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 - February 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
    • 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 - February 2026
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • Half page-REGRAP-ISSUE 23-1-January 2026
      Regulatory Rapporteur January 2026 – Contents
    • AdobeStock_921561253_cover
      Navigating complexity: Regulation at the interface of innovation, technology and confidence
    • AdobeStock_521699095
      A year of change for the US FDA: An update on notable pilots and programmes
  • Veterinary
    • 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
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
    • WEARABLES_main image
      Wearable technology: The fine regulatory line between health and wellness
    • REQUEST_main image
      Navigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
    • RISK_main image
      Reckoning with risk: Navigating MedTech innovation
  • Industry news
      • Industry news
        • Read latest news
        • Video
    • ICH M15 image
      New ICH M15 Guideline sets harmonised framework for MIDD
    • FDA approval image
      FDA approves non-invasive device for pancreatic cancer treatment
    • DIN SPEC 91509_image
      DIN SPEC 91509: A milestone for structured, digital medical device documentation
  • Commentary
      • Editorials
      • Letters to the Editor
      • Podcasts
    • Final cover image
      MedTech in transition: Regulation, risk and real-world impact
    • TOPRA RR JCA 800x533px (6.4 ratio) (002)
      RegRapPod − InConversation with Parexel
    • AdobeStock_921561253_cover
      Navigating complexity: Regulation at the interface of innovation, technology and confidence
  • 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

November 2025 – Contents: Human medicines sessions

  • No comments
 

Write to the Editor at publications@topra.org

 

Florian Schmidt

HM1: General pharmaceutical legislation – Platform technology and sandbox approaches

By Evyenia Shaili

 

Falk Ehmann

HM2: Fireside chat

By Cristina Dragan

 

Martin Huber

HM3: Applying Artificial Intelligence in real life

By Natasha Bankowski

 

Kora Doorduyn-van der Stoep

HM4: Revision of the EU Variation Regulation – Continuing innovation in lifecycle management

By Jessica Roe

 

Margareth Jorvid

HM5/MD1/IVD1: Programme COMBINE – Accelerating clinical trials and medical innovation in the EU

By Nathalie Boeglin

 

Mónica Perea-Vélez

HM6: How Artificial Intelligence is transforming regulatory approaches towards chemistry, manufacturing and controls (CMC)

By Francisco Baptista

 

Regina Skavron

HM7: First experiences with the HTA Regulation

By Andrea Laslop

 

Katja Pečjak Reven

HM8: ePI is on FHIR – Preparing for implementation

By Frank Vandendriessche

 

Jens Reinhardt, Christine Grew and Ralf Sazenbacher

HM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development

By Bruno Speder

 

Claudia Riedel

HM10: Strengthening Europe’s clinical trials competitiveness

By Nathalie Boeglin

 

 

Topics

  • Advanced therapy medicinal products (ATMPs)
  • Artificial intelligence (AI)
  • Chemistry, manufacturing and controls (CMC)
  • Clinical trial
  • COMBINE
  • Electronic product information (ePI)
  • EU general pharmaceutical legislation (GPL)
  • EU HTA Regulation
  • European Medicines Agency (EMA)
  • Pharmaceuticals
  • No comments

Related articles

  • PARENT_main image
    Journal

    Parenteral drug delivery systems: Driving clinical success

    2026-02-06T08:44:00Z

    By David Karvani and Susan Neadle

  • TOPRA RR JCA 800x533px (6.4 ratio) (002)
    Podcasts

    RegRapPod − InConversation with Parexel

    2026-01-28T15:21:00Z

    By Claire McDermott, Sangeeta Budhia and Sinan Sarac

  • MHRA AI call for evidence image 2
    Industry news

    MHRA invites Call for Evidence to assess AI regulation

    2026-01-27T15:25:00Z

    By Rebecca Harding

  • FDA guiding principles image 3
    Industry news

    FDA and EMA publish guiding principles of good AI practice in drug development

    2026-01-27T11:42:00Z

    By Rebecca Harding

  • RAPS EUMDR-055 (1)
    Journal

    2025 UK MDR Regulatory Conference: Meeting report

    2026-01-14T09:46:00Z

    By John Wilkinson OBE, Steve Lee and Claire McDermott

  • AdobeStock_985826835_ROLE
    Journal

    The evolving role of the regulatory professional in the age of Artificial Intelligence

    2026-01-14T09:45:00Z

    By Peter Lassoff

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