies Delft Leiden (BSDL): - Top Institute Pharma: - European Federation of Pharmaceutical Sciences (EUFEPS): - International Pharmaceutical Federation (FIP): WHERE? All modules are organized in : Hotel Bergse Bossen, Driebergen, Traaij GM DRIEBERGEN T +31 (0) E STANDARD COURSE FEE The 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 FEE Upon 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 REGISTRATION For registration, please submit your application on-line via select course Quality Management INFORMATION PAOFarmacie, Zeist, T: +31 (0) E: Program changes reserved PAOFARMACIE Netherlands Centre for Post-Academic Education in Pharmacy since 2001 adress: Broederplein 39, Zeist 3703 CD Zeist Antwoordnummer 5519, 3700 VB Zeist phone: +31 (0) fax +31 (0)

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