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
Patient Information Leaflet (PIL)
Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally designated representative(s), shall be fully…
glossary
Patient Centricity for Biotechs
Priority given to offering an optimal quality of life to patients along all the steps to real access of a…
glossary
Patent
An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined…
glossary
Parallel Distribution
The distribution of a medicine from one Member State to another by a pharmaceutical company independently of the marketing authorization…
glossary
Parallel Consultation (PC)
It refers to the parallel consultation between European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (EMA).…
glossary
Notified Body
An accredited body that conducts conformity assessments for medical devices.
glossary
Non-substantial Amendment
A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact…
glossary
New Drug Application (NDA)
A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug…
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