14
Oct 20
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
14
Oct 20
The Italian Data Protection Authority publishes Frequently Asked Questions and Infographic on the Electronic Health Record
On September 14, 2020, the Italian Data Protection Authority (“Garante”) published on its website a set of Frequently Asked Questions (“FAQ”) and an Infographic on the main characteristics of the Electronic Health Record (“EHR”).
13
Oct 20
Ecommerce of medicines: the European Court of Justice states the applicability of certain restrictions imposed by a Member State destination of ecommerce upon a provider established in another Member State
On October 1, 2020, the European Court of Justice (“ECJ”) issued a very interesting judgment in a case between a company incorporated under Netherlands law that operates both a dispensing pharmacy established in the Netherlands and a website specifically targeting French customers and associations representing the professional interests of pharmacists in France.
12
Oct 20
Remote clinical trials: from emergency to new normal
This article first appeared on the website of the Healthcare and Life Sciences Law Committee of the Legal Practice Division of the International Bar Association, and is reproduced by kind permission of the International Bar Association, London, UK. © International Bar Association.
