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
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
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
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
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that...more
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
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
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