SME status in the UK

Are you a small or medium-sized enterprise (SME)? If so the Medicines and Healthcare Products Regulatory Agency (MHRA) fees legislation currently has provision for some payment waivers for SMEs. What is the criteria for a small or medium company? The criteria that needs to be met in the UK in order to be defined as […]

SME status in the EU

Are you a small or medium-sized enterprise (SME) established in the European Union (EU)/ European Economic Area (EEA)? If so the European Medicines Agency (EMA) provides incentives and support for SMEs developing medicines for humans. Criteria The criteria are:   Category Head count Annual turnover Or balance-sheet total Medium-sized < 250 ≤ € 50 m […]

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 […]

The Importance of Cross-functional Working – a Marketing Perspective

We are delighted to introduce Michelle Bridgman who brings along with her 10 years of experience working as a Pharmaceutical Brand Marketer with Prescription Medicines, OTCs and Medical Devices. Michelle understands well the benefits and importance of cross-functional working and discusses this here in more detail and from a Marketing perspective.   We are all […]