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Member State Data Protection Clinical Trials

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

Alston & Bird

Major Overhaul of EU Clinical Trial Rules Kicks In on 31 January 2022

Alston & Bird on

On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory...more

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