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
Redaction
In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA…
glossary
Real World Study (RWS)
Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT and aims to reflect health…
glossary
Real World Evidence (RWE)
Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world data (RWD).
glossary
Quality-by-Design(QbD)
Quality by design (QbD) is an approach that aims to ensure the quality of medicines by employing risk management, experimental…
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Protocol Assistance (PA)
Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases. Protocol…
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Personal Data
Any information relating to an identified or identifiable individual; an identifiable person is someone who can be identified, directly or…
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Project Management Plan
The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide…
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Pre-Sub Meeting
FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in…
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