Authors: Jessica Hartmann, Martina Schüßler‐Lenz, Attilio Bondanza, Christian J Buchholz DOI 10.15252/emmm.201607485 | Published online 01.08.2017 EMBO Molecular Medicine (2017) e201607485   In recent years, an increasing emphasis has been put on cancer treatment in the field of change in the patient’s immune response. One of the promising therapies is called CAR T-cells therapy. The

The FDA (Food and Drug Administration) has released the well known standard 21 CFR PART 11, which governs how affected systems should handle electronic records and signatures. The scope of this standard extends to all companies within the food, clinical or pharmaceutical industries.   The question is if a web-based training system (also called Learning


MeDRA (Medical Dictionary for Regulatory Activities) is an internationally used medical dictionary developed by the ICH in the 1990s which will be widely utilized during pharmaceutical regulatory processes. One of its scopes of use is the data coding of adverse events and adverse reactions. MedRA has been translated into English, Japanese, Czech, Dutch, French, German,

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