EDUCATIONAL MATERIALS

include resources for children and adolescents, such as children’s books, textbooks, lesson plans, activities, games, and online resources on disaster prevention and school safety.

LABORATORY EQUIPMENTS

the various tools and equipment that are used by professionals or students working in a laboratory. The different laboratory equipment used are Bunsen burner, microscopes, calorimeters, reagent bottles, beakers and many more. Test tubes, beakers, Erlenmeyer flasks, volumetric flasks, graduated cylinders, and pipettes are common lab equipment used to hold, store, and transfer liquids.

 

An educational program is a system consisting of educational materials and targeted communication aimed to provide information that is not sufficiently covered in the product information. They should therefore be developed on the premise that applying this measure is considered essential for minimizing an important risk; they can convey information/recommendations on how to prevent and/or minimize the risk; and risk minimization recommendations are actionable for the targeted stakeholders.

Educational materials can have several different target audiences (e.g., HCP, patients and/or their caregivers, or laboratories) and can address more than one safety concern. In the EU, the need for an educational material, its key elements, and the targeted population is agreed at central level, whereas detailed implementation, including communication and delivery plans, is generally subject to an agreement between the marketing authorization holder and the national competent authority (EMA, 2015b). This is because it is acknowledged there could be relevant differences on how educational tools could be incorporated most easily and effectively into the different health-care systems across the EU. However, there are some situations where some educational tools can be agreed centrally, for example, by engaging the targeted stakeholders (i.e., patients representatives and learned societies) to generate concepts in regard to which tool types pose less potential burden and are more acceptable to use. In the United States, the nearest equivalent of the EU educational materials can be found in the REMS as a part of the Medication Guide and/or PPI and/or ETASU. Examples of relevant materials include HCP training materials, patient educational materials, information on medical monitoring procedures, and data collection forms (FDA, 2009).