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
CE-Marking Technical File
A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification…
glossary
CE Marking
CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable…
glossary
Value Proposition
The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where…
glossary
Target Product Profile (TPP)
Target product profile (TPP) in the US A TPP can be prepared by a sponsor and then shared with the…
glossary
Safety Data Exchange Agreement (SDEA)
A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product…
glossary
Real World Data (RWD)
An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource use, etc) that are not…
glossary
Qualified Person for PharmacoVigilance (QPPV)
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market. Qualified Person for PharmacoVigilance A…
glossary
Paediatric Investigation Plan (PIP)
A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies…
Resources 