Life Sciences

Life Sciences

The life sciences encompass all the fields of science concerned with the study of living organisms, and not ecluding other subjects such as bioethics.

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Life Sciences > Regulatory

Common Technical Document

Life Sciences; Regulatory

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United ...

EMA

Life Sciences; Regulatory

The acronym for European Medicines Agency. The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the ...

SmPC, L or PL

Life Sciences; Regulatory

summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of medicinal products

QRD templates

Life Sciences; Regulatory

The QRD templates on the EMA website give you the official wording that has to be used in the summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of ...

QRD

Life Sciences; Regulatory

QRD stands for Quality Review of Documents, which is a working group associated with the Committee for Medicinal Products for Human Use (CHMP).

EDQM

Life Sciences; Regulatory

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe that traces its origins and statutes to an international treaty ...