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Glossary
With plenty of acronyms, procedures or references, the regulatory and market access
environments are sometimes perceived as daunting. Deciphering the language is the
start to finding one’s path.
A (3) | C (9) | D (2) | E (8) | F (4) | I (8) | M (3) | N (4) | O (1) | P (12) | Q (2) | R (1) | S (6) | T (1) | V (1)

Latest Glossary Articles


Individual Case Safety Report (ICSR)

An Individual Case Study Report is an adverse event report for an individual patient.

Adverse Drug Reaction (ADR)

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.

Investigator's Brochure

Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding of the rationale for, and their compliance with

Case Report Form (CRF)

Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is complied with and as a basis for the analysis of the study results.

Foods for Special Medical Purpose (FSMP)

These are specially formulated foods that provide partial or complete nutrient requirements for post-operative convalescing patients or other nutritionally vulnerable subjects with specific medical

Disease risk-factor reduction claims (RDRC)

Possibly the highest level of medicine-like health claim that can be made on a non-drug product.

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