We look at the issue of pharmacovigilance for orphan or rare diseases. You can read the article by clicking here.
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What Are Post-Marketing Surveillance Studies?
We look at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s) in this article.
How To Improve The Readability of Package Leaflets
What changes could be made to the readability of package leaflets to make them more accessible for...
What You Need To Know About Drug Device Combination Products
This drug device explainer looks at the issues concerning combimation products as the sector moves from the MDD to MDR in 2021.
Expectations for Human Use Products During The Covid-19 Pandemic
What guidance has been provided to Marketing Authorisation Holders on regulatory expectations and flexibility during the Covid-19 pandemic?