The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day training on patient involvement in medicines safety
Safety of Medicines
A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose and pose a major threat to public health and patient safety.
Safety communication is put in place to communicate adverse reactions or any safety findings to regulators, healthcare providers and patients. Safety communications are provided by marketing authorisation holders and health authorities, and may include restrictions, contraindications, dose limitations, warnings, and recommendations.
Early clinical trials (Phase I and II) must establish above all that an investigational medicinal product is safe for humans, as well as to show that the medicine is effective against the intended disease or condition.
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 distribution of medicines. GxP rules and guidelines ensure that all aspects of the medicines development process are conducted according to the best methods for safety, efficacy, and quality.
Risk communication is a two-way exchange of information on the risks and benefits of a medicine. Patients, companies, and health authorities all have important roles to play in risk communication and management.
The European Pharmacopoeia comprises quality standards for active pharmaceutical substances, as well as analytical methods for the identification of the substance and the evaluation of its quality and quantitative strength.
Medicine shortages can occur for many reasons and may impact patients in different ways.
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation (MA) and detailed in the Summary of Product Characteristics (SmPC) of the medicine.
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.