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
Periodic Safety Update Report (PSUR)
The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization. Periodic Safety Update…
Patient Reported Outcome (PRO)
A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a…
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…
Patient Centricity for Biotechs
Priority given to offering an optimal quality of life to patients along all the steps to real access of a…
Patent
An official document securing the exclusive right to make, use, or sell an invention to its inventor for a defined…
Parallel Distribution
The distribution of a medicine from one Member State to another by a pharmaceutical company independently of the marketing authorization…
Parallel Consultation (PC)
It refers to the parallel consultation between European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (EMA).…
Notified Body
An accredited body that conducts conformity assessments for medical devices.