EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
EU
The article provides an overview of the approach to be applied when calculating regulatory fees associated with registration and authorization for medicines intended to be marketed and used in Ireland.
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