News & Analysis as of August 31, 2025

Data Management

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

Hogan Lovells on 5/20/2025

The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

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

Nelson Mullins Riley & Scarborough LLP on 7/24/2023

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

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

Nelson Mullins Riley & Scarborough LLP on 7/20/2023

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

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

Hogan Lovells on 10/14/2019

The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data...more

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

Hogan Lovells on 1/23/2019

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

EMA launches public consultation on the use of patient disease registries for regulator purposes

Hogan Lovells on 11/28/2018

On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries...more

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