A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children in Europe.
Latest Glossary Definitions
A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.
Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent physician in the same field would provide under similar circumstances.
Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies to be performed during product development/ application for product reimbursement, in order to avoid major objections being raised during evaluation of the marketing authorisation application/
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.
Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT and aims to reflect health intervention effectiveness in routine clinical practice.
Market access is the definition and achievement of a strategy aiming that all patients included in a target population will receive a fast, secured and long-term access to a health tech product in development and at the right price, both for the manufacturer and the payer considering th
Identification of the stakeholders which are likely to use, benefit or assess the health tech product in development and which opinions, publications and priorities should be identified and considered.
Priority given to offering an optimal quality of life to patients along all the steps to real access of a health tech product in development with a continuous dialogue with stakeholders in which patient expertise matters, while accurate and intelligible information is delivered to patients and fa