Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and...
The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give...
Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
The way patients are involved in an HTA body depends on the political and cultural context. Patient involvement in HTA should be developed as the result of a partnership...
Health-related Quality of Life (HRQoL) measures provide important information about the added value of a health technology and are often used to support decision-making in Health Technology Assessment (HTA)...
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest,...
During clinical development the manufacturing and distribution facilities available may not be suitable for a trial medicine (investigational medicinal product (IMP)), however, IMPs must be manufactured, stored and distributed...
Partners from Ethic Committees (National Commission of Ethic Committees – CNCP), patient associations, and investigating centres worked in a writer’s guide of five recommendations and six rules for Informed...
