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 2026
  • 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
    • Podcasts
    • Thought leadership
    • Letters to the Editor
  • Collections
    • Back to parent navigation item
    • Collections
    • Interviews
    • Symposium 2025
    • Symposium 2024
    • Symposium 2023
    • Symposium 2022
    • Symposium 2021
    • Regulatory Careers Live
    • CPD supplements
      • Back to parent navigation item
      • CPD supplements
      • 2021/2022
      • 2020
      • 2019
  • JOIN TOPRA
  • topra-logo

    The Organisation for Professionals in Regulatory Affairs

  • Regulatory Rapporteur - September 2026
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • EXCIPIENT main image
      Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S
    • MODERN main image
      Modernising India’s drug submissions: Embracing eCTD 4.0 for international regulatory alignment
    • SYNAPSE main image
      Navigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations
  • Veterinary
    • VET main image
      A career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
    • Jana Schalansky
      November 2025 – Contents: Veterinary medicines sessions
    • RR-June-2025-half cover _masthead
      June 2025 – Contents
    • June cover image licensed
      Veterinary medicines: Translating regulation into practice
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
    • VOLUME main image
      China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
    • TRACE main image
      From regulation to implementation: Medical device serialisation and traceability in India
    • 1. image 1 same image in previous MedDev updates
      Medical device standards update: July 2026
  • Industry news
      • Industry news
        • Read latest news
        • Video
    • FDA pilot accelerated IND image
      FDA introduces new pilot programme to accelerate early-stage clinical research
    • EMA pre-submission pilot 2
      EMA launches new pre-submission interactions model pilot
    • AdobeStock_1527594934
      FDA launches final guidance on therapeutic equivalence evaluations
  • Commentary
      • Editorials
      • Podcasts
      • Thought leadership
      • Letters to the Editor
    • RegRapPod Website Graphic 800x533px (6.4 ratio)
      RegRapPod − InConversation with TMC Pharma
    • cover image
      Asia-Pacific: A changing regulatory landscape
    • TOPRA RR Future-Proof Regulatory Affairs 800x533px (6.4 ratio)
      RegRapPod − InConversation with Aman Khera
  • Collections
      • Interviews
      • Symposium 2025
      • Symposium 2024
      • Symposium 2023
      • Symposium 2022
      • Symposium 2021
      • Regulatory Careers Live
      • CPD supplements
        • 2021/2022
        • 2020
        • 2019
    • TOPRA_assets-banner
      Closing the gap between quality and regulatory delays with Scilife’s eQMSSponsored by Scilife | Electronic quality management software for life sciences
    • Banner_new
      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
    • AdobeStock_59790119
      The Olaratumab experience
  • JOIN TOPRA
  • More from navigation items
Pharmaceuticals

November 2024 – Contents

  • No comments

 

RR-Nov-2024-Half-Cover

Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

November 2024  |  Vol. 21  |  No. 10

 

EDITORIAL

Improving health outcomes through regulatory excellence

Cover option 1 MichaelKipping

READ HERE

By Kornelia Grein, Sobhey Nassar and Marie Uguen

 

HUMAN MEDICINES

Human medicines sessions

SabineHaubenreisser

READ THE SESSION SUMMARIES HERE

 

MEDICAL DEVICES/IVDS

Medical devices/IVDs sessions   

MD1 -MargarethJorvid

READ THE SESSION SUMMARIES HERE

 

VETERINARY MEDICINES

Veterinary medicines sessions

VM1 - RickClayton

READ THE SESSION SUMMARIES HERE

 

PARALLEL SESSION

PS1: Resolving specific development hurdles via scientific advice

PS1 - SandraLourenço

READ HERE

By Ophélie Poujade

 

PARALLEL SESSION

PS2: Patient experience data – The next steps towards medicines evaluation

PS2 - JuanGarciaBurgos

READ HERE

By Anna Koptina

 

SME, ACADEMIA AND START-UPS

SME: Regulatory updates for SME, academia and start-ups

SME -MarjonPasmooij

READ HERE

By Marie Uguen

 

ANNUAL LECTURE

The TOPRA annual lecture: Status of global health  

AnnualLecture - IlonaKickbusch

READ HERE

By Margareth Jorvid

 

Topics

  • 2024
  • Human medicines
  • IVD
  • Medical Devices
  • November 2024
  • Pharmaceuticals
  • Symposium 2024
  • Veterinary
  • No comments

More from Pharmaceuticals

  • TGA main image
    Journal

    Pathways to medicine registration in Australia

    2026-09-01T15:05:00Z

    By Cecile Cabadie-Taib

  • Half cover_final
    Contents

    Regulatory Rapporteur July/August 2026 – Contents

  • AdobeStock_2031070488_main image
    Journal

    Drug development and regulatory pathways across therapeutic areas

    2026-07-01T14:45:00Z

    By Dr Asha Kattige, Dan Cafaro, Dr Bethany Aykroyd and Basia Grodynska

  • AdobeStock_230080191_main image
    Journal

    Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives

    2026-06-30T15:16:00Z

    By Dakshatha M, Shivanand K Mutta, Venugopal N and Sateesha SB

  • AdobeStock_1057710391_main image
    Journal

    The development of novel influenza drugs: Current regulatory challenges

    2026-06-30T14:55:00Z

    By Bruno Speder and Robin Rogiers

  • AdobeStock_487121091_main image
    Journal

    Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction

    2026-06-30T14:20:00Z

    By Evan Sussman

Related articles

  • FDA pilot accelerated IND image
    Industry news

    FDA introduces new pilot programme to accelerate early-stage clinical research

    2026-09-29T09:25:00Z

    By Sarah Milner

  • EMA pre-submission pilot 2
    Industry news

    EMA launches new pre-submission interactions model pilot

    2026-09-28T10:31:00Z

    By Sarah Milner

  • AdobeStock_1527594934
    Industry news

    FDA launches final guidance on therapeutic equivalence evaluations

    2026-09-17T14:05:00Z

    By Sarah Milner

  • Half cover
    Contents

    Regulatory Rapporteur September 2026 – Contents

  • VOLUME main image
    Journal

    China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access

    2026-09-04T08:08:00Z

    By Jack Bacon

  • EXCIPIENT main image
    Journal

    Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S

    2026-09-03T15:21:00Z

    By Janine Jamieson

No comments yet

You're not signed in.

Only registered users can comment on this article.

Sign in Register
  • 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 © 2015-2026 The Organisation for Professionals in Regulatory Affairs Ltd. t/a Regulatory Rapporteur - All rights reserved

Site powered by Webvision Cloud