Introduction Involvement of the charitable foundation ‘Children with SMA’ (spinal muscular atrophy) to establish contact with the academic institution ‘Institute of Neurology, Psychiatry and Narcology of NAMS Ukraine’ to...
For collaborations between the patient community and stakeholders in the health care system. 1. Introduction PARADIGM (Patients active in research and dialogues for an improved generation of medicines) was...
In the last decades, the evolution of new technologies contributed to the development and implementation of the new regulatory framework on which Medical Devices Regulation (MDR) and In...
Paediatric medicine development requires careful planning and decision making. Legislation in the EU mandates that paediatric medicine development should occur early in the medicine development process.
The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising...
Transcription My name is Klaartje Spijkers. I’m from the Netherlands. I’m a mother of a young boy with the Duchenne muscular dystrophy which is a progressive muscular disorder....
Galenic formulation deals with the principles of preparing and compounding active ingredients into ready-to-use medicines in order to optimise their absorption by the body.
GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...
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