Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development sponsors are often faced with challenges that require a “case-by-case” and a “scientific-based” approach.
Stuart Mudge
2004 – ERA news
Consulting with EU experts: Why, When & How
All our resources
webinar
The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under…
blog
2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
webinar
The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often…
Case study
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
