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.
9
Apr 20
AIFA: latest indications for "remote" clinical trials during the COVID-19 health emergency
On April 7, 2020, the Italian Medicines Agency (“AIFA”) provided guidance on the management of clinical trials in light of the restrictive measures adopted by the Government against the COVID-19 pandemic.
8
Apr 20
COVID-19 emergency: clinical trials and early access to drugs
To address the current emergency caused by COVID-19, several initiatives have been undertaken at the regulatory level to promote and facilitate clinical trials and early access to drugs.
17
Dec 19
EU commission publishes a new version of the draft Q&A on the application of the clinical trials regulation
In November 2019, the European Commission published a draft version of the answers to the numerous questions (“Q&A”) raised by stakeholders relating to the implementation of the rules laid down in Regulation (EU) No. 536/2014 on clinical trials.
12
Dec 19
Pharmaceutical trademarks: the proof of genuine use and proper reason for non-use
In its decision issued on 3 July 2019 in Viridis, Case C-668/17 (the “Decision”), the Court of Justice of the European Union (“CJEU”) ruled that the lengthy time necessary to complete a clinical drug trial is not a proper reason to prevent the prematurely registered trademark from being revoked for non-use.
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.
