4
Apr 19
A joint HMA and EMA taskforce analyzes the use of big data for the evaluation and monitoring of medicines
The Joint Big Data taskforce (“Taskforce”) between the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) was formed to describe the big data landscape from a regulatory perspective in order to ensure that the EU regulatory system has the capability and capacity to guide, analyze and interpret this data. Its work aims to facilitate the use of such data for the process of evaluation and monitoring of medicines by the regulatory authorities, analyzing the risk-benefit of medicinal products during their lifetime.
3
Apr 19
Italian administrative court judgments on biosimilars
In the past two months, the Italian administrative courts issued two judgments on biosimilars that substantially confirmed the previous case law on the relevant subjects.
2
Apr 19
Patient disease registries: potential use for regulatory purposes
Public consultation on the discussion paper published by the European Medicines Agency (EMA) regarding the crucial role of patient disease registries in monitoring the safety of medicines is open until June 30, 2019.
1
Apr 19
<!--:it-->Personal Data: new interpretative recommendations in Clinical Trials<!--:-->
On January 23, 2019, the European Data Protection Board (EDPB) published an opinion on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) regarding the processing of clinical trial data.
9
Feb 19
<!--:it-->Italian government approves a draft legislative decree amending italian legislation on clinical trials<!--:-->
On February 14, 2019, the Italian Government approved a draft legislative decree, implementing Law no. 3/2018 which delegated the Government to take measures to reform the Italian legislation on clinical trials on medicinal products for human use, with the purpose, among other things, to prepare the Italian legal framework to the future application of the Clinical Trial Regulation (EU) 536/2014.
New safety features for most prescription medicines and some OTC medicines supplied in the EU
