Life with GDPR - Meta Fined €405 million by Irish Data Protection Commission
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
We currently live in a world where the rapid spread of COVID-19 has provoked the urge to initiate the search for an effective vaccine or medicines to fight against it....more
Anonymisation has always been (and still is) a real challenge for those carrying out clinical research. To shed some light on this matter, the Medical Research Council (MCR) – which is part of UK Research and Innovation – has...more
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data. In January, the European Data Protection Board (EDPB)...more
On 23 January 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the EU General Data Protection Regulation (“GDPR”) and the EU Clinical Trials Regulation (“CTR”). The CTR is not yet...more
On January 23, 2019, the European Data Protection Board (“EDPB”) issued an interesting opinion about personal data processed in relation to clinical trials. The main role of the EDPB – which succeeded the Article 29...more
On January 23, 2019, the European Data Protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, adopted an Advisory Opinion...more
Companies conducting clinical trials in the EU have been grappling with many questions regarding how to conduct a clinical trial that complies with the requirements of the GDPR. Two key questions have arisen: What is the...more
Clinical trials and the EU General Data Protection Regulation (GDPR): The European Data Protection Board (EDPB) has issued a much-awaited opinion on the legal basis for processing clinical trial data....more