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Strategies for Structured Product Information Management

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Strategies for Structured Product Information Management EMA’s Product Information Management (PIM) project halted – Impact from the perspective of biotech companies on strategies for structured product information management Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels „Master of Drug Regulatory Affairs“ der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von Dr. André Dorochevsky aus Augsburg Bonn 2011 Dr. André Dorochevsky Page 2 Strategies for structured product information management 04 July 2011 Betreuer und 1. Referent: Dr. Barbara Lachmann Zweiter Referent: Dr. Klaus Menges Dr. André Dorochevsky Page 3 Strategies for structured product information management 04 July 2011 TABLE OF CONTENTS TABLE OF CONTENTS........................................................................................................ 3 LIST OF TABLES .................................................................................................................. 5 LIST OF FIGURES ................................................................................................................ 5 LIST OF ABBREVIATIONS................................................................................................. 6 INTRODUCTION................................................................................................................... 8 1 THE BASIS OF STRUCTURED CONTENT: COMPONENT-BASED AUTHORING........................................................................................................... 10 1.1 PRINCIPLE OF COMPONENT-BASED AUTHORING ................................. 10 1.2 STRUCTURED (= COMPONENT-BASED AUTHORED) CONTENT EXCHANGE VIA XML .................................................................................... 12 2 POTENTIAL OF STRUCTURED CONTENT EXCHANGE: HEALTH AUTHORITY INITIATIVES ................................................................................. 13 2.1 STRUCTURED PRODUCT LABELING (SPL) IN THE US........................... 13 2.2 PRODUCT INFORMATION MANAGEMENT (PIM) IN EUROPE .............. 15 2.2.1 Structure of product information for centrally authorised products............ 16 2.2.2 Structure of a PIM file ................................................................................ 17 2.2.2.1 The tree zone: Flexible data model for the PI of CAPs....................... 18 2.2.2.2 The document zone: Flexible PI document generation ....................... 22 2.2.3 Life cycle management of the PI of CAPs with PIM.................................. 22 2.2.4 Layout of PI documents and customization of QRD templates.................. 26 3 IMPACT OF HEALTH AUTHORITY INITIATIVES ....................................... 27 3.1 STRUCTURED PRODUCT LABELING (SPL) IN THE US........................... 27 3.2 PRODUCT INFORMATION MANAGEMENT (PIM) IN EUROPE .............. 27 4 THE PHARMACEUTICAL INDUSTRY PERSPECTIVE................................. 30 4.1 POTENTIAL BENEFITS ASSOCIATED WITH THE TRANSITION FROM WORD-BASED TO COMPONENT-BASED AUTHORING .............. 31 4.1.1 Content re-use ............................................................................................. 31 4.1.2 Preparation of product information documents........................................... 33 4.2 BASIC FUNCTIONAL REQUIREMENTS FOR AUTHORING TOOLS....... 33 4.3 EXTENDED SCOPE: COMPREHENSIVE LABELLING SYSTEMS............ 34 4.3.1 Support of legal compliance ....................................................................... 35 4.3.2 Support of GMP compliance....................................................................... 36 4.3.3 Translation support ..................................................................................... 36 4.3.4 Support of associated processes.................................................................. 36 Dr. André Dorochevsky Page 4 Strategies for structured product information management 04 July 2011 4.4 IMPLEMENTATION OPTIONS: GENERAL COST-BENEFIT CONSIDERATIONS AND BASIC CRITERIA FOR DECISION ANALYSIS ........................................................................................................ 37 5 THE BIOTECH VIEW ON STRUCTURED PRODUCT INFORMATION MANAGEMENT...................................................................................................... 43 5.1 EVALUATION OF IMPLEMENTATION OPTIONS FROM THE BIOTECH PERSPECTIVE................................................................................ 43 5.2 IMPACT OF THE PIM PROJECT BEING HALTED ...................................... 44 6 OUTLOOK AND CONCLUSIONS ....................................................................... 46 LIST OF REFERENCES ..................................................................................................... 49 APPENDIX 1: SCREENSHOT SPLFORM_DRUGLISTING.XHTML......................... 53 APPENDIX 2: SCREENSHOT LAT V 4.2......................................................................... 54 APPENDIX 3: COMPANIES WITH CENTRALLY APPROVED PRODUCTS .......... 55 Dr. André Dorochevsky Page 5 Strategies for structured product information management 04 July 2011 LIST OF TABLES Table 1 Elements used for the generation of the name of the medicinal product in different PI documents....................................................................................... 21 Table 2 Levels where PI documents can be generated ................................................... 22 Table 3 Key exchange steps for an initial MAA............................................................. 25 Table 4 Basic functions required for authoring tools...................................................... 34 Table 5 Evaluation of alternative implementation designs: Performance criteria .......... 39 Table 6 Evaluation of alternative implementation designs: Cost criteria ....................... 40 LIST OF FIGURES Figure 1 EMA implementation plan for PIM for centrally approved products (Status: September 2009).................................................................................................. 8 Figure 2 Principle of component-based authoring ........................................................... 11 Figure 3 Exchange of PDF documents versus exchange of structured content via XML .................................................................................................................. 12 Figure 4 Structure of an SPL file ..................................................................................... 15 Figure 5 Instability of the DES standard.......................................................................... 16 Figure 6 Data exchange standard (DES): Hierarchical data model.................................. 18 Figure 7 Structure of a PIM file ....................................................................................... 20 Figure 8 Data exchange standard (DES): Multiplication of branches.............................. 21 Figure 9 Components of the PIM system......................................................................... 24 Figure 10 Statistics on companies involved in the centralised procedure according to the number of CAPs per company..................................................................... 29 Figure 11 Workload savings potential in dependence of the complexity of the product information......................................................................................................... 32 Figure 12 Workload savings potential in dependence of the complexity of the product information, the activity and the number of managed products ........................ 33 Figure 13 Evaluation of alternative implementation designs: Performance criteria .......... 41 Figure 14 Evaluation of alternative implementation designs: Cost criteria ....................... 41 Figure 15 Evaluation of alternative implementation designs from the biotech perspective ......................................................................................................... 44 Dr. André Dorochevsky Page 6 Strategies for structured product information management 04 July 2011 LIST OF ABBREVIATIONS ANSI American National Standards Institute AR Assessment report CAPs Centrally authorised products CBER Center for Biologics Evaluation and Research CC Country code CCDS Company core data sheet CCM Component content management CCSI Company core safety information CDER Center for Drug Evaluation and Research CEN European Committee for Standardization CFR Code of Federal Regulations CHMP Committee for Medicinal Products for Human Use CIOMS Council for International Organizations of Medical Sciences CP Centralized procedure CRO Contract research organisation DCP Decentralised procedure DES Data Exchange Standard DITA Darwin Information Typing Architecture DRLS Drug Registration and Listing System EC European Commission EFPIA European Federation of Pharmaceutical Industries and Associations EMA European Medicines Agency EN English EPAR European public assessment report EU European Union FDA US Food and Drug Administration FTE Full time equivalent GMP Good Manufacturing Practice HA Health authority HL7 Health Level Seven International HTML Hypertext Markup Language ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ID Identifier IDMP Identification of Medicinal Products ISO International Organization for Standardization IT Information technology JAR Joint assessment report LAT Light Authoring Tool LOINC Logical Observation Identifiers Names and Codes LoOI List of outstanding
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