The new MDR has brought about many changes. This article focuses on the adjustments within Post Market Surveillance that have come about since the introduction of the new MDR.
https://t.co/iztDPYNY9v
In the second instalment of our series focusing on the EU Medical Device Vigilance System, we answer the most frequently asked questions we receive from clients. https://t.co/OfF6eoEH0M
We have updated this article, one of the most popular on our site. Pharmacovigilance KPIs and how they can assist you. Read the article here.
https://t.co/Rk9xcmGjs2
The introduction of the new MDR greatly expands the obligations of Importers and Distributors. This article tells you what you need to know regarding Importers and Distributors responsibilities.
https://t.co/mVZKGg0kOe
This article looks at the commonly used strategies for evaluation of post-approval safety and the effectiveness of rare and orphan drugs.
https://t.co/Xn7ShFu2YV
This article looks at the three options open to companies when considering how to manage eCTD publishing & submission within their company.
https://t.co/peZ73qHzcf
Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article. The article looks at Module 1 specification issues and more.
https://t.co/fANN30zhee
What changes could be made to the readability of package leaflets to make them more accessible for patients? We look at the requirements, the consultations that can be carried out, and the recommendations for improving leaflets.
https://t.co/MaWAoWWGMG