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Life Sciences Data Management European Union

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Nelson Mullins Riley & Scarborough LLP

EMA Releases Official Guidance for Protecting PPD and CCI in Clinical Trial Filings within the European Economic Area (EEA)

Version 1.1 of the European Medicines Agency's (EMA) “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Hogan Lovells

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective...

Hogan Lovells on

Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more

Hogan Lovells

French legal and regulatory update - July/August 2019

Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e - newsletter, which offers a legal and regulatory update covering France and Europe for April 2018. ...more

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