PFU

Compilation of quality review of documents (QRD) on stylistic matters in product information

Retrieved on: 
Sunday, March 10, 2024
Capsule, HPRA, EXP, NAAM, Pi, CS, ATMP, Table, Unicode, Health education, Potassium iodide, Syringe, VIAL, Inn, Potassium, NRG, Powder, Translation, Blister, Patient, Guideline, Abbreviation, SIDC, WHO, COPD, ISO, Compilation, Diabetes, DA, Prohibition, Times New Roman, Excipient, Narcotic, FAQ, Approximation error, Sodium chloride, PI, Cmax, Microsoft Word, NOT, Veterinary medicine, European Medicines Agency, Council, PFU, QRD, Helicobacter pylori, Tablet, Microsoft, Total, Medication package insert, European, DIE, Language, Single Supervisory Mechanism, Plaque, Vaccine, MAH, Safety, Printing, International standard, Sodium, Osteoporosis, Reproduction, Name, Marketing authorisation, Marketing, Caregiver, Imperial, NCA, Food, EDQM, Confusion, Risk, Cell, Medicine, Disease, Public, Medical device

29 February 2024

Key Points: 
    • 29 February 2024
      EMA/25090/2002 rev.23*
      Human Medicines Division

      Compilation of QRD decisions on stylistic matters in product information
      Issues
      Abbreviations

      Connected problems
      Subscript and superscript

      QRD Suggestions
      Acronyms must be written in their standard form; e.g.

    • Cmax, Cmax
      Abbreviations and

      Not always understood,

      Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.

    • The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
      i.e.
    • critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 2/23

      Issues

      Connected problems

      QRD Suggestions

      emphasise in the labelling
      the special handling prior
      to administration of the
      product.

    • Consistency

      Inconsistencies in style are

      Once a particular style or house style has been selected, it must be used consistently throughout the text.

    • Tradename 150 mg solution for injection in pre-filled syringe
      Tradename 150 mg solution for injection in pre-filled pen

      information annexes?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 3/23

      Issues
      Desiccant

      Connected problems

      QRD Suggestions

      For medicinal products

      The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

      packaged with a desiccant

      the desiccant.

    • For bottles containing a desiccant, a similar statement should also be considered provided there

      mistake the desiccant for a

      is available space.

    • It can only be included in brackets in section 3 of the

      where can this be

      SmPC and section 4 of the labelling.

    • Direct speech should only
      be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
    • The term ?drug? though can be used in the product information annexes when it is part of a standard set of
      terms (e.g.
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 5/23

      Issues
      Foreign terms

      Connected problems

      QRD Suggestions

      Foreign terms, particularly

      Foreign terms must be written in italics; e.g.

    • Patients can be referred to as ?he? or

      physician is often referred

      as ?she? when the medicinal product is exclusively for use by males or females.

    • if the product in question might be

      measurements are

      used by elderly patients), in brackets after the metric measures in the English text.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 6/23

      Issues

      Connected problems

      QRD Suggestions

      product name is composed
      of MAH+INN?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 7/23

      Issues

      Connected problems

      QRD Suggestions
      MT: English
      BG: Bulgarian
      NL: Dutch
      CZ: Czech or English at applicant?s discretion.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 14/23

      Issues

      Connected problems

      QRD Suggestions
      considered, e.g.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 16/23

      Issues
      Symbols: Non-Unicode

      Connected problems

      QRD Suggestions

      The use of non-Unicode

      Only Unicode symbols must be used in submitted product information annexes.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 20/23

      Issues

      Connected problems

      Units: SI base units -

      International Standard

      litre

      base units have been
      introduced in the European
      Union with Council
      Directive 80/181/EEC of
      20.12.79 (O.J.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 23/23

Former SEC Private Funds Unit Exam Manager Michele Foldenauer Joins Optima Partners as Director, Strengthening Global Regulatory Compliance Expertise

Retrieved on: 
Wednesday, January 24, 2024
Knowledge, CFOS, Financial regulation, PFU, Mentorship, Risk management, Security (finance), Growth, Financial adviser

At Optima, Ms. Foldenauer will focus on the regulatory and compliance needs of hedge funds, private equity funds, registered investment advisers, broker-dealers, and global financial services firms.

Key Points: 
  • At Optima, Ms. Foldenauer will focus on the regulatory and compliance needs of hedge funds, private equity funds, registered investment advisers, broker-dealers, and global financial services firms.
  • Michele  joins our team of highly talented regulatory compliance professionals advising over 1000 clients globally."
  • Ms. Foldenauer added, I am thrilled to join Optima Partners, a dynamic force in global regulatory compliance.
  • Before joining Optima, as a  Senior Securities Compliance Examiner and Exam Manager in the Private Funds Unit (PFU) at the SEC's Miami office, Michele conducted extensive compliance examinations, and presented detailed reports summarizing findings and violations of federal securities laws.

PFU America, Inc. Expands Line of RICOH Laser Projectors With Introduction of Three New Models

Retrieved on: 
Tuesday, January 16, 2024
Consumer Electronics, Technology, Other Technology, Audio, Video, Software, Hardware, WUXGA, PJ, Multimedia, School, PFU, AV, PFU Limited, Organization, RICOH, Government, Television

Expands Line of RICOH Laser Projectors With Introduction of Three New Models (Photo: Business Wire)

Key Points: 
  • Expands Line of RICOH Laser Projectors With Introduction of Three New Models (Photo: Business Wire)
    The RICOH PJ WUL5A40ST is PFU America, Inc.’s first short throw projector offering.
  • The PJ WUL5A40ST creates stunning visuals and lifelike color reproduction, making it ideal for presentations, interactive displays, digital signage, and more.
  • The newest addition to PFU America, Inc.’s line-up of high-end laser projectors, the RICOH PJ WUL6760, features advanced 3LCD technology and provides 6,000 lumens of brightness to project high quality, 300-inch WUXGA displays from up to 42.3 feet away.
  • These three projectors all feature an innovative multi-module laser light source, ensuring up to 20,000 hours of maintenance-free operation, providing users with the reliability that they’ve come to expect from Ricoh products.

PFU America, Inc. Announces New Feature-Rich, High-Speed Production Scanners

Retrieved on: 
Thursday, January 11, 2024
Hardware, Consumer Electronics, Apps, Applications, Technology, Software, OCR, Multimedia, PFU, AI, Workflow, MSRP, Gold, ADF, PFU Limited, Organization, Patent, RICOH, Government, Printed circuit board

The new flagship scanners support the growing need for document digitization and centralized scanning in business enterprises, government agencies, and educational institutions, as well as financial and healthcare organizations.

Key Points: 
  • The new flagship scanners support the growing need for document digitization and centralized scanning in business enterprises, government agencies, and educational institutions, as well as financial and healthcare organizations.
  • View the full release here: https://www.businesswire.com/news/home/20240111841065/en/
    The stylish scanners have a modest footprint and feature a 4.3” touchscreen control panel, along with easy set-up, operation, and maintenance.
  • The scanners also help ensure complete data capture and more stable stacking, saving the operator time, creating a more efficient operational workflow.
  • For more information on PFU America, Inc. and its award-winning RICOH scanners, please visit https://www.pfu-us.ricoh.com/ .

PFU America, Inc. Celebrates 15 Million Global Shipments of Award-Winning Document Scanners

Retrieved on: 
Wednesday, December 13, 2023
Consumer Electronics, Retail, Apps, Applications, Technology, Software, Office Products, Hardware, PFU, PFU Limited, Social media, Multimedia, Television, Amazon

PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced the launch of its “Infinite Stories Unfold Campaign,” to celebrate the achievement of surpassing 15 million PFU-delivered document scanners shipped globally* .

Key Points: 
  • PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced the launch of its “Infinite Stories Unfold Campaign,” to celebrate the achievement of surpassing 15 million PFU-delivered document scanners shipped globally* .
  • View the full release here: https://www.businesswire.com/news/home/20231213036034/en/
    PFU America, Inc. announces the launch of its “Infinite Stories Unfold Campaign” to celebrate the achievement of surpassing 15 million PFU-delivered document scanners shipped globally.
  • The page serves as a valuable resource offering in-depth insights into the capabilities of PFU’s document scanners.
  • To learn more about PFU’s 15 million document scanners shipped, please visit: https://www.pfu.ricoh.com/global/scanners/news/press231016 .

PFU America, Inc. Introduces ScanSnap® iX1600 Chromebook® Edition

Retrieved on: 
Wednesday, November 22, 2023
Software, Technology, Hardware, Apps, Applications, Cloud, Android, PFU, PDF, Multimedia, ChromeOS, PFU Limited, System, LCD, Chromebook, IOS, MSRP, Education, Television

PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced the ScanSnap® iX1600 Chromebook Edition document imaging scanner, featuring a Google Chrome® operating system solution.

Key Points: 
  • PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced the ScanSnap® iX1600 Chromebook Edition document imaging scanner, featuring a Google Chrome® operating system solution.
  • Introduces ScanSnap® iX1600 Chromebook® Edition (Photo: Business Wire)
    The new ScanSnap iX1600 Chromebook Edition integrates and leverages the power of the enhanced ScanSnap Home mobile app—an all-in-one solution that allows users to easily manage, edit, and utilize scanned data including documents, business cards, photos, receipts, and more.
  • Priced starting at $554.00 MSRP, ScanSnap iX1600 Chromebook Edition is available in the U.S. now.
  • For more information on the latest addition to the ScanSnap line of scanners please visit the ScanSnap iX1600 Chromebook Edition webpage .

PFU America, Inc. Announces ScanSnap® iX1600 Receipt Edition

Retrieved on: 
Tuesday, October 31, 2023
Professional Services, Consumer Electronics, Small Business, Technology, Software, Hardware, Accounting, Online, Small business, LCD, Nintendo of America, Inc. vs. Blockbuster LLC., Microsoft, MSRP, PFU, Multimedia, PFU Limited, QuickBooks, Mail

PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced the ScanSnap® iX1600 Receipt Edition document imaging scanner featuring integration with Intuit® QuickBooks® Online.

Key Points: 
  • PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced the ScanSnap® iX1600 Receipt Edition document imaging scanner featuring integration with Intuit® QuickBooks® Online.
  • Announces ScanSnap® iX1600 Receipt Edition (Photo: Business Wire)
    In addition to new Receipt Edition features, the robust ScanSnap iX1600 allows for PC-less scanning to any destination, including mobile devices, folders, or popular applications such as Google Drive®, Dropbox®, Evernote®, and more.
  • ScanSnap iX1600 Receipt Edition preserves the quality of raw images, and once scanned, documents can be corrected and renamed.
  • For more information on the latest addition to the ScanSnap line of scanners please visit the ScanSnap iX1600 Receipt Edition webpage .

PFU America, Inc. Unveils Innovative HHKB Studio

Retrieved on: 
Tuesday, October 24, 2023
Retail, Consumer Electronics, Technology, Mobile, Wireless, Office Products, Hardware, Linux, MX, Lewis Galoob Toys, Inc. v. Nintendo of America, Inc., Hobby, Happy Hacking Keyboard, Keyboard, PFU, Multimedia, Android, HHKB, MacOS, IOS, Map, Philosophy, Video game, Industrial design, Satellite navigation device, Microsoft Windows

PFU America, Inc. , the primary authorized distributor of the award-winning Happy Hacking Keyboard (HHKB) in the United States, today announced the launch of HHKB Studio —a reimagined, all-in-one keyboard to let users complete any task comfortably and efficiently.

Key Points: 
  • PFU America, Inc. , the primary authorized distributor of the award-winning Happy Hacking Keyboard (HHKB) in the United States, today announced the launch of HHKB Studio —a reimagined, all-in-one keyboard to let users complete any task comfortably and efficiently.
  • The HHKB Studio offers the next evolution in original minimalist design, while integrating key technological advances based upon customer feedback.
  • Customizable key layout for one-of-a-kind keyboard: With HHKB Studio, users can build a one-of-a-kind keyboard to reflect work, hobbies, preferences, and usability.
  • In addition to the existing HHKB keymap modification functionality, the new HHKB Studio keymap modification tool allows users to customize Gesture Pad settings.

PFU America, Inc. Announces Four New Compact, Fast, and Reliable Workgroup Printers

Retrieved on: 
Tuesday, October 17, 2023
Office Products, Networks, Hardware, Retail, Technology, Multimedia, USB, Organization, System, RICOH, AirPrint, Health, MF, Accounting, PFU Limited, SNMP, PFU, Wi-Fi, Dongle, 3D printing, Office supplies, Ethernet

PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced four new high performance, compact, workgroup printers.

Key Points: 
  • PFU America, Inc. , the U.S.-based subsidiary of PFU Limited and the leader in document scanning solutions, today announced four new high performance, compact, workgroup printers.
  • Announces Four New Compact, Fast, and Reliable Workgroup Printers (Photo: Business Wire)
    These high speed, reliable workgroup printers fit in nearly any workspace, and with USB, Ethernet, and Wi-Fi print connectivity, they offer support for AirPrint™ and Mopria®.
  • All four RICOH printers meet TLS1.3 and SNMP v3 security standards and integrate innovative 4-in-1 multifunctionality, enabling organizations to fax, print, copy, and scan.
  • PFU America, Inc. is selling these new RICOH workgroup printers via its extensive channel partner network in the U.S. and will continue to work closely with them to expand its growing product portfolio and business.

 PFU America, Inc. Enters Projector Market With Two New Series of RICOH Laser Projectors

Retrieved on: 
Tuesday, October 17, 2023
Technology, Photography, Mobile, Wireless, Nanotechnology, Audio, Video, Other Technology, Software, Networks, Internet, Hardware, Semiconductor, Data Management, Consumer Electronics, Satellite, Government, Multimedia, School, Organization, Workplace, RICOH, MSRP, PJ, PFU Limited, PFU, Versata Development Group, Inc. v. SAP America, Inc., Television, Telescopic sight

PFU America, Inc. , the U.S.-based subsidiary of PFU Limited, today announced it is entering the projector market by unveiling two new series of enterprise-ready laser projectors to address the growing market of 4K lumens and above products.

Key Points: 
  • PFU America, Inc. , the U.S.-based subsidiary of PFU Limited, today announced it is entering the projector market by unveiling two new series of enterprise-ready laser projectors to address the growing market of 4K lumens and above products.
  • View the full release here: https://www.businesswire.com/news/home/20231017286699/en/
    PFU America, Inc. Enters Projector Market With Two New Series of RICOH Laser Projectors (Photo: Business Wire)
    RICOH Compact Laser Projectors, the PJ WXL5860 and PJ WUL5860, are easy-to-use, compact, and lightweight projectors designed for small to medium-sized meeting room applications.
  • RICOH High-End Laser Projectors, the installation-friendly PJ WUL6670, PJ WUL6680, and PJ WUL6690, are suitable for large conference rooms and large venues with a projection area of up to 300 inches.
  • For more information on all five new laser projectors please visit https://www.pfu-us.ricoh.com/projectors .