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Data Collection › European Medicines Agency (EMA)

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

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

Hogan Lovells on

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

Jones Day

Ten Years of Conditional Marketing Authorizations

Jones Day on

The European Medicines Agency ("EMA") published a report ("EMA report") concerning the data collected over 10 years—between July 2006 and June 2016—on the so-called "conditional marketing authorizations" ("CMAs")....more

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