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SME status in the UK

SME status in the UK

by Nosheen Majid | Mar 9, 2022 | Medical, Pharmacovigilance, Quality, Regulatory Affairs, Regulatory Intelligence

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...
SME status in the EU

SME status in the EU

by Nosheen Majid | Mar 4, 2022 | Pharmacovigilance, Quality, Regulatory Affairs, Regulatory Intelligence

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 main criteria are:...
PSURs/PBRERs – UK Processing

PSURs/PBRERs – UK Processing

by Dr Lorraine Marsh | Dec 13, 2021 | Pharmacovigilance, Regulatory Affairs

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...
PSURs/PBRERs – EU Processing

PSURs/PBRERs – EU Processing

by Dr Lorraine Marsh | Nov 9, 2021 | Pharmacovigilance, Regulatory Affairs

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...
Preparation of PSURs/PBRERs

Preparation of PSURs/PBRERs

by Dr Lorraine Marsh | Oct 21, 2021 | Pharmacovigilance, Regulatory Affairs

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...
An Introduction to PSURs and PBRERs

An Introduction to PSURs and PBRERs

by Dr Lorraine Marsh | Oct 19, 2021 | Pharmacovigilance, Regulatory Affairs

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...
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