- Pharmaceuticals
- Veterinary
- Medical devices
Lean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance
Emergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
TOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
- Industry news
- Commentary
- Collections
VM3: Regulatory updates in veterinary pharmacovigilance – Navigating evolving challenges
Key points:
- Signal management is most effective when supported by clear, two-way feedback between marketing authorisation holders (MAHs) and regulators
- Bilateral discussions between individual MAHs and regulators help clarify expectations and build trust; pharmacovigilance inspections can facilitate this within the new signal management framework
To read more key points and the session summary, login as a member or register for free using the links below.
How to read this journal article
Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to TOPRA members and registered users.
If you are a TOPRA member, or have already registered for limited free access, log in now (Option 1 below).
Not yet a member? You can either join TOPRA (Option 2 below) or register to view limited content for free (Option 3 below).
The Organisation for Professionals in Regulatory Affairs
- Contact us
- Copyright © 2015-2026 The Organisation for Professionals in Regulatory Affairs Ltd. t/a Regulatory Rapporteur - All rights reserved