BiopharmaceuticalA biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues.
Member state of the European UnionThe European Union (EU) is a political and economic union of 27 member states that are party to the EU's founding treaties, and thereby subject to the privileges and obligations of membership. They have agreed by the treaties to share their own sovereignty through the institutions of the European Union in certain aspects of government. State governments must agree unanimously in the Council for the union to adopt some policies; for others, collective decisions are made by qualified majority voting.
Personal protective equipmentPersonal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, electrical, heat, chemicals, biohazards, and airborne particulate matter. Protective equipment may be worn for job-related occupational safety and health purposes, as well as for sports and other recreational activities.
Health technologyHealth technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.
Software requirementsSoftware requirements for a system are the description of what the system should do, the service or services that it provides and the constraints on its operation. The IEEE Standard Glossary of Software Engineering Terminology defines a requirement as: A condition or capability needed by a user to solve a problem or achieve an objective. A condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed document.
