DOCSLIB.ORG

Reportable Changes to a Who Prequalified Male Circumcision Device

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Reportable Changes to a Who Prequalified Male Circumcision Device DRAFT FOR COMMENT REPORTABLE CHANGES TO A WHO PREQUALIFIED MALE CIRCUMCISION DEVICE PQMC _v1 DRAFT for comments - 27 June 2018 Reportable changes to a WHO Prequalified Male Circumcision Device 1 Contents 2 AUTHORIZATION ................................................................................................................ ERROR! BOOKMARK NOT DEFINED. 3 DOCUMENT REVISION HISTORY SHEET .................................................................... ERROR! BOOKMARK NOT DEFINED. 4 CONTENTS .................................................................................................................................................................... 2 5 1 PURPOSE OF THIS DOCUMENT .................................................................................................................... 3 6 1.1 INTENDED AUDIENCE .....................................................................................................................................................3 7 1.2 SCOPE ...............................................................................................................................................................................3 8 1.3 BACKGROUND ..................................................................................................................................................................3 9 2 REPORTING OF CHANGES TO WHO ........................................................................................................... 4 10 3 CHANGES REQUIRING A NEW PREQUALIFICATION APPLICATION ................................................ 5 11 4 REPORTABLE CHANGES ................................................................................................................................. 6 12 4.1 REPORTABLE CHANGES TO THE MANUFACTURING PROCESS ..................................................................................6 13 4.2 REPORTABLE CHANGES TO THE PRODUCT ..................................................................................................................7 14 4.3 REGUALTORY STATUS AND OTHER CHANGES .............................................................................................................8 15 5 REPORTABLE ADMINISTRATIVE CHANGES ............................................................................................ 9 16 6 NON-REPORTABLE CHANGES ................................................................................................................... 10 17 7 DETERMINING THE IMPACT OF A CHANGE ......................................................................................... 10 18 8 REPORTING TO WHO ................................................................................................................................... 11 19 9 ASSESSMENT OF SUBMITTED PQMC CHANGE REPORTING FORMS ............................................ 11 20 9.1 INITIAL SCREENING OF REPORTING FORM ............................................................................................................. 11 21 9.2 REVIEW OF REPORTING FORM .................................................................................................................................. 12 22 10 OUTCOME OF ASSESSMENT OF THE CHANGE ..................................................................................... 13 23 11 FAILURE TO REPORT A REPORTABLE CHANGE TO WHO ............................................................... 13 24 12 MONITORING OF CHANGE REPORTING ................................................................................................. 13 25 13 CHANGE ASSESSMENT FEE ......................................................................................................................... 14 26 14 RELEVANT DOCUMENTS ............................................................................................................................. 14 27 15 CONTACT INFORMATION ........................................................................................................................... 15 28 ANNEX 1 – CHANGE PROCESS ............................................................................................................................. 16 29 ANNEX 2: EXAMPLES OF REPORTABLE CHANGES TO PREQUALIFIED MALE CIRCUMCISION 30 DEVICES ...................................................................................................................................................................... 18 31 ANNEX 3: EXAMPLES OF NON-REPORTABLE CHANGES ............................................................................ 21 32 ANNEX 4: FORMATTING REQUIREMENTS FOR SUBMISSIONS ................................................................ 21 33 REFERENCES ............................................................................................................................................................. 23 PQMC _ v01.4 DRAFT for comments - 27 June 2018 Page 2 of 23 Reportable changes to a WHO Prequalified Male Circumcision Device 34 1 Purpose of this document 35 1.1 Intended audience 36 This document aims to provide manufacturers of WHO prequalified male 37 circumcision devices with information on when they must report to WHO 38 about: 39 • changes to the prequalified device or its manufacture; 40 • changes to the Quality Management System (QMS) that the device is 41 designed and manufactured under; and/or 42 • other reportable administrative changes. 43 44 Manufacturers of WHO prequalified male circumcision devices should read 45 and understand this document so that they are aware of their duties and 46 responsibilities as a supplier of a prequalified male circumcision device as to 47 when to report to WHO applicable changes to the device, its manufacture 48 and other related activities. 49 50 Note: for the purpose of this document the following definition of 51 “manufacturer” applies: any natural or legal person with responsibility for 52 design and/or manufacture of a male circumcision device with the intention 53 of making the device available for use, under his/her name; whether or not 54 such a device is designed and/or manufactured by that person 55 himself/herself or on his/her behalf by another person(s) [1]. 56 57 This document does not address the required response to changes 58 made during the prequalification assessment. For changes 59 implemented during the assessment process, manufacturers should 60 contact WHO to seek guidance. 61 1.2 Scope 62 63 This document describes when and how a manufacturer will report to WHO 64 changes to a prequalified male circumcision device and its manufacture, the 65 QMS under which it is manufactured and certain administrative changes 66 associated with the device. To assist the understanding of when to report a 67 change to WHO, this document provides guidance and a non-exhaustive list 68 of generic examples. 69 70 1.3 Background 71 72 As part of the life cycle of a medical device, changes to the product, and/or 73 its intended use, its manufacturing process or location or the QMS under 74 which it is produced may become necessary for technical or economic PQMC _ v01.4 DRAFT for comments - 27 June 2018 Page 3 of 23 Reportable changes to a WHO Prequalified Male Circumcision Device 75 reasons. Such changesa to a prequalified male circumcision device range from 76 minor which have little potential to impact the quality, safety, performance , 77 performance or intended use of the device, to substantial which are likely to 78 affect the quality, safety, performance or intended use of the device. 79 80 A critical part of a manufacturer’s QMS is a documented, controlled and 81 approved process to design, review, verify, validate (if appropriate), approve 82 and implement changes. As part of this change process, a manufacturer 83 should also determine the significance of the change, on the quality, function, 84 performance, usability, safety, intended use, and applicable WHO 85 requirements for the prequalified male circumcision device and its intended 86 use. Manufacturers should also evaluate the effect of the change on 87 constituent parts of the of the device, on devices that are in-process or have 88 been delivered, and if the change has introduced new hazards that will alter 89 the initial risk analysis and risk control measures. Changes applied to a male 90 circumcision device must be made in conformance with the requirements for 91 control of design change according to ISO 13485:2016 [2]. 92 93 Annex 1 gives an overview of the Change Reporting process and associated 94 sub-processes. 95 96 97 2 Reporting of changes to WHO 98 99 For the purpose of this guidance, changes are defined either as reportable or 100 non-reportable. 101 102 All substantialb changes and certain administrative changes (information that 103 impacts the WHO public report) associated with a prequalified male 104 circumcision device are considered as reportable changes. These types of 105 changes must be reported to the WHO Prequalification Team – Diagnostics 106 Assessment at [email protected] by way of the “Change Reporting Form 107 for a WHO Prequalified Male Circumcision Device” (WHO document PQMC 108 REF to be added) and in some cases by way of a new prequalification 109 application. 110 111 Unless specified in this document, minor changes associated with a 112 prequalified male circumcision device are considered as non-reportable and 113 do not require the submission of a Change Reporting Form for a WHO 114 Prequalified Male Circumcision Device to WHO. These types of changes and a Some regulatory
Load more

Recommended publications
  • Artificial Intelligence in Health Care: the Hope, the Hype, the Promise, the Peril
    Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril Michael Matheny, Sonoo Thadaney Israni, Mahnoor Ahmed, and Danielle Whicher, Editors WASHINGTON, DC NAM.EDU PREPUBLICATION COPY - Uncorrected Proofs NATIONAL ACADEMY OF MEDICINE • 500 Fifth Street, NW • WASHINGTON, DC 20001 NOTICE: This publication has undergone peer review according to procedures established by the National Academy of Medicine (NAM). Publication by the NAM worthy of public attention, but does not constitute endorsement of conclusions and recommendationssignifies that it is the by productthe NAM. of The a carefully views presented considered in processthis publication and is a contributionare those of individual contributors and do not represent formal consensus positions of the authors’ organizations; the NAM; or the National Academies of Sciences, Engineering, and Medicine. Library of Congress Cataloging-in-Publication Data to Come Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: Matheny, M., S. Thadaney Israni, M. Ahmed, and D. Whicher, Editors. 2019. Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril. NAM Special Publication. Washington, DC: National Academy of Medicine. PREPUBLICATION COPY - Uncorrected Proofs “Knowing is not enough; we must apply. Willing is not enough; we must do.” --GOETHE PREPUBLICATION COPY - Uncorrected Proofs ABOUT THE NATIONAL ACADEMY OF MEDICINE The National Academy of Medicine is one of three Academies constituting the Nation- al Academies of Sciences, Engineering, and Medicine (the National Academies). The Na- tional Academies provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions.
    [Show full text]
  • Don't Risk It! ISO 13485:2016 and How to Determine Compliance Level
    Don’t Risk It! ISO 13485:2016 and How to Determine Compliance Level August 18, 2016 John Beasley, RAC(US) MedTech Review, LLC Thought of the Day: “Act after having made assessments. The one who first knows the measure of far and near wins.” - Sun Tzu, The Art of War 2 Today’s Topics • Overview of changes in ISO 13485, 3rd Edition – Risk management – Usability – Outsourced processes • Supplier evaluation – determining LSP level of compliance • Concluding remarks • Q&A ISO 13485:2016 1 Overview of Changes in the 3rd Edition History of ISO 13485 13485 13485 13485 9001 9001 9001 1994 / 2000 / 2003 2015 / 1996 2008 / 2009 2016 5 Publication History 1996 - Publication of standards ISO 13485 and ISO 13488. • 13485 variant intended for manufacturers responsible for design, manufacture and distribution of devices. • 13488 variant intended for manufacturers not responsible for designing devices. Variants must be used with ISO 9001:1994 and ISO 9002:1994 as applicable. 2003 - Publication of 2nd edition ISO 13485:2003. Considered to be “stand alone”. ISO 13488 now obsolete. Organizations that previously used 13488 must now use 13485 but can exclude section 7.3 “design and development” if allowed by regulations. Device specific requirements that do not apply to the manufacturer are tagged as “not applicable”. 6 Publication History 2004 - Publication of guidance document ISO/TR 14969. Its purpose is to provide a single source of guidance on the interpretation and implementation of 13485. 2009 - Corrigendum to 13485:2003 published to change reference from ISO 9001:2000 to ISO 9001:2008. 2012 - CEN (European standards organization) publishes EN ISO 13485:2012 as the European adoption of ISO 13485:2003 (2009 corrigendum).
    [Show full text]
  • Senior Data Engineer Cala Health, Inc
    875 Mahler Road, Ste. 168 Burlingame, CA, 94010 +1 415-890-3961 www.calahealth.com Job Description: Senior Data Engineer Cala Health, Inc. About Cala Health Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company's wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. Cala Health’s lead product, Cala Trio™, is the only non-invasive prescription therapy for essential tremor and is now available through a unique digital business model of direct- to-patient solutions. New therapies are under development in neurology, cardiology, and psychiatry. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. For more information, visit CalaHealth.com. The Opportunity We are looking for a Senior Data Engineer to expedite our Data Platform Stack to support our growth and also enable new product development in a dynamic, fast-paced startup environment. Specific Responsibilities also include ● Key stakeholder in influencing the roadmap of Cala’s Digital Therapeutics Data Platform. ● Build, operate and maintain highly scalable and reliable data pipelines to enable data collection from Cala wearables, partner systems, EMR systems and 3rd party clinical sources. ● Enable analysis and generation of insights from structured and unstructured data. ● Build Datawarehouse solutions that provide end-to-end management and traceability of patient longitudinal data, enable and optimize internal processes and product features. ● Implement processes and systems to monitor data quality, ensuring production data is always accurate and available for key stakeholders and business processes that depend on it.
    [Show full text]
  • Software Assurance
    Information Assurance State-of-the-Art Report Technology Analysis Center (IATAC) SOAR (SOAR) July 31, 2007 Data and Analysis Center for Software (DACS) Joint endeavor by IATAC with DACS Software Security Assurance Distribution Statement A E X C E E C L I L V E R N E Approved for public release; C S E I N N I IO DoD Data & Analysis Center for Software NF OR MAT distribution is unlimited. Information Assurance Technology Analysis Center (IATAC) Data and Analysis Center for Software (DACS) Joint endeavor by IATAC with DACS Software Security Assurance State-of-the-Art Report (SOAR) July 31, 2007 IATAC Authors: Karen Mercedes Goertzel Theodore Winograd Holly Lynne McKinley Lyndon Oh Michael Colon DACS Authors: Thomas McGibbon Elaine Fedchak Robert Vienneau Coordinating Editor: Karen Mercedes Goertzel Copy Editors: Margo Goldman Linda Billard Carolyn Quinn Creative Directors: Christina P. McNemar K. Ahnie Jenkins Art Director, Cover, and Book Design: Don Rowe Production: Brad Whitford Illustrations: Dustin Hurt Brad Whitford About the Authors Karen Mercedes Goertzel Information Assurance Technology Analysis Center (IATAC) Karen Mercedes Goertzel is a subject matter expert in software security assurance and information assurance, particularly multilevel secure systems and cross-domain information sharing. She supports the Department of Homeland Security Software Assurance Program and the National Security Agency’s Center for Assured Software, and was lead technologist for 3 years on the Defense Information Systems Agency (DISA) Application Security Program. Ms. Goertzel is currently lead author of a report on the state-of-the-art in software security assurance, and has also led in the creation of state-of-the-art reports for the Department of Defense (DoD) on information assurance and computer network defense technologies and research.
    [Show full text]
  • Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries
    MQP – FRH – FHO2 Regulatory Feasibility Analysis for a New Atrial Fibrillation Ablator in Selected Countries A Major Qualifying Project Report Submitted to the Faculty of the Worcester Polytechnic Institute in partial fulfillment of the requirements for the Degree of Bachelor of Science in Management by ______________________ Matthew Hammond Approved: _______________________ _______________________ Martin Sklar, President and CEO Frank Hoy, Ph.D. AblaCor Medical Corporation Paul R. Beeswick Professor of Project Sponsor Innovation and Entrepreneurship Project Advisor _______________________ Jerome Schaufeld, Ph.D. Professor of Practice Project Co-Advisor 1 | P a g e Abstract Medical device registration for class three devices, such as a catheter ablator, can be a long and difficult process. The regulatory requirements can vary greatly by country, overlap and benefit one another, or require repeating a certification depending on the country in question. Determining the order in which to enter specific countries greatly depends on the size of the potential market and the costs and time needed for regulatory approval. Prior approval on major facets such as clinical trials may greatly reduce the costs of entering a particular country if the data from an outside source is deemed acceptable. This creates a complex problem where start- ups who cannot afford to pursue regulatory approval in all major markets simultaneously must carefully chose and enter individual markets a few at a time. The paper will evaluate the regulatory pathways of ten select countries. This regulatory analysis, combined with a market analysis on these same countries by the other three members of the project, will form a basis from which we can create a suggested order of entry.
    [Show full text]
  • Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices
    Technical Guidance Series (TGS) Risk management for manufacturers of in 1 TGS–07 vitro diagnostic medical devices Draft for comment 25 September 2017 © World Health Organization 2017 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied.
    [Show full text]
  • FDARA Section 710 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices
    May 2018 FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) Executive Summary The Food and Drug Administration Reauthorization Act (FDARA) became law on August 18, 2017. Section 710 of FDARA charges the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing. FDA has considered information including but not limited to the information presented at a public workshop, responses to a request for comments, and evaluation of objective evidence related to the quality, safety, and effectiveness of medical device servicing in the compilation of this report. Stakeholders have differing views about the quality, safety, and effectiveness of servicing performed by original equipment manufacturers (OEMs) and third party entities, and the need for imposing additional regulation. Based on the available information, we have concluded: • The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time; • Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices; • A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing”; and • The continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S.
    [Show full text]
  • Mdcg 2019-16
    Medical Device Medical Device Coordination Group Document MDCG 2019-16 MDCG 2019-16 Guidance on Cybersecurity for medical devices December 2019 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. Page 1 of 46 Medical Device Medical Device Coordination Group Document MDCG 2019-16 Table of Contents 1. Introduction ........................................................................................................................................ 4 1.1. Background ............................................................................................................................. 4 1.2. Objectives ............................................................................................................................... 4 1.3. Cybersecurity Requirements included in Annex I of the Medical Devices Regulations ........ 4 1.4. Other Cybersecurity Requirements ......................................................................................... 6 1.5. Abbreviations .........................................................................................................................
    [Show full text]
  • Phihong Ev Chargers 2021-2022
    2021-2022 PHIHONG EV CHARGERS World Class Quality, International Standards Phihong Technology Co., Ltd is a core member of the organization Charging Interface Initiative e. V. (CharIN e. V.) and member of CHAdeMO Association. The goal is to promote and continuously develop the Combined Charging System (CCS) also ensuring compatibility between the infrastructure and the EVs. PHTV2102E Phihong Technology Phihong is a leading global power products manufacturer with over 50 years of industry experience. As a supplier to many of the world’s leading brands, Phihong continues to design innovative products with an emphasis on envi- ronmental protection and carbon reduction. Phihong offers a complete product line of EV charging OEM/ODM - AC Chargers solutions supporting both commercial and passenger electric vehicles. This includes Level 3 DC chargers ranging from 30kW to 360kW and Level 2 AC EVSE rang- ing from 16 to 48 amps. In addition, Phihong offers DC charging modules, auxiliary power, control & supervisor units (CSU), discrete type DC chargers, integrated type DC chargers, moveable DC chargers, and portable DC chargers. Phihongs EV charging software solutions include a front- OEM/ODM - DC Chargers end mobile APP and user interface (HMI) and a cloud- based management, payment, and monitoring platform. Through the front-end mobile APP, people can search for nearby chargers, schedule charging appointments, and monitor charging status. System operators can monitor the status of individual EV chargers and remotely up- date them, enabling long-term maintenance and man- agement. With strong R&D design capabilities and solid manufacturing experience, Phihong Technology delivers high-quality and cost-effective hardware/software prod- Modules ucts based on specific customer needs.
    [Show full text]
  • BSI Medical Devices: Webinar Q&A
    ISO 14971:2019 Risk Management for Medical Devices: Webinar Q&A November 2019 BSI Medical Devices: Webinar Q&A ISO 14971:2019 Risk Management for Medical Devices 13 November 2019 Page 1 of 10 ISO 14971:2019 Risk Management for Medical Devices: Webinar Q&A November 2019 Q&A Q. Should EN ISO 14971:2012 be used to demonstrate continued compliance to the ERs or GSPRs or use the 2019 revision of the standard? A. A manufacturer must demonstrate compliance to the applicable legislation. Harmonization of a standard allows for a presumption of conformity to the applicable legislation where the standard is applied and the manufacturer considers the Qualifying remarks/Notes in Annex Z. Additional clarification has been made available from the European Commission, whereby it is now considered that the recent editions of standards published by standardizers reflect the state of the art, regardless of its referencing in the OJEU and therefore the ISO 14971:2019 version represents the state of the art for the Medical Device Directives and Regulation. This update is welcomed as it provides clarity for industry and ensures manufacturers need only to comply with a single version of a standard. It is anticipated the 2019 revision will be harmonized to the Regulations. Q. From the Date of Application of the MDR and IVDR will the technical documentation for existing Directive certificates be required to be updated to the 2019 revision of the standard, considering the transitional provisions of MDR Article 120 and IVDR Article 110? A. A manufacturer must demonstrate compliance to the applicable legislation.
    [Show full text]
  • A Reference Architecture for Secure Medical Devices Steven Harp, Todd Carpenter, and John Hatcliff
    FEATURE © Copyright AAMI 2018. Single user license only. Copying, networking, and distribution prohibited. A Reference Architecture for Secure Medical Devices Steven Harp, Todd Carpenter, and John Hatcliff Abstract and users cannot assume that medical Steven Harp, is a distinguished We propose a reference architecture aimed at devices will operate in a benign security engineer at Adventium Labs in supporting the safety and security of medical environment. Any device that is capable of Minneapolis, MN. Email: steven. devices. The ISOSCELES (Intrinsically connecting to a network or physically [email protected] Secure, Open, and Safe Cyber-Physically exposes any sort of data port is potentially at Enabled, Life-Critical Essential Services) risk. How should we think about and Todd Carpenter, is chief engineer architecture is justified by a collection of design manage risk in this context? at Adventium Labs in Minneapolis, principles that leverage recent advances in This question has been explored exten- MN. Email: todd.carpenter@ software component isolation based on sively.3,4 Special publications from the adventiumlabs.com hypervisor and other separation technologies. National Institute of Standards and Technol- The instantiation of the architecture for ogy (e.g., 800-39) provide a conceptual risk John Hatcliff, PhD, is a particular medical devices is supported by a management framework.5,6 AAMI TIR577 distinguished professor at Kansas development process based on Architecture describes how security risk management State University in Manhattan, KS. Analysis and Design Language. The architec- can be integrated with safety risk manage- Email: [email protected] ture models support safety and security ment (e.g., as addressed in ISO 14971 and analysis as part of a broader risk management specifically for medical devices in IEC framework.
    [Show full text]
  • Annual Report 2020 PDF Data
    Contents KWE Group Corporate Guidelines (1) We strive to further increase corporate value by delivering 02 Aiming for Sustainable Growth customers quality services that meet their needs and earn their confidence. 06 Foundation for Creating New Value (2) We strive to be an organization that grows and expands through logistics business. 08 Top Message (3) We promote communications with stakeholders and disclose corporate information accurately and 15 Report by Six Segments appropriately. (4) We are committed to comply with external regulations, 21 Sustainability Management and compliance monitoring and assessment are built into all levels of the business. 36 Management’s Discussion and Analysis (5) We ensure a safe and healthy work environment where 43 Financial Highlights people are treated respectfully and fairly. (6) We contribute in sustainable community development, 44 Financial Statements with attention to global environmental issues. 62 Investor Information Guide to Buttons Move Back to Previous Page Expectations and Forecasts This annual report contains statements about our expectations and forecasts regarding plans, strategies, and business results related to the future of Kintetsu World Express, Move Forward to Next Page Inc. (KWE). These statements reflect our expectations based on personal beliefs and assumptions that were determined in light of information that was available at the time Print Search PDF Content the report was prepared. There are innumerable risk factors and uncertainties that could affect the future, including economic trends, competition in the logistics industry, market conditions, fuel prices, exchange rates, and tax or other regulatory system considerations. Go to Contents Page Please be well advised that because of these risk factors, actual results may differ from our expectations.
    [Show full text]