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Clinical Trials European Medicines Agency (EMA) Regulatory Agenda

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

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From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

Hogan Lovells

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

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The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

Hogan Lovells

The EMA launches a public consultation on eSource Direct Data Capture in clinical trials

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The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU....more

Hogan Lovells

Personalised Medicines at the top of the European Agenda

Hogan Lovells on

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare...more

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