DOCSLIB.ORG

Download Master-Thesis

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Download Master-Thesis The impact of the revised EU-legislation concerning particular needs of blind and partially-sighted patients and user testing – a challenge for pharmaceutical companies with focus on Germany Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels „Master of Drug Regulatory Affairs“ der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von Dr. Ursula Schickel aus Limburg/Lahn Bonn 2007 Betreuer und 1. Referent: Frau Prof. Dr. B. Sickmüller Zweiter Referent: Herr W. Gering Table of Contents 1 Introduction............................................................................................................... 9 2 Braille requirements for labelling and the package leaflet ...................................... 10 2.1 Regulatory background....................................................................................... 10 2.2 The Braille alphabet............................................................................................ 11 2.3 Status of implementation at European member state level................................. 13 2.3.1 Status of implementation of Braille labelling in Germany............................. 13 2.3.1.1 Transition provisions................................................................................ 14 2.3.1.2 Facilitations according to German Drug Law............................................ 15 2.3.1.3 Marburg Medium for Braille characters .................................................... 16 2.4 Implementation of Braille on the packaging in the pharmaceutical industry........ 17 2.4.1 Preparation of Braille labelling on the packaging......................................... 17 2.4.1.1 Translation in Braille................................................................................. 17 2.4.1.2 Nationally different special characters in Braille for European languages 18 2.4.1.3 Braille labelling for multilingual packaging................................................ 20 2.4.1.4 Requirements for Braille on folding cartons (technical aspects)............... 21 2.4.2 Implications on the outer packaging materials, manufacture and release ...... procedures................................................................................................... 24 2.4.2.1 Description of necessary internal steps for creation of Braille labelling ....... on folding cartons and proposal for a workflow within pharmaceutical ........ companies ................................................................................................ 24 2.4.2.2 Implications for internal release of Braille-labelled folding cartons........... 28 2.4.2.3 Implications on regulatory activities for Braille labelling ........................... 29 2.5 Package information leaflets in formats appropriate for the blind and ................... partially-sighted................................................................................................... 30 2.5.1 Potential approaches for implementation in the pharmaceutical industry .... 31 2.5.1.1 Implementation in Germany: The RLS-Project......................................... 32 2.5.1.1.1 Technical aspects of the RLS-project ............................................... 34 2.5.1.1.2 Responsibilities according to the German Drug Law with respect ....... to the RLS-project and legal aspects ................................................ 35 2.5.1.1.3 Potential shortcomings of the RLS-project........................................ 37 2.5.1.2 Guidelines from the European Blind Union (EBU) and implementation ....... in the United Kingdom (UK), the Netherlands and Sweden...................... 38 2.6 Critical evaluation................................................................................................ 41 2.6.1 Braille labelling............................................................................................. 41 3 2.6.2 Package leaflets in formats appropriate for blind and partially-sighted ........... patients ........................................................................................................ 44 3 Readability of package leaflets of medicinal products for human use ................... 46 3.1 Regulatory and historical background................................................................. 46 3.1.1 Situation in Germany ................................................................................... 46 3.1.1.1 Purpose of package leaflets and liability aspects..................................... 47 3.1.2 Situation in Europe ...................................................................................... 47 3.1.3 Requirements for package leaflets and main objections.............................. 48 3.1.4 Readability guidelines on European level and in Germany.......................... 50 3.2 Consultation with target patient groups by interview technique based ................... on the “Australian method”.................................................................................. 53 3.2.1 Description and evaluation of procedure and major steps ........................... 54 3.2.1.1 Performing of and preparation for the test................................................ 55 3.2.1.2 Selecting participants and recruitment ..................................................... 57 3.2.1.3 Sample size and use................................................................................ 60 3.2.1.4 Success criteria........................................................................................ 61 3.2.1.5 Test protocol ............................................................................................ 63 3.2.2 Structure of testing report for marketing authorisation application............... 65 3.3 Description of further methods for testing ........................................................... 67 3.3.1 Standardised interview in writing according to Fuchs .................................. 67 3.3.2 Communication science based approach .................................................... 68 3.3.3 Communication and discussion with specific patient groups ....................... 70 3.4 Timing of submission to the competent authorities ............................................. 71 3.5 Justification for waivers and for bridging studies................................................. 75 3.5.1 Waivers........................................................................................................ 76 3.5.2 Bridging studies ........................................................................................... 79 3.6 Fields of general improvement concerning package leaflets and critical items ...... as per the draft “readability guideline”................................................................. 82 3.6.1 Structure of QRD-templates ........................................................................ 83 3.6.2 Extent and preciseness of package leaflets................................................. 84 3.6.3 Print size and design................................................................................... 85 3.6.4 Style............................................................................................................. 87 3.6.5 Syntax.......................................................................................................... 88 3.6.6 Print colour and symbols / pictograms ......................................................... 89 3.7 Outlook and critical evaluation ............................................................................ 91 4 Summary................................................................................................................ 97 5 References ............................................................................................................. 98 6 Appendices........................................................................................................... 108 4 Abbreviations AMG Arzneimittelgesetz (Medicinal Products Act; The German Drug Law) AOK Allgemeine Ortskrankenkasse (Statutory health insurance fund) AR Assessment Report BAH Bundesverband der Arzneimittel-Hersteller e.V. (German Medicines Manufacturers’ Association) BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) BGG Behindertengleichstellungsgesetz (Equality law for disabled persons) BITV Barrierefreie Informationstechnik-Verordnung (Barrier-free communication technology regulation) Blista Deutsche Blindenstudienanstalt e.V. (German Study Institute for the Blind in Marburg) BPI Bundesverband der Pharmazeutischen Industrie e.V. (German Association of Pharmaceutical Industries) CBG MEB College Ter Beoordeling Van Geneesmiddelen - Medicine Evaluation Board (The Netherlands) CMD(h) Coordination Group for Mutual Recognition Procedures and Decentralised Procedures (human) CMS Concerned Member State CP Centralised Procedure CRO Contract Research Organisation CTD Common Technical Document DAISY Digital Accessible Information System DAZ Deutsche Apotheker Zeitung (German Journal for Pharmacists) DBSV Deutscher Blinden- und Sehbehindertenverband e.V. (The German Federation of Blind and Visually Impaired People) DCP Decentralised Procedure 5 DIN Deutsches Institut für Normung e.V. (German Standards Institute) DTD Document Type Definition DZB Deutsche Zentralbibliothek für Blinde (German Central Library for Blind) EAN International Article Number (former: Europan Article Number) EEC European Economic Community EBU
Load more

Recommended publications
  • Catalogo De Livros Braille
    BIBLIOTECA NACIONAL DE PORTUGAL ÁREA DE LEITURA PARA DEFICIENTES VISUAIS LIVROS BRAILLE Catálogo de Autores - 2011 - BIBLIOTECA NACIONAL DE PORTUGAL - Área de Leitura para Deficientes Visuais Campo Grande, 83 - 1749-081 Lisboa Tel.: 217982129; Fax: 217982138 www.bnportugal.pt E-mail: [email protected] ÍNDICE NOTA PRÉVIA ........................................................................................................ 3 A .......................................................................................................................... 4 B ........................................................................................................................ 11 C ........................................................................................................................ 18 D ........................................................................................................................ 30 E ........................................................................................................................ 34 F ........................................................................................................................ 36 G ........................................................................................................................ 41 H ........................................................................................................................ 46 I .........................................................................................................................
    [Show full text]
  • A STUDY of WRITING Oi.Uchicago.Edu Oi.Uchicago.Edu /MAAM^MA
    oi.uchicago.edu A STUDY OF WRITING oi.uchicago.edu oi.uchicago.edu /MAAM^MA. A STUDY OF "*?• ,fii WRITING REVISED EDITION I. J. GELB Phoenix Books THE UNIVERSITY OF CHICAGO PRESS oi.uchicago.edu This book is also available in a clothbound edition from THE UNIVERSITY OF CHICAGO PRESS TO THE MOKSTADS THE UNIVERSITY OF CHICAGO PRESS, CHICAGO & LONDON The University of Toronto Press, Toronto 5, Canada Copyright 1952 in the International Copyright Union. All rights reserved. Published 1952. Second Edition 1963. First Phoenix Impression 1963. Printed in the United States of America oi.uchicago.edu PREFACE HE book contains twelve chapters, but it can be broken up structurally into five parts. First, the place of writing among the various systems of human inter­ communication is discussed. This is followed by four Tchapters devoted to the descriptive and comparative treatment of the various types of writing in the world. The sixth chapter deals with the evolution of writing from the earliest stages of picture writing to a full alphabet. The next four chapters deal with general problems, such as the future of writing and the relationship of writing to speech, art, and religion. Of the two final chapters, one contains the first attempt to establish a full terminology of writing, the other an extensive bibliography. The aim of this study is to lay a foundation for a new science of writing which might be called grammatology. While the general histories of writing treat individual writings mainly from a descriptive-historical point of view, the new science attempts to establish general principles governing the use and evolution of writing on a comparative-typological basis.
    [Show full text]
  • =RS PRICE MF02/PC21 Plus Postage
    DOCUMENT RESUME ED 283 307 it 192 419 AUTHOR Brandenburg, Sara A., Ed.; Vanderheiden, Gregg C., Ed. TITLE Communication, Control, and Computer Access for Disabled and Elderly Individuals. ResourceBook 3: Software and Hardware. Rehab/Education Technology ResourceBook Series-. INSTITUTION Wisconsin Univ., Madison. Trace Ceater. SPONS AGENCY Department of Education, Washington, DC. REPORT NO ISBN-0-316-896144 PUB_DATE 87 GRANT G008300045 NOTE 502p.; A product of the kesea=ch and Development Center on Communication, Control, and ComputerAccess for Handicapped Individuals, For ResourceBnoks1 and 2,_see BC 192 417-418. AVAILABLE FROMTrace Research and De-..elopment Center 5-151 Weisman Center, 1500 Highland Ave., Hadison, WI 53705-2280. PUB TYPE Reference MaterialS = Dire toties/Catalogs (132) =RS PRICE MF02/PC21 Plus Postage. DESCRIPTORS *Accessibility (for DisableOr Braille; *Comptvers; *computer Software; *Disabilities; *Electronic Equipment; Input Output Devices; Older Adults; Tactile Adaptation ABSTRACT One of a series of three resource guides concerned with communication, control, andcomputer access for the disabled or the elderly, the book foccseson hardware and software. The gnide's 13 chapters_each cover products with thesame primary function. Cross reference_indexes allow access to listings of productsby function, input/output feature,and computer model. Switchesare listed_ separately by input/output features. Typically providedfor each product are usually an illustration, the productname, vendor, size, weight, power source, connector_type,cost,
    [Show full text]
  • Writing As Language Technology
    HG2052 Language, Technology and the Internet Writing as Language Technology Francis Bond Division of Linguistics and Multilingual Studies http://www3.ntu.edu.sg/home/fcbond/ [email protected] Lecture 2 HG2052 (2021); CC BY 4.0 Overview ã The origins of writing ã Different writing systems ã Representing writing on computers ã Writing versus talking Writing as Language Technology 1 The Origins of Writing ã Writing was invented independently in at least three places: ­ Mesopotamia ­ China ­ Mesoamerica Possibly also Egypt (Earliest Egyptian Glyphs) and the Indus valley. ã The written records are incomplete ã Gradual development from pictures/tallies Writing as Language Technology 2 Follow the money ã Before 2700, writing is only accounting. ­ Temple and palace accounts ­ Gold, Wheat, Sheep ã How it developed ­ One token per thing (in a clay envelope) ­ One token per thing in the envelope and marked on the outside ­ One mark per thing ­ One mark and a symbol for the number ­ Finally symbols for names Denise Schmandt-Besserat (1997) How writing came about. University of Texas Press Writing as Language Technology 3 Clay Tokens and Envelope Clay Tablet Writing as Language Technology 4 Writing systems used for human languages ã What is writing? A system of more or less permanent marks used to represent an utterance in such a way that it can be recovered more or less exactly without the intervention of the utterer. Peter T. Daniels, The World’s Writing Systems ã Different types of writing systems are used: ­ Alphabetic ­ Syllabic ­ Logographic Writing
    [Show full text]
  • World Braille Usage, Third Edition
    World Braille Usage Third Edition Perkins International Council on English Braille National Library Service for the Blind and Physically Handicapped Library of Congress UNESCO Washington, D.C. 2013 Published by Perkins 175 North Beacon Street Watertown, MA, 02472, USA International Council on English Braille c/o CNIB 1929 Bayview Avenue Toronto, Ontario Canada M4G 3E8 and National Library Service for the Blind and Physically Handicapped, Library of Congress, Washington, D.C., USA Copyright © 1954, 1990 by UNESCO. Used by permission 2013. Printed in the United States by the National Library Service for the Blind and Physically Handicapped, Library of Congress, 2013 Library of Congress Cataloging-in-Publication Data World braille usage. — Third edition. page cm Includes index. ISBN 978-0-8444-9564-4 1. Braille. 2. Blind—Printing and writing systems. I. Perkins School for the Blind. II. International Council on English Braille. III. Library of Congress. National Library Service for the Blind and Physically Handicapped. HV1669.W67 2013 411--dc23 2013013833 Contents Foreword to the Third Edition .................................................................................................. viii Acknowledgements .................................................................................................................... x The International Phonetic Alphabet .......................................................................................... xi References ............................................................................................................................
    [Show full text]
  • On the Compatibility of the Braille Code and Universal Grammar
    On the Compatibility of the Braille Code and Universal Grammar Von der Philosophisch-Historischen Fakultät der Universität Stuttgart zur Erlangung der Würde eines Doktors der Philosophie (Dr. phil.) genehmigte Abhandlung Vorgelegt von Christine Lauenstein Hauptberichterin: Prof. Dr. Artemis Alexiadou Mitberichterin: Prof. Dr. Diane Wormsley Tag der mündlichen Prüfung: 6.12.2006 Institute of English Linguistics Universität Stuttgart 2007 Data Perhaps. Perhaps not. Captain Picard This is hardly a scientific observation, Commander. Data Captain, the most elementary and valuable statement in science, the beginning of wisdom is I do not know. Star Trek: The Next Generation Where Silence has Lease Acknowledgements First I would like to thank the members of my thesis committee Artemis Alexiadou, that she has agreed on supervising this rather exotic topic, and Diane Wormsley for her support and undertaking the long journey to Germany. I would like to express my gratitude to all the people who have substantially contributed to my interest in braille and working with children who have a visual impairment, these are Dietmar Böhringer from Nikolauspflege Stuttgart, Maggie Granger, Diana King and above all Rosemary Parry, my braille teacher from The West of England School and College for young people with little or no sight, Exeter, UK. My special thanks goes to students and staff at The West of England School, the RNIB New College Worcester and the Royal National College for the Blind, Hereford for participating in the study. Further to those who helped to make this study possible: Paul Holland for enabling my numerous visits to The West of England School, Ruth Hardisty for co-ordinating the study, Chris Stonehouse and Mary Foulstone for their support in Worcester and Hereford and to Maggie Granger and Diana and Martin King for their friendship and for making things work even if braille was the most important thing in the world.
    [Show full text]
  • Man Speaking Students and Young Adults with Visual Impairments
    THE BRAILLE READING SKILLS 1 The Braille Reading Skills of German speaking Students and young Adults with Visual Impairments (manuscript version) Markus Lang1, Ursula Hofer2 und Fabian Winter2 1University of Education Heidelberg, Germany 2University of Applied Sciences in Special Needs Education, Switzerland published Lang, M., Hofer, U. & Winter, F. (2021). The Braille reading skills of German-speaking students and young adults with visual impairments. British Journal of Visual Impairment, 39(1), 6-19. https://doi.org/10.1177/0264619620967689 THE BRAILLE READING SKILLS 2 Abstract This study aims to investigate the literacy skills of braille readers in the areas of reading fluency, reading and listening comprehension, and spelling. A total of 119 German-speaking, braille readers aged between 11.0 and 22.11 years were tested for this purpose. Data collection was carried out using a questionnaire, psychometric tests and self-constructed assessments. Wherever possible, the results were compared with the standards of sighted peers. Regarding reading fluency, braille readers performed significantly slower than print readers. In terms of spelling, the braille users performed within an average range of sighted peers. Furthermore, a positive correlation was obtained between braille reading fluency and spelling, whereas the use of auditory aids (e.g. speech output) showed a negative correlation with braille reading fluency and spelling. In addition, a comparison between listening and reading within the study sample revealed that reading braille proved to be better for comprehension, although listening was significantly faster. In conclusion, the findings provide evidence that braille reading skills are important for the development of literacy skills in general.
    [Show full text]
  • UEB Foreign Language Guidelines
    Transcribing Foreign Language Material in UEB Introduction ................................................................................................. 1 Method 1. Using standard UEB signs throughout ....................................... 2 Method 2. Using foreign language signs for accented letters ...................... 3 Method 3. Using the full foreign language braille code ................................ 6 Languages in non-Roman Scripts ............................................................... 8 Latin ............................................................................................................ 9 Old English ................................................................................................. 9 Welsh........................................................................................................ 10 Standard Usage for Educational Materials ................................................ 10 Reference for Foreign Language Braille Codes ........................................ 11 Appendix ................................................................................................... 12 Introduction The rules of UEB allow a range of approaches for transcribing foreign language text, enabling the resulting braille to be convenient to read for a variety of types of text, as well as for different groups of readers. (Full details are given in Rules of Unified English Braille, Sections 13 and 14.) To simplify matters, in the UK we have decided to focus on and recommend three general methods
    [Show full text]
  • Hardware-Based Text-To-Braille Translation
    Department of Electrical and Computer Engineering Hardware -Based Text -to -Braille Translation Xuan Zhang This thesis is presented for the Degree of Master of Engineering of Curtin University of Technology July 2007 Declaration To the best of my knowledge and belief this thesis contains no material previously published by any other person except where due acknowledgment has been made. This thesis contains no material which has been accepted for the award of any other degree or diploma in any university. Signature: Date: Abstract Braille, as a special written method of communication for the blind, has been globally accepted for years. It gives blind people another chance to learn and communicate more efficiently with the rest of the world. It also makes possible the translation of printed languages into a written language which is recognisable for blind people. Recently, Braille is experiencing a decreasing popularity due to the use of alternative technologies, like speech synthesis. However, as a form of literacy, Braille is still playing a significant role in the education of people with visual impairments. With the development of electronic technology, Braille turned out to be well suited to computer-aided production because of its coded forms. Software based text-to-Braille translation has been proved to be a successful solution in Assistive Technology (AT). However, the feasibility and advantages of the algorithm reconfiguration based on hardware implementation have rarely been substantially discussed. A hardware-based translation system with algorithm reconfiguration is able to supply greater throughput than a software-based system. Further, it is also expected as a single component integrated in a multi-functional Braille system on a chip.
    [Show full text]
  • Braille Sense U2 User Manual
    Braille Sense U2 User Manual ENGLISH MANUAL For Software Version 8.6 (September, 2015) When there are any manual updates, the readme files or appendices will be added to the manual CD and website. HIMS International 174, Gajung-ro, Yuseong-gu, Daejeon, Korea 305-350 Phone: +82-42-864-4460 Fax: +82-42-864-4462 Email: [email protected] Website: www.himsintl.com 1 Safety Precautions For your safety and protection of the Braille Sense U2, please read and abide by the following safety precautions. 1. The input voltage of the AC adapter is 100V - 240V, and the output is DC 5V / 2A. 2. When the Braille Sense U2 is shipped, the battery may be packaged separate from the unit to avoid damage. When you use the Braille Sense U2 for the first time, you may need to open the package, remove the battery, and insert it into the battery slot at the rear panel of the unit. (See section 1, introduction, for more details on inserting the battery.) It is possible that the dealer or distributor from whom you purchased the Braille Sense U2 has already done this for you. The battery may not be fully charged when it is shipped. Before you use the Braille Sense U2, you should ensure the battery is fully charged. 3. When you use the Braille Sense U2 with the battery for the first time, the battery status may not be displayed accurately. To avoid this, leave the Braille Sense U2 connected to the AC adapter for about six hours with the unit turned on.
    [Show full text]
  • Provisional Guidance for Transcribing Foreign Language Material in UEB
    Provisional Guidance for Transcribing Foreign Language Material in UEB Approved May 2015 Content of This Publication Introduction .............................................................................. 1 Method 1. UEB Accents and Contractions in Anglicized Words ............ 2 Method 2. UEB Accented Letters and Uncontracted Words ................ 3 Method 3. Using Foreign Language Signs for Accented Letters ........... 4 Method 4. Using the Full Foreign Language Braille Code ................... 6 Languages in Non-Roman Scripts .................................................. 7 Old English ................................................................................ 8 Standard Usage for Educational Materials ....................................... 8 Reference for Foreign Language Braille Codes ................................. 9 References: ............................................................................... 9 Introduction The rules of Unified English Braille (UEB) allow a range of approaches for transcribing foreign language text. These methods result in braille that is appropriate for a variety of types of texts as well as for different groups of readers. Full details are given Rules of Unified English Braille, Sections 13 and 14. BANA recommends four general methods that should be suitable to cover the majority of cases. This document will briefly explain each of these methods and indicate the circumstances for which they are most appropriate. The examples and some of the language used in this document are from
    [Show full text]
  • Text and Braille Computer Translation
    Text and Braille Computer Translation A dissertation submitted to the University of Manchester Institute of Science and Technology for the degree of Master of Science, 2001. Alasdair King Department of Computation 28 September 2001 Text and Braille Computer Translation Declaration No portion of the work referred to in the dissertation has been submitted in support of an application for another degree or qualification of this or any other university or other institution of learning. 1 Text and Braille Computer Translation Acknowledgements I gratefully acknowledge the great support of my supervisor, Dr Gareth Evans, without whom this dissertation would not have been possible. 2 Text and Braille Computer Translation Abstract This project is concerned with the translation of text to and from Braille code by a number of Java programs. It builds on an existing translation system that combines a finite state machine with left and right context matching and a set of translation rules. This allows the translation of different languages and different grades of Braille contraction, and both text-to-Braille and Braille-to-text. An existing implementation in C, allowing the translation of languages based on 256-character extended-ANSI sets, has been successfully integrated into a Microsoft Word- based translation system. In this project, three Java implementations of this translation system were developed. LanguageInteger is a port of the existing C code. Language256 uses the same translation language files but is coded using Java programming idioms. LanguageUnicode is based upon the use of Unicode to encode characters. Each implements a Language Java interface, which defines common public methods for the classes in accordance with object-oriented software development principles of encapsulation and reuse.
    [Show full text]