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UK-U.S. Data Bridge Allows Transfer of Personal Data From the United Kingdom to the United States

Beginning October 12, 2023, the UK-U.S. Data Bridge will allow UK companies to transfer personal data to the United States using the new EU-U.S. Data Privacy Framework....more

EU Proposes Corporate Criminal Penalties for Sanctions Breaches

On 2 December 2022, the European Commission proposed a new Directive aiming to unify the approach taken by its Member States to enforce European Union ("EU") sanctions and criminalize their violations (the "proposal")....more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

Global Privacy & Cybersecurity Update Vol. 13

On December 28, 2016, the New York Department of Financial Services ("DFS") released a revised version of a proposed regulation that would require banks, insurance companies, and other financial services institutions...more

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