Please ensure Javascript is enabled for purposes of website accessibility

Welcome to Regulatory Rapporteur. This site uses cookies. Read our policy.

  • Skip to main content
  • Skip to navigation
Site name
topra-logo

The Organisation for Professionals in Regulatory Affairs
Site name
Mast navigation
  • Become a member
  • Sign in
Search our site
Menu
Close menu
  • Regulatory Rapporteur - September 2025
  • Pharmaceuticals
    • Back to parent navigation item
    • Pharmaceuticals
    • Artificial intelligence
    • ATMP
    • Biologics
    • Chemistry, manufacturing and controls
    • Clinical trials
    • Non-clinical development
    • Oncology
    • Product information
    • Regulatory procedures
  • Veterinary
  • Medical devices
    • Back to parent navigation item
    • Medical devices
    • Combination products
    • In-vitro diagnostics
    • Software
    • Artificial intelligence
  • Industry news
    • Back to parent navigation item
    • Industry news
    • Industry news
      • Back to parent navigation item
      • Industry news
      • Read latest news
      • Video
  • Commentary
    • Back to parent navigation item
    • Commentary
    • Editorials
    • Letters to the Editor
    • Podcasts
  • Collections
    • Back to parent navigation item
    • Collections
    • Interviews
    • Symposium 2024
      • Back to parent navigation item
      • Symposium 2024
      • Annual lecture
    • Symposium 2023
      • Back to parent navigation item
      • Symposium 2023
      • Annual lecture
    • Symposium 2022
      • Back to parent navigation item
      • Symposium 2022
      • Annual lecture
    • Regulatory Careers Live
    • CPD supplements
      • Back to parent navigation item
      • CPD supplements
      • 2021/2022
      • 2020
      • 2019
    • Symposium 2021
      • Back to parent navigation item
      • Symposium 2021
      • Annual lecture
  • JOIN TOPRA
  • topra-logo

    The Organisation for Professionals in Regulatory Affairs
  • Regulatory Rapporteur - September 2025
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • TARGET licensed
      ​Target product profile and product profile characteristics for labelling during drug development
    • September half cover-larger text
      September 2025 – Contents
    • AdobeStock_1097840833_compressed
      Reimagining product information
  • Veterinary
    • RR-June-2025-half cover _masthead
      June 2025 – Contents
    • June cover image licensed
      Veterinary medicines: Translating regulation into practice
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
    • SUSIMPERATIVE_compressed
      The sustainability imperative for the healthcare sector
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
    • MDR-innovation-compressed
      The EU Medical Device Regulation: Balancing innovation with regulation
    • final licensed cover image_compressed
      Medical device regulation: Challenges, innovation and the future
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Medical devices/IVDs sessions
  • Industry news
      • Industry news
        • Read latest news
        • Video
    • RegRapPoll-Masthead
      Survey shapes Regulatory Rapporteur’s future plans
    • EFPIA novel methodologies guidance news image 1(1)
      EFPIA publishes guidance document to help support novel methodology submissions
    • FDA new director licensed compressed
      ​New Director appointed at the FDA’s Center for Drug Evaluation and Research
  • Commentary
      • Editorials
      • Letters to the Editor
      • Podcasts
    • AdobeStock_1097840833_compressed
      Reimagining product information
    • TOPRA RR Careers 800x533px (6.4 ratio)
      RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
    • RR issue cover licensed final
      Patient voice: Shaping the future of medicine regulation
  • Collections
      • Interviews
      • Symposium 2024
        • Annual lecture
      • Symposium 2023
        • Annual lecture
      • Symposium 2022
        • Annual lecture
      • Regulatory Careers Live
      • CPD supplements
        • 2021/2022
        • 2020
        • 2019
      • Symposium 2021
        • Annual lecture
    • Banner_new
      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
    • AdobeStock_59790119
      The Olaratumab experience
    • AdobeStock_207448226
      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
  • JOIN TOPRA
  • More from navigation items

Pharmaceutical latest

  • DIGITAL licensed cropped

    ​Digital transformation of global regulatory affairs: Then, now and next

    2025-09-05T09:10:00+01:00

  • TARGET licensed

    ​Target product profile and product profile characteristics for labelling during drug development

    2025-09-05T09:10:00+01:00

  • GRAVITATE licensed

    ​ What could the future of labelling look like? The Gravitate-Health story

    2025-09-05T09:09:00+01:00

  • BELGIUM licensed

    Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals

    2025-09-05T09:09:00+01:00

  • interview_225322

    ​The EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future

    2025-09-05T09:08:00+01:00

  • September half cover-larger text

    September 2025 – Contents

    2025-09-05T07:41:00+01:00



  • AdobeStock_1097840833_compressed

    Reimagining product information

    2025-09-04T14:53:00+01:00

  • Overview_compressed

    Product information: An overview

    2025-09-03T14:40:00+01:00

  • TOOLS image

    Translating real-world needs into digital medication tools: Good practices for co-creation with patients

    2025-08-29T14:26:00+01:00

  • FDAMANU licensed

    FDA comparability guidance: The impact of cell and gene therapy products

    2025-07-11T10:26:00+01:00

  • Diversity licensed image

    ​Diversity in clinical research: Regulatory considerations and updates

    2025-07-11T10:23:00+01:00

  • ODD licensed image (2)

    ​The importance of patient advocacy in the EMA ODD process

    2025-07-11T10:22:00+01:00

  • EUPATI licensed image

    Patient involvement in the regulatory area: Insights into national level dialogues

    2025-07-11T10:22:00+01:00

  • PRAGMATIC licensed image

    ​Realising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials

    2025-07-11T10:22:00+01:00

  • PPI licensed image

    ​The evolving landscape of public and patient involvement

    2025-07-11T10:21:00+01:00

  • RR_July_masthead_halfcover

    July/August 2025 – Contents

    2025-07-11T08:17:00+01:00

  • RR issue cover licensed final

    Patient voice: Shaping the future of medicine regulation

    2025-07-10T14:28:00+01:00

  • AdobeStock_521314530_Editorial_Use_Only

    NHS app opens access to trials for UK patients

    2025-06-23T09:44:00+01:00

More pharmaceutical content

  • What is Regulatory Affairs?
  • TOPRA Membership
  • Regulatory Rapporteur Editorial Board
  • Regulatory Rapporteur Editorial Area
  • Future Focus Topics
  • FAQs
  • Glossary
  • Privacy Policy
  • ISSN 2755-5070 (online)

    ISSN 1742-8955 (print - legacy)

Regulatory Rapporteur

The peer-reviewed journal, published 11 times per year and available free to TOPRA members.

Follow TOPRA
topra-logo

The Organisation for Professionals in Regulatory Affairs

TOPRA office
TOPRA Publishing, Third floor, City Reach, 5 Greenwich View Place, London E14 9NN, UK
Tel: +44 (0) 20 7510 2560
Email: publications@topra.org

TOPRA AISBL
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70

  • Contact us
  • Copyright © 2015-2025 The Organisation for Professionals in Regulatory Affairs Ltd. t/a Regulatory Rapporteur - All rights reserved

Site powered by Webvision Cloud