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Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

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Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Alston & Bird

Why the New EU-U.S. Data Privacy Framework May Be Good News for Life Sciences Companies in the U.S.

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BACKGROUND - U.S.-based life sciences companies can be subject to the European Union (‘EU’) General Data Protection Regulation (‘GDPR’), even if they do not have any subsidiary, affiliate or other physical presence in the...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

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Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

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The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

Cooley LLP

Alert: Brexit Readiness: Possible Key Impacts of the Conclusion of the Transition Period on 31 December 2020

Cooley LLP on

On 31 January 2020, the UK left the European Union and entered a transition period that is due to end at 11:00 pm GMT on 31 December 2020. At this point, it is still uncertain whether a new EU/UK deal will be reached. To...more

Morgan Lewis

Life Sciences International Review - Q2 2019

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EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

McDermott Will & Emery

International News: Focus on International M&A

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The Impact of The EU General Data Protection Regulation - The EU General Data Protection Regulation 2016/679 (GDPR) was published in the Official Journal of the European Union on 4 May 2016 following the compromise...more

Morgan Lewis

International Life Sciences Data Transfers After Schrems

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With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

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