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

Retrieved on: 
Sunday, March 10, 2024

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

Can ChatGPT edit fiction? 4 professional editors asked AI to do their job – and it ruined their short story

Retrieved on: 
Monday, February 12, 2024

We are professional editors, with extensive experience in the Australian book publishing industry, who wanted to know how ChatGPT would perform when compared to a human editor.

Key Points: 
  • We are professional editors, with extensive experience in the Australian book publishing industry, who wanted to know how ChatGPT would perform when compared to a human editor.
  • To find out, we decided to ask it to edit a short story that had already been worked on by human editors – and we compared the results.

The experiment: ChatGPT vs human editors

  • The story we chose, The Ninch (written by Rose), had gone through three separate rounds of editing, with four human editors (and a typesetter).
  • The first version had been rejected by literary journal Overland, but its fiction editor Claire Corbett had given generous feedback.
  • We had a wealth of human feedback to compare ChatGPT’s recommendations with.
  • By comparing it with human examples, we tried to determine where and at what stage in the process ChatGPT might be most successful as an editorial tool.

Round 1: the first draft

  • (Authors submitting stories to magazines and journals generally don’t give human editors a detailed, prescriptive brief.)
  • Interestingly, ChatGPT did not pick up that the story was now published and attributed to an author.
  • Nor did it define the genre, which is one of the first assessments an editor makes.
  • And the advice for more foreshadowing, dialogue and description, along with shorter paragraphs and an alternative ending, was generally sound.

Stage two: AI (re)writes

  • Could you please suggest places in the story where the pace needs to speed up or slow down?
  • Could you please suggest places where there is too much imagery and it needs more action storytelling instead?
  • Could you please suggest places in the story where the pace needs to speed up or slow down?
  • Could you please suggest places where there is too much imagery and it needs more action storytelling instead?
  • ChatGPT also changed the text from Australian English (which all Australian publications require) to US spelling and style (“realization”, “mom”).

What did the human editors do?

  • The biggest problem is that final transition – I don’t know how to read the narrator.
  • For me stories are driven by choices and I’m not clear what decision our narrator, or anyone else, in the story faces.
  • It’s entirely possible I’m not getting something important, but I think that if I’m not getting it, our readers won’t either.
  • It incorporates intellectual, creative and emotional capital – all gained from lived experience, complemented by technical skills and industry expertise, applied through the prism of human understanding.
  • (After all, the author doesn’t have to do what we say – ours is a persuasive profession.)

Round 2: the revised story

  • Next, we submitted a revised draft that had addressed Claire’s suggestions and incorporated the conversations with Nicola.
  • Again, it didn’t pick up that the story had already been published, nor did it clearly identify the genre.
  • It was a laborious process: the 2,500-word piece had to be submitted in chunks of 300–500 words and the revised sections manually combined.
  • Read more:
    'The entire industry is based on hunches': is Australian publishing an art, a science or a gamble?

Round 3: our final submission

  • In the third and final round of the experiment, we submitted the draft that had been accepted by Meanjin.
  • This time, we followed up with separate prompts for each element we wanted ChatGPT to review: title, pacing, imagery/description.
  • ChatGPT came back with suggestions for how to revise specific parts of the text, but the suggestions were once again formulaic.
  • There was no attempt to offer – or support – any decision to go against familiar tropes.


Sometimes editorial expertise shows itself in not changing a text. Different isn’t necessarily good. It takes an expert to recognise when a story is working just fine. If it ain’t broke, don’t fix it. It also takes a certain kind of aerial, bird’s-eye view to notice when the way type is set creates ambiguities in the text. Typesetters really are akin to editors.

The verdict: can ChatGPT edit?

  • But we recommend editors and authors don’t ask it to give individual assessments or expert interventions any time soon.
  • A major problem that emerged early in this experiment involved ethics: ChatGPT did not ask for or verify the authorship of our story.
  • Human editors demonstrate their credentials through their work history, and keep their experience up-to-date with professional training and qualifications.
  • In Rose’s case, her oceanic allegory about difference, with a nod to the supernatural, was turned it into a story about a fish.

ChatGPT is ‘like the new intern’

  • AI suggestions can be scrutinised – and integrated or dismissed – by authors or editors during the creative process.
  • But when used by human editors, it’s like any other tool – as good, or bad, as the tradesperson who wields it.
  • Renée Otmar is affiliated with the Institute of Professional Editors, the Australian Society of Authors, Writers Victoria, Small Press Network and Life Stories Australia.
  • She is an Honorary Research Fellow in the Faculty of Health, Deakin University.

MyCase and Clearbrief Launch Dynamic A.I. Integration, Transforming Workflows For Legal Professionals

Retrieved on: 
Friday, January 26, 2024

MyCase , a leading legal practice management software for the modern law firm, has announced a new integration with Clearbrief.ai , the award-winning AI-assisted legal writing software.

Key Points: 
  • MyCase , a leading legal practice management software for the modern law firm, has announced a new integration with Clearbrief.ai , the award-winning AI-assisted legal writing software.
  • “We are excited to partner with Clearbrief to continue delivering outstanding outcomes for our customers,'' said Dru Armstrong, Chief Executive Officer of AffiniPay, parent company of MyCase.
  • “MyCase is dedicated to providing its customers with the best innovative legal tech solutions needed to elevate their business.
  • For more information about MyCase and Clearbrief, please visit: mycase.com .

Joshua Stein's New Guide to Ground Leases Now Available: Comprehensive Guide for Commercial Real Estate Professionals

Retrieved on: 
Sunday, January 21, 2024

NEW YORK, Jan. 21, 2024 /PRNewswire/ -- Commercial real estate attorney Joshua Stein has just published his three-volume New Guide to Ground Leases, a complete update of his earlier ground lease treatise, published nearly 20 years ago, and covers:

Key Points: 
  • Updated and Expanded after 20 Years;
    NEW YORK, Jan. 21, 2024 /PRNewswire/ -- Commercial real estate attorney Joshua Stein has just published his three-volume New Guide to Ground Leases, a complete update of his earlier ground lease treatise, published nearly 20 years ago, and covers:
    How have ground lease negotiators responded to recent disastrous rent increases?
  • How can future rent adjustments protect the landlord, but also preserve the value of the tenant's position?
  • Commercial real estate is all about financing.
  • How does financing fit into a ground lease structure?

AutomatedDocs Launches Innovative Document Automation Software for Small Businesses

Retrieved on: 
Friday, January 19, 2024

MALAGA, Spain, Jan. 19, 2024 /PRNewswire-PRWeb/ -- Small businesses nationwide are poised to transform their document management processes with the launch of AutomatedDocs, a groundbreaking software designed to save time, cut costs, and streamline document automation.

Key Points: 
  • MALAGA, Spain, Jan. 19, 2024 /PRNewswire-PRWeb/ -- Small businesses nationwide are poised to transform their document management processes with the launch of AutomatedDocs , a groundbreaking software designed to save time, cut costs, and streamline document automation.
  • Small businesses utilizing AutomatedDocs can save an impressive average of three hours per contract, significantly boosting efficiency and productivity.
  • AutomatedDocs eliminates manual tasks, enabling businesses to quickly generate and deliver crucial documents to recipients with precision and speed.
  • Small businesses can now leap into a future where document creation is not just efficient but also aligned with brand style.

Robin AI Raises $26 million as Legal Sector Embraces AI

Retrieved on: 
Wednesday, January 3, 2024

LONDON and NEW YORK, Jan. 2, 2024 /PRNewswire/ -- As demand for generative AI in the legal sector explodes, Robin AI, the AI-powered legal copilot, today announces that it has raised $26 million in new funding. The Series B round is led by Temasek, a global investment company headquartered in Singapore. Other investors include QuantumLight, Plural and AFG Partners.

Key Points: 
  • Brands
    Investment will be used to accelerate US expansion, launch in Asia Pacific and hire more AI engineers
    LONDON and NEW YORK, Jan. 2, 2024 /PRNewswire/ -- As demand for generative AI in the legal sector explodes, Robin AI, the AI-powered legal copilot, today announces that it has raised $26 million in new funding.
  • Robin AI was founded in 2019 by Richard Robinson, a lawyer at Clifford Chance, and James Clough, a machine learning research scientist at Imperial College.
  • Robin AI places quality and accuracy at the heart of its approach.
  • We are building the AI platform for the legal sector - a service that deeply understands every aspect of the legal function, from drafting contracts, researching case law to explaining legal concepts - our AI will help people tackle every legal task.

Robin AI Raises $26 million as Legal Sector Embraces AI

Retrieved on: 
Wednesday, January 3, 2024

LONDON and NEW YORK, Jan. 2, 2024 /PRNewswire/ -- As demand for generative AI in the legal sector explodes, Robin AI, the AI-powered legal copilot, today announces that it has raised $26 million in new funding. The Series B round is led by Temasek, a global investment company headquartered in Singapore. Other investors include QuantumLight, Plural and AFG Partners.

Key Points: 
  • Brands
    Investment will be used to accelerate US expansion, launch in Asia Pacific and hire more AI engineers
    LONDON and NEW YORK, Jan. 2, 2024 /PRNewswire/ -- As demand for generative AI in the legal sector explodes, Robin AI, the AI-powered legal copilot, today announces that it has raised $26 million in new funding.
  • Robin AI was founded in 2019 by Richard Robinson, a lawyer at Clifford Chance, and James Clough, a machine learning research scientist at Imperial College.
  • Robin AI places quality and accuracy at the heart of its approach.
  • We are building the AI platform for the legal sector - a service that deeply understands every aspect of the legal function, from drafting contracts, researching case law to explaining legal concepts - our AI will help people tackle every legal task.

Introducing Felt 2.0: The Most Powerful Tool for Professional Map Making

Retrieved on: 
Monday, November 13, 2023

Felt , the world’s first collaborative mapping tool, today launched Felt 2.0 with powerful data transformation tools that enhance its intuitive and professional platform.

Key Points: 
  • Felt , the world’s first collaborative mapping tool, today launched Felt 2.0 with powerful data transformation tools that enhance its intuitive and professional platform.
  • Now with spatial analysis features, users can manipulate and analyze geographic data, making it easier to unite and extract meaningful information from different datasets on a map.
  • “With Felt 2.0, we’ve expanded on our foundation built for teams to meet the needs of GIS professionals.
  • Felt 2.0 marks the beginning of a new chapter for the platform, introducing its first set of powerful spatial analysis tools alongside a beautiful new UI experience for professionals.

Odyssey Communications Inc. delivers 5 million Microsoft Office Specialist certification exams

Retrieved on: 
Tuesday, November 21, 2023

SALT LAKE CITY, Nov. 21, 2023 /PRNewswire-PRWeb/ -- Certiport, a Pearson VUE business and the leading provider of performance-based IT certification exams that accelerate academic and career opportunities for learners, today congratulates Odyssey Communications Inc. (OCI), the Certiport Authorized Partner in Japan, for delivering five million Microsoft Office Specialist certification exams.

Key Points: 
  • Certiport, a Pearson VUE business and the leading provider of performance-based IT certification exams that accelerate academic and career opportunities for learners, today congratulates Odyssey Communications Inc. (OCI), the Certiport Authorized Partner in Japan, for delivering five million Microsoft Office Specialist certification exams.
  • SALT LAKE CITY, Nov. 21, 2023 /PRNewswire-PRWeb/ -- Certiport, a Pearson VUE business and the leading provider of performance-based IT certification exams that accelerate academic and career opportunities for learners, today congratulates Odyssey Communications Inc. (OCI), the Certiport Authorized Partner in Japan, for delivering five million Microsoft Office Specialist certification exams.
  • Originally launched over 25 years ago, the Microsoft Office Specialist (MOS) certification exams are industry-leading, project-based assessments of Microsoft Office skills and knowledge.
  • Taken by learners in school as well as professionals, these exams validate knowledge in applications such as Microsoft Word, Microsoft Excel, and Microsoft PowerPoint.

Justia Launches Justia AI Writer: New Tool to Help Law Firms Efficiently Draft Website Content

Retrieved on: 
Monday, October 30, 2023

Justia is proud to announce the launch of the Justia AI Writer tool, available exclusively for lawyers with a Justia Elevate law firm website.

Key Points: 
  • Justia is proud to announce the launch of the Justia AI Writer tool, available exclusively for lawyers with a Justia Elevate law firm website.
  • The proprietary Justia AI Writer tool is designed explicitly for law firm website content creation.
  • The Justia AI Writer tool gives legal professionals ideas of pages to add to their sites, makes it fast and easy to draft content, and takes the guesswork out of AI.
  • For more information about the features and benefits of Justia Elevate and the Justia AI Writer, please visit: https://j.st/aiwriter