The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
glossary
European Union (EU) Legal Representative
Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA. EU Legal Representative…
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European Network for Health Technology Assessment (EUnetHTA)
The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European…
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European Medicines Agency (EMA)
Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines. European…
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European Directorate for the Quality of Medicines (EDQM)
The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European…
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EudraCT Form
A harmonized application form is used for clinical trial applications across the European Union. EudraCT form (concerns only the EU)…
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eTMF/ TMF: electronic Trial Master File / Trial Master File
Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH…
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Ethics Committee (EC)
The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals…
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Environmental Risk Assessment (ERA)
In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal…
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