2
Dec 17
Product information: EMA starts digitization
The European Medicines Agency (EMA) gives the go-ahead for digitization in terms of product information.
1
Dec 17
EUCJ’s ruling on the classification of software as medical devices
According to a very recent ruling of the European Court of Justice (EUCJ), (C-329/16, Snitem v. Syndicat national de l’industrie des technologies médicales, published on 7 December 2017), software with at least one function that makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, even if that software does not act directly in or on the human body.
3
Nov 17
Published the new ministerial decree on compassionate use of medicinal products
On 7 September 2017, the Italian Ministry of Health issued a new decree on compassionate use of medicinal products (“Decree”) that, starting from 2 December 2017, will replace the previous ministerial decree of 8 May 2003.
2
Nov 17
Digital health revolution, how medicine is changing
When you hear about digital health, it’s sometimes hard to understand what it is really about.
1
Nov 17
Positive outcome for ema’s policy 0070, one year after the publication of the clinical trial results
On October 18, 2017, the European Medicines Agency (EMA) published a report on the implementation of the Policy 0070 on the proactive publication of clinical trials results (Policy).
3
Oct 17
Diligent requirements for life sciences deals and earn-outs
Contingent payments (a.k.a. earn-outs in transactions among private companies, and contingent payment rights (CPRs) in transactions among listed companies) are a very common and valuable component of purchase price constructs in today’s life sciences and healthcare M&A deals.
