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
  • Home
  • Medical devices
    • Back to parent navigation item
    • Medical devices
    • Combination products
    • In-vitro diagnostics
    • Software
  • Pharmaceuticals
    • Back to parent navigation item
    • Pharmaceuticals
    • ATMP
    • Chemistry, manufacturing and controls
    • Clinical trials
    • Non-clinical development
    • Product information
    • Regulatory procedures
  • Veterinary
  • CPD supplements
    • Back to parent navigation item
    • CPD supplements
    • 2021/2022
    • 2020
    • 2019
  • Interviews
  • Meeting reports
    • Back to parent navigation item
    • Meeting reports
    • Symposium 2022
      • Back to parent navigation item
      • Symposium 2022
      • Human Medicines
      • Medical Devices/IVDs
      • Veterinary Medicines
      • Annual Lecture
    • Symposium 2021
      • Back to parent navigation item
      • Symposium 2021
      • Human Medicines
      • Medical Devices/IVDs
      • Veterinary Medicines
      • Annual Lecture
  • Editorials
  • topra-logo

    The Organisation for Professionals in Regulatory Affairs

  • Home
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
    • AdobeStock_497948986 (1)
      Successful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
    • AdobeStock_337955476 (1)
      Medical Device Standards Update
    • AdobeStock_405906571-min
      Practical insights into the recent EU MDR framework
  • Pharmaceuticals
      • ATMP
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Product information
      • Regulatory procedures
    • AdobeStock_507177586
      A View of…The Environmental Impact of Pharmaceuticals
    • Patient information, why do things go wrong?
      Patient information: why do things go wrong?
    • AdobeStock_244609855
      A regulatory view on the change management process for medicinal products
  • Veterinary
  • CPD supplements
      • 2021/2022
      • 2020
      • 2019
    • AdobeStock_507759233
      FDA meetings: How to hold a successful meeting across the drug development lifecycle
    • AdobeStock_207448226
      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
    • AdobeStock_207448226
      Digital health technologies – an overview of EU and US frameworks
  • Interviews
  • Meeting reports
      • Symposium 2022
        • Human Medicines
        • Medical Devices/IVDs
        • Veterinary Medicines
        • Annual Lecture
      • Symposium 2021
        • Human Medicines
        • Medical Devices/IVDs
        • Veterinary Medicines
        • Annual Lecture
    • 5M4A11193_TOPRA Symposium 2022_Day 1_20221017
      HM3: Lessons learned and strategic priorities
    • [FROM LEFT] Claudia Popp, Olga Tkachenko and Marta Carnielli
      IVD1: Current state –
      and update on IVDR implementation
    • 5M4A2062_TOPRA Symposium 2022_Day 2_20221018
      VM2: Novel therapies in animal health – Balancing guidance versus gaining flexibility
  • Editorials
  • More navigation items

Interviews Stories

  • Tyner Headshot 2020

    The power of collaboration

    2022-10-31T14:40:00+00:00By Nancy Pire-Smerkanich

  • AdobeStock_297198041

    Digital and data-driven: Information management at the EMA

    2022-06-22T09:58:00+01:00By Kasia Nowok

  • paediatric

    A review of paediatric development challenges, FDA collaboration and future trends

    2022-03-24T11:51:00+00:00By Catriona Roscoe-Cutting, Charity-Anne M. Schuller

  • AdobeStock_389455582 (1)

    A strong advocate for global harmonisation in animal health

    2022-02-21T08:52:00+00:00By Pascale Canning

  • AdobeStock_274998909 (1)

    Building best regulatory practices in Brazil

    2022-01-24T10:02:00+00:00By Victoria Goff

  • AdobeStock_228931204

    Evolutions in patient healthcare at the MHRA

    2022-05-26T14:09:00+01:00By Kasia Nowok

  • AdobeStock_218594788 (1)

    Facilitating the use of information to improve global health

    2021-12-20T09:21:00+00:00By Leah Kleylein

  • medicines

    Regulating medicines in a surge of change

    2022-02-23T15:41:00+00:00By Victoria Goff

  • ipad doctor

    The national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot

    2022-03-24T11:24:00+00:00By Nathalie Lambot, Marie Vande Ginste

  • AdobeStock_151718711

    Updates to quality legislation from the EMA

    2022-05-26T14:47:00+01:00By Victoria Goff

  • Editorial board
  • Future focus topics
  • Glossary
  • Privacy policy
  • Search the archive
  • TOPRA membership
  • What is regulatory affairs?
  • ISSN 1742-8955

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, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, 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

  • Issues
  • Contact us
  • Topics A-Z
  • Contributors A-Z
  • © 2023 Regulatory Rapporteur

Site powered by Webvision Cloud