News & Analysis as of

European Commission Clinical Trials Life Sciences

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Hogan Lovells

Clinical Trials Regulation: Transition your clinical trial now

Hogan Lovells on

On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Cooley LLP

European Commission Publishes Updated Q&A on Clinical Trials Regulation

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In December 2022, the European Commission published an updated version of the Q&A guidance on the Clinical Trials Regulation (CTR). This new version was issued ahead of the 31 January 2023 deadline from which all new...more

King & Spalding

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

King & Spalding on

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

Hogan Lovells

The new Clinical Trials Regulation – what you need to know now - Episode 1: Transitional period and timeline

Hogan Lovells on

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 1: Transitional period and timeline Do you wonder when you need to apply the new rules...more

A&O Shearman

EU Clinical Trial Regulation to Take Effect on 31 January 2022

A&O Shearman on

The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more

King & Spalding

Europe Update – Life Sciences Products and COVID-19: From Clinical Trials to Regulatory Flexibility

King & Spalding on

In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more

Hogan Lovells

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

Hogan Lovells on

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

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With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

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