PSURs/PBRERs – UK Processing

UK processing of PSURs/ PBRERs Today we are concluding our foray into the topic of Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs) by focusing on how these are processed for medicinal products in the UK. Don’t forget to check out Today’s Top Tip below! How should I submit my PSUR […]

PSURs/PBRERs – EU Processing

EU processing of PSURs/ PBRERs Today we are focusing on the processing of Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs) for medicinal products in the EU. This blog follows on from my previous blogs on this topic. Don’t forget to check out Today’s Top Tip below! How should I submit my […]

Preparation of PSURs/PBRERs

How to prepare your PSURs/ PBRERs Today we are continuing our series on PSURs and PBRERs by focusing on how to prepare your Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs) for medicinal products. Don’t miss the important tip for today at the end of this blog…   How many PSURs/ PBRERs […]

An Introduction to PSURs and PBRERs

An introduction to PSURs and PBRERs Today I am introducing Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs) for medicinal products.   Don’t miss the important tip for today at the end of this blog…   What is a PSUR/ PBRER? A PSUR/ PBRER is a pharmacovigilance document intended to provide an […]

Brexit – CAP Renewals

Today we’re looking at renewals submitted for Marketing Authorisations (MAs) granted through the Centrally Authorised Procedure (CAP). For the basics on renewals please see my previous blog. A quick recap on how CAP licences will be handled – also see my previous blog on this subject: All existing MAs authorised through the CAP will automatically be […]

Renewals – The Basics

Dr Marsh answers a few fundamental questions on licence renewals, with a UK slant.   For how long is my Marketing Authorisation valid? A Marketing Authorisation (MA) is granted for up to 5 years. You need to renew it at least 9 months before it expires.   Can I renew multiple MAs at the same […]

Fusion Chat

This month we speak with Dr. Lorraine Marsh, Head of Scientific Affairs at Fusion Pharma, about her career highlights, her advice for graduates looking to start a career in Regulatory or Scientific Affairs and much more! 1. Do you have a career highlight, a moment that stands apart, working within your field of expertise within […]

ILAP – Innovative Licensing and Access Pathway

Today we are focusing on the Innovative Licensing and Access Pathway (ILAP). What is the ILAP? The ILAP is a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. It aims to accelerate the time to market, facilitating patient access to medicines. Horizon scanning and regulatory […]

Project Orbis

Today we are focusing on the Project Orbis initiative, with a UK slant.   What is Project Orbis? Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) involving several other participants. The programme has been set up to allow participating partners to review and approve applications for promising cancer […]

Access Consortium

Today we’re focusing on the Access Consortium. The trend towards globalisation of therapeutic products industries and the rapid emergence of new technologies in the last decade accompanied with shared global challenges have created an increased need for regulatory bodies to co-operate and communicate with each other routinely. This maximises the use of up-to-date technical expertise, […]